CGEM Cullinan Oncology Inc.

22.93
-1.81  -7%
Previous Close 24.74
Open 24.74
52 Week Low 22.59
52 Week High 59.85
Market Cap $997,824,746
Shares 43,516,125
Float 21,345,754
Enterprise Value $556,950,746
Volume 123,060
Av. Daily Volume 253,714
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Drug Pipeline

Drug Stage Notes
CLN-081
Non-Small Cell Lung Cancer
Phase 1/2
Phase 1/2
Phase 1/2 updated data at ASCO June 4-8, 2021 noted objective partial responses (PR) were observed in 21 of 42 (50%) patients.
CLN-619
Solid tumors
Phase 1
Phase 1
Phase 1 IND filing due 2Q 2021.

Latest News

    • 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

    Jeffrey Trigilio

    +1 617.410.4650

     



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  1. CAMBRIDGE, Mass., June 07, 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 Florentine's IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML," stated Patrick Baeuerle, Cullinan's Chief Scientific Officer, Biologics. "We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with…

    CAMBRIDGE, Mass., June 07, 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 Florentine's IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML," stated Patrick Baeuerle, Cullinan's Chief Scientific Officer, Biologics. "We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with relapsed/refractory AML."

    About CLN-049



    CLN-049 is a humanized bispecific antibody being developed for relapsed/refractory AML. 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 by FACS staining on AML blasts in at least 75% of AML patients, regardless of an oncogenic driver mutation. The expression of FLT3 on the surface of leukemic blasts in most AML patients and its role as a known oncogenic driver make it an attractive therapeutic target for a T cell engager approach.

    In preclinical studies, CLN-049 led to potent FLT3-dependent killing of leukemic cells in vitro at a wide range of FLT3 expression levels on AML cells. Treatment with CLN-049, even at low doses, led to survival benefit in an AML xenograft model and complete elimination of leukemic blasts in various mouse models implanted with primary patient leukemic cells or AML cell lines. 

    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.

    About Cullinan Florentine

    Cullinan Florentine is a partially owned subsidiary of Cullinan Oncology that has exclusive worldwide rights to CLN-049 pursuant to a License with the Deutsches Krebsforschungszentrum, or DKFZ, Eberhard Karls University of Tübingen, Faculty of Medicine, or University of Tübingen, and Universitätsmedizin Gesellschaft für Forschung und Entwicklung mbH, Tübingen, or UFE.

    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-049. 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

     

    Jeffrey Trigilio

    +1 617.410.4650



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    • CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity Profile

    • As of the Data Cutoff, No Grade 3 TRAE Diarrhea at Doses Below 150mg BID; No Grade 3 Rash TRAEs

    • Objective Responses Were Observed Across the Dose Range, with a Confirmed Objective Response Rate of 46% in Patients Treated at 100 mg BID

    • Phase 2a Expansion Initiated at 100 mg BID

    CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced additional details pertaining to Cullinan Pearl's ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose tumors harbor epidermal…

    • CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity Profile



    • As of the Data Cutoff, No Grade 3 TRAE Diarrhea at Doses Below 150mg BID; No Grade 3 Rash TRAEs



    • Objective Responses Were Observed Across the Dose Range, with a Confirmed Objective Response Rate of 46% in Patients Treated at 100 mg BID



    • Phase 2a Expansion Initiated at 100 mg BID

    CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced additional details pertaining to Cullinan Pearl's ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. CLN-081 is an orally available, irreversible EGFR inhibitor, utilizing a unique pyrrolopyrimidine scaffold that was designed to selectively target cells expressing mutant EGFR variants, including exon 20, while sparing cells expressing wild type (WT) EGFR.

    These data will be featured in an on-demand poster presentation available this morning at 9:00 am EDT at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and during a company sponsored webinar at 10:30 am EDT today, which can be accessed here or in the ‘Events' section on Cullinan's investor website.

    "We remain encouraged with CLN-081's emerging profile," stated Owen Hughes, Cullinan's Chief Executive Officer. "In heavily pretreated patients, CLN-081 continues to show antitumor activity across the dose range, with a safety profile that appears to be differentiated, most specifically with respect to GI adverse events."

    The current analysis of the ongoing trial evaluated a total of 45 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 as of the April 1, 2021, data cutoff, and were evaluable for safety. CLN-081 was dosed orally, at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). As of the data cutoff, 42 of 45 patients were response evaluable across all dose cohorts tested.

    Overall Safety:

    Regarding treatment related adverse events (TRAEs) associated with WT EGFR inhibition:

    • Rash has been limited to Grade 1 and 2 events (76% of patients experienced an event across all doses as of the data cutoff); events were manageable with conventional supportive care; no patients have experienced Grade ≥3 TRAE rash.



    • Similarly, diarrhea has been mostly limited to Grade 1 and 2 events (22% across the dose range) as of the data cutoff, with a single Grade ≥3 TRAE at the highest dose tested to date, 150 mg BID, which resolved with supportive care. No prophylactic regimen has been required to ameliorate the incidence or severity of diarrhea to date.

    Overall Efficacy:

    Objective partial responses (PR) were observed in 21 of 42 (50%) response evaluable patients treated across all dose levels.

    • Of the 21 PRs as of the data cutoff, 13 were confirmed (31% confirmed objective response rate), 5 were pending confirmation (i.e., patient had not reached their second post-baseline disease assessment as of the data cutoff), and 3 will remain unconfirmed.



    • 41 of 42 (98%) response evaluable patients have achieved a best response of stable disease (SD) or PR, with 76% of all patients showing some degree of tumor regression at the initial scan post baseline (week 6).

    100 mg BID Expansion Cohort:

    In February 2021, Cullinan announced a Phase 2a expansion at the 100mg BID cohort, allowing enrollment of up to 36 patients.

    • Safety: Treatment-related rash has been limited to Grade 1 and 2 events (66%), manageable with conventional supportive care; no patients have experienced Grade ≥3 TRAE rash. In addition, the overall incidence of treatment-related diarrhea was 26%, with no Grade ≥3 events to date.



    • Efficacy: As of the data cutoff, objective responses were observed in 7 of 13 (54%) response evaluable patients; 6 of which were confirmed (46%) and 1 will remain unconfirmed.



    • Of the 13 response evaluable patients, 9 (69%) patients achieved disease control (PR of any duration or SD ≥ 6 months) as of the data cutoff; an additional 3 patients had stable disease and remained on treatment but had started therapy less than 6 months prior to data cutoff.

    "We are pleased with the CLN-081 safety and efficacy data to date in our Phase 1/2a trial. CLN-081 has demonstrated antitumor activity in patients post systemic chemotherapy, including among patients who were also treated previously with other EGFR inhibitors and/or cancer immunotherapy, across the range of CLN-081 doses tested to date, and across a spectrum of exon-20 mutational sub-types," said Jon Wigginton, M.D., Chairman of the Cullinan Oncology Scientific Advisory Board and Senior Advisor. "We are working diligently to evaluate CLN-081 in additional patients, and to set the stage for further clinical advancement of CLN-081 in this group of patients with significant unmet need."

    About CLN-081



    CLN-081 is an orally available, irreversible EGFR inhibitor that was designed to selectively target cells expressing mutant EGFR variants, including Ins20, while sparing cells expressing wild type EGFR. In preclinical studies, CLN-081 demonstrated inhibition against traditional sensitizing mutations (exon 19 deletions and L858R), Ins20 (the third most common EGFR mutation), and other less common mutations (G719X, L861Q, and S768I).

    Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring Ins20 mutations that have progressed post chemotherapy. Based on pre-specified efficacy and safety criteria, Cullinan recently initiated Phase 2a dose expansion in the 100 mg BID dosing cohort, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients.

    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 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 activity of CLN-081. 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

    Jeffrey Trigilio

    +1 617.410.4650

     



    Primary Logo

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  2. CAMBRIDGE, Mass., May 21, 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 Jon Wigginton, M.D. is stepping down from his day-to-day role as Chief Medical Officer, and will assume the role of Chairman of the company's Scientific Advisory Board (SAB) and Senior Advisor to the CEO.

    "I want to thank Jon for his many contributions to Cullinan, having helped the company transition to a public, clinical-stage biotech company, and establishing the clinical infrastructure necessary to run multiple global clinical trials," stated Owen Hughes, Cullinan's Chief Executive Officer. "More importantly, I'm delighted that we…

    CAMBRIDGE, Mass., May 21, 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 Jon Wigginton, M.D. is stepping down from his day-to-day role as Chief Medical Officer, and will assume the role of Chairman of the company's Scientific Advisory Board (SAB) and Senior Advisor to the CEO.

    "I want to thank Jon for his many contributions to Cullinan, having helped the company transition to a public, clinical-stage biotech company, and establishing the clinical infrastructure necessary to run multiple global clinical trials," stated Owen Hughes, Cullinan's Chief Executive Officer. "More importantly, I'm delighted that we will continue to benefit from Jon's experience and clinical development expertise as we progress a diversified pipeline of novel targeted and immuno-oncology agents into the clinic."

    "I am pleased to continue to work with Owen and my valued colleagues at Cullinan in our quest to help those living with cancer," stated Dr. Wigginton. "I am looking forward to further assisting the outstanding team at Cullinan, and to providing strategic oversight of the depth and breadth of Cullinan's innovative development programs."

    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

    Jeffrey Trigilio

    +1 617.410.4650



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  3. CAMBRIDGE, Mass., May 19, 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 it will provide a clinical update on CLN-081 during a webinar on Friday, June 4th, 2021 at 10:30 am ET ("Pearl Clinical Update Webinar").

    During the webinar, members of Cullinan's management team will review updated safety and efficacy data from an ongoing Phase 1/2a trial evaluating CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutations (Ins20).

    As previously announced, data from this trial was selected for a poster presentation at the 2021 American Society…

    CAMBRIDGE, Mass., May 19, 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 it will provide a clinical update on CLN-081 during a webinar on Friday, June 4th, 2021 at 10:30 am ET ("Pearl Clinical Update Webinar").

    During the webinar, members of Cullinan's management team will review updated safety and efficacy data from an ongoing Phase 1/2a trial evaluating CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutations (Ins20).

    As previously announced, data from this trial was selected for a poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster will include information using an April 1st, 2021 data cutoff and it will be available for on-demand viewing starting on Friday, June 4th at 9:00 am ET. Cullinan is hosting the Pearl Clinical Update Webinar at 10:30 am ET, after the poster release, in order to align with ASCO's embargo policies.

    Pearl Clinical Update Webinar Information

    Please register for the webinar directly here, or through the ‘Events' section on Cullinan's investor website here (https://investors.cullinanoncology.com/news-events/events). All materials presented will be accessible on the Cullinan website, and an archived recording of the live audio webcast will be available on Cullinan's website for approximately 30 days.

    ASCO Poster Presentation Information

    Abstract Title: Safety and activity of CLN-081 (TAS6417) in NSCLC with EGFR Exon 20 insertion mutations (Ins20)

    Abstract Number: 9077

    Date and Time: June 4th, 2021, 9:00 am ET (On-Demand)

    About CLN-081



    CLN-081 is an orally available, irreversible EGFR inhibitor that was designed to selectively target cells expressing mutant EGFR variants, including Ins20, while sparing cells expressing wild type EGFR. In preclinical studies, CLN-081 demonstrated inhibition against traditional sensitizing mutations (exon 19 deletions and L858R), Ins20 (the third most common EGFR mutation), and other less common mutations (G719X, L861Q, and S768I).

    Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring Ins20 mutations that have progressed post chemotherapy. Based on pre-specified efficacy and safety criteria, Cullinan recently initiated Phase 2a dose expansion in the 100 mg BID dosing cohort, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients.

    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 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 activity of CLN-081. 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

    Jeffrey Trigilio

    +1 617.410.4650



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