Biotech Rated Outperform Advances Top Drug Candidate
Source: Dr. David Nierengarten
April 19, 2023 (Investorideas.com Newswire) The biotech launches another trial of its KIT inhibitor and reports preclinical data for other inhibitors in its pipeline, noted a Wedbush report.
Cogent Biosciences Inc. (COGT:NASDAQ) initiated Part 2 of the Apex Phase 2 clinical trial of bezuclastinib (CGT9486) in advanced systemic mastocytosis, Wedbush analyst Dr. David Nierengarten reported in an April 17 research note.
Given the positive data from Part 1 and "the higher predicted clinical exposure of bezuclastinib's optimized formulation, we believe that Apex Part 2 is likely to succeed," Nierengarten wrote.
The analyst reiterated Wedbush's Outperform rating and US$20 per share price target on the Massachusetts-based biotech. In comparison, Cogent is currently trading at about US$10.84 per share.
Part 2 Enrollment Goals
For the main efficacy group in Apex's Part 2, about 65 patients will be enrolled, Nierengarten relayed and administered bezuclastinib. This is Cogent's selective and potent inhibitor of KIT (D816V), a common mutation in systemic mastocytosis and gastrointestinal stromal tumor.
Patients will receive 150 milligrams (150 mg) of bezuclastinib once daily versus the 100 mg twice daily administered in Part 1. The optimized 150 mg dose is expected to have greater clinical exposure than the 100 mg, the analyst wrote.
Nierengarten noted that other cohorts are planned for Part 2 as well. One will consist of up to 20 patients with systemic mastocytosis and an associated hematologic neoplasm. Another group will comprise up to 15 patients with inevaluable modified IWG disease without C-findings. A third cohort of up to 10 patients will receive bezuclastinib 300 mg daily "to assess the effect of exceeding IC90 KIT D816V engagement," wrote Nierengarten.
Completion of Part 2 enrollment is anticipated around year-end 2024.
Part 1 Results
Cogent previously reported data from the Part 1 portion of the Phase 2 study, which were positive, at the annual American Society of Hematology meeting in December 2022. Since then, efficacy and safety have remained the same.
Later this year, in H2, the company expects to present, also at a medical conference, updated Part 1 clinical data for about 30 patients.
Positive Preclinical Data
Nierengarten also discussed in his research report Cogent's recent update on some of its other inhibitor candidates. The biotech provided preclinical data for two of them: CGT3103 and CGT1786.
CGT3103 is Cogent's noncovalent, reversible inhibitor of FGFR2. Results of pharmacokinetic studies in mice and rats showed that CGT3103 covered FGFR2 for 12 hours and demonstrated greater selectivity for FGFR2 over FGFR1 than approved pan FGFR inhibitors did.
"The data suggest that Cogent's FGFR2 candidate may be able to effectively treat patients with gatekeeper and molecular brake mutations while avoiding the dose-limiting hyperphosphatemia associated with FGFR1 inhibition," Nierengarten wrote.
Cogent's CGT1786, an early inhibitor of ErbB2, or HER2, showed cellular activity against a handful of oncogenic mutations in preclinical studies. Compared to tucatinib, it demonstrated better inhibition of pErbB2 and BT474 as well as superior efficacy in terms of tumor growth inhibition.
The biotech's next generation ErbB2 inhibitors, CGT2724 and CGT4069, showed superior central nervous system penetration of about 40% and better human whole blood stability at around 24 hours.
All of the preclinical results indicate Cogent's ErbB2 inhibitors "block all key resistance (YMVA, S310F, V842I) and primary driver mutations while sparing WT EGFR, which should help avoid adverse events including diarrhea, stomatitis, and hepatotoxicity," wrote Nierengarten.
Cogent is still working toward identifying a clinical candidate for its ErbB2 program.
In the Near Term
What investors can expect soon, in H1/23, is lead-in data from Cogent's Peak Phase 3 study of bezuclastinib plus sutent in gastrointestinal stromal tumor. Wedbush expects the results to be positive, Nierengarten noted.
1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with: None. Please click here for more information.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
Disclosures For Wedbush, Cogent Biosciences, April 17, 2023
Analyst Certification: We, David Nierengarten and Dennis Pak, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.
Company Specific Disclosures:
1. WS makes a market in the securities of Cogent Biosciences.
The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request.
Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information.
This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders
Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.
More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/