SNSE Sensei Biotherapeutics Inc.

11.12
-0.01  -0%
Previous Close 11.13
Open 11.12
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SNS-301 and KEYTRUDA (pembrolizumab)
Squamous Cell Carcinoma of the Head and Neck
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Latest News

  1. – Data continue to show that SNS-301 in combination with pembrolizumab is well tolerated

    – One deep (71% tumor reduction) and durable (11 months) partial response and two longstanding (8 and 10 months) stable diseases observed in patients with no response to prior PD-1 blockade

    – Data show potential of company's proprietary ImmunoPhage™ platform to expand and improve current oncology treatments

    BOSTON, May 19, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced new data from the ongoing Phase 1/2 clinical trial of SNS-301, an investigational medicine in patients with advanced squamous cell…

    – Data continue to show that SNS-301 in combination with pembrolizumab is well tolerated

    – One deep (71% tumor reduction) and durable (11 months) partial response and two longstanding (8 and 10 months) stable diseases observed in patients with no response to prior PD-1 blockade

    – Data show potential of company's proprietary ImmunoPhage™ platform to expand and improve current oncology treatments

    BOSTON, May 19, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced new data from the ongoing Phase 1/2 clinical trial of SNS-301, an investigational medicine in patients with advanced squamous cell carcinoma of the head and neck (SCCHN), in combination with pembrolizumab. The data will be presented as a poster by Alain Algazi, M.D., from the University of California San Francisco to the medical community at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually June 4 – 8, 2021.

    As of the April 14, 2021 cut-off date, 21 patients with locally advanced unresectable or metastatic SCCHN had been enrolled and treated in the study. Twenty of the patients enrolled did not achieve an objective response to prior treatment with PD-1 blockade (Cohort A) and one patient was PD-1 blockade naïve (Cohort B). The safety profile of SNS-301 in combination with pembrolizumab observed from 20 evaluable patients was favorable and consistent with previously reported data. Efficacy data was available from twelve patients in Cohort A. Notably, the efficacy bar was set high by enrolling patients with no objective response to prior PD-1 blockade (median 7.5 months). Data from nine evaluable patients from Cohort A were last reported from this study at the Society for Immunotherapy of Cancer's (SITC) 35th Annual Meeting.

    "These data suggest SNS-301, when combined with PD-1 blockade, has the potential to provide long-term benefit as second and later line treatment for patients with late-stage cancer and few other treatment options," said Marie-Louise Fjallskog, M.D., Ph.D., Chief Medical Officer of Sensei Biotherapeutics. "We expect to report more mature data, including data for SNS-301 combination therapy in the frontline setting, by the end of this year."

    "This study continues to enhance our understanding of the broad potential of our ImmunoPhage™ platform," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "The information we are gathering is just one aspect of the potential of our ImmunoPhage platform to expand the durability and improve the treatment of many devastating cancers. Our team continues to lead advances in the understanding of bacteriophage through internal research and collaborations with world-class academic laboratories, and we are excited to apply these learnings to our pipeline of ImmunoPhage programs."

    Data from Phase 1/2 Trial of SNS-301 SSCCHN As of April 14, 2021

    Data highlighted today are part of a poster (#6029), titled: "Update on Safety and Efficacy of a Phase 1/2 Trial of SNS-301 and Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck." The abstract and related poster can be downloaded from the ASCO Meeting Library.

    Safety Data

    As of the data cut-off, a safety analysis conducted in 20 evaluable patients showed that SNS-301 in combination with pembrolizumab continues to have a favorable safety profile.

    • The combination of SNS-301 and pembrolizumab was well tolerated. Mostly Grade 1-2, mild to moderate, unrelated adverse events (AE) were observed. Four Grade 3 AEs were reported as treatment-related: dehydration, pruritus, rash and EKG QT prolongation.

    Efficacy Data

    An analysis of anti-tumor activity was conducted in 12 patients who did not achieve an objective response to prior treatment with PD-1 blockade (Cohort A). No patients were evaluable from Cohort B as of the cut-off date.

    • 67% (n=8/12) of patients achieved stable disease (SD) or partial response (PR), including:
      • One patient with PD-L1 negative tumor who achieved a tumor reduction of 71% that is still ongoing after 11 months of therapy. Nanostring™ data for this patient show T-cell increase and T-cell activation.
      • Seven patients achieved SD, including two patients with long-standing SD (8 and 10 months).

    Patient outcomes appear to correlate to post-treatment PD-L1 expression and immune infiltration in tumors.

    Analyses of secondary endpoints using ELISA and ELISPOT assays to evaluate SNS-301 specific B and T cell responses in patient samples are ongoing. Sensei expects to report these data as part of the larger dataset planned by the end of 2021. Sensei also plans to add a third cohort by the end of 2021 to evaluate SNS-301 with HPV-specific E6/E7 ImmunoPhage.

    About the Phase 1/2 Clinical Study

    The multi-center Phase 1/2 clinical trial is designed to evaluate safety, tolerability, and anti-tumor activity of SNS-301 in combination with pembrolizumab, as well as immune response and tumor/immune biomarkers. The study has two cohorts with a total of 60 patients with locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) who did not achieve a response to prior treatment with PD-1 blockade (Cohort A) or patients who did not receive prior therapy with PD-1 blockade (Cohort B).

    About ImmunoPhage™ Platform

    Sensei's proprietary ImmunoPhage™ platform enables the delivery of innovative treatments that are personalized to a patient's own tumor specific antigens. Bacteriophages have built-in capabilities that utilize the inherent nature of viruses to elicit the innate and adaptive immune system, supporting a highly immunogenic approach. SNS-301 is a first-in-class and self-adjuvanted bacteriophage-base immune-activating vaccine targeting human aspartate β-hydroxylase (ASPH), a tumor-associated antigen commonly overexpressed in cancer.

    About SNS-301

    SNS-301 is a first-in-class cancer immunotherapy designed to overcome immune tolerance and induce robust and durable antigen-specific humoral and cellular responses. It is a bio-engineered, inactivated bacteriophage virus expressing a fragment of the tumor-associated antigen, ASPH, as a fusion protein to the bacteriophage lambda capsid decoration protein, gpD. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and expression levels in various tumors are generally inversely correlated with disease prognosis. ASPH signaling is related to cancer cell growth, cell motility and invasiveness, occurs through the Notch pathway and is implicated in the epithelial to mesenchymal transition (EMT).

    About Sensei Biotherapeutics

    Sensei Biotherapeutics is a clinical-stage biopharmaceutical company engaged in discovery, development, and delivery of next generation immunotherapies with an initial focus on treatments for cancer. Sensei has developed two unique approaches – its ImmunoPhage platform that leverages bacteriophage to fully engage the immune system, and its monoclonal antibody (mAb) and nanobody platform, which is comprised of unique human monoclonal antibodies and alpaca derived nanobodies that are selectively active in the tumor microenvironment. Using the ImmunoPhage platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized, yet off-the-shelf cocktail approach for treating cancer patients. The platform enables efficient, scalable and cost-effective manufacturing to support all of Sensei's clinical programs. The company's most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced squamous cell carcinoma of the head and neck. SNS-401 is an ImmunoPhage cocktail in preclinical development for the treatment of Merkel Cell Carcinoma. Using its mAb platform, the company has developed SNS-VISTA, an antibody-based therapeutic in lead generation targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit www.senseibio.com, and follow the company on Twitter @SenseiBio and LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Sensei's current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Sensei's product candidates, including SNS-301, the availability of data from Sensei's clinical trials and the potential benefits of Sensei's product candidates and proprietary ImmunoPhage platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Sensei's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Lora Pike

    VP, Investor Relations and Communications

    Sensei Biotherapeutics

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    312-961-2502



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  2. - ImmunoPhage™ platform programs and the VISTA program continue to advance -

    - New safety and efficacy data from ongoing Phase 1/2 combination study of SNS-301 in squamous cell carcinoma of the head and neck accepted for presentation at ASCO 2021 -    

    - Patient dosing underway in second cohort of Phase 1/2 combination study of SNS-301 in patients with no prior treatment with PD-1 blockade -

    - Ended quarter with a strong cash position of $169.4 million, runway at least into second half of 2023 -

    BOSTON and ROCKVILLE, Md., May 12, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial…

    - ImmunoPhage™ platform programs and the VISTA program continue to advance -

    - New safety and efficacy data from ongoing Phase 1/2 combination study of SNS-301 in squamous cell carcinoma of the head and neck accepted for presentation at ASCO 2021 -    

    - Patient dosing underway in second cohort of Phase 1/2 combination study of SNS-301 in patients with no prior treatment with PD-1 blockade -

    - Ended quarter with a strong cash position of $169.4 million, runway at least into second half of 2023 -

    BOSTON and ROCKVILLE, Md., May 12, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.

    "The first quarter was a productive time for Sensei with the successful execution of our IPO, continued progress with our pipeline, and expansion of our headcount to support anticipated growth," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "As we approach several near-term events, we continue to believe in the strength of our proprietary ImmunoPhage platform to potentially generate multiple immune activating therapeutics and our monoclonal antibody and nanobody platform targeted to key immune pathways. We are looking forward to the presentation of more mature data from the Phase 1/2 clinical trial of SNS-301 at ASCO, and to further explore the potential breadth and depth of our programs in collaboration with leading researchers. With the proceeds raised from our recent IPO, we are well capitalized to advance our current programs and our drug discovery operations."

    Sensei Biotherapeutics is developing a pipeline of medicines designed to fulfill the substantial potential of the immune system to defeat cancer and other diseases. The company has developed two unique approaches – the ImmunoPhage™ platform, which leverages its proprietary knowledge and expertise in bacteriophage (widespread viruses that infect bacteria but not mammalian cells) immunology, and its monoclonal antibody and nanobody platform, which are comprised of unique human monoclonal antibodies and alpaca-derived nanobodies that are selectively active in the tumor microenvironment. Together, these platforms are designed to create a new class of personalized immuno-oncology medicines.

    First Quarter and Recent Highlights:

    • Strengthened Immuno-Oncology Advisory Board and Board of Directors In May 2021, Sensei announced that it appointed Maura Gillison, M.D., Ph.D., Professor of Medicine, Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and Richard Ulevitch, Ph.D., Professor of Immunology and Chairman Emeritus at The Scripps Research Institute to its Immuno-Oncology Advisory Board. In April 2021, Sensei appointed Jessie M. English, Ph.D. to its Board of Directors.

    • Completed Upsized Initial Public Offering (IPO) In February 2021, Sensei completed its initial public offering of 8,030,295 shares of common stock, inclusive of the exercise by the underwriters of their option to purchase 1,030,243 shares, at a public offering price of $19.00 per share. Gross proceeds were $152.6 million.

    Anticipated Pipeline Milestones and Events:

    ImmunoPhage™ Platform Updates

    SNS-301: a first-in-class, bacteriophage-based immune activating agent targeting human aspartate β-hydroxylase (ASPH), a tumor associated antigen overexpressed in multiple tumor types – SNS-301 is being evaluated in a signal-seeking Phase 1/2 study in combination with pembrolizumab. The study is designed to have two cohorts and enroll 60 patients with locally advanced unresectable or metastatic SCCHN who did not achieve a response to prior treatment with PD-1 blockade or patients who did not receive prior therapy with PD-1 blockade. The company expects to add a third cohort by the end of 2021 to evaluate SNS-301 with HPV-specific E6/E7 ImmunoPhage.

    • American Society for Clinical Oncology (ASCO) 2021 conference: An abstract titled: "Update on Safety and Efficacy of a Phase 1/2 Study of SNS-301 and Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)" has been accepted for poster presentation at the 2021 ASCO Annual Meeting taking place virtually from June 4-8, 2021.
    • Phase 1/2 Topline Data Readout on Track: Sensei remains on track to report a substantial subset of data from the Phase 1/2 study by the end of 2021.
    • Enrollment Ongoing in Frontline Therapy Trial: Sensei announced that patient dosing has been initiated in the second cohort of the Phase 1/2 study evaluating SNS-301 as a first-line therapy in combination with pembrolizumab. The company continues to evaluate early enrollment trends in this cohort and the impact of COVID-19 on this clinical program.
    • Evaluation of New Opportunities for SNS-301 in the Neoadjuvant Setting: Sensei's current Phase 1/2 studies in head and neck cancer are focusing only on SNS-301 in combination with pembrolizumab (Keytruda®). Sensei has concluded its clinical trial collaboration with AstraZeneca for durvalumab (Imfinzi®). Sensei is currently evaluating additional opportunities to study SNS-301 in the neoadjuvant setting following the results in February from AstraZeneca's Phase 3 KESTREL trial of durvalumab for the treatment of first line recurrent or metastatic head and neck squamous cell carcinoma.

    SNS-401: a first-in-class personalized ImmunoPhage cocktail being developed in collaboration with the University of Washington – SNS-401 is in preclinical development for the treatment of Merkel Cell Carcinoma, an aggressive form of skin cancer commonly caused by the Merkel Cell Carcinoma Polyoma Virus.

    • IND submission planned for first half of 2022: Sensei plans to submit an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for its SNS-401 program in the first half of 2022.

    ImmunoPhage Platform and Phortress™ Library – Phortress is Sensei's proprietary library of ImmunoPhages, derived from antigens found across multiple patient populations and tumor types. Sensei has manufactured more than 25 ImmunoPhages and continues to add inventory to this "off-the-shelf" library as well as drive technologic innovations to the ImmunoPhage platform itself.

    Monoclonal Antibody Platform Update

    VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses – SNS-VISTA is in preclinical development in collaboration with Adimab LLC.

    • IND-Enabling Studies on Track: Sensei announced it is on track to initiate IND-enabling studies for its SNS-VISTA program by year-end 2021.

    Corporate Update

    Sensei Biotherapeutics announced that it will move its corporate headquarters to the Seaport Innovation District in Boston, MA. The new space more than doubles the size of the company's current research and development footprint. The company's manufacturing operations will remain in Rockville, MD.

    First Quarter 2021 Financial Results

    Cash Position – Cash and cash equivalents were $169.4 million as of March 31, 2021, as compared to $16.6 million as of December 31, 2020. Sensei expects the current cash balance to fund operations at least into the second half of 2023.

    Research and Development (R&D) Expenses – R&D expenses were $3.4 million for the quarter ended March 31, 2021, compared to $2.2 million for the quarter ended March 31, 2020. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei's research, development, and manufacturing activities.

    General and Administrative (G&A) Expenses – G&A expenses were $4.6 million for the quarter ended March 31, 2021, compared to $1.9 million for the quarter ended March 31, 2020. The increase was primarily attributable to higher personnel costs, including stock-based compensation expense, to support Sensei's business.

    Net Loss – Net loss was $8.0 million, for the quarter ended March 31, 2021, compared to $4.7 million for the quarter ended March 31, 2020.  

    KEYTRUDA® is a registered trademark of Merck, and IMFINZI® is a registered trademark of the AstraZeneca group of companies.

    About Sensei Biotherapeutics

    Sensei Biotherapeutics is a clinical-stage biopharmaceutical company engaged in discovery, development, and delivery of next generation immunotherapies with an initial focus on treatments for cancer. Sensei has developed two unique approaches – its ImmunoPhage platform that leverages bacteriophage to fully engage the immune system, and its monoclonal antibody (mAb) and nanobody platform, which is comprised of unique human monoclonal antibodies and alpaca derived nanobodies that are selectively active in the tumor microenvironment. Using the ImmunoPhage platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized, yet off-the-shelf cocktail approach for treating cancer patients. The platform enables efficient, scalable and cost-effective manufacturing to support all of Sensei's clinical programs. The company's most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced squamous cell carcinoma of the head and neck. Additional ImmunoPhage program is SNS-401, an ImmunoPhage cocktail in preclinical development for the treatment of Merkel Cell Carcinoma. Using its mAb platform, the company has developed SNS-VISTA, an antibody-based therapeutic in lead generation targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit www.senseibio.com, and follow the company on Twitter @SenseiBio and LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Sensei's current beliefs and expectations. These forward-looking statements include expectations regarding the potential clinical development of Sensei's product candidates, the availability of data from Sensei's clinical trials and the timing of regulatory filings, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations at least into the second half of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Sensei's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Condensed Consolidated Statements of Operations
    (Unaudited, in thousands except share and per share data)
         
      Three Months Ended March 31,
       2021   2020 
    Operating expenses:    
    Research and development $3,365  $2,195 
    General and administrative  4,604   1,908 
    Total operating expenses  7,969   4,103 


    Loss from operations
      (7,969)  (4,103)


    Total other expense
      (3)  (589)
    Net loss  (7,972)  (4,692)
    Cumulative dividends on convertible preferred stock     (104)


    Net loss attributable to common stockholders
     $(7,972) $(4,796)
             
    Net loss per share, basic and diluted $(0.42) $(4.00)
    Weighted-average common shares outstanding, basic and diluted  18,904,853   1,199,550 








    Selected Condensed Consolidated Balance Sheet Data
     
    (Unaudited, in thousands) 
          
      March 31, December 31, 
       2021

      2020  
    Cash and cash equivalents $169,418 $16,596  
    Total assets  174,476  21,428  
    Total liabilities  3,224  5,535  
    Convertible preferred stock    72,336  


    Total stockholders' equity (deficit)
      171,252  (56,443) 

    Investor Contact:

    Lora Pike

    VP, Investor Relations and Communications

    Sensei Biotherapeutics

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    312-961-2502



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  3. BOSTON and ROCKVILLE, Md., May 05, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a  clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced the appointments of Maura Gillison, M.D., Ph.D., Professor of Medicine, Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and Richard Ulevitch, Ph.D., Professor of Immunology and Chairman Emeritus at The Scripps Research Institute, to its Immuno-Oncology Advisory Board.

    "We are honored to welcome both Dr. Gillison and Dr. Ulevitch to our Immuno-Oncology Advisory Board, two astounding leaders in the field of oncology and immunology." said John Celebi, President and Chief Executive…

    BOSTON and ROCKVILLE, Md., May 05, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a  clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced the appointments of Maura Gillison, M.D., Ph.D., Professor of Medicine, Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and Richard Ulevitch, Ph.D., Professor of Immunology and Chairman Emeritus at The Scripps Research Institute, to its Immuno-Oncology Advisory Board.

    "We are honored to welcome both Dr. Gillison and Dr. Ulevitch to our Immuno-Oncology Advisory Board, two astounding leaders in the field of oncology and immunology." said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "With their addition, we now have seven advisors who bring to the company in-depth domain expertise across discovery, development and real-world patient care. We intentionally formalized our Immuno-Oncology Advisory Board to bring a collective perspective to Sensei's decision-making. We believe this particular advisory board of experts will expand our knowledge and the potential of the ImmunoPhage™ platform and create a network for each advisor to gain insights from their peers in the field."

    Dr. Maura Gillison, widely known as an expert in head and neck cancers, molecular epidemiology and virology, is a Professor of Medicine in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. Included in more than 200 scientific publications, her research expertise has led to developments related to the causation of head and neck cancers from human papillomavirus (HPV) infection and groundbreaking shifts in concepts for risk, diagnosis and therapeutic approaches to treat those cancers. She is a member of the National Academy of Medicine and also a CPRIT scholar.

    Dr. Richard Ulevitch, Professor of Immunology and Chairman Emeritus of the Department of Immunology at The Scripps Research Institute brings experience in business development from his involvement in life science investment funds, as well as deep scientific knowledge related to innate immunity. Dr. Ulevitch is currently a Venture Partner Emeritus at 5AM Ventures, which he joined in 2002. Previously, he was affiliated with The Lombard Immunology Fund and Aravis Ventures. Dr. Ulevitch remains active in laboratory research at The Scripps Research Institute, with funding from the National Institute of Allergy and Infectious Diseases (NIAID). His research spans over 200 academic publications in innate immunity that include seminal publications describing the discovery of p38 MAP Kinase, the discovery of Lipopolysaccharides (LPS) binding protein, and the biological function of CD14. Dr. Ulevitch's team characterized CD14 as an upstream master regulator of immune response nearly 30 years ago. This discovery led to the development of IC-14, a product candidate being evaluated in the clinic to determine if treatment can decrease the time it takes for people with COVID-19 respiratory disease to recover without the need for long-term hospitalization. Previously, Dr. Ulevitch served as an advisor to the National Institutes of Health, the Food & Drug Administration (FDA), the American Heart Association and multiple biotechnology and pharmaceutical companies.

    For more information on members of the Immuno-Oncology Advisory Board, visit senseibio.com.

    About Sensei Biotherapeutics

    Sensei Biotherapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation immunotherapies for the treatment of cancer and infectious diseases. The company has developed a proprietary bacteriophage-based platform, ImmunoPhage™, that enables the rapid generation of immune activating therapeutic agents that fully engage the immune system. Using the ImmunoPhage™ platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized, yet off-the-shelf cocktail approach for treating cancer patients. The platform enables efficient, scalable and cost-effective manufacturing to support all of Sensei's clinical programs. The company's most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage™ targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced Squamous Cell Carcinoma of the Head and Neck. Earlier stage programs include SNS-401, an ImmunoPhage™ cocktail for the treatment of Merkel Cell Carcinoma, and SNS-VISTA, an antibody-based therapeutic targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit www.senseibio.com, and follow the company on Twitter @SenseiBio and LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements



    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Sensei's current beliefs and expectations. These forward-looking statements include expectations regarding the potential benefits of Sensei's Immuno-Oncology Advisory Board. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Sensei's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Lora Pike

    VP, Investor Relations and Communications

    Sensei Biotherapeutics

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    312-961-2502

     



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  4. BOSTON and ROCKVILLE, Md., April 05, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced the appointment of Jessie M. English, Ph.D. to its Board of Directors. Dr. English is a proven biotechnology leader and brings over 20 years of experience in oncology research as well as business and leadership development.

    "Jessie's experience in building vibrant, data-driven companies will serve as an important asset to our Board of Directors as we continue to build Sensei Bio's research capabilities and pipeline. I am excited to welcome her to our Board of Directors at this critical time in Sensei's…

    BOSTON and ROCKVILLE, Md., April 05, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced the appointment of Jessie M. English, Ph.D. to its Board of Directors. Dr. English is a proven biotechnology leader and brings over 20 years of experience in oncology research as well as business and leadership development.

    "Jessie's experience in building vibrant, data-driven companies will serve as an important asset to our Board of Directors as we continue to build Sensei Bio's research capabilities and pipeline. I am excited to welcome her to our Board of Directors at this critical time in Sensei's development. Her expertise in both oncology drug discovery and business development will support our advancement of novel next-generation immunotherapies," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics.

    "Sensei is leading the advancement of ImmunoPhage™, a potentially new class of therapeutics. Advances in cancer immunotherapy such as this represent a critical shift in the drug discovery paradigm," said Dr. English. "I am excited to join Sensei's Board of Directors and work alongside the team to further advance personalized, yet off-the-shelf product candidates."

    Dr. English is an experienced and innovative drug discovery researcher and drug developer. Throughout her career, she has led high impact and high growth companies developing pioneering therapeutics. She currently serves as the Chief Scientific Officer of Bakx Therapeutics. Previously, she was Chief Scientific Officer of Tilos Therapeutics, which was acquired by Merck in 2019. Dr. English's expertise spans leadership experience in industry and academic collaborations in oncology drug discovery, establishment of translational programs and development of novel translational platforms. She previously held senior roles in immuno-oncology and translational drug discovery and research at Merck KGaA, the Dana-Farber Cancer Institute (the Belfer Center for Applied Cancer Science), Merck Research Laboratories, ArQule, Pfizer, and Schering-Plough. Her experiences include serving on the leadership counsel of AACR Women in Cancer Research and as its Chairperson from 2014-2015. Dr. English holds a Ph.D. in Neurobiology from the University of North Carolina at Chapel Hill and a B.S. in Biochemistry from Kansas State University.

    About Sensei Biotherapeutics

    Sensei Biotherapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation immunotherapies for the treatment of cancer and infectious diseases. The company has developed a proprietary bacteriophage-based platform, ImmunoPhage™, that enables the rapid generation of immune activating therapeutic agents that fully engage the immune system. Using the ImmunoPhage™ platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized yet off-the-shelf cocktail approach for treating cancer patients. The platform enables efficient, scalable and cost-effective manufacturing to support all of Sensei's clinical programs. The company's most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage™ targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced Squamous Cell Carcinoma of the Head and Neck. Earlier stage programs include SNS-401, an ImmunoPhage™ cocktail for the treatment of Merkel Cell Carcinoma, and SNS-VISTA, an antibody-based therapeutic targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit www.senseibio.com, and follow us on Twitter @SenseiBio and on LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements



    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Sensei's current beliefs and expectations. These forward-looking statements include expectations regarding the potential clinical development of Sensei's product candidates and the advancement and potential benefits of ImmunoPhage. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Sensei's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Julie Seidel

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    312-961-2502

     



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  5.  -Successfully completed upsized IPO in February 2021 raising approximately $152.6 million in gross proceeds –

    -Large subset of data expected from ongoing Phase 1/2 study of SNS-301 in combination with pembrolizumab for the treatment of locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) by year-end -

    BOSTON and ROCKVILLE, Md., March 25, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial results for the full year ended 2020 and provided an update on recent business progress.

    "With a strong foundation built in 2020, Sensei…

     -Successfully completed upsized IPO in February 2021 raising approximately $152.6 million in gross proceeds –

    -Large subset of data expected from ongoing Phase 1/2 study of SNS-301 in combination with pembrolizumab for the treatment of locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) by year-end -

    BOSTON and ROCKVILLE, Md., March 25, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial results for the full year ended 2020 and provided an update on recent business progress.

    "With a strong foundation built in 2020, Sensei has already achieved significant milestones in 2021, highlighted by our upsized initial public offering completed in February. Throughout 2020, we have worked diligently and efficiently to broaden our in-house R&D capabilities to deliver our novel and versatile ImmunoPhage platform and Phortress library to patients," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Looking ahead, we have a well-capitalized foundation on which to further advance our pipeline of immunotherapies based on our proprietary ImmunoPhage platform for the treatment of cancer. We expect to report a large additional subset of data from our ongoing Phase 1/2 study of SNS-301 in SCCHN by year-end, as well as progressing our other personalized, off-the-shelf product candidates."

    Recent Business Highlights

    • Addition to Russell 2000 Index: On March 22, 2021, Sensei was added to the Russell 2000® Index as part of its quarterly IPO additions. The Russell 2000® Index is a subset of the Russell 3000® Index, which measures the performance of the small-cap segment of the U.S. equity market.
    • Completed Upsized Initial Public Offering – In February 2021, Sensei completed its initial public offering of 8,030,295 shares of common stock, inclusive of the exercise by the underwriters of their option to purchase 1,030,243 shares, at a public offering price of $19.00 per share. Gross proceeds from the IPO were $152.6 million.
    • Completed Private Financing to Support Pipeline Advancement - In January 2021, Sensei announced a private financing round, co-led by Apeiron Investment Group and Catalio Capital Management, which was subsequently upsized for gross proceeds of $34.5 million.



    • Presented Data from Ongoing Phase 1/2 Study of SNS-301 in Combination with Pembrolizumab for the Treatment of Locally Advanced Unresectable or Metastatic SCCHN –At the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting in November 2020, Sensei presented new data demonstrating that one patient with PD-L1 negative disease achieved a partial response (PR) with a tumor reduction of 43% at week 12 and was confirmed at week 18. Additionally, one patient achieved a stable disease (SD) for more than 4 months following progressive disease (PD) after 10 months of PD-1 blockade treatment prior to study entry, and two patients achieved SD for more than 36 weeks. These data were supportive of earlier data presented at the European Society for Medical Oncology (ESMO) Virtual Congress in September 2020. Further, immunohistochemical staining of paired pre- and on-treatment biopsies (12 weeks) from the responding patient's tumor demonstrated a conversion from a PD-L1-negative, poorly inflamed phenotype into an inflamed, PD-L1-positive tumor, characterized by tumor necrosis, and abundant infiltrating immune cells, including CD4, CD8 T cells and macrophages. SNS-301 was well tolerated with no dose-limiting toxicities and observed adverse events (AEs) have primarily been either Grade 1 or 2 and mostly unrelated to treatment.



    • Advanced the ongoing SNS-301 Phase 1/2 study - Enrollment in Stage 2 of the ongoing Phase 1/2 clinical trial commenced in the first half of 2021, including the initiation of enrollment of the newly opened PD-1 naïve cohort of the study.



    • Strengthened ImmunoPhage™ Platform with the Acquisition of Alvaxa Biosciences – In May 2020, Sensei announced the acquisition of Alvaxa Biosciences and its existing camelid nanobody libraries, expertise in nanobody discovery, as well as its partnership with Hope Farms, LLC, a United States Department of Agriculture (USDA) licensed Alpaca farm, for the generation of future alpaca-derived nanobodies, or camelid antibodies that are small, highly-specific antigen-binding domains with high-affinity binding. Nanaobodies are a core component of Sensei's proprietary ImmunoPhage platform, enabling both precision APC targeting and the delivery of immunomodulatory payloads.



    • Expanded Executive Team and Board of Directors with Multiple Appointments  Sensei grew its executive management team with the appointments of Anu Hoey as chief business officer, Marie-Louise Fjaellskog, M.D., Ph.D. as chief medical officer, and Robert Pierce, M.D. as chief scientific officer. In addition, Sensei added Deneen Vojta, M.D. to its board of directors.

    Multiple Upcoming Anticipated Milestones for 2021 and 2022 Across Pipeline:

    • Sensei expects to announce multiple updates from its SNS-301 program, a first-in-class cancer immunotherapy designed to overcome immune tolerance and induce robust and durable antigen-specific humoral and cellular responses including:
      • Initiation of a Phase 2 study in the neoadjuvant setting in combination with durvalumab
      • Commencement of an additional cohort of the ongoing Phase 1/2 study of HPV-specific E6/E7 ImmunoPhage in combination with SNS-301 and pembrolizumab
      • Announcement of a large subset of data from the Phase 1/2 study in combination with pembrolizumab for the treatment of locally advanced unresectable or metastatic SCCHN
    • Sensei expects to submit an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for its SNS-401 program, a personalized ImmunoPhage™ cocktail for the treatment of Merkel Cell Carcinoma in the first half of 2022.
    • Sensei expects to initiate IND-enabling studies for its SNS-VISTA, antibody-based therapeutic targeting V-domain Ig suppressor of T cell activation (VISTA) program by year end 2021.

    Full Year 2021 Financial Results

    • Cash Position – Cash and cash equivalents were $16.6 million as of December 31, 2020, as compared to $0.3 million as of December 31, 2019. Total cash and cash equivalents at December 31, 2020 does not include net proceeds of approximately $138.5 million from the company's upsized IPO in February 2021 or the closing of the company's final private round of financing in January 2021. Sensei expects the current cash balance to fund operations at least into the second half of 2023.
    • Research and Development (R&D) Expenses – R&D expenses were $11.9 million for the year ended December 31, 2020, compared to $8.4 million for the year ended December 31, 2019 including costs related to the Alvaxa acquisition. The increase in expenses is primarily attributable to investments being made in early research and development activities and the clinical and preclinical development of SNS-301, SNS-401 and SNS-VISTA.
    • General and Administrative (G&A) Expenses – G&A expenses were $7.5 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. The increase is mainly driven by strategic external consulting, legal and recruiting costs, as well as stock compensation.
    • Net Loss – Net loss was $20.1 million, for the year ended December 31, 2020, compared to $16.7 million for the year ended December 31, 2019.

    About Sensei Biotherapeutics

    Sensei Biotherapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation immunotherapies for the treatment of cancer and infectious diseases. The company has developed a proprietary bacteriophage-based platform, ImmunoPhage™, that enables the rapid generation of immune activating therapeutic agents that fully engage the immune system. Using the ImmunoPhage™ platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized yet off-the-shelf cocktail approach for treating cancer patients. The platform enables efficient, scalable and cost-effective manufacturing to support all of Sensei's clinical programs. The company's most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage™ targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced Squamous Cell Carcinoma of the Head and Neck. Earlier stage programs include SNS-401, a ImmunoPhage™ cocktail for the treatment of Merkel Cell Carcinoma, and SNS-VISTA, an antibody-based therapeutic targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA).

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Sensei's current beliefs and expectations. These forward-looking statements include expectations regarding the potential clinical development of Sensei's product candidates, the availability of data from Sensei's clinical trials and the timing of regulatory filings. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Sensei's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei's prospectus filed with the U.S. Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, on February 4, 2021 and Sensei's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Condensed Statements of Operations
    (Unaudited, in thousands except share and per share data)
         
      Year Ended December 31,

      2020   2019 
    Operating expenses:   
    Research and development$11,185  $8,350 
    General and administrative 7,528   4,085 
    Alvaxa IPR&D 738    
    Total operating expenses 19,451   12,435 
    Loss from operations (19,451)  (12,435)
    Total other expense (649)  (4,305)
    Net loss (20,100)  (16,740)
    Cumulative dividends on convertible preferred stock (104)  (3,804)
    Net loss attributable to common stockholders$(20,204) $(20,544)
    Net loss per share, basic and diluted$(12.53) $(55.92)
    Weighted-average common shares outstanding, basic and diluted 1,612,140   367,359 



    Selected Condensed Balance Sheet Data
    (Unaudited, in thousands)
        
     Year Ended December 31,
      2020   2019 
    Cash and cash equivalents$16,596  $251 
    Total assets 21,428   1,217 
    Total liabilities 5,535   22,334 
    Convertible preferred stock 72,336   47,545 
    Total stockholders' deficit (56,443)  (68,662)

    Investor Contact:

    Julie Seidel

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact:

    Mike Beyer

    Sam Brown Inc. Healthcare Communications

    312-961-2502

     



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