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Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

OncologyMonoclonal AntibodyLeadership Change
  • Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.
  • The appointment comes as Syndax continues to expand its portfolio, which includes FDA-approved Revuforj (menin inhibitor) and Niktimvo (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor.
  • Dr. Botwood succeeds Dr. Neil Gallagher, who oversaw multiple positive data readouts, two product approvals, and the recent submission of Revuforj's supplemental New Drug Application for relapsed or refractory mNPM1 acute myeloid leukemia.

FDA Approves Tzield as First Disease-Modifying Therapy for Type 1 Diabetes Prevention

Drug ApprovalMonoclonal Antibody
  • Provention Bio received FDA approval for teplizumab (Tzield), marking the first disease-modifying therapy to delay onset of stage 3 type 1 diabetes in at-risk patients aged eight and older.
  • Clinical trial data showed Tzield delayed progression to stage 3 disease by 25 months compared to placebo, with only 45% of treated patients progressing versus 72% on placebo after 51 months median follow-up.
  • The approval comes after an initial FDA rejection in July 2021 due to pharmacokinetic concerns, which Provention addressed through resubmission with modified dosing data.
  • Sanofi has partnered with Provention for US co-promotion, providing $20 million upfront with an additional $35 million equity investment following approval.

Dupilumab Shows 31% Greater Likelihood of Avoiding Negative Outcomes in COPD Patients with Type 2 Inflammation

Monoclonal AntibodyDrug Approval
  • Patients with COPD and type 2 inflammation treated with dupilumab were 31% more likely to avoid a combination of negative outcomes including death, hospitalization, exacerbations, and lung function decline.
  • The win ratio analysis of BOREAS and NOTUS phase 3 trials demonstrated dupilumab's superiority over placebo across all individual clinically important outcomes, with researchers noting that every 16th patient treated completely stopped having exacerbations.
  • Dupilumab (Dupixent), already approved for eligible patients with uncontrolled COPD, showed significant benefits in preventing hospitalizations, moderate exacerbations, lung function deterioration, and symptom worsening compared to placebo.

Agenus Reports Breakthrough Response Rates for BOT/BAL Combination in Cold Tumors

Monoclonal Antibody
  • Agenus' botensilimab and balstilimab combination achieved 100% pathological complete response rates in dMMR colorectal cancer patients at higher doses, demonstrating breakthrough activity in microsatellite stable "cold tumors."
  • New data from the pan-cancer NEOASIS study showed the combination can induce pathological responses across multiple solid tumor types including triple-negative breast cancer and sarcomas, with no dose-limiting toxicities observed.
  • The company appointed Dr. Richard Goldberg as Chief Development Officer to advance regulatory engagement for the BOT/BAL program while reducing operating cash burn below $50 million annually.
  • Agenus reported Q1 2025 revenue of $24.1 million with a net loss of $26.4 million, ending the quarter with $18.5 million in cash as it prepares for a near-term capital transaction.

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

NCT05608044Active, Not RecruitingPhase 2
Agenus Inc.
Posted 11/30/2022

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

NCT05630183Active, Not RecruitingPhase 2
Agenus Inc.
Posted 3/27/2023

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

NCT05529316Active, Not RecruitingPhase 2
Agenus Inc.
Posted 12/12/2022

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272Active, Not RecruitingPhase 1
Agenus Inc.
Posted 3/20/2019

Singapore's PRL3-zumab Shows Promise in Phase II Trial for Treatment-Resistant Solid Tumors

Monoclonal Antibody
  • PRL3-zumab, a novel humanized antibody therapy developed by Singapore's A*STAR IMCB and Intra-ImmuSG, demonstrated safety and efficacy in delaying disease progression in 51 patients with advanced solid tumors resistant to standard treatments.
  • The therapy uniquely targets PRL3, an intracellular protein expressed in approximately 80% of solid tumors but absent in healthy tissues, marking a breakthrough in targeting previously "undruggable" intracellular oncoproteins.
  • One patient with Stage IV gastric cancer achieved disease stabilization for over 13 months compared to typical two-month progression with existing therapies, while ongoing trials in Malaysia and China show encouraging tumor regression.
  • The Phase II trial reported no serious drug-related adverse events and employed an innovative Single Evaluable Patient Single Cohort design for rigorous efficacy assessment.

Taiwan's Formosa Pharmaceuticals Signs Exclusive Licensing Deal with Almac Discovery for ADC Development

Monoclonal AntibodyTargeted TherapyOncology
  • Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Northern Ireland's Almac Discovery to develop novel antibody-drug conjugates for cancer treatment.
  • The partnership combines Formosa's antibody expertise with Almac's proprietary drug-linker technology, aiming to address unmet needs in oncology with more targeted therapeutic approaches.
  • This collaboration represents a significant expansion of Taiwan's growing presence in the global biopharmaceutical sector, particularly in the rapidly evolving ADC market.

Hepatitis D Pipeline Shows Strong Progress with Multiple FDA Breakthrough Designations and Promising Phase 3 Results

Monoclonal Antibody
  • The U.S. FDA granted Breakthrough Therapy designation to brelovitug from Bluejay Therapeutics in January 2025, accelerating development for this investigational hepatitis D treatment.
  • Vir Biotechnology's combination therapy tobevibart and elebsiran received both FDA Breakthrough Therapy and EMA PRIME designations in December 2024.
  • The SOLSTICE Phase 2 trial demonstrated that tobevibart achieved 100% virologic response with 80% of participants reaching undetectable HDV RNA levels by Week 60.
  • Over 8 pharmaceutical companies are actively developing 10+ pipeline therapies for hepatitis D, addressing significant unmet medical needs in this severe liver condition.

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

NCT05461170Active, Not RecruitingPhase 2
Vir Biotechnology, Inc.
Posted 9/17/2022

Panitumumab Plus FOLFOX Significantly Improves Survival in RAS/BRAF Wild-Type Locally Advanced Colon Cancer

Monoclonal AntibodyTargeted TherapyOncology
  • Exploratory findings from the FOxTROT trial reveal that adding panitumumab to neoadjuvant FOLFOX chemotherapy significantly reduced recurrence and improved survival in patients with RAS/BRAF wild-type locally advanced colon cancer.
  • The combination therapy demonstrated impressive results with a 49% reduction in disease-free survival risk (HR, 0.51), 77% reduction in colon cancer death risk (HR, 0.23), and 64% improvement in overall survival (HR, 0.36) compared to FOLFOX alone.
  • These results provide the first evidence that anti-EGFR therapy can improve long-term cancer control in locally advanced colon cancer, validating molecular selection for targeted therapy in non-metastatic disease.

Novel Antibody PLT012 Targets Fat Metabolism to Overcome Immunotherapy Resistance in Cancer

Monoclonal AntibodyOncology
  • Ludwig Cancer Research scientists developed PLT012, a humanized antibody that blocks the CD36 fat transporter to restore immune function in tumors that exploit fat metabolism for immune evasion.
  • Preclinical studies in hepatocellular carcinoma and colon cancer liver metastases demonstrated PLT012's effectiveness both as monotherapy and in combination with checkpoint inhibitors.
  • The FDA granted PLT012 orphan drug status, and the therapy showed promise in human tumor samples while demonstrating favorable safety profiles in animal models.
  • This metabolic immunotherapy approach could address a broad range of cancers with lipid-rich microenvironments that resist conventional checkpoint blockade therapies.

Lundbeck Presents Phase II Data for Amlenetug in Multiple System Atrophy at International Congress

Monoclonal AntibodyRare Disease
  • Lundbeck presented results from the AMULET phase II trial investigating amlenetug, a monoclonal antibody targeting α-synuclein, as a potential treatment for multiple system atrophy (MSA).
  • The company shared new insights from the TALISMAN natural history study, providing critical data on early disease progression in MSA patients to support phase III development.
  • Patient perspectives from the AMULET trial informed the design of the upcoming phase III MASCOT trial, demonstrating Lundbeck's commitment to patient-centered drug development.
  • MSA remains a rare, rapidly progressing neurodegenerative disease with no approved therapies and significant unmet medical need.

A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476Active, Not RecruitingPhase 2
H. Lundbeck A/S
Posted 11/16/2021

A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)

NCT06706622RecruitingPhase 3
H. Lundbeck A/S
Posted 12/3/2024

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