On February 12, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults (Press release, Cidara Therapeutics, FEB 12, 2024, View Source [SID1234639978]).

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This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.

"The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients."

Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year.

On February 12, 2024 Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (Nasdaq: RYZB) reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or HSR Act, in connection with Bristol Myers Squibb’s previously reported tender offer to acquire all of the outstanding shares of RayzeBio common stock for a purchase price of $62.50 per share in cash, or approximately $4.1 billion (Press release, Bristol-Myers Squibb, FEB 12, 2024, View Source [SID1234639977]). The expiration of the waiting period occurred at 11:59 p.m. EST on February 9, 2024.

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Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transaction, including the tender offer and the merger, which remains subject to the tender of a majority of the outstanding shares of RayzeBio’s common stock, as well as other customary closing conditions. Unless the tender offer is extended, the offer will expire one minute after 11:59 p.m. New York City time, on February 22, 2024.

On February 12, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its fourth quarter 2023 financial results on Monday, February 26, 2024 (Press release, BioCryst Pharmaceuticals, FEB 12, 2024, View Source [SID1234639976]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

On February 12, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that treatment has commenced for the fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, FEB 12, 2024, View Source [SID1234639975]). The study is being conducted through a research partnership with Moffitt Cancer Center.

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The first-in-human trial is enrolling patients with recurrent/resistant ovarian cancer who have progressed on at least two prior therapies. The CAR T was safe and tolerable in the first three patients treated. The fourth patient, the first patient enrolled in the second cohort, received triple the dose of CAR-T cells compared with the dose of the first cohort. Anixa’s Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting FSHR, which research indicates is expressed on ovarian cells, as well as in the vasculature of tumors.

Dr. Amit Kumar, Chairman and CEO of Anixa, commented, "With no safety issues observed in the first cohort of patients, we have successfully advanced to the next cohort to evaluate a 3x higher dose. As the trial progresses, we seek to demonstrate efficacy of our cell therapy in solid tumors—a difficult challenge for traditional CAR-T therapies that have been shown to be efficacious in hematological tumors and lymphoma."

Dr. Robert Wenham, the Principal Investigator of the trial and the Chair of Gynecologic Oncology at Moffitt, stated, "First, we have the advantage of a target that is much more specific to our tumor tissue, which should minimize any on-target, off-tumor effect. Additionally, we are administering the engineered T-cells directly into the peritoneum (IP), which is the location of most of the ovarian tumor lesions. We hope that this delivery approach will enable direct trafficking of the CER-T-cells to the tumor sites and minimize adverse events such as cytokine release syndrome (CRS)".

ON February 12, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche (Press release, Repare Therapeutics, FEB 12, 2024, View Source [SID1234639967]).

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Roche notified Repare that, effective May 7, 2024, it is terminating its worldwide license and collaboration agreement for the development and commercialization of camonsertib following a review of Roche’s pipeline and evolving external factors. Repare regains full control of all rights for camonsertib, a potential best-in-class inhibitor of ATR.

"Camonsertib is a valuable, high-potential precision oncology medicine that has achieved clinical proof-of-concept in multiple tumor types and genotypes both as monotherapy and in combination, as previously reported. We have been continuously running clinical trials for camonsertib since July 2020 and are excited to steward the progress of this promising therapy," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "While we are disappointed to end this collaboration, we appreciate the contributions Roche has made to the program. With the return of camonsertib, Repare’s deep clinical pipeline consists of four wholly-owned synthetic lethal therapies."

Camonsertib is also part of Repare’s ongoing Phase 1 MYTHIC trial evaluating the combination of camonsertib and lunresertib, a first-in-class, oral small molecule inhibitor of PKMYT1, in patients with molecularly selected, advanced solid tumors. In October 2023, Repare presented data on the camonsertib and lunresertib combination, demonstrating clear evidence of clinical benefit across multiple tumor types and all selected genotypes, with an overall response of 33.3% across all tumor types and 50% RECIST objective response in patients with heavily pre-treated gynecologic tumors at the preliminary recommended Phase 2 dose of the combination. Repare expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024.

Repare has met all obligations under the Roche agreement to date, and recently earned a $40 million milestone payment from Roche. Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026.

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.