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Compugen Doses First Patient in Triple Combination COM701,
COM902 and Pembrolizumab MSS CRC Proof of Concept Study

On March 6, 2023 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the first patient has been dosed in the triple combination proof of concept study evaluating COM701, Compugen’s potential first-in-class anti-PVRIG antibody, in combination with COM902, Compugen’s potential best-in-class anti-TIGIT antibody and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) (Press release, Compugen, MAR 6, 2023, View Source [SID1234628163]).

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"We are very excited that the first patient with MSS CRC has been dosed with the triple combination of COM701, COM902 and pembrolizumab in our proof-of-concept study, reflecting our ability to execute. This milestone keeps us on track to report initial findings by the end of this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "The goal of the study is to build on the encouraging data previously reported by us at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), 2022, with the dual blockade of PVRIG and PD-1; help us better understand the contribution of the components, and build on the biomarker work we are doing to try and identify the patients most likely to respond, with the purpose of building a path to registration."

"Treatment options are limited for patients with metastatic microsatellite stable colorectal cancer who have exhausted standard of care and in particular for the majority of patients who also have liver metastases," said Dr. Manish Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan. "I am very excited to have dosed the first patient in this proof-of-concept study with the novel triple combination of COM701, COM902 and pembrolizumab which I hope will bring new treatment options for patients with MSS CRC."

Details on the study:

This proof-of-concept study (NCT04354246) is an open label study evaluating the combination of COM701 with COM902 and pembrolizumab in up to 20 patients with metastatic microsatellite stable colorectal cancer patients who have previously received up to 3 lines of therapy. The study includes patients with liver metastases. The initiation of the study is based on Phase 1 cohort expansion data reported at SITC (Free SITC Whitepaper) 2022, showing anti-tumor activity and potent immune modulation with the combination of COM701 and nivolumab in metastatic MSS CRC patients.

Bicara Therapeutics Announces Oversubscribed $108 Million Series B Financing to Advance Clinical-Stage Pipeline of Dual-Action Biologics to Treat Cancer

On March 6, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable anti-tumor response, reported that it completed an oversubscribed $108 million Series B financing to advance its lead program BCA101 and its pipeline of investigational candidates to treat solid tumor cancers (Press release, Bicara Therapeutics, MAR 6, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-announces-oversubscribed-108-million-series-b-financing-to-advance-clinical-stage-pipeline-of-dual-action-biologics-to-treat-cancer [SID1234628162]).

The financing was co-led by Red Tree Venture Capital and RA Capital Management, with participation from existing investors, including F-Prime Capital, Eight Roads Ventures, Invus, Piper Heartland Healthcare Capital and Premji Invest. New investors include Omega Funds, Bioqube Ventures, Acorn Bioventures and Janus Henderson Investors. In conjunction with the financing, Krishna Polu, M.D., Principal at Red Tree Venture Capital, Jake Simson, Ph.D., Partner at RA Capital Management, and Ketan Patel, M.D., Partner at F-Prime Capital, will join the Company’s Board of Directors.

"The support from this strong syndicate of investors positions us to execute on future clinical studies in the U.S. and Europe of our lead program, BCA101, a first-in-class bifunctional antibody that we believe can be very impactful across multiple tumor types including head and neck cancers," said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. "A significant unmet need remains in head and neck cancer, and the Bicara team is moving with great urgency and focus to deliver this potential new treatment option that could elevate the standard of care."

BCA101 is a dual-action bifunctional antibody designed to inhibit EGFR and disable TGF-b directly at the tumor site, achieving superior anti-tumor response with an improved therapeutic window. Bicara has previously reported promising efficacy and safety data from its ongoing Phase 1/1b clinical trial and intends to present additional data at an upcoming medical conference in 2023. Additionally, the Company continues to advance Investigational New Drug-enabling studies for BCA356, a second precision tumor modulator program.

"RA Capital Management is excited to co-lead this round to support Bicara’s efforts to develop a differentiated approach to treating cancer," said Jake Simson, Ph.D., Partner at RA Capital Management. "Bicara has reported compelling clinical data demonstrating BCA101’s potential as a more efficacious treatment option for patients with several types of solid tumors and we are committed to supporting this exceptional team as they advance this program toward key data milestones."

"We have been impressed and encouraged by the significant progress the team at Bicara has made to demonstrate the efficacy of BCA101, which has shown clear signals of activity both as a single agent and in combination," said Krishna Polu, M.D., Principal at Red Tree Venture Capital. "Through its localization of TGF-b inhibition, BCA101 has the potential to address resistance mechanisms to approved immunotherapies and substantially improve outcomes for patients with EGFR-expressing tumors. This investment is a strong fit for our fund as we seek to invest in early-stage companies that are developing transformational biologics that address diseases with high unmet needs."

Immuneering Presents Preclinical Data with Lead Program IMM-1-104 Supporting Universal-RAS Activity

On March 5, 2023 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, reported that it will be presenting preclinical data on its lead program IMM-1-104 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) special conference targeting RAS, held March 5-8, 2023, in Philadelphia (Press release, Immuneering, MAR 5, 2023, View Source [SID1234628145]). The data showed response to IMM-1-104 across a diverse panel of RAS mutant preclinical models regardless of mutation position or amino acid substitution, suggesting potential relevance to a broad RAS-driven patient population.

"We are excited to share these preclinical data that support the universal-RAS activity of IMM-1-104 through its novel target engagement mechanism combined with deep cyclic inhibition. These results further demonstrate the rationale for the unique design of our Phase 1/2a clinical trial with IMM-1-104, which is enrolling patients with advanced solid tumors harboring RAS mutations," said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering.

The poster presentation at AACR (Free AACR Whitepaper) special conference targeting RAS highlighted the following preclinical data:

Across all RAS-mutant models tested (132 tumor models, 75 of which have a reported RAS mutation), at least one model displayed response to IMM-1-104 for each observed RAS mutation, regardless of mutation position or amino acid substitution.
No significant preference was observed with respect to response to IMM-1-104 across 30 KRAS G12 mutated cell lines, the most commonly mutated position in KRAS, from three major cancer indications including pancreatic, lung and colorectal cancer models.
Title: Pan-RAS IMM-1-104 activity in humanized 3D tumor models is independent of specific amino acid substitution

Date: Tuesday, March 7, 2023, 4:45 – 7:00p.m. ET
Poster session: B
Abstract Number: B021

CIDARA THERAPEUTICS ANNOUNCES PRICING OF PUBLIC OFFERINGS OF COMMON STOCK AND PREFERRED STOCK

On March 03, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, reported the pricing of concurrent but separate underwritten public offerings of 9,640,000 shares of its common stock and 286,000 shares of its Series X Convertible Preferred Stock (each share of which is initially convertible into 10 shares of common stock), for aggregate expected gross proceeds of approximately $17.5 million, before deducting underwriting discounts and commissions and estimated offering expenses (Press release, Cidara Therapeutics, MAR 3, 2023, View Source [SID1234636990]). The offerings are expected to close on or about March 7, 2023, subject to satisfaction of customary closing conditions. The closing of each offering is not contingent upon the closing of the other.

In addition, with respect to the common stock offering, Cidara has granted the underwriter a 30-day option to purchase up to an additional 1,446,000 shares of its common stock.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for each offering.

The underwriter may offer the shares of common stock from time to time for sale in one or more transactions on the Nasdaq Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices subject to receipt and acceptance by it and subject to its right to reject any order in whole or in part. On March 2, 2023, the last sale price of the shares as reported on the Nasdaq Capital Market was $1.81 per share.

The securities described above are being offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus and prospectus supplements. Preliminary prospectus supplements and the accompanying prospectus relating to the offerings have been filed with the SEC and are available for free on the SEC’s website at View Source Final prospectus supplements and the accompanying prospectus relating to the offerings will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplements and the accompanying prospectus relating to these offerings, when available, may be obtained from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis

On March 3, 2023 Incyte (Nasdaq:INCY) reported that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population (Press release, Incyte, MAR 3, 2023, View Source [SID1234628161]). The recommendation to stop the study was not due to safety. LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus ruxolitinib (Jakafi) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.

While further review of the data is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient. Data from this study will be submitted for presentation at an upcoming scientific meeting.

The primary endpoint of LIMBER-304 (NCT04551053) was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography. Secondary endpoints included the proportion of patients who have a targeted reduction in Total Symptom Score (TSS), change in TSS, time to the first ≥50% reduction in TSS, overall survival, number of treatment emergent adverse events, time of onset of targeted reduction in spleen volume and duration of maintenance of targeted reduction in spleen volume.

About LIMBER

Incyte is a leader in the discovery and development of therapies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD). The LIMBER clinical trial program is designed to evaluate multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD. These include ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab and novel targets such as mutant CALR.