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 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 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported that it is presenting data about its proprietary INTASYL platform and INTASYL compounds (Press release, Phio Pharmaceuticals, OCT 7, 2024, View Source [SID1234647067]).

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INTASYL compounds offer precise targeting by silencing mRNA both intracellularly and extracellularly, significantly enhancing immune responses against cancer. They are effective as intratumoral injections and as excipients during immune cell expansion for adoptive cell therapy. INTASYL’s efficient delivery system requires no special formulations to streamline siRNA delivery to target cells.

INTASYL compound PH-762 silences PD-1, improving therapeutic efficacy in vivo. The PH-894 compound precisely silences BRD4 to enhance tumor cell immunogenicity and induce apoptosis. Silencing TIGIT in NK cells, using compound PH-804, enhances their activation, cytokine release, and target cell killing. The PH-905 compound silences CBLB, increasing NK cell cytotoxicity and proliferation.

The data is being presented on October 8th at the 20th Annual Oligonucleotide Therapeutics Society (OTS) Meeting in Montreal.

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 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported being selected to present two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2024, which is scheduled to be held November 6-10 at the George R. Brown Convention Center in Houston, Texas (Press release, Beyond Cancer, OCT 7, 2024, View Source [SID1234647068]). Abstracts are scheduled to be released to SITC (Free SITC Whitepaper) registrants on November 5, 2024, 9:00 AM U.S. ET.

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SITC Annual Meeting Presentations:

Title: Intratumoral Administration of Low Volume High-Concentration Nitric Oxide and Anti-rPD-L1 Treatment Leads to Prolonged Survival in MAT B III Tumor-Bearing Rats
Session Date and Time: Friday, November 8, 2024, 9:00 AM – 7:00 PM CDT
Session Type: Poster Presentation
Abstract Number: 723
Location: Exhibit Halls A B, George R. Brown Convention Center

Title: Intratumoral Administration of Low Volume Ultra-High Concentration Nitric Oxide and Immune Checkpoint Inhibitors in CT26 Tumor-Bearing Mice
Session Date and Time: Saturday, November 9, 2024, 9:00 AM – 8:30 PM CDT
Session Type: Poster Presentation
Abstract Number: 724
Location: Exhibit Halls A B, George R. Brown Convention Center

A copy of the ePublications can be accessed on the Science and Technology page of the Company’s website on November 7, 2024 at 9:00 am EDT.

About Nitric Oxide

Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.

About UNO Therapy for Solid Tumors

Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects.