Mural Oncology Cuts 90% of Workforce Following Failed Cancer Immunotherapy Trials
• Mural Oncology is discontinuing all clinical development of nemvaleukin alfa after the immunotherapy failed to meet target goals in melanoma and ovarian cancer trials.
• The Waltham-based biotech company will lay off approximately 104 employees (90% of its workforce) by the end of the second fiscal quarter of 2025.
• With approximately $144.4 million in cash reserves, Mural is now exploring strategic alternatives including potential acquisitions, mergers, or business combinations to maximize shareholder value.
Merck Accelerates Subcutaneous Keytruda Launch Following Positive Phase 3 Results
• Merck is expediting the launch of a subcutaneous formulation of Keytruda, anticipating approval and market availability in 2025, to extend patent protection.
• Phase 3 trial results demonstrated the subcutaneous Keytruda formulation's effectiveness, mirroring the intravenous version, paving the way for regulatory submissions.
• Keytruda, a cornerstone of Merck's portfolio, generated $21.6 billion in revenue in the first nine months of 2024, representing approximately 45% of the company's total income.
• The subcutaneous formulation aims to provide an alternative administration route as Merck prepares for the intravenous Keytruda's U.S. patent expiration in 2028.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
Mural Oncology Gears Up for Key Data Readouts of Nemvaleukin in Ovarian Cancer and Melanoma in 2025
• Mural Oncology's ARTISTRY-7 trial evaluating nemvaleukin with pembrolizumab in platinum-resistant ovarian cancer has reached 75% of overall survival events.
• Top-line data from ARTISTRY-6, a phase 2 trial of nemvaleukin monotherapy in mucosal melanoma, is expected in Q2 2025, potentially supporting accelerated approval.
• Preliminary data for less-frequent intravenous dosing of nemvaleukin in cutaneous melanoma is anticipated in 1H and 2H 2025 for monotherapy and combination therapy, respectively.
• Mural Oncology plans to submit an IND application for MURA-8518, a novel IL-18 candidate, in Q4 2025, expanding its cytokine-based immunotherapy pipeline.
BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer
• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer.
• The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs.
• Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer.
• The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.
TNBC Advances: Chemo-Free Regimen Shows Promise; Novel Immunotherapy Achieves High Response Rates
• Neoadjuvant nivolumab with or without ipilimumab induced immune activation and pathologic complete responses in early triple-negative breast cancer (TNBC).
• A novel immunotherapy strategy achieved high complete response rates in TNBC without typical immune-related adverse effects.
• Cetuximab improved 2-year disease-free survival versus durvalumab in cisplatin-ineligible advanced head and neck cancer patients.
Nemvaleukin Shows Promising Antitumor Activity in Advanced Solid Tumors
• Nemvaleukin, an engineered IL-2 fusion protein, demonstrates tolerability and antitumor activity in the ARTISTRY-1 phase 1/2 trial, both as monotherapy and in combination with pembrolizumab.
• The study showed a 10% overall response rate with nemvaleukin monotherapy and a 13% ORR with nemvaleukin plus pembrolizumab across heavily pretreated patients with advanced solid tumors.
• Notably, a 21% ORR was observed in patients with platinum-resistant ovarian cancer (PROC), a population that typically does not respond well to immunotherapy.
• Mural Oncology's ongoing registrational trials, based on ARTISTRY-1, are expected to have data readouts in late Q1/early Q2 2025 for PROC and Q2 2025 for mucosal melanoma.
Leqembi's EU Approval Faces Further Delay as EMA Re-evaluates Safety Data
• The European Commission has requested the EMA to re-examine Leqembi's safety data, potentially delaying its EU approval beyond the expected timeframe.
• The CHMP will assess recent safety data to determine if an update to its positive opinion is needed, particularly regarding risk minimization measures.
• Eisai and Biogen believe existing data support Leqembi's safety profile, reinforced by clinical use in the US and other approved regions.
• Leqembi is already approved in the US, Japan, China and other countries, with a new once-monthly intravenous maintenance dose approved in the US.
Mural Oncology's Nemvaleukin Trials Progressing, Data Readouts Anticipated in 2025
• Mural Oncology remains on track with late-stage trials for nemvaleukin alfa, expecting data readouts for platinum-resistant ovarian cancer in late Q1/early Q2 2025.
• Top-line results from the ARTISTRY-6 trial cohort 2, focusing on mucosal melanoma, are anticipated in Q2 2025, with a target response rate of 25%.
• Candidate nominations for IL-18 and IL-12 programs are expected in Q4 2024, with an IND submission for the IL-18 program planned for Q4 2025.
• The company reaffirms its cash runway guidance, projecting sufficient funds to support operations into the fourth quarter of 2025.
Mural Oncology Highlights Nemvaleukin Progress and IL-18 Program at Investor Day
• Mural Oncology's ARTISTRY-7 trial, evaluating nemvaleukin plus pembrolizumab in platinum-resistant ovarian cancer, anticipates interim data in early Q2 2025.
• Top-line results from the ARTISTRY-6 trial of nemvaleukin in mucosal melanoma are expected in Q2 2025, potentially supporting a BLA submission.
• Mural Oncology plans to submit an Investigational New Drug (IND) application for its IL-18 program to the FDA in Q4 2025.
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