Sutro Biopharma

B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area. • Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025. • Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.

Sutro Biopharma Faces Multiple Downgrades After Discontinuing Lead Program Luvelta

2 months ago

• Sutro Biopharma (STRO) has been downgraded by multiple financial firms following the company's decision to discontinue its lead program luvelta. • Citizens JMP lowered Sutro from Outperform to Market Perform, while Piper Sandler downgraded the stock from Overweight to Neutral with a price target reduction from $8 to $2. • Analysts expect Sutro shares to trade in line with the broader biotech market until clinical data from its early-stage antibody-drug conjugates pipeline emerges in 2026.

Sutro Biopharma Reports Promising Results for Luvelta in Platinum-Resistant Ovarian Cancer Trial

2 months ago

• Sutro Biopharma's luveltamab tazevibulin (luvelta) demonstrated a 32% overall response rate at the optimized dose of 5.2 mg/kg in platinum-resistant ovarian cancer patients, significantly outperforming the 13.8% rate seen at lower doses. • The FR𝛼-targeting antibody-drug conjugate showed consistent efficacy across all levels of FR𝛼 expression (≥25%), including patients with lower expression levels who aren't eligible for currently approved FR𝛼-targeting treatments. • Despite the promising clinical data presented at SGO 2025, Sutro Biopharma has announced it is deprioritizing investment in luvelta's development and is seeking out-licensing opportunities to continue advancing the treatment.

Soleno Therapeutics Advances Toward Potential DCCR Approval for Prader-Willi Syndrome with Strong Financial Position

3 months ago

• Soleno Therapeutics maintains robust financial standing with $318.6 million in cash reserves as they await FDA review of DCCR for Prader-Willi Syndrome treatment. • The company has intensified its commercial preparation efforts, investing significantly in supply chain, marketing programs, and expanding its workforce to support potential product launch. • DCCR shows promising results in addressing hyperphagia, the defining symptom of PWS, along with improvements in aggressive behaviors and metabolic parameters in Phase 3 trials.

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.

Ipsen Advances Pipeline with Multiple Regulatory Wins and Strategic Partnerships in 2024

3 months ago

• Ipsen secured FDA approval for Onivyde in first-line pancreatic cancer treatment and gained approvals for Iqirvo and Kayfanda in the U.S. and EU markets, expanding their therapeutic portfolio. • The company strengthened its pipeline through strategic partnerships, including agreements with Sutro Biopharma, Foreseen Biotechnology, and DayOne Biopharmaceuticals for innovative oncology assets. • Looking ahead to 2025, Ipsen projects sales growth exceeding 5.0% and anticipates key regulatory decisions for Cabometyx in neuroendocrine tumors and tovorafenib in pediatric low-grade glioma.

Vaxcyte Advances 31-Valent Pneumococcal Vaccine to Final Phase II Stage in Infant Trial

4 months ago

• Vaxcyte has initiated the final stage of Phase II trials for VAX-31, its 31-valent pneumococcal conjugate vaccine, following successful safety review of Stage 1 data in infants. • VAX-31 demonstrates potential to provide approximately 94% coverage against invasive pneumococcal disease and 93% coverage for acute otitis media in U.S. children under five years. • The company expects to report topline data from the primary three-dose immunization series by mid-2026, with booster dose results following approximately nine months later.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Luvelta Demonstrates Promising Efficacy in Platinum-Resistant Ovarian Cancer Trial

5 months ago

• Sutro Biopharma's luvelta achieved a 32% objective response rate (ORR) in patients with platinum-resistant ovarian cancer (PROC) in the REFRαME-O1 trial. • The data confirms luvelta's efficacy across varying levels of Folate Receptor Alpha (FRα) expression, potentially benefiting a broader patient population. • The safety profile of luvelta was favorable, with neutropenia well-managed and no new safety concerns identified in the trial. • Sutro Biopharma anticipates submitting an Accelerated Approval application for luvelta by mid-2027, marking a significant step toward a new treatment option.

Merck's Zilovertamab Vedotin Shows Promise in Phase 2 DLBCL Trial, Phase 3 Initiated

5 months ago

• Merck's zilovertamab vedotin, combined with R-CHP, achieved a 100% complete response rate in previously untreated DLBCL patients in a Phase 2 trial. • The 1.75 mg/kg dose of zilovertamab vedotin was established as the recommended dose for the Phase 3 trial based on efficacy and safety. • A Phase 3 trial, waveLINE-010, has been initiated to evaluate zilovertamab vedotin plus R-CHP versus R-CHOP in previously untreated DLBCL patients. • The waveLINE-010 trial aims to enroll 1,046 patients globally, with progression-free survival as the primary endpoint.

Follicular Lymphoma Pipeline Shows Promise with Over 55 Therapies in Development

6 months ago

• The follicular lymphoma treatment landscape is evolving, with over 55 therapies in development by more than 50 active pharmaceutical companies. • Key players like Incyte, AstraZeneca, and Johnson & Johnson are evaluating novel drugs, including CAR-T therapies and targeted agents, to improve patient outcomes. • Tafasitamab is expected to have a supplemental Biologics License Application filed in August 2024 for patients who have failed prior therapies. • Emerging therapies in the pipeline include TQ-B3525, NKTR-255, and Zilovertamab vedotin, targeting various mechanisms to combat follicular lymphoma.

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.

Sutro Biopharma Initiates Pivotal Trial of Luvelta for Pediatric AML

7 months ago

• Sutro Biopharma has commenced the REFRαME-P1 trial to evaluate Luvelta (luveltamab tazevibulin) in children under 12 with CBFA2T3::GLIS2 acute myeloid leukemia (AML). • Luvelta, a folate receptor alpha (FRα) targeting antibody-drug conjugate (ADC), aims to address the limited effective treatment options for this aggressive leukemia form. • Compassionate use data showed Luvelta achieved complete remission in 42% of relapsed/refractory CBF/GLIS AML patients with ≥5% blasts, with sustained overall survival. • The FDA has granted Luvelta fast-track designation for ovarian cancer and orphan/rare pediatric disease designations for CBF/GLIS pediatric AML.

Sutro Biopharma Initiates Pivotal Trial of Luvelta for Pediatric CBF/GLIS AML

7 months ago

• Sutro Biopharma has begun the REFRαME-P1 trial, a registration-directed study of luveltamab tazevibulin (luvelta) for pediatric patients with CBF/GLIS AML. • Luvelta targets Folate Receptor-α (FRα), which is highly expressed in CBF/GLIS AML, offering a potential treatment for this aggressive leukemia subtype. • Compassionate use data showed luvelta produced complete remission in 42% of patients with ≥5% blasts, and prolonged overall survival in treated pediatric AML. • The global REFRαME-P1 trial will evaluate luvelta's efficacy and safety in children under 12, with multiple sites expected to be open by year's end.

Sutro Biopharma Initiates Pivotal Trial of Luvelta for Pediatric CBF/GLIS AML

7 months ago

• Sutro Biopharma has commenced the REFRαME-P1 trial, a registration-enabling study of luveltamab tazevibulin (luvelta) for pediatric patients with CBF/GLIS AML. • Compassionate use data showed a 42% complete remission rate in patients with ≥5% blasts, with some patients able to receive potentially curative stem cell transplants. • CBF/GLIS AML is a rare, aggressive leukemia in infants and young children, characterized by an over 80% resistance rate to conventional chemotherapy. • The global trial will assess luvelta's efficacy and safety in children under 12 years with CBF/GLIS AML, addressing a critical unmet need in this patient population.

Basecamp Research Secures $60M and Partners with Broad Institute to Advance AI-Driven Genetic Medicine

7 months ago

• Basecamp Research has raised $60 million in Series B funding and established a collaboration with the Broad Institute's David Liu lab to develop programmable genetic medicines. • The London-based startup is leveraging its extensive biological interactions database to train AI models, distinguishing itself from traditional AI drug discovery approaches. • The partnership aims to explore novel fusion proteins and large molecules, with potential applications in gene editing by studying bacterial-viral warfare mechanisms.

Oncolytics Biotech's Pelareorep Shows Promise in Breast Cancer Treatment, Fueling Optimism in Oncology

8 months ago

• Oncolytics Biotech's BRACELET-1 trial showed pelareorep, combined with paclitaxel, significantly improved survival rates in HR+/HER2- advanced or metastatic breast cancer patients. • The median overall survival for patients treated with pelareorep was not reached, with estimates suggesting a 32-month survival benefit compared to 18 months for the control arm. • Incyte's CDK2 inhibitor INCB123667 demonstrated clinical activity in patients with advanced solid tumors, particularly platinum-resistant ovarian cancer, showing a 24.3% overall response rate. • Regeneron presented five-year survival data for Libtayo as a first-line monotherapy in advanced non-small cell lung cancer, reinforcing its role as a key component in oncology treatment.

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

8 months ago

• Sutro Biopharma's luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended phase 2 dose (4.3 mg/kg) in late-stage ovarian cancer patients. • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression, offering a potential non-biomarker-driven treatment approach. • An expansion phase with an additional 23 patients is ongoing, with initial data expected in the first half of 2025, to further evaluate the efficacy and safety of the combination. • No new safety signals were observed, reinforcing the tolerability of luvelta in combination with bevacizumab, with neutropenia being the most common adverse event.

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

8 months ago

• Sutro Biopharma's Luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended Phase 2 dose in late-stage ovarian cancer patients. • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression or prior bevacizumab treatment. • An additional 23 patients have been enrolled in the expansion phase at the recommended dose, with initial data expected in the first half of 2025. • The combination showed no new safety signals compared to either agent alone, with neutropenia being the most common adverse event.