On January 29, 2025 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), reported the publication of an article entitled "Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study," in the peer-reviewed journal Clinical Breast Cancer (Press release, Sermonix Pharmaceuticals, JAN 29, 2025, View Source [SID1234649982]).
The previously reported Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study (NCT03781063) was an open-label, randomized trial evaluating the efficacy and safety of lasofoxifene versus fulvestrant. In the study of women with ESR1-mutant breast cancer who previously had aromatase inhibitor-CDK4/6is, 52 women were randomized to lasofoxifene and 51 to fulvestrant, with progression-free survival (PFS) as the primary endpoint. Lasofoxifene monotherapy had numerically greater PFS (median 5.6 vs 3.7 months; P=0.138; hazard ratio [HR] 0.669 [95% CI, 0.434-1.125]), objective response rate (ORR, 13.2% vs 2.9%; P=0.124), and clinical benefit rate (CBR, 36.5% vs 21.6%; P=0.117) versus fulvestrant. The small sample size of this Phase 2, signal-seeking study limited the statistical power. A favorable safety profile was reported in both treatment groups.1
In this secondary endpoint analysis just published, patients treated with investigational lasofoxifene – but not fulvestrant – demonstrated improved vaginal and vulvar symptoms of dryness and pain as assessed by the validated vaginal and vulvar symptom scale (VAS and VuAS) patient-reported outcome instrument.
"Recent progress in breast cancer management is leading to improved patient outcomes and longevity. Sermonix is highly focused on advancing oral lasofoxifene to hopefully build on that progress and to potentially improve patient quality of life particularly around urogenital health, an issue important to many patients and couples coping with current breast cancer treatments," said Dr. David Portman, Sermonix founder and chief executive officer. "While lasofoxifene has been previously studied in healthy post-menopausal women with urogenital syndrome of menopause, it has not been explored in a population with advanced breast cancer. We are very pleased that Clinical Breast Cancer, a prestigious peer-reviewed journal, recognized the importance of the results from ELAINE-1 and the need for further research in this area."

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Results: Of 103 enrolled patients, 72 (70%) completed the mean vaginal (VAS) and vulvar (VuAS) assessment scales (mean age 61.5 years). Vaginal (40%)/vulvar (25%) dryness and vaginal pain (22%) were the most frequently reported symptoms; 26% reported ≥1 moderate/severe symptom. Lasofoxifene decreased the mean composite VAS/VuAS, VAS, and VuAS from baseline to week 16 by 74%, 74%, and 79%, respectively, while fulvestrant increased them by 36%, 15%, and 63%, respectively. Baseline vaginal/vulvar symptoms were more severe if patients were under age 40, had no visceral disease, used adjuvant tamoxifen previously, or had a longer duration of AI use in the adjuvant/metastatic settings.
The currently enrolling Phase 3, registrational, ELAINE-3 trial (NCT05696626) comparing the efficacy and safety of lasofoxifene plus abemaciclib to fulvestrant plus abemaciclib will incorporate the FACT B-Endocrine Symptoms scale to further explore the potential impact of treatment on vaginal dryness, painful intercourse, sexual interest and other quality-of-life domains.
The open-access Clinical Breast Cancer paper can be accessed online here.
To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit View Source To learn more about the ELAINE studies, visit View Source
Goetz MP et al Annals of Oncology 2023;34:1141-1151

About Lasofoxifene
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc., has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

On January 29, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported a collaboration with aimed analytics, a cutting-edge medical data analytics company (Press release, TME Pharma, JAN 29, 2025, View Source [SID1234649941]). This partnership supports TME Pharma’s strategic plan, announced on December 4, 2024, by enhancing its capability profile for potential strategic partners.

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This partnership aims to leverage artificial intelligence (AI) to create new and improved drug candidates without the need for time and resource-intensive laboratory testing. The collaboration leverages recent cutting-edge advances in AI to accelerate timelines while reducing associated costs and need for experimental infrastructure.

"The 2024 Nobel Prize in Chemistry was awarded for AI-based models that allow remarkable prediction of molecular structures. This technology can also be used to discover new drugs and improved versions of existing drugs. We believe that the collaboration with aimed analytics will further advance our strategic vision announced last December. By combining our expertise in development of oligonucleotide drugs, cancer biology and immune-oncology with aimed analytics’ cutting-edge capabilities, we aim to integrate AI- and Deep Learning-driven insights into our drug discovery capabilities," said Aram Mangasarian, CEO of TME Pharma. "The goal of this collaboration is to allow TME Pharma to not only bring its existing drugs to the table for strategic partners, but also the potential for rapid and efficient discovery of new drugs. We are committed to delivering on the goals of our new strategy announced in December 2024 and plan to share further information about our progress in the coming weeks."

"We are excited to partner with TME Pharma and contribute our deep-learning and structural modelling expertise to their innovative approach in cancer treatment," said Dr. Patrick Günther, CEO of aimed analytics. "By enabling a comprehensive search for promising therapeutic compounds and bringing a new level of technological sophistication to TME Pharma’s drug discovery efforts, we aim to accelerate the discovery of more effective treatments and potentially lead to breakthrough therapies for patients in need."

On January 29, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference being held from February 5-6, 2025 in New York (Press release, Adicet Bio, JAN 29, 2025, View Source [SID1234649940]).

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Details of the event are as follows:
Date: Wednesday, February 5, 2025
Time: 2:00 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On January 29, 2025 Leveragen Inc., a Boston-based biotech company specializing in next-generation genetic models for antibody discovery, reported a strategic collaboration with Moonlight Bio, a Seattle-based biotech company pioneering advanced T cell therapies (Press release, Moonlight Bio, JAN 29, 2025, View Source [SID1234649939]). This partnership aims to develop cutting-edge T cell therapies to address some of the most challenging and difficult-to-treat cancers.

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The collaboration integrates Leveragen’s proprietary Singularity Sapiens Mouse platform, a groundbreaking tool for generating fully human single-domain antibodies, with Moonlight Bio’s expertise in T cell engineering. Together, the two companies seek to create T cell therapies with enhanced functionality, persistence, and efficacy, overcoming significant barriers in the treatment of solid tumors.

"Leveragen’s mission is to drive innovation in the fight against life-threatening diseases, and expanding our fully human single-domain antibody technology into transformative T cell therapies aligns seamlessly with this vision," said Weisheng Chen, Founder and CEO of Leveragen. "Through this partnership with Moonlight Bio, we are combining our state-of-the-art antibody discovery platform with their advanced cell engineering capabilities to develop T cell therapies that have the potential to make a meaningful difference for patients."

"At Moonlight Bio, we are dedicated to delivering T cell therapies that break through barriers obstructing successful outcomes in solid tumors – the vast majority of the global cancer disease burden," said Jordan Jarjour, Moonlight Bio’s CSO. "Leveragen’s Singularity Sapiens Mouse platform is a powerful tool for generating fully human single-domain antibodies with properties that could optimally translate into advanced T cell therapies, particularly when combined with the tools and technologies that the Moonlight Bio team is advancing. We are very excited to collaborate with Leveragen as we explore and create new solutions in this space."

Under the terms of the agreement, Leveragen will spearhead the discovery of fully human single-domain antibodies against therapeutic targets and Moonlight Bio will oversee the preclinical development of T cell therapies.

This collaboration highlights Leveragen’s leadership in single-domain antibody discovery and its commitment to advancing immunotherapy through innovative science and transformative applications.

On January 29, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported it has entered into an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property (IP) assets from Ayala Pharmaceuticals (OTC: ADXS) (Press release, OS Therapies, JAN 29, 2025, View Source [SID1234649938]). The assets being acquired include a Phase 2 lung cancer and Phase1 prostate cancer program, in addition to the gaining direct ownership of the underlying IP related to OS Therapies’ lead asset OST-HER2 for osteosarcoma and other HER2-related indications.

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"The assets being acquired from Ayala complete OS Therapeutics’ ownership of the key intellectual property underlying our listeria monocytogenes immunotherapy platform, as well as bolster our development pipeline with the addition of clinical-stage lung cancer and prostate cancer immunotherapy assets," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "Importantly, this agreement eliminates certain near-term milestone payment obligations related to OST-HER2 in osteosarcoma, projected sales milestone payments, and significantly reduces our effective royalty rate. As a result, we have enhanced both the clinical and financial prospects for the Company with minimal impact to our cash position. The elimination of these milestones payment obligations and reduction in royalties obligations significantly improves the net present value of the OST-HER2 program while also improving our negotiating position with potential partners. Taken together, this agreement bolsters our financial and partnership prospects."

OS Therapies anticipates requesting Biologics Licensing Authorization (BLA) for OST-HER2 in osteosarcoma in the second quarter of 2025, and hopes to be granted a BLA and related Priority Review Voucher (PRV) from FDA by the end of 2025. Additionally, the Company intends to sell the PRV immediately upon issuance and does not intend to initiate any new clinical development programs until it has completed interactions with FDA around OST-HER2 in osteosarcoma.

Under the terms of the agreement, OS Therapies has agreed to pay $0.5 million in cash and issue $7.5 million worth of OS Therapies’ common shares to Ayala. The transaction is expected to close 60 days from execution of the agreement, subject to customary closing conditions.

OS Therapies previously disclosed that it completed a $7.1 million financing, priced at $4.00 per share primarily with existing shareholders, that provides the Company with sufficient cash runway into 2026 inclusive of payments to Ayala. Under the terms of the financing agreement, OS Therapies is prohibited from issuing shares to raise capital for at least 6 months and suspended the issuance of shares to raise capital under its equity line of credit so long as the price of the common stock is below $12.00. The Company’s burn rate is now approximately $0.4M per month.

As part of the financing agreement, OS Therapies agreed to appoint Karim Galzahr to the Company’s Board of Directors. Galzahr is managing partner at OKG Capital, a medtech and life science investor. Galzahr brings over 30 years of experience in all aspects of finance including M&A, asset management, corporate development and strategic advisory work across the technology sector and medical technology sectors.

"I am honored to join the OS Therapies Board of Directors at such a pivotal moment in the Company’s journey," said Galzahr, newly appointed Board Member of OS Therapies. "With compelling Phase 2b osteosarcoma data, the anticipated FDA approval of OST-HER2, and the potential to earn a saleable Priority Review Voucher, the Company is positioned to unlock the full potential of its market leading listeria-based immunotherapy platform. This acquisition not only strengthens its intellectual property portfolio but also clears financial hurdles, paving the way for groundbreaking work in osteosarcoma and expanding opportunities in lung and prostate cancer. I look forward to contributing to OS Therapies’ mission of transforming cancer care and improving patient outcomes worldwide."

Lung Cancer Asset Clinical Data

Lung Cancer

ASCO 2022 Poster: A phase 2 study of an off-the-shelf, multi-neoantigen vector (ADXS-503 / OST-503) in patients with metastatic non-small cell lung cancer either progressing on prior pembrolizumab or in the first line setting.

Conclusions: The addition of ADXS-503 (OST-503) to pembro (Keytruda) after disease progression on pembro appears to be well tolerated and induced antigen-specific T-cell responses and durable disease control in 46% of patients in Part B and 67% of patients in Part C. Additional patients are currently being enrolled into both parts of the study to further explore the potential of A503 to restore or enhance sensitivity to checkpoint inhibitors. Clinical trial information: NCT03847519.

ASCO 2022 Poster: Immunogenicity and disease control induced by a multi-neoantigen vaccine (ADXS-503 / OST-503)) in patients with metastatic non-small cell lung cancer who have progressed on pembrolizumab.

Conclusions: Adding ADXS-503 (OST-503) to pembro (Keytruda) after Progression of Disease appears to induce innate and adaptive immune responses that may restore or enhance sensitivity to checkpoint inhibitors in pts with clinical benefit. Clinical trial information: NCT03847519.
The global lung cancer treatment market size was estimated at $19 billion in 2023 according to Grandview Research and is expected to grow to over $44 billion by 2030. The global prostate cancer treatment market was estimated at $6.4 billion in 2023 according to Grandview Research and is expected to grow to over $16 billion by 2030.