CGEM Cullinan Oncology Inc.

22.21
-1.21  -5%
Previous Close 23.42
Open 23.38
52 Week Low 20.35
52 Week High 59.85
Market Cap $967,049,586
Shares 43,541,179
Float 21,370,808
Enterprise Value $616,411,408
Volume 132,458
Av. Daily Volume 260,859
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Upcoming Catalysts

Drug Stage Catalyst Date
CLN-081 - Pearl
Non-Small Cell Lung Cancer
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
CLN-049 - Florentine
Acute myeloid leukemia (AML)
Phase 1
Phase 1
Phase 1 clinical trial to be initiated by year-end 2021.
CLN-619 - MICA
Solid tumors
Phase 1
Phase 1
Phase 1 trial to be initiated by year-end 2021.

Latest News

  1. CAMBRIDGE, Mass., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan" or "the Company"), a biopharmaceutical company focused on developing a diversified pipeline of targeted and immuno-oncology therapies, announced the appointment of Nadim Ahmed as President and Chief Executive Officer, effective today. Mr. Ahmed will also join the Company's Board of Directors. Mr. Ahmed succeeds Owen Hughes, who resigned as CEO and as a member of the Company's Board of Directors. Mr. Hughes will take on the role of Strategic Advisor to the company to support the transition.

    "Owen has successfully built-out Cullinan's organization and pipeline since its inception, while also leading the Company through multiple capital raises…

    CAMBRIDGE, Mass., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan" or "the Company"), a biopharmaceutical company focused on developing a diversified pipeline of targeted and immuno-oncology therapies, announced the appointment of Nadim Ahmed as President and Chief Executive Officer, effective today. Mr. Ahmed will also join the Company's Board of Directors. Mr. Ahmed succeeds Owen Hughes, who resigned as CEO and as a member of the Company's Board of Directors. Mr. Hughes will take on the role of Strategic Advisor to the company to support the transition.

    "Owen has successfully built-out Cullinan's organization and pipeline since its inception, while also leading the Company through multiple capital raises, including its IPO earlier this year," said Anthony Rosenberg, Chairman of the Board of Directors at Cullinan. "Cullinan, via both internal discovery and external collaboration, has constructed a diverse portfolio of novel oncology programs that are advancing to later stages of development. Nadim brings to Cullinan a proven track record in oncology drug development and commercialization success. His experience at Celgene during a period of tremendous growth will be invaluable to Cullinan as we advance Pearl into later-stage clinical development, while also moving our first two immuno-oncology programs, MICA and Florentine, into clinical trials by year-end 2021. We will provide an update for Pearl in Q4 2021 as originally planned. On behalf of Cullinan, I want to welcome Nadim to Cullinan and thank Owen for his contributions. We look forward to him supporting the transition."

    "I am excited to be leading the incredibly talented team at Cullinan to advance our deep, multi-modality pipeline as we strive to bring important medicines to cancer patients," said Mr. Ahmed. "With a world-class leadership team in place and a robust cash position, Cullinan is well-poised to execute on its evolution into a company with multiple clinical-stage novel oncology programs."

    Mr. Ahmed has more than twenty-five years of leadership experience in oncology across a range of development and commercialization roles, including recently at Bristol Myers Squibb (BMS), where he served as President, Hematology and at Celgene Corporation (Celgene) where he served as President, Global Hematology & Oncology through its acquisition by BMS. As President, Hematology at BMS, Mr. Ahmed oversaw multiple product launches and participated as a member of the company's Leadership Team. Prior to BMS, Mr. Ahmed served in leadership roles at Celgene across both development and commercialization functions. During this time at Celgene, he successfully launched multiple cancer medicines, including Pomalyst®, Abraxane® and several key indications for Revlimid®. Mr. Ahmed has worked with various treatment modalities, including small molecules, biologics and cell therapy in hematology and solid tumors. Mr. Ahmed holds a Master of Science degree from Loughborough University, UK and a Bachelor of Science degree from University College London, UK.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company with a diversified pipeline of targeted and immuno-oncology therapeutic candidates across multiple modalities, with a focus on advanced stage assets built on novel technology platforms with differentiated mechanisms, via both internal discovery and external collaboration. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements

    This press release contains forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, and the timing and success of our planned regulatory submissions; our ability to evaluate strategic opportunities to accelerate development timelines; our ability to optimize the impact of our collaborations and license agreements with external parties; our ability to continue our growth; and our expectations regarding our use of capital.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission (SEC), including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  2. CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") today announced its participation in the following upcoming investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference taking place Thursday, September 9th through Wednesday, September 15th
      • Cullinan's CEO, Owen Hughes, will participate in a virtual fireside chat on Monday, September 13th, at 12:30pm ET, and will provide a corporate update at 4:15pm ET
    • H.C. Wainwright 23rd Annual Global Investment Conference on Monday, September 13th through Wednesday, September 15th
      • Cullinan's Chief Development Officer of Biologics, Jennifer Michaelson, will participate in a panel discussion titled "Engineered Cytokines: The Next Big…

    CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") today announced its participation in the following upcoming investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference taking place Thursday, September 9th through Wednesday, September 15th
      • Cullinan's CEO, Owen Hughes, will participate in a virtual fireside chat on Monday, September 13th, at 12:30pm ET, and will provide a corporate update at 4:15pm ET
    • H.C. Wainwright 23rd Annual Global Investment Conference on Monday, September 13th through Wednesday, September 15th
      • Cullinan's Chief Development Officer of Biologics, Jennifer Michaelson, will participate in a panel discussion titled "Engineered Cytokines: The Next Big Wave in Immuno-oncology", which will be broadcast to conference participants on Tuesday, September 14th, from 1:30 – 3:00pm ET

    Members of Cullinan's management will be presenting virtually at each conference, as well as participating in one-on-one investor meetings. Please visit the investor section of Cullinan's website at www.investors.cullinanoncology.com for more information.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  3. Follow-up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate (DCR) of 92% in the 100mg dose cohort

    IND clearance of two immuno-oncology pipeline programs, Cullinan MICA and Cullinan Florentine, with clinical trial starts for each program expected in 2H 2021

    Strong balance sheet with cash and investments of $456.3 million as of June 30, 2021

    CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the second quarter ended June 30, 2021 and reported on recent business highlights.

    "Solid execution led to the advancement…

    Follow-up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate (DCR) of 92% in the 100mg dose cohort

    IND clearance of two immuno-oncology pipeline programs, Cullinan MICA and Cullinan Florentine, with clinical trial starts for each program expected in 2H 2021

    Strong balance sheet with cash and investments of $456.3 million as of June 30, 2021

    CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the second quarter ended June 30, 2021 and reported on recent business highlights.

    "Solid execution led to the advancement of our clinical pipeline this quarter," stated Owen Hughes, Chief Executive Officer of Cullinan Oncology. "We are pleased with the encouraging results of Cullinan Pearl (EGFR exon 20) showcased at ASCO as well as the recent IND clearance for the first two programs in our immuno-oncology pipeline, Cullinan MICA (MICA/B antibody) and Cullinan Florentine (FLT3 bispecific). With over $456 million of cash and investments on hand, we remain well capitalized to advance our broad pipeline through multiple clinical readouts. In the near term, we expect to provide updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in September as well as a Cullinan Pearl clinical and regulatory update in the fourth quarter."

    Q2 2021 Portfolio Highlights

    • Cullinan Pearl: Presented interim data at ASCO 2021 from ongoing Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 mutations (press release).
      • Safety: CLN-081 continues to demonstrate promising overall safety and tolerability, with an encouraging GI toxicity profile.
      • Efficacy: As of the ASCO data cutoff, there were 5 pending partial responses (PR), 4 of which subsequently confirmed. In addition, follow-up data from patients in the 100mg Phase 1 cohort showed the DCR, defined as best response of PR + stable disease ≥6 months, increased to 92% (12 / 13 patients).
      • Phase 1/2a trial status: Cullinan recently completed enrollment of the Phase 2a 100mg expansion cohort (total n=36) and initiated expansion at 150mg (from 7 patients treated to date to 13 total). Cullinan intends to provide a clinical and regulatory update in Q4 2021.
    • Cullinan MICA: Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug application (IND) for CLN-619, a novel MICA/B-targeted antibody for the treatment of solid tumors (press release). CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications. Cullinan intends to initiate a first-in-human (FIH) trial of CLN-619 in 2H 2021, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy.
    • Cullinan Florentine: Received FDA clearance of IND for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML) (press release). CLN-049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering the T cells to kill the targeted cancer cells via their intrinsic cytolytic mechanisms. Studies have shown that FLT3 is expressed on AML blasts in over 75% of AML patients, regardless of FLT3 mutational status. Cullinan intends to initiate a FIH trial of CLN-049 in 2H 2021.
    • Cullinan Amber: Continued progress towards final candidate selection for CLN-617, a fusion protein combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding tumor retention domain for the treatment of solid tumors. IND-enabling studies are planned to commence in the 2H 2021.
    • Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.

    Q2 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $456.3 million as of June 30, 2021, compared to $473.0 million as of March 31, 2021. Net cash used in operating activities for the second quarter of 2021 was $16.4 million.
    • R&D Expenses: Research and development (R&D) expenses were $11.8 million for the second quarter of 2021, including $2.3 million of non-cash equity-based compensation expense, compared to $12.5 million for the second quarter of 2020. The decrease in R&D expenses is primarily related to a non-recurring non-cash charge related to the MICA acquisition in the second quarter of 2020, partially offset by increased expenses from headcount growth as well as expanded clinical and CMC activity from other portfolio programs.
    • G&A Expenses: General and administrative (G&A) expenses were $4.8 million for the second quarter of 2021, including $1.9 million of non-cash equity-based compensation expense, compared to $1.6 million for the second quarter of 2020. The increase in G&A expenses is primarily related to headcount growth as well as additional costs associated with operations as a public company.
    • Net loss: The Company's net loss (before items attributable to noncontrolling interest) was $16.4 million for the second quarter of 2021, compared to $13.9 million for the second quarter of 2020, driven predominantly by increases in costs associated with public company operations and non-cash equity-based compensation expenses.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements



    This press release contains forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, including for CLN-081, CLN-619, and CLN-049, and the timing and success of our planned regulatory submissions; our expectations and beliefs around the safety and activity of CLN-081 in our Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have had at least one prior treatment; our ability to evaluate strategic opportunities to accelerate development timelines; the presentation of additional data at upcoming scientific conferences in 2021; our ability to optimize the impact of our collaborations and license agreements with external parties; our ability to continue our growth; and our expectations regarding our use of capital.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission (SEC), including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.



    Cullinan Oncology, Inc.

    Consolidated Balance Sheets (Unaudited)

    (in thousands, except shares and per share amounts)

      December 31,

    2020
      June 30,

    2021
     
    Assets        
    Current assets:        
    Cash and cash equivalents $168,198  $123,670 
    Short-term investments  42,008   213,035 
    Prepaid expenses and other current assets  2,072   7,762 
    Total current assets  212,278   344,467 
    Property and equipment, net  130   102 
    Other assets  2,300   147 
    Long-term investments     119,637 
    Total assets $214,708  $464,353 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $9,679  $1,510 
    Accrued expenses and other current liabilities  4,641   4,233 
    Total current liabilities  14,320   5,743 
    Long-term liabilities:        
    Deferred rent  74   70 
    Total liabilities  14,394   5,813 
    Commitments and contingencies (Note 11)        
    Stockholders' equity:        
    Common stock, $0.0001 par value, 34,900,878 and 150,000,000 shares authorized as of December 31, 2020 and June 30, 2021, respectively; 29,831,125 and 43,526,224 shares issued and outstanding as of December 31, 2020 and June 30, 2021, respectively.  3   4 
    Additional paid-in capital  292,348   564,705 
    Accumulated other comprehensive loss  (2)  (115)
    Accumulated deficit  (93,339)  (109,045)
    Total Cullinan stockholders' equity  199,010   455,549 
    Noncontrolling interests  1,304   2,991 
    Total stockholders' equity  200,314   458,540 
    Total liabilities and stockholders' equity $214,708  $464,353 



    Cullinan Oncology, Inc.

    Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except shares and per share amounts)

      Three Months Ended June 30,  Six Months Ended June 30, 
      2020  2021  2020  2021 
    License revenue $  $  $  $18,943 
    Operating expenses:                
    Research and development  12,496   11,778   16,669   24,193 
    General and administrative  1,626   4,826   2,994   9,982 
    Total operating expenses  14,122   16,604   19,663   34,175 
    Loss from operations  (14,122)  (16,604)  (19,663)  (15,232)
    Other income (expense):                
    Interest income 246  173  624  222 
    Other income (expense), net  1   (8)  1   (10)
    Net loss  (13,875)  (16,439)  (19,038)  (15,020)
    Net income/(loss) attributable to noncontrolling interest  (5,253)  (803)  (5,443)  686 
    Net loss attributable to common stockholders of Cullinan $(8,622) $(15,636) $(13,595) $(15,706)
    Net loss per share, basic and diluted $(0.44) $(0.36) $(0.71) $(0.37)
    Total weighted-average shares used in computing net loss per share, basic and diluted  19,619,748   43,295,372   19,115,380   42,713,059 
    Comprehensive loss:                
    Net loss $(13,875) $(16,439) $(19,038) $(15,020)
    Unrealized gain/(loss) on investments 177   (55) 207   (113)
    Comprehensive loss  (13,698)  (16,494)  (18,831)  (15,133)
    Comprehensive income/(loss) attributable to noncontrolling interest  (5,253)  (803)  (5,443)  686 
    Comprehensive loss attributable to Cullinan $(8,445) $(15,691) $(13,388) $(15,819)

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  4. CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that it will be participating in the 41st Annual Canaccord Genuity Growth Conference from August 10th to August 12th, 2021.

    Jeff Trigilio, Cullinan's Chief Financial Officer, will be presenting on Thursday, August 12th at 4:00pm ET. The presentation will be accessible through the Canaccord conference portal.

    Event: Canaccord Genuity Growth Conference
    Date: Thursday, August 12th
    Time: 4:00pm ET
    Location: Virtual

    Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with Cullinan's management should contact their Canaccord representative…

    CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that it will be participating in the 41st Annual Canaccord Genuity Growth Conference from August 10th to August 12th, 2021.

    Jeff Trigilio, Cullinan's Chief Financial Officer, will be presenting on Thursday, August 12th at 4:00pm ET. The presentation will be accessible through the Canaccord conference portal.

    Event: Canaccord Genuity Growth Conference

    Date: Thursday, August 12th

    Time: 4:00pm ET

    Location: Virtual

    Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with Cullinan's management should contact their Canaccord representative.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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    • CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trials

    • Cullinan will initiate a FIH trial in 3Q21, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy

    CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA's IND application for CLN-619. CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with…

    • CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trials



    • Cullinan will initiate a FIH trial in 3Q21, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy

    CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA's IND application for CLN-619. CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications.

    "The MICA/B-targeted antibody CLN-619 represents a novel approach to broadly engage both innate and adaptive immune cells to achieve tumor cell lysis through multiple mechanisms of action," stated Jennifer Michaelson, Cullinan's Chief Development Officer, Biologics. "Given that MICA/B ligands are expressed across a wide range of solid and liquid tumors and the strong biological rationale for combination with other therapies, successful clinical development of CLN-619 may demonstrate the potential to become a novel backbone agent for immuno-oncology therapy. We are excited to now focus our efforts on initiating a clinical trial evaluating the safety, tolerability and single-agent anti-tumor activity of CLN-619 in multiple solid tumor types. The trial design also includes a module to evaluate the safety, tolerability and anti-tumor activity of CLN-619 in combination with checkpoint inhibitor therapy."

    About CLN-619



    CLN-619 is a humanized IgG1 monoclonal antibody that binds to MICA and MICB expressed on a wide variety of cancer cells. MICA/B are stress-induced ligands that are recognized by both cytotoxic innate and adaptive immune cells via their NKG2D receptor. To evade lysis by these immune cells, tumor cells shed MICA/B from their cell surface. CLN-619 promotes an antitumor response through multiple mechanisms of action, including prevention of the proteolytic release of MICA/B from cancer cells, antibody-dependent cell-mediated cytotoxicity, or ADCC, enhancement of MICA/B binding to NKG2D, and reduction of the inhibitory effect of shed MICA/B.

    In preclinical studies, animals treated with CLN-619 as a monotherapy demonstrated significant inhibition of tumor growth and a dramatic reduction of serum levels of soluble MICA. Multiple studies evaluating serum samples from cancer patients have demonstrated that high serum levels of shed MICA correlate with a poor prognosis.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for its various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, unique modes of action, and are either first- or best-in-class. Learn more about Cullinan at www.cullinanoncology.com.

    About Cullinan MICA



    Cullinan MICA is a Cullinan Oncology company that acquired exclusive worldwide rights to CLN-619, which was discovered by PDI Therapeutics, a portfolio company of Avalon Ventures.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and efficacy of CLN-619. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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