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]).

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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.

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"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

Radiopharm Theranostics Partners With Next Generation Preclinical Platform for Therapeutic Radiopharmaceuticals

On March 03, 2023 Radiopharm Theranostics reported the company has entered into a binding agreement to acquire Pharma15 Corporation (Pharma15), a private US-based venture which is developing next-generation therapeutic radiopharmaceuticals for Prostate Cancer. Pharma15 was founded by leading radiopharmaceutical scientist Professor David Ulmert and CEO Suzanne Dance.

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Pharma15 is developing assets which seek to overcome resistance to prostate-specific membrane antigen (PSMA) targeting cancer therapies currently available or in late-stage development. In each case, the technologies exhibit highly specific targeting of receptors expressed on cancer cells, but not in healthy tissues. This selectivity may further limit toxicity in the new approaches to targeted radiotherapy in prostate cancer.

Together with Pharma15’s scientific co-founder Professor Ulmert, KOL Professor Ken Herrmann will join RAD’s Scientific Advisory Board (SAB) and spearhead the development of the acquired technologies.

Consideration for the acquisition has been structured to minimise impact on RAD’s cash flow. It comprises the issue of ordinary shares and cash up-front, with some consideration deferred and some subject to the achievement of significant clinical milestone.

Under the direction of the founders, the development of the technology will not be a drain on RAD’s management team.

Riccardo Canevari, CEO and Managing Director of RAD, said: "Targeted Radiopharmaceutical Therapies (TRT) in PSMA-expressing tumor in prostate cancer represent a major innovation and they are transforming the clinical approach. With this agreement, we are looking at the potential next generation of radiopharmaceuticals in prostate cancer to go beyond PSMA and to continue innovation for patients suffering from this disease. We are in early preclinical stage with these technologies, but we wanted to secure them in our pipeline, before other competitors may have, and we are excited by the underlying potential of going after those two new targets."

"Additionally, we will benefit from gaining access to the Pharma15 team of experienced scientists, clinicians and radiochemists and their deep experience in preclinical and translational TRT development."

Paul Hopper, RAD Founder and Executive Chairman, added: "Professors David Ulmert, Ken Herrmann and their colleagues from Pharma15 are broadly recognized as pre-eminent subject matter experts in cancer therapy development. In addition, through the Pharma15 acquisition, RAD further improves its access to strong academic networks in Europe and USA."

Professor David Ulmert, MD PhD, Assistant Professor and Director in the Preclinical Theranostics Program at the University of California at Los Angeles and Project Investigator at Department of Clinical Sciences, Lund University, Lund, Sweden, said: "Since the licensing of my PSA monoclonal antibody technology by RAD in 2021 and the subsequent IPO of the Company, I have become increasingly involved with the RAD senior team. I am impressed with their knowledge and expertise and believe that the Pharma15 technology is in very safe hands and will be driven into the clinic at the earliest opportunity. Further, for Ken Herrmann and I to remain embedded in the development of these two drugs has been of critical importance to us."

Professor Ken Herrmann, Chair in the Department of Nuclear Medicine at the Universitätsmedizin Essen, Germany and a globally recognized leader in radiopharmaceutical Research and Development, said: "I have watched RAD’s progress since IPO and the skill with which their portfolio is being developed. The decision to merge Pharma15 into RAD was supported by the quality of the joint assets and the commercial and scientific experience of the team. It is a pleasure to not only join RAD’s SAB, but also to remain deeply involved in the translation of Pharma15’s technologies."

About the Pharma15 Purchase Agreement

Radiopharm, through its wholly owned subsidiary, Radiopharm Theranostics (USA) Inc., has entered a stock purchase agreement (Agreement) to acquire 100% of Pharma15 shares effective 3 March 2023 AEDT.

The purchase price under the Agreement is US$4 million (A$5.9 million), which is to be paid 50% in cash and 50% in shares, split between two equal instalments, the first instalment upon completion scheduled for 3 March 2023 and the second instalment on the first anniversary following completion. 10.4 million Radiopharm ordinary shares will be issued in the first instalment as part of the purchase price, determined by the volume-weighted average price (vwap) of RAD shares traded on ASX during the seven consecutive trading days ending at the close of normal trading three trading days prior to the instalment. The seven day vwap for the first instalment is $0.1431. The number of shares to be issued for the second instalment on the first anniversary following completion will vary according to the exchange rate at that time and the seven consecutive trading days volume weighted average market price ending at the close of normal trading three trading days prior to the instalment. The consideration will be funded from existing cash reserves, and the estimated share issue is within the Company’s existing 15% share issue capacity.

In addition to the purchase price, the Agreement sets out contingent consideration, subject to successful attainment of the significant value-adding clinical milestone of an Investigational New Drug Application with the U.S.A. Federal Drug Administration (FDA) for Pharma15’s product. The milestone is unlikely to be achieved before CY 2025. The contingent consideration under the Agreement, should the milestone be achieved, is US$2.3 million (A$3.4 million), to be paid in shares (to be determined by the volume-weighted average price of RAD shares traded on ASX during the seven consecutive trading days ending at the close of normal trading three trading days prior to the milestone event). Shares issued to satisfy the contingent consideration are subject to a floor price equal to the volume-weighted average price of a RAD shares traded on the ASX during the 20 consecutive trading days ending at the close of normal trading immediately preceding the date of this Agreement, being $0.139. Using the same seven day vwap as the initial instalment of the purchase price and the current exchange rate, approximately 24 million shares would be issued if the milestone is achieved. The Company has no obligation to issue more than 47,000,000 shares in total under the Agreement, which is within the Company’s existing 15% share issue capacity. Any contingent consideration not satisfied by the issue of shares will be settled by transfer of funds.

The Agreement is binding and effective immediately, with the anticipated Closing Date on or before 6 March 2023. Title passes on the Closing Date. The Agreement may be terminated for failure to meet usual conditions precedent, including any material adverse change in the circumstances of Pharma 15; otherwise only in the event of a material breach of the Agreement or by mutual consent.

Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman Paul Hopper.

(Press release, Radiopharm Theranostics, MAR 3, 2023, View Source [SID1234670424])

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.

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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.