Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
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.
SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025
• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16.
• Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options.
• Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.
Summit Therapeutics' Ivonescimab Shows Promising Results in Phase 3 NSCLC Trial
• Summit Therapeutics reported statistically significant improvement in progression-free survival for ivonescimab plus chemotherapy versus BeiGene's Tevimbra combination in advanced squamous non-small cell lung cancer.
• The bispecific antibody ivonescimab, licensed from Chinese biotech Akeso, is already approved in China but still undergoing multiple clinical trials globally for various cancer indications.
• Despite mixed results against Merck's Keytruda in a separate NSCLC trial, ivonescimab's potential as a "pipeline in a drug" positions it for possible blockbuster status in the lucrative lung cancer market.
City of Hope to Present Groundbreaking Cancer Research at AACR Annual Meeting 2025
• City of Hope researchers will present over 74 sessions at the AACR Annual Meeting 2025, showcasing innovative work in AI, precision medicine, and immunotherapies for various cancers.
• A phase 3 clinical trial led by Dr. Aditya Shreenivas demonstrated that penpulimab combined with chemotherapy significantly improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
• Novel AI tools and spatial transcriptomic technologies developed at City of Hope are advancing precision medicine approaches and revealing unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients.
Akeso Secures FDA Approval for Novel Cancer Drug While Partner Summit Therapeutics Faces Sharp Stock Decline
• Akeso has received FDA approval for its first internally developed cancer therapeutic, marking a significant milestone for the Chinese biopharmaceutical company's expansion into the US market.
• Summit Therapeutics experienced a dramatic 35% stock plunge following the FDA approval announcement, ending five consecutive sessions of gains and triggering a trading halt.
• The contrasting market reactions highlight the complex dynamics of pharmaceutical partnerships, with over 11.7 million shares of Summit changing hands during the volatile trading session.
Summit's Ivonescimab Shows Promise in Phase III Trial Against Established Lung Cancer Therapies
• Summit Therapeutics and Akeso's bispecific antibody ivonescimab demonstrated superior progression-free survival compared to BeiGene's tislelizumab in squamous non-small cell lung cancer patients, adding to previous positive results against Merck's Keytruda.
• The PD-1/VEGF bispecific antibody has already secured approval in China for certain NSCLC indications, with global Phase III trial results expected in mid-2025 that could potentially reshape the $90 billion cancer immunotherapy market.
• Despite promising progression-free survival data, questions remain about ivonescimab's overall survival benefit, as interim analysis showed a non-statistically significant 22.3% reduction in death risk compared to Keytruda, creating uncertainty about its long-term competitive position.
Akeso Reports Positive Phase 3 Results for Ivonescimab in Lung Cancer, Building on Recent FDA Approval Success
• Akeso announced positive Phase 3 results for ivonescimab, a novel PD-1/VEGF bispecific antibody, demonstrating superior tumor progression control when combined with chemotherapy compared to PD-1 inhibitor plus chemotherapy in lung cancer patients.
• The company recently secured FDA approval for penpulimab, its PD-1 monoclonal antibody, for first-line treatment of nasopharyngeal carcinoma, marking significant expansion of Akeso's oncology portfolio.
• Akeso and Summit Therapeutics are advancing ivonescimab in a global study against the standard Keytruda-chemotherapy regimen, with results expected in 2027, potentially challenging the current treatment paradigm in lung cancer.
Trodelvy-Keytruda Combination Shows Promising Results in First-Line Treatment for Triple-Negative Breast Cancer
• Gilead Sciences and Merck's phase 3 ASCENT-04/KEYNOTE-D19 trial demonstrated statistically significant improvement in progression-free survival with Trodelvy plus Keytruda compared to Keytruda with chemotherapy in metastatic TNBC patients.
• The novel combination of antibody-drug conjugate (Trodelvy) with immunotherapy (Keytruda) represents a potential paradigm shift in treatment approach for aggressive triple-negative breast cancer, potentially displacing conventional chemotherapy.
• Early data shows a positive trend toward improved overall survival, with detailed results to be presented at upcoming medical meetings and discussed with regulatory authorities.
FDA Accepts Scholar Rock's BLA for Apitegromab in Spinal Muscular Atrophy with Priority Review
• The FDA has accepted Scholar Rock's Biologics License Application for apitegromab with priority review, assigning a PDUFA date of September 22, 2025 for this investigational muscle-targeted treatment for spinal muscular atrophy.
• Apitegromab is being developed as an adjunctive therapy for SMA patients already receiving SMN-targeted treatments, potentially offering significant improvements in motor function through its novel mechanism of action.
• The SMA treatment landscape continues to evolve with recent developments including FDA approval of Evrysdi tablets and Biogen's supplemental New Drug Application for a higher dose regimen of nusinersen.
Robust Pipeline for Nasopharyngeal Cancer Treatment Emerges with 25+ Pharmaceutical Companies Developing Novel Therapies
• A comprehensive pipeline analysis reveals over 25 pharmaceutical companies actively developing approximately 30 drug candidates for nasopharyngeal cancer, signaling significant industry investment in this therapeutic area.
• BL-B01D1, a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3, has advanced to Phase III clinical trials, showing promise for patients with recurrent or metastatic nasopharyngeal carcinoma.
• Novel approaches in development include Takeda's TAK-500, a STING agonist immunostimulatory antibody drug conjugate, and Ascentage Pharma's APG-5918, highlighting diverse therapeutic strategies targeting this challenging cancer.
Chinese Cancer Drug Outperforms Merck's Keytruda in Landmark Lung Cancer Trial
• A novel Chinese experimental cancer drug has demonstrated unprecedented efficacy in late-stage trials, nearly doubling progression-free survival in non-small-cell lung cancer patients compared to Keytruda.
• Merck's Keytruda, a leading cancer immunotherapy drug, has generated over $130 billion in sales since 2014, including $29.5 billion in the previous year.
• The breakthrough Chinese trial results of 11.1 months versus Keytruda's 5.8 months mark a significant advancement in cancer immunotherapy and challenge Western pharmaceutical dominance.
EPCORE NHL-2 Trial Shows Promise Combining Chemotherapy and Immunotherapy for DLBCL
• A phase Ib/II clinical trial led by Mount Sinai researchers demonstrates successful outcomes in combining chemotherapy with immunotherapy for diffuse large B-cell lymphoma treatment.
• The groundbreaking research, published in Blood journal, was conducted under the leadership of Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute.
• The study represents a significant advancement in lymphoma treatment, supported by the Leukemia & Lymphoma Society's research initiatives, which have invested over $600 million in hematologic oncology research.
Akeso Completes Patient Enrollment in Phase III Trial Comparing Ivonescimab for First-Line Squamous NSCLC Treatment
• Akeso has completed enrollment for the HARMONi-6 Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy for first-line squamous non-small cell lung cancer treatment.
• Ivonescimab, a novel PD-1/VEGF bispecific antibody, is currently being evaluated in six Phase III lung cancer trials globally, with potential applications across multiple cancer types.
• The drug addresses a significant unmet need among 520,000 annual cases of advanced sq-NSCLC patients, offering a promising alternative for those ineligible for current anti-angiogenesis treatments.
Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China
• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis.
• Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks.
• Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments.
• Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.
FDA Sets PDUFA Date for Lower-Dose Neffy Nasal Spray in Young Pediatric Patients with Anaphylaxis
• The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray).
• This lower dose is intended for pediatric patients weighing 33 to 66 lbs (15 to 30 kg), expanding treatment options for this vulnerable population.
• Neffy was initially approved in August 2024 for anaphylaxis in adults and children over 66 lbs, offering a needle-free alternative to epinephrine injections.
• Pending approval, Neffy 1 mg could be available in the second quarter of 2025, providing a more accessible and less intimidating treatment option for young children.
Ivonescimab Demonstrates Superior PFS Over Pembrolizumab in PD-L1 Positive NSCLC
• Ivonescimab significantly improved progression-free survival (PFS) compared to pembrolizumab in patients with advanced NSCLC and PD-L1 TPS ≥ 1%.
• The HARMONi-2 trial showed a hazard ratio of 0.51 (95% CI, 0.38-0.69; P < .0001) for PFS with ivonescimab versus pembrolizumab.
• China's NMPA granted priority review to ivonescimab for first-line treatment of PD-L1 positive NSCLC, and the FDA granted fast track designation for EGFR-mutant NSCLC.
• Ivonescimab, a PD-1/VEGF bispecific antibody, showed PFS benefits across PD-L1 expression subgroups and histological subtypes.
Bioxodes Advances BIOX-101 for Intracerebral Hemorrhage Treatment with New Funding and Clinical Milestones
• Bioxodes secured €2.7 million in Series A extension funding to advance BIOX-101, a novel therapy for intracerebral hemorrhage (ICH).
• The funding supports the completion of the BIRCH Phase 2a trial and preparations for a Phase 2b trial of BIOX-101 in ICH.
• Interim data from the BIRCH Phase 2a trial, evaluating BIOX-101 in ICH patients, is expected in Q1 2025.
• BIOX-101, derived from tick saliva, aims to reduce secondary brain injuries post-hemorrhagic stroke by preventing clot formation and neuroinflammation.
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.
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