On October 7, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into a Clinical Manufacturing Agreement with SpectronRx for the production of the diagnostic 64Cu-SAR-bisPSMA product for its Phase III trials (Press release, Clarity Pharmaceuticals, OCT 7, 2024, View Source [SID1234647052]). This agreement builds on the earlier Master Services Agreement and Supply Agreement for the production of the 64Cu isotope, now allowing for a streamlined manufacturing process of both the isotope and the 64Cu-SAR-bisPSMA product at the same facility.

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SpectronRx’s facility enables on-demand 64Cu-SAR-bisPSMA manufacturing and distribution to all 50 states. This provides reliable, universal access of 64Cu-SAR-bisPSMA in the U.S. for Clarity’s Phase III trials, including the ongoing CLARIFY trial in the pre-prostatectomy setting, as well as the upcoming pivotal trial for prostate cancer patients with biochemical recurrence (BCR). The agreement with SpectronRx complements Clarity’s existing supply network, providing a layered and abundant supply approach, which is unique in the radiopharmaceutical space.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are excited to continue strengthening our supply network, ensuring vulnerable patients in need of novel diagnostic options can get access to what we believe is a best-in-class product, on time and at any treatment centre with a positron emission tomography (PET) camera.

"Current-generation radiopharmaceutical diagnostic products rely on isotopes with very short half-lives, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours, which translate into short shelf-lives of the diagnostic products. This limits the use of these products to large treatment centres and hospitals with radiopharmacy facilities nearby that can produce F-18 and/or Ga-68. Cu-64 has an ideal 12.7-hour half-life and can overcome the overwhelming supply restraints of other diagnostic isotopes through central manufacture and distribution across the U.S. from a single facility. At Clarity, we believe that this approach has the potential to reduce disparities in prostate cancer care, providing patients with access to next-generation imaging products, regardless of their geographic location."

SpectronRx has a proven track record in generating multi-curie activities, representative of hundreds of patient doses, in a short irradiation window. SpectronRx also has in-house target preparation and integrated recycling facilities for Ni-64, the starting material for Cu-64 production. As such, the leftover Ni-64 after the initial production cycle can be recycled at SpectronRx. This avoids the inefficiencies, low yields and costs associated with the use of third-party systems for Ni-64 target production and target recycling that are more suited to small-scale on-site cold kit labelling.

"We look forward to swiftly progressing our Phase III trials with the assurance of abundant product supply and seamless distribution across the U.S. as we are getting closer to our ultimate goal of improving treatment outcomes for people with cancer," Dr Taylor said.

The Clinical Manufacturing Agreement is effective as of 8 October 2024 and is for an initial period of 24 months. Cancellation and extension provisions are aligned with industry standard rates.

On October 7, 2024 Celyad Oncology (Euronext: CYAD) (the "Company"), reported two poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Houston, November 6-10, 2024 (Press release, Celyad, OCT 7, 2024, View Source [SID1234647051]).

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Poster Presentation Details

Abstract 262: PSMA/NKG2DL tandem CAR T-cells to overcome antigen heterogeneity and improve anti-tumor efficacy against prostate cancer. To be presented on Saturday, November 9 at the Poster session (Cellular Therapies)
Abstract 1133: Efficient, safe and customizable modulation of multiple target genes in CAR T-cells through a miRNA-based shRNA platform. To be presented on Friday November 8 at the Poster session (Immuno-Engineering)
Posters will be available in the poster hall and virtually to registrants of the SITC (Free SITC Whitepaper) Annual Meeting, beginning Nov. 7 at 10 a.m. ET. Posters will also be archived under "Scientific Publications" in the Science section of the Company’s website located at www.celyad.com.

On October 7, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported a corporate restructuring to focus resources on advancing lead program BDTX-1535 into pivotal development, and to extend the Company’s expected cash runway into Q2 2026 (Press release, Black Diamond Therapeutics, OCT 7, 2024, View Source [SID1234647050]). BDTX-1535 has demonstrated robust Phase 2 clinical activity across a broad spectrum of epidermal growth factor receptor mutations (EGFRm) in patients with recurrent non-small cell lung cancer (NSCLC).

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In Q1 2025, Black Diamond anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for patients with EGFRm NSCLC. Also in Q1 2025, the Company plans to present updated Phase 2 results for BDTX-1535 in patients with recurrent EGFRm NSCLC and a potential registration path in the recurrent setting based on feedback from the FDA.

Black Diamond is actively seeking partnerships as it deprioritizes its BDTX-4933 program in RAF/RAS-mutant solid tumors. To enable focused investment in BDTX-1535, Black Diamond has also taken steps to optimize operations, including a reduction in force, while retaining core drug development and management expertise. As part of the restructuring, Chief Business Officer and Chief Financial Officer Fang Ni and Chief People Officer Elizabeth Montgomery are departing the Company. Erika Jones, Senior Vice President of Finance and Principal Accounting Officer, has been appointed Principal Financial Officer of the Company. Cost savings from the restructuring and other actions described above are expected to be sufficient to fund operations into Q2 2026.

"BDTX-1535 is a well-tolerated oral TKI with the potential to benefit patients with EGFRm NSCLC across multiple lines of therapy," said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics. "We remain focused on advancing BDTX-1535 and presenting additional Phase 2 data in Q1 2025. I am deeply grateful to each member of the Black Diamond team, whose hard work and valuable contributions have brought us to the threshold of pivotal development for our lead program."

About BDTX-1535

BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic EGFR mutations in NSCLC, including classical mutations, non-classical mutations, and the C797S resistance mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity" trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).

On October 6, 2024 Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, reported that the first patient has been dosed in a Phase 1 investigator-sponsored study of BTX-A51 at Dana-Farber Cancer Institute (Press release, Edgewood Oncology, OCT 6, 2024, View Source [SID1234651961]). The trial is evaluating BTX-A51 in patients with metastatic and/or recurrent liposarcoma, which is characterized by Murine Double Minute Clone 2 (MDM2) amplifications.

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BTX-A51 is a multi-specific kinase inhibitor targeting casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9)—key regulators of transcriptional control and tumor cell survival.

The ongoing Phase 1 study is a single-arm pilot trial designed to assess the safety and tolerability of BTX-A51, along with an initial evaluation of its biological activity in patients with advanced MDM2-amplified liposarcoma. The trial is currently open for enrollment. Additional details about the study can be found at clinicaltrials.gov under the identifier NCT06414434.

On October 7, 2024 OnKure Therapeutics, Inc. (Nasdaq: OKUR) ("OnKure"), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, reported the completion of its previously announced merger of OnKure, Inc. and Reneo Pharmaceuticals, Inc. ("Reneo") (Press release, OnKure Therapeutics, OCT 4, 2024, View Source [SID1234647061]). The combined company will operate under the name OnKure Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on October 7, 2024 under the ticker symbol "OKUR".

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Concurrent with the closing of the merger, the company completed a $65 million private placement with a group of new and existing investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), Vestal Point Capital, and other undisclosed investors. Following the transactions, OnKure is expected to have a cash runway through multiple clinical readouts and into Q4-2026.

"We are ecstatic to finalize this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "Our lead program OKI-219, a highly selective inhibitor of PI3KαH1047R, has the potential to provide benefit to breast cancer patients. With the PIKture-01 trial of OKI-219 well underway, we look forward to releasing early clinical data in the fourth quarter of 2024 and initiating planned combination arms of the PIKture-01 trial."

Transaction Details

In connection with the closing of the merger, Reneo effected a 1-for-10 reverse stock split of its common stock. Following the reverse stock split and based on the final exchange ratios of 0.0236 shares of Reneo common stock for each share of OnKure common stock and 0.1448 shares of Reneo common stock for each share of OnKure preferred stock, at the closing of the merger there were approximately 13.3 million shares of common stock outstanding, with prior Reneo stockholders owning approximately 31.8% and prior OnKure, Inc. stockholders holding approximately 68.2% of the combined company’s outstanding common stock before the concurrent financing. Following the consummation of the private placement of $65.0 million of newly issued common stock, prior OnKure, Inc. stockholders own approximately 53.6%, prior Reneo stockholders own approximately 25.1%, and the private placement investors own approximately 21.3% of the combined company’s outstanding stock.

Leerink Partners served as exclusive financial advisor for Reneo. Jones Day and Cooley LLP served as legal counsel for Reneo for the transactions. Leerink Partners, Evercore ISI and LifeSci Capital served as the placement agents for the private placement financing. Covington & Burling LLP served as legal counsel to the placement agents in connection with the private placement financing. Oppenheimer & Co. served as capital markets advisor to OnKure, Inc., and Wilson Sonsini Goodrich & Rosati, P.C. served as legal counsel to OnKure, Inc.

Leadership Team and Board of Directors Updates

The combined company will be led by Nicholas A. Saccomano, Ph.D. as President and Chief Executive Officer of OnKure. In addition to Dr. Saccomano, the OnKure leadership team includes Samuel Agresta, M.D., as Chief Medical Officer, Dylan Hartley, Ph.D., as Chief Scientific Officer, and Jason Leverone, as Chief Financial Officer.

The Board of Directors of OnKure will be composed of Dr. Saccomano, Isaac Manke, Ph.D., R. Michael Carruthers, Andrew Philips, Ph.D., who join from OnKure, Inc.’s Board of Directors, Michael Grey and Edward T. Mathers, who continue from Reneo’s Board of Directors, and Valerie M. Jansen, who joined the Board at the closing of the merger.

About PI3Kα and OKI-219

PI3Kα is the most frequently mutated oncogene in cancers, and PI3KαH1047R is the most common mutation in this gene, being found in 15% of breast cancer and 4% of cancers overall. While novel drugs targeting PI3Kα have been approved for treatment, the lack of mutant selectivity of these therapeutics drives considerable on-target toxicity by inhibiting the normal version of this protein in various tissues.

OnKure is discovering and developing a portfolio of highly mutant-selective PI3Kα inhibitors with the goal of improving efficacy and safety with molecules that fully inhibit the mutant oncogene while sparing the wild-type enzyme in normal tissues. OnKure’s lead product candidate, OKI-219, is an orally bioavailable, highly selective inhibitor of PI3KαH1047R with approximately 80-fold selectivity for the mutated form of the enzyme compared to wild-type. OnKure believes that the wild-type-sparing properties of OKI-219 should significantly improve the activity and safety relative to currently approved PI3Kα inhibitors. Currently, OKI-219 is being evaluated in a Phase 1 clinical trial in solid tumor patients with PI3KαH1047R mutations, including breast cancer.