On May 21, 2024 Alloy Therapeutics, a biotechnology ecosystem company dedicated to democratizing access to biologics drug discovery platforms and services, reported a licensing agreement for its murine platforms for fully human antibody discovery with Eli Lilly and Company (Press release, Alloy Therapeutics, MAY 21, 2024, View Source [SID1234643573]). The non-exclusive license provides Lilly access to the ATX-Gx and ATX-CLC mouse platforms and broad rights to use the Alloy platforms for antibody drug discovery and development under this multi-year collaboration.

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Launched in 2019, the Alloy ATX-Gx platform has rapidly become the industry standard fully human transgenic mouse platform to enable therapeutic discovery programs utilized by over 170 partners. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its murine platforms, adding new strains such as ATX-GL with the full human lambda repertoire as well as ATX-GKH hyperimmune strain for increased generation of antigen-specific B-cells and enhanced IgG class switching. In 2023 Alloy launched the ATX-CLC platform expressing common light chain antibodies with full heavy chain diversity to enable efficient, modular bispecific discovery.

Access to Alloy’s platforms extends to Lilly’s Catalyze360 program, a comprehensive platform designed to enable drug discovery and development for biotech partners, including opportunities for capital investment, world-class lab space, and exceptional R&D capabilities and expertise. Under the arrangement, biotech companies that work with Lilly Catalyze360 will have the opportunity for Alloy antibody discovery platforms to be deployed to rapidly progress partnered discovery campaigns and accelerate medicines to the clinic for patients.

"Lilly is a great collaboration partner, and we are excited to further enable the company’s broader R&D ecosystem with access to Alloy’s best-in-class technologies for discovering superior fully human antibodies and bispecifics against even the most challenging targets," said Heather Schwoebel, CBO of Antibodies and Strategic Collaborations at Alloy. "This collaboration represents just one example of the many ways Alloy is flexible in enabling our partners with a breadth of discovery solutions to support their objectives and improve patient lives."

On May 21, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Bristol-Myers Squibb, MAY 21, 2024, View Source [SID1234643483]). The updated goal date is December 29, 2024.

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The application is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

On May 21, 2024 NuCana plc (Nasdaq: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present at TD Cowen’s 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) (Press release, Nucana BioPharmaceuticals, MAY 21, 2024, View Source [SID1234643500]).

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Event: TD Cowen’s 5th Annual Oncology Innovation Summit
Date: Tuesday, May 28, 2024
Time: 8:30 AM EDT
Location: Virtual

The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On May 21, 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 two patients with metastatic breast cancer were treated with BTX-A51, a multi-specific kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9), that synergistically targets master regulators of cancer (Press release, Edgewood Oncology, MAY 21, 2024, View Source [SID1234643484]). BTX-A51 is being evaluated in a Phase 2a study for the treatment of estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer with and without GATA binding protein 3 (GATA3) mutations.

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GATA3 is a protein that helps maintain healthy breast cells but mutations in this protein, which are found in approximately 15% of breast cancer cases, are associated with shorter progression free (PFS) and overall survival (OS). Moreover, these mutations are almost always accompanied by a wild type (non-mutated) p53 tumor suppressor protein. Recent studies have shown that targeting MDM2, a molecule that degrades the p53 protein, could be particularly effective in treating cancers with these GATA3 mutations. Due to its ability to reduce MDM2 expression, Edgewood Oncology is testing the hypothesis that BTX-A51 may be beneficial in this breast cancer sub-population.

"This represents an important milestone for both Edgewood Oncology and for patients with ER+/HER2- breast cancer, particularly those with a GATA3 mutation, who need better treatment options targeted to their underlying mutation profile," said Zung L. Thai, M.D., Ph.D., chief medical officer of Edgewood Oncology. "Moreover, while CDK4/6 inhibitors remain a cornerstone of current treatment regimens, resistance to these therapies poses a formidable challenge. By targeting CDK7 and CDK9, key regulators of cell cycle progression, BTX-A51 not only aims to circumvent this resistance but also to transform the treatment landscape."

The ongoing Phase 2a trial of BTX-A51 is a multicenter, open-label, nonrandomized, multiple dose study evaluating the safety, toxicity, pharmacokinetics and preliminary efficacy of BTX-A51 in patients with ER+/HER2- metastatic breast cancer with and without GATA3 mutations. Multiple sites for the clinical study are open for enrollment. For more information, visit clinicaltrials.gov (NCT04872166).

On May 21, 2024 Molecular Targeting Technologies, Inc. (MTTI), reported that it will update findings on both 177Lu-EBTATE clinical and 225Ac-EBTATE preclinical work during the 2024 SNMMI meeting in Toronto June 8-11 (exhibition booth #1819) (Press release, EvaThera Theranostics, MAY 21, 2024, View Source [SID1234643485]).

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177Lu-EBTATE an EvaThera drug, is the first patented long-acting peptide targeted radiotherapeutic drugs. It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide payload. Evans blue in EBTATE binds to serum albumin, extending in vivo circulatory half-life and tumor residence time, enabling effective use of significantly lower radiopharmaceutical activity and fewer dosing cycles vs. the current standard of care (SOC). These benefits are also evident in recent studies of the 225Ac-EBTATE homolog.

Professor Zhaohui Zhu, MD, Peking Union Medical College Hospital, reflected "In our 3-year follow up on 30 patients* with metastatic neuroendocrine tumors (mNETs), 177Lu-EBTATE demonstrated good safety, with no nephro- or hepatoxicity and 86% disease control rate using 60% less radioactivity than 177Lu-DOTATATE. We observed low incidence of grade 3 hematoxicity (3.4% vs 15% of reported SOC) and no long-term nephrotoxicity of any grade."

The study "Long acting 225Ac-EBTATE is highly efficacious against somatostatin receptor-2-positive small-cell lung cancer (SCLC)**" has been accepted for presentation at 2024 SNMMI. Professor Humphrey Fonge of the University of Saskatchewan commented, "225Ac-EBTATE (2x 30 kBq administered 10 days apart) was effective against SCLC with 80% complete remissions and 100% survival. Treatment yielded a 2-fold greater tumor growth inhibition when compared with 225Ac-DOTATATE, at 60% less administered radioactivity. Toxicity, as measured by body weight, blood counts, and chemistry showed that 225Ac-EBTATE was well tolerated at a highly effective dose. 225Ac-EBTATE shows great promise against SCLC." Chris Pak, President & CEO of MTTI commented: "We are pleased to learn that 177Lu-EBTATE exhibited no safety concerns and was effective at a lower dose than SOC in mNET patients. We are also encouraged that 225Ac-EBTATE out-performed 225Ac-DOTATATE, providing a 2-fold greater tumor growth inhibition in preclinical findings using a much lower dose of radioactivity. We look forward to advancing our clinical trials with these radiotherapeutic drugs in small-cell lung and other cancers."