GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment
• GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion.
• The acquisition includes an upfront payment of $1.2 billion, with potential for additional success-based milestone payments totaling $800 million.
• This strategic move strengthens GSK's pharmaceutical portfolio in the liver disease therapeutic area, addressing significant unmet medical needs.
GSK Acquires Efimosfermin for $1.2 Billion to Target Steatotic Liver Disease
• GSK has agreed to acquire efimosfermin alfa from Boston Pharmaceuticals for $1.2 billion upfront, with potential additional milestone payments of $800 million, strengthening its hepatology pipeline.
• Efimosfermin, a phase III-ready FGF21 analog, has shown promising results in reversing liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH), with a convenient once-monthly dosing regimen.
• Steatotic liver disease affects approximately 5% of the global population with limited treatment options, and interventions that reduce fibrosis could save the US healthcare system between $40-100 billion over the next two decades.
GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure
• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.
• The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments.
• iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• 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.
e-therapeutics' ETX-312 Shows Promise as Disease-Modifying MASH Treatment in Preclinical Studies
• e-therapeutics has presented new preclinical data demonstrating ETX-312, their GalOmic siRNA candidate, significantly improves NAFLD Activity Score in MASH mouse models both as monotherapy and in combination with other agents.
• The experimental treatment showed comparable fibrosis progression reduction to GLP-1/GIP receptor agonists and FGF-21 analogues, with statistically significant reductions in hepatic collagen staining and circulating biomarkers.
• ETX-312, currently in IND-enabling studies, is being developed with potential for quarterly subcutaneous dosing, with regulatory submission planned by the end of 2025.
Merck's Subcutaneous Pembrolizumab Shows Comparable Efficacy to IV KEYTRUDA with Significantly Reduced Administration Time
• Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment.
• The subcutaneous formulation, administered in approximately two minutes versus standard IV infusion, reduced patient chair time by nearly 50% and healthcare professional active time by 45.7%, potentially improving treatment efficiency.
• FDA review of the subcutaneous pembrolizumab application is underway with a target action date of September 23, 2025, which could make it the first subcutaneous checkpoint inhibitor available across all KEYTRUDA's approved solid tumor indications.
iTeos Therapeutics Reports Encouraging Phase 2 Results for Belrestotug-Dostarlimab Combination in NSCLC
• Interim Phase 2 GALAXIES Lung-201 study demonstrates superior objective response rate for belrestotug-dostarlimab combination compared to dostarlimab monotherapy in PD-L1-high non-small cell lung cancer patients.
• Pivotal data from the Phase 2 GALAXIES Lung-201 trial is scheduled for release in 2025, with additional Phase 2 results in head and neck squamous cell carcinoma expected the same year.
• The promising interim results could positively impact the ongoing Phase 3 GALAXIES Lung-301 study, potentially strengthening the treatment's market position in frontline NSCLC therapy.
Novartis Partners with BeiGene for TIGIT Drug Development
Novartis has entered into a partnership with Chinese biotech BeiGene to develop ociperlimab, a TIGIT antibody currently in phase 3 testing for non-small cell lung cancer. The deal includes a $300 million upfront payment to BeiGene, with the potential for an additional $700 million if Novartis exercises its option by 2023. This collaboration aims to explore the synergistic effects of combining TIGIT-targeted drugs with PD-1 inhibitors in cancer immunotherapy.
Incyte and iTeos Terminate Development of Zilurgisertib and Inupadenant Following Disappointing Trial Data
• Incyte has halted the development of zilurgisertib, an ALK2 inhibitor, due to limited efficacy observed in a Phase I trial for myelofibrosis-associated anemia and fibrodysplasia ossificans progressiva.
• iTeos Therapeutics has deprioritized inupadenant, an A2AR blocker, for metastatic non-small cell lung cancer after Phase II data showed insufficient clinical activity to justify further investment.
• Both companies are shifting focus to other pipeline candidates, with iTeos planning to provide further details on its prioritized therapies in 2025.
iTeos Deprioritizes Inupadenant for NSCLC Treatment After Mid-Stage Data
• iTeos Therapeutics has deprioritized inupadenant for non-small cell lung cancer (NSCLC) treatment due to underwhelming Phase II trial results.
• The Phase II A2A-005 trial assessed inupadenant with chemotherapy in post-immunotherapy metastatic NSCLC patients, meeting safety endpoints but showing limited efficacy.
• The objective response rate (ORR) of inupadenant plus chemotherapy was 63.9%, similar to standard chemotherapy alone, questioning its added benefit.
• iTeos will now focus on its TIGIT antibody belrestotug (EOS-448) in Phase III trials for NSCLC, developed with GSK, showing promising earlier results.
iTeos Therapeutics' Inupadenant Shows Promise in NSCLC Phase 2 Trial
• iTeos Therapeutics reported a 63.9% overall response rate (ORR) in a Phase 2 trial of inupadenant plus chemotherapy for metastatic non-small cell lung cancer (NSCLC).
• The recommended Phase 2 dose (RP2D) of inupadenant (80mg) combined with carboplatin/pemetrexed showed a 73.3% ORR and 64.6% six-month progression-free survival (PFS).
• Despite promising results, iTeos has decided to deprioritize inupadenant to focus on other programs, citing insufficient clinical activity to warrant further investment.
• The safety profile of inupadenant combined with carboplatin/pemetrexed was manageable and tolerable, with no dose-dependent toxicities observed.
iTeos Therapeutics Presents Inupadenant Data at ESMO IO Congress, Prioritizes Other Programs
• iTeos Therapeutics presented Phase 2 A2A-005 trial data of inupadenant plus chemotherapy in post-immunotherapy metastatic NSCLC at ESMO IO Congress.
• The combination showed a 63.9% overall response rate and a median progression-free survival of 7.7 months across all evaluable patients.
• The recommended Phase 2 dose of inupadenant 80mg with chemotherapy demonstrated a 73.3% ORR and 64.6% landmark 6-month PFS.
• Despite encouraging results, iTeos will deprioritize inupadenant to focus on other promising therapies in its 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.
Adenosine Antagonists Show Promise in Clinical Trials for Cancer and COPD
• Adenosine antagonists are under investigation for novel therapeutic applications in neurodegenerative diseases, oncology, and cardiovascular disorders.
• Several companies, including Arcus Biosciences and Corvus Pharmaceuticals, are advancing adenosine antagonists through clinical trials to improve treatment landscapes.
• Clinical trials are evaluating drugs like etrumadenant, ciforadenant and PBF-680 in various phases for conditions like colorectal cancer, prostate cancer and COPD.
SKYSCRAPER-01: Tiragolumab Plus Atezolizumab Fails to Improve Overall Survival in PD-L1-High NSCLC
• Roche's SKYSCRAPER-01 phase 3 trial evaluating tiragolumab plus atezolizumab did not meet its primary endpoint of overall survival in PD-L1-high NSCLC patients.
• The combination therapy's safety profile remained consistent with previous reports, and no new safety signals were identified during the study.
• Detailed data from the SKYSCRAPER-01 trial will be presented at an upcoming medical meeting in 2025, according to Roche.
• Roche plans to review its tiragolumab study programs to determine necessary adjustments based on the SKYSCRAPER-01 results and other ongoing trials.
iTeos Therapeutics Announces Pipeline Updates and Financial Results for Q3 2024
• iTeos received EMA clearance for belrestotug 400mg + dostarlimab in the GALAXIES Lung-301 trial, enabling EU site activation.
• Interim data from the inupadenant Phase 2 A2A-005 trial in 2L NSCLC were presented at ESMO-IO.
• Enrollment in the EOS-984 Phase 1 monotherapy dose escalation is complete, with combination dosing initiated.
• With a pro forma cash balance of $683.9 million, iTeos anticipates funding through 2027, supporting key portfolio milestones.
iTeos Therapeutics Announces Strategic Priorities for 2025, Anticipating Multiple Data Readouts
• iTeos Therapeutics is set to release multiple TIGIT clinical data readouts throughout 2025, involving over 400 patients from Phase 2 and Phase 1/2 trials.
• Interim data from Phase 2 studies of belrestotug plus dostarlimab in first-line NSCLC and HNSCC are expected, offering insights into safety and efficacy.
• An IND submission for EOS-215, a potential best-in-class anti-TREM2 monoclonal antibody, is anticipated in Q1 2025, targeting tumor-associated macrophages.
• With a strong cash position of $683.9 million as of September 30, 2024, iTeos expects financial runway through 2027, supporting multiple Phase 3 trials.
GSK and iTeos' Jemperli-Belrestotug Combo Shows Promise in NSCLC
• GSK and iTeos' combination of Jemperli and belrestotug demonstrated a confirmed objective response rate of approximately 60% in NSCLC patients.
• Circulating tumor DNA levels decreased significantly in patients receiving the combination therapy compared to Jemperli alone, indicating a deeper response.
• The GALAXIES Lung-201 study showed manageable immune-related adverse events with the doublet therapy, supporting its potential for further development.
• The ongoing GALAXIES Lung-301 study aims to advance the Jemperli-belrestotug combination toward registration for PD-L1 high NSCLC patients.
iTeos' TIGIT Inhibitor Shows Promise in Lung Cancer, Reviving Interest in the Target
• iTeos Therapeutics' belrestotug, combined with GSK's Jemperli, demonstrated encouraging tumor shrinkage in lung cancer patients, with overall response rates significantly higher than Jemperli alone.
• The Phase 2 trial results have sparked renewed interest in TIGIT as a therapeutic target, despite previous setbacks with other TIGIT inhibitors from companies like Roche and Merck.
• Safety concerns exist, as the combination therapy was associated with a higher incidence of serious side effects and treatment-related deaths compared to Jemperli monotherapy.
• iTeos and GSK have initiated a Phase 3 trial to further evaluate the efficacy and safety of belrestotug plus Jemperli against the current standard of care, Keytruda.
Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial
• Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a significant increase in body weight compared to placebo in cancer patients with cachexia.
• The highest dose of ponsegromab resulted in a 5.61% mean increase in body weight after 12 weeks, along with improvements in appetite, physical activity, and muscle mass.
• The investigational monoclonal antibody targets GDF-15, a key driver of cachexia, and was generally safe and well-tolerated across all dose levels.
• Pfizer plans to initiate registration-enabling studies in 2025 based on these positive results, potentially offering a new treatment option for this debilitating condition.
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