MERCK KGAA | MedPath

ReproNovo Secures $65 Million Series A Funding to Advance Novel Reproductive Medicine Therapies

16 hours ago

• ReproNovo has raised $65 million in Series A financing led by Jeito Capital to advance two Phase 2-ready compounds targeting male infertility, adenomyosis, and embryo implantation success. • The company's lead candidates include RPN-001 (leflutrozole) for male infertility due to low testosterone levels and RPN-002 (nolasiban) for adenomyosis treatment and improving assisted reproductive technology outcomes. • This investment addresses critical gaps in reproductive medicine amid declining global fertility rates, with male sperm counts having fallen by 50-60% over the past four decades.

Imec Unveils Revolutionary Miniaturized Ingestible Sensor for Non-Invasive Gut Health Monitoring

2 days ago

• Imec has developed a highly miniaturized ingestible sensor measuring just 2.1cm in length and 0.75cm in diameter, three times smaller than existing capsule endoscopies, capable of monitoring gut health for up to a week. • The innovative device is the first to measure redox balance, a marker for oxidative stress and inflammation, alongside pH and temperature throughout the entire gastrointestinal tract without requiring unpleasant bowel preparation. • Following successful testing in healthy volunteers, Imec plans to evaluate the sensor in patient populations with cancer and inflammatory disorders in collaboration with Radboud University Medical Center.

TILT Biotherapeutics Secures $25.6M Series B to Advance Novel Oncolytic Virus Therapy for Ovarian Cancer

9 days ago

• TILT Biotherapeutics has raised $25.6 million in Series B funding to advance TILT-123, an oncolytic adenovirus engineered to enhance immune response against tumors, into Phase 2 trials for platinum-resistant ovarian cancer. • Phase 1a trial results showed disease control in 64% of evaluable patients with platinum-resistant ovarian cancer, with a 20% overall response rate at the highest dose level and median overall survival of 190 days. • The Helsinki-based company is expanding its U.S. clinical footprint with multiple new trial sites planned for 2025, while also pursuing additional Phase 1b studies in melanoma and other indications.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Eli Lilly Commits $250 Million to Expand Purdue University Research Alliance Through 2032

13 days ago

• Eli Lilly has extended its research collaboration with Purdue University through 2032, investing up to $250 million over the next eight years in what could become the largest industry-academic partnership in the United States. • The expanded alliance will facilitate researcher exchanges between Purdue's campus and Lilly's Indianapolis facilities, while also utilizing Indiana's LEAP Research and Innovation District to accelerate drug discovery and development. • This partnership represents a significant investment in pharmaceutical innovation infrastructure, focusing on improving both drug discovery processes and manufacturing capabilities in the U.S.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Merck's Enpatoran Shows Promise for Lupus Rash in Phase 2 Trial Despite Mixed Results

3 months ago

• Merck's oral TLR7/8 inhibitor enpatoran demonstrated clinically meaningful reduction in disease activity for patients with cutaneous lupus erythematosus and systemic lupus erythematosus with active lupus rash in the Phase 2 WILLOW study. • The drug met its primary endpoint in Cohort A with up to 91.3% of patients achieving CLASI-50 response at Week 24, though it failed to meet the primary endpoint in the systemic lupus erythematosus cohort (Cohort B). • As a potential first-in-class oral therapy targeting the TLR7/8 pathway, enpatoran could address significant unmet needs for lupus patients, with Merck now in discussions with health authorities regarding a global Phase 3 program.

FDA Grants Breakthrough Therapy Status to Radiprodil for GRIN-Related Seizure Treatment

3 months ago

• GRIN Therapeutics' radiprodil receives FDA Breakthrough Therapy designation for treating seizures in patients with GRIN-related neurodevelopmental disorder, showing 86% median reduction in seizure frequency during Phase 1b trials. • The investigational drug demonstrated significant efficacy in Phase 1b Honeycomb study, with 71% of patients achieving over 50% reduction in countable motor seizures and most patients showing behavioral improvements. • The company plans to initiate Phase 3 pivotal trials in mid-2025, backed by a $200M capital commitment from Blackstone Life Sciences, to evaluate radiprodil's impact on seizures and behavioral outcomes.

PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial

3 months ago

• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months. • The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk. • Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.

FDA Reviews Accelerated Approvals for Keytruda, Opdivo, and Tecentriq in Multiple Cancers

5 months ago

• The FDA is re-evaluating the accelerated approvals of Merck's Keytruda, Bristol-Myers Squibb's Opdivo, and Roche's Tecentriq across six cancer types due to failed confirmatory trials. • ODAC will discuss Tecentriq with Abraxane for advanced triple-negative breast cancer, focusing on alternative confirmatory studies after the Impassion131 trial failure. • Keytruda and Tecentriq's first-line treatment status for urothelial carcinoma is under review, considering the approval of Bavencio as a first-line maintenance therapy. • The committee will also assess Keytruda for gastric cancer and Keytruda/Opdivo for hepatocellular carcinoma, examining if the initial benefits have been confirmed.

AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC

5 months ago

• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial. • The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients. • A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients. • Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). • The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo. • Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression. • Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.

Merus' Petosemtamab and Mersana's Emi-Le Show Promise in Cancer Treatment

6 months ago

• Merus' petosemtamab demonstrates a 36% overall response rate in recurrent/metastatic head and neck squamous cell carcinoma, with median overall survival of 11.4 months. • Mersana Therapeutics' Emi-Le receives Fast Track designation for HER2-negative breast cancer, showing promising monotherapy activity in multiple tumors. • Petosemtamab's clinical trials are ongoing, including phase 3 studies in HNSCC and expanded evaluation in metastatic colorectal cancer, with data updates planned for 2025.

Pimicotinib Achieves Primary Endpoint in Phase 3 Trial for Tenosynovial Giant Cell Tumor

6 months ago

• Merck KGaA's pimicotinib demonstrated a significant objective response rate (ORR) of 54% at week 25 compared to 3.2% for placebo in the MANEUVER trial. • The CSF-1R inhibitor showed efficacy in reducing joint stiffness and pain, as measured by NRS and BPI pain scores, respectively. • Pimicotinib is poised to compete with existing TGCT therapies, including Daiichi Sankyo's Turalio and Ono Pharma's vimseltinib. • Abbisko Therapeutics will collaborate with Merck on the registration of pimicotinib as a systemic therapy for TGCT in China.

Evolution of Pharmaceutical Industry: From Apothecaries to Modern Drug Development Giants

5 years ago

• The pharmaceutical industry transformed from traditional apothecaries in the 19th century to scientific enterprises, with companies like Merck and Pfizer pioneering industrial medicine production. • Major breakthroughs including insulin treatment and penicillin development in the early 20th century marked the beginning of modern pharmaceutical research and mass production. • Recent innovations in immunotherapy, gene therapy, and COVID-19 vaccines showcase the industry's advancement, while challenges remain in antibiotic development and drug pricing.