ImmunoGen, Inc.

CytomX's CX-2051 Shows Promising 28% Response Rate in Advanced Colorectal Cancer Phase 1 Trial

11 days ago

• CytomX's EpCAM-targeting antibody-drug conjugate CX-2051 demonstrated a 28% confirmed response rate in late-line colorectal cancer patients, significantly outperforming current standard therapies with single-digit response rates. • The novel PROBODY® masking technology appears to successfully target EpCAM, a previously "undruggable" tumor antigen, with manageable safety profile and no dose-limiting toxicities observed in the Phase 1 study. • Median progression-free survival reached 5.8 months with 43% response rate at the highest dose level (10 mg/kg), supporting plans to advance to Phase 2 trials in first half of 2026.

Cantargia's Novel Anti-IL1RAP Antibody-Drug Conjugate Shows Promising Preclinical Efficacy Against Cancer

2 months ago

• Cantargia's anti-IL1RAP antibody-drug conjugate demonstrated potent anti-tumor activity across different IL1RAP expression levels in preclinical models, with a single dose achieving 100% survival in high-expressing tumors. • The ADC targets IL1RAP, a protein overexpressed in many tumor cells and their microenvironment, providing a dual-targeting approach that could potentially improve cancer treatment outcomes. • Preclinical safety data showed the ADC was well-tolerated with no significant changes in body weight, liver and kidney enzyme levels, or histological abnormalities in assessed organs.

Luveltamab Tazevibulin Shows Promising Results in Platinum-Resistant Ovarian Cancer with Low to High FRα Expression

2 months ago

• Luveltamab tazevibulin demonstrated a 32% overall response rate in platinum-resistant ovarian cancer patients with FRα expression ≥25%, showing similar efficacy in both low-medium and high expression subgroups. • The antibody-drug conjugate achieved a remarkable 96% disease control rate when administered at 5.2 mg/kg with G-CSF prophylaxis for the first two cycles, then 4.3 mg/kg in subsequent cycles. • Common side effects included arthralgia, nausea, and neutropenia, with researchers selecting the optimized dose regimen for the ongoing phase 3 portion of the REFRΑME-O1 trial.

Federal Circuit Ruling on ImmunoGen's Dosing Patent Highlights Challenges in Pharmaceutical Patent Strategy

2 months ago

• The Federal Circuit has affirmed that ImmunoGen's patent application for a specific dosing regimen of mirvetuximab soravtansine (IMGN853) was obvious, despite the inventors' claim of solving an unknown ocular toxicity problem. • The court emphasized that "the obviousness inquiry is generally agnostic to the particular motivation of the inventors," establishing that a solution can be obvious even if the specific problem it addresses wasn't recognized in prior art. • The ruling creates significant implications for pharmaceutical companies developing second-generation patents on dosing regimens, potentially strengthening generic companies' ability to challenge Orange Book-listed patents.

U.S. Monoclonal Antibodies Market Projected to Reach $284.9 Billion by 2034, Growing at 13.1% CAGR

3 months ago

• The U.S. monoclonal antibodies market is expected to grow from $94.09 billion in 2025 to $284.90 billion by 2034, driven by rising prevalence of chronic diseases and expanding therapeutic applications beyond oncology. • Human-source monoclonal antibodies dominated the market with 34.3% share in 2024, while oncology applications led with 38.2% of market value, reflecting the critical role of mAbs in targeted cancer therapies. • Artificial intelligence integration is revolutionizing the mAb industry by accelerating drug discovery, optimizing manufacturing processes, and enabling more personalized treatments with improved efficacy and reduced development costs.

Antibody-Drug Conjugates (ADCs) Emerge as Promising Therapeutic Modality in Oncology

4 months ago

• Antibody-drug conjugates (ADCs) combine monoclonal antibody specificity with potent small molecule cytotoxicity, precisely delivering toxins to tumors and sparing normal tissues. • Clinical trial volumes for ADCs have dramatically accelerated, with 2.5 times more Phase 2 and 3 trials initiated in 2022 compared to 2017, indicating growing interest and investment. • ADCs in Phase 3 trials demonstrate a 12% higher probability of success compared to other oncology drugs, including monoclonal antibodies, highlighting their potential impact. • The ADC field is expanding beyond solid tumors, with approximately 15% of ongoing trials exploring their efficacy in hematological malignancies, suggesting broader applicability.

Clinical Trial Industry Faces Complex Challenges in 2025: Adaptive Designs, Political Shifts, and Diversity Requirements

4 months ago

• Clinical trials are becoming increasingly complex and expensive as they target smaller patient populations and face stricter regulations, driving the need for smarter and more efficient trial designs. • Political changes, including Trump's presidency, could lead to significant regulatory shifts in the clinical trial landscape, potentially affecting approval pathways and oversight mechanisms. • New legislation like the Inflation Reduction Act is expected to impact trial initiations and drug development, while diversity guidelines from WHO, FDA, and EMA present both opportunities and challenges for patient recruitment.

SIL-204 Demonstrates Synergy with Chemotherapy in KRAS-Driven Pancreatic Cancer Models

4 months ago

• Silexion Therapeutics' SIL-204, a next-generation siRNA candidate, shows synergistic effects with first-line chemotherapies in preclinical models of KRAS-mutated pancreatic cancer. • SIL-204 amplified the efficacy of chemotherapeutic agents like 5-fluorouracil, irinotecan, and gemcitabine, leading to greater reductions in cancer cell confluence. • Silexion is advancing SIL-204 with toxicology studies underway and Phase 2/3 trials planned for 2026, aiming to address a significant unmet need in KRAS-driven cancers. • The company recently announced a $5 million public offering to support the clinical development of SIL-204 and other pipeline programs.

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.

ImmunoGen's ELAHERE Receives Accelerated FDA Approval for Ovarian Cancer Treatment

5 months ago

ImmunoGen, Inc. has achieved accelerated FDA approval for its ovarian cancer drug ELAHERE, targeting patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This marks a significant advancement in treatment options for patients with limited alternatives.

Cytokinetics and Pyxis Oncology Announce Key Milestones for 2025; CytomX Prioritizes Pipeline

5 months ago

• Cytokinetics anticipates a pivotal year in 2025, focusing on the potential FDA approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S. • Pyxis Oncology is prioritizing the advancement of PYX-201, a novel antibody-drug conjugate (ADC), with data readouts expected in the second half of 2025 and the first half of 2026. • CytomX Therapeutics is focusing on its lead program, CX-2051, an EpCAM-targeting PROBODY ADC for advanced metastatic colorectal cancer, with initial Phase 1a data expected in 1H 2025.

Multispecific Antibodies Market Set to Exceed $40 Billion as Next-Generation Cancer Therapies Advance

5 months ago

• The multispecific antibodies market has surpassed $8.6 billion in sales as of Q3 2024, with 16 approved therapies demonstrating efficacy across oncology and other therapeutic areas. • Bispecific antibodies currently dominate the market, while more complex trispecific and tetraspecific antibodies are emerging in early development phases with potential for enhanced therapeutic advantages. • Over 900 multispecific antibodies are currently in clinical trials, reflecting substantial investment from pharmaceutical companies and biotechnology firms seeking to address complex diseases through multi-target approaches.

Error parsing response

5 months ago

Error occurred while parsing the model response.

DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer

6 months ago

• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy. • The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months. • This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.

Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer

6 months ago

• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC). • Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT. • Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS). • Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.

Mirvetuximab Soravtansine Gains Global Approvals for FRα-Positive Platinum-Resistant Ovarian Cancer

6 months ago

• Mirvetuximab soravtansine receives European Commission approval for treating FRα-positive, platinum-resistant ovarian cancer after 1-3 prior systemic treatments. • The approval was based on the MIRASOL trial, demonstrating a 35% reduction in disease progression or death risk and a 33% reduction in mortality compared to chemotherapy. • The FDA granted full approval in March 2024, reinforcing mirvetuximab soravtansine's efficacy and superiority over standard care options for advanced ovarian cancer. • Early FRα testing and specialist management of ocular toxicities are crucial for maximizing the efficacy and maintaining the quality of life for patients on mirvetuximab soravtansine.

Elahere Receives European Commission Approval for Platinum-Resistant Ovarian Cancer

6 months ago

• The European Commission has granted marketing authorization to AbbVie's Elahere for treating folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer. • Elahere is now the first and only FRα-directed antibody-drug conjugate (ADC) approved for this specific patient population in the European Union. • The approval was based on the Phase III MIRASOL study, which demonstrated a 35% reduction in tumor progression or death risk and a 33% reduction in death risk compared to chemotherapy. • Elahere, acquired through AbbVie's ImmunoGen acquisition, shows promise in earlier lines of ovarian cancer therapy, potentially boosting future sales.

EU Approves AbbVie's Elahere for Platinum-Resistant Ovarian Cancer

6 months ago

• AbbVie's Elahere (mirvetuximab soravtansine) receives EU approval for folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer, marking a significant advancement in treatment options. • Elahere is the first antibody-drug conjugate (ADC) approved in the EU for this indication, demonstrating improved overall survival compared to chemotherapy in the MIRASOL trial. • The approval addresses a critical unmet need, as it ends a decade-long gap in new treatments for platinum-resistant ovarian cancer in the EU, offering hope for improved outcomes. • This approval, based on the MIRASOL trial, showed a 33% reduction in the risk of death and a 35% improvement in progression-free survival compared to chemotherapy.

European Commission Approves AbbVie's Elahere for Folate Receptor-Alpha Positive Ovarian Cancer

6 months ago

• The European Commission has approved AbbVie's Elahere for treating folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer in adults after one to three prior systemic treatments. • Elahere demonstrated a significant 35% reduction in disease progression or death risk compared to standard chemotherapy in the Phase III MIRASOL trial. • Patients on Elahere experienced a median progression-free survival of 5.6 months and a median overall survival of 16.5 months, compared to 4 and 12.8 months, respectively, with chemotherapy. • As the first FRα-targeted antibody-drug conjugate approved in the EU, Elahere addresses a critical unmet need in platinum-resistant ovarian cancer treatment.

AbbVie's Emraclidine Fails in Phase 2 Schizophrenia Trials, Benefiting BMS

6 months ago

• AbbVie's emraclidine failed to show improvement over placebo in two Phase 2 trials (EMPOWER 1 and 2) for schizophrenia, impacting AbbVie's stock value. • Emraclidine, a selective muscarinic M4 receptor-positive allosteric modulator (PAM), aimed to improve tolerability compared to current antipsychotics. • The failure potentially benefits Bristol-Myers Squibb, whose schizophrenia drug Cobenfy (xanomeline tartrate/trospium chloride) recently gained FDA approval. • AbbVie will analyze the data to determine the next steps for emraclidine, acquired as part of the Cerevel Therapeutics acquisition.