Cullinan Oncology, Inc. ( CGEM Quick Quote CGEM - Free Report) announced encouraging interim data from an ongoing phase I/IIa study — Cullinan Pearl — evaluating its sole pipeline candidate, CLN-081, The study is evaluating the safety and efficacy of the candidate as potential treatment for non-small cell lung cancer (NSCLC) patients whose tumors harbor EGFR exon 20 insertion mutations. The data were presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.
Interim data constitutes data from the phase I portion of the study that evaluated multiple oral dose levels — 30, 45, 65, 100 and 150 mg — of the selective, irreversible EGFR inhibitor candidate, as of Apr 1, 2021. Treatment with CLN-081 led to antitumor activity across the dose range in heavily pretreated patients. Data showed that among response-evaluable patients, 50% achieved objective partial response (PR) with 31% patients achieving confirmed objective response rate (ORR). Moreover, 76% of patients showed some degree of tumor regression at week 6 compared to baseline. Meanwhile, the candidate demonstrated acceptable overall safety and tolerability.
We remind investors that Cullinan completed its initial public offering in January and started trading publicly since Jan 11.
Shares of Cullinan gained 11.3% on Jun 4, following the study data readout. So far this year, shares of the company have increased 10.7% against the
industry’s 3.2% decrease. Image Source: Zacks Investment Research
During the first quarter, the company started the phase IIa portion of the Cullinan Pearl study with 100mg dose of CLN-081. Treatment with 100mg dose has achieved 46% confirmed ORR as of Apr 1.
Apart from CLN-081, Cullinan has four pre-clinical candidates in its pipeline. In January 2021, the company submitted an investigational new drug (IND) application to the FDA seeking approval to initiate a phase I/IIa study to evaluate its antibody candidate, CLN-049, in relapsed or refractory acute myeloid leukemia. However, the FDA requested the company to consider alternative study designs. The company has amended the study protocol based on FDA feedback and plans to resubmit the IND application in mid-2021. The company also plans to submit another IND application by the end of June for another antibody candidate, CLN-619.
Zacks Rank & Stocks to Consider
Cullinan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include
Akero Therapeutics ( AKRO Quick Quote AKRO - Free Report) , Bellerophon Therapeutics ( BLPH Quick Quote BLPH - Free Report) and Legend Biotech ( LEGN Quick Quote LEGN - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Akero’s loss per share estimates have narrowed 34% for 2021 over the past 30 days.
Bellerophon’s loss per share estimates have narrowed 2.2% for 2021 over the past 30 days.
Legend Biotech’s loss per share estimates have narrowed 10.8% for 2021 over the past 30 days. The stock has jumped 37.3% so far this year.
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