Alloy Therapeutics Announces Platform License Agreement with Lilly

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."

Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

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.

NuCana to Present at TD Cowen’s 5th Annual Oncology Innovation Summit

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.

Edgewood Oncology Announces First Patients Dosed in Phase 2a Study of BTX-A51 in Genetically-Defined Breast Cancer

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).

FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

On May 20, 2024 Genentech, a member of the Roche Group reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (Press release, Genentech, MAY 20, 2024, View Source [SID1234643467]).

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"We are pleased that the FDA granted Breakthrough Therapy Designation for inavolisib in recognition of the substantial clinical benefit observed with this regimen," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "This promising inavolisib-based regimen could transform the PI3K inhibitor class, potentially becoming the standard of care for this patient population in the first-line setting."

Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over existing therapies.

The FDA’s decision is based on positive Phase III INAVO120 results, which showed the inavolisib-based regimen reduced the risk of disease worsening or death (progression-free survival) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). Overall survival (OS) data were immature at this time, but a clear positive trend has been observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary of 0.0098). Follow-up for OS will continue to the next analysis. These data reinforce the potential for this inavolisib-based regimen to benefit patients with PIK3CA-mutated locally advanced or metastatic breast cancer.

PIK3CA is one of the most commonly mutated genes in advanced or metastatic breast cancer. Despite the prevalence of PIK3CA mutations, many patients are not tested until later in their treatment journey. Early testing for PIK3CA prior to initiating first-line treatment helps clinicians make a personalized treatment decision.

Data from INAVO120 are also being submitted to other global health authorities, including the European Medicines Agency.

Inavolisib is currently being investigated in three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations. We continue to evaluate potential clinical development program expansion opportunities to address patient unmet needs in various tumor types across oncology.

About inavolisib

Inavolisib is an investigational, oral targeted treatment with best-in-class potential that could provide well-tolerated, durable disease control and potentially improved outcomes for people with PIK3CA-mutated, HR-positive, HER2–negative, locally advanced or metastatic breast cancer, who often have a poor prognosis and are in urgent need of new treatment options. Inavolisib has been designed to help minimize the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.

About the INAVO120 study

The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.

Beyond INAVO120, inavolisib is currently being investigated in two additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:

in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and
in combination with dual HER2 blockade vs dual HER2 blockade and optional physician’s choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).

About Hormone Receptor-Positive Breast Cancer

HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.

About Genentech in Breast Cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.