Full Press Release Details
Cullinan Oncology Announces Phase 1/2a Interim Data For
Cullinan Pearl s CLN-081 in NSCLC EGFR Exon 20 Patients
Cambridge, MA, June 4, 2021 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 EST at the 2021
American Society of Clinical Oncology (ASCO) Annual Meeting and during a company sponsored webinar at 10:30 am EST 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.
Regarding treatment related adverse events (TRAEs) associated with WT EGFR inhibition:
Objective partial responses (PR) were observed in 21 of 42 (50%) response evaluable patients treated across all dose levels.
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.
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.
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.