Optiva Inc | MedPath

Granite Bio Emerges with $100M Funding and Novel Immunology Pipeline for IBD and Allergies

a month ago

• Versant Ventures has launched Granite Bio with $100 million in funding, advancing two novel antibody drugs targeting inflammatory conditions through its Ridgeline Therapeutics initiative. • Granite's lead candidate GRT-001 targets pro-inflammatory monocytes in IBD and is currently in Phase 1 trials, with ulcerative colitis studies planned for later this year. • The company's second candidate, GRT-002, targets IL-3 for treating itch and allergies, representing a different approach from established therapies like Dupixent and Cosentyx.

Opthia Faces $1 Billion Investor Obligation Following Sozinibercept Trial Failure in WetAMD

2 months ago

• Opthia may owe up to $1 billion to investors following the failure of sozinibercept in clinical trials for wet age-related macular degeneration (WetAMD). • Regeneron Pharmaceuticals reports positive outcomes from the Phase III QUASAR trial of Eylea HD (aflibercept) 8mg injection, strengthening its position in the WetAMD market. • Ocugen advances its WetAMD pipeline as the Data and Safety Monitoring Board approves dosing of the second patient cohort in a Phase I trial of OCU200.

Vertanical Achieves Phase 3 Success with Novel Non-Opioid Pain Medication

2 months ago

• Vertanical has announced positive Phase 3 results for its non-opioid pain management therapy, potentially offering a new alternative in the midst of the ongoing opioid crisis. • The clinical success comes as other biotech companies face challenges, with Apriori Therapeutics implementing a 40% workforce reduction to extend its operational runway. • Industry analysts suggest this breakthrough could significantly impact the pain management landscape, addressing the critical need for effective non-addictive alternatives to opioid medications.

Opthea's Clinical Trial Failure Threatens Company Survival and Impacts Regal Partners

2 months ago

• Biotech company Opthea's eye treatment clinical trial has failed, potentially forcing the company to repay over $1 billion in development funding and threatening its survival. • Phil King's Regal Partners, holding a 30% stake as Opthea's largest shareholder, faces a potential $220 million reduction in funds under management if the company collapses. • The negative trial results have already impacted Regal Partners' stock, which dropped 16% on Monday, while Opthea's shares had previously declined 22% this year amid increasing short interest.

EMA Validates Aspaveli® Extension Application for Rare Kidney Diseases C3G and IC-MPGN

3 months ago

• The European Medicines Agency has validated the application to extend Aspaveli® (pegcetacoplan) use for treating C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, two rare kidney diseases currently lacking approved treatments. • Phase 3 VALIANT study demonstrated significant 68% reduction in proteinuria with pegcetacoplan compared to placebo (p<0.0001), along with stabilization of kidney function and reduced C3c staining intensity. • The potential approval could provide the first targeted treatment for approximately 8,000 European patients affected by these conditions, with possible US launch in second half of 2025.

Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment

3 months ago

• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss. • The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections. • FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.

FDA Approves Roche's Susvimo for Diabetic Macular Edema, Offering Fewer Injections

4 months ago

• The FDA has approved Roche's Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. • Susvimo is the first FDA-approved treatment for DME that requires fewer injections than standard eye injections, helping to maintain vision for affected individuals. • The approval was based on the Phase 3 Pagoda study, which demonstrated non-inferior vision improvements with Susvimo refilled every six months compared to monthly ranibizumab injections. • Susvimo, a refillable eye implant, delivers a customized formulation of ranibizumab continuously, offering a convenient alternative to routine eye injections for DME patients.

Opthea's OPT-302 Eye Disease Treatment Shows Promise as Phase III Trials Progress

4 months ago

Canaccord Genuity initiates coverage on Opthea with a buy rating, citing strong potential for their lead drug OPT-302 in treating wet AMD and DME. The drug's unique mechanism targeting VEGF-C and VEGF-D pathways, combined with promising Phase II results showing significant vision improvements, positions it as a potential breakthrough treatment for patients who don't respond well to current therapies.

Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations

4 months ago

• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy. • Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities. • Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease. • The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 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.

Percheron Therapeutics' Duchenne Muscular Dystrophy Trial Fails to Meet Primary Endpoint

5 months ago

• Percheron Therapeutics' Phase 2b trial of avicursen (ATL-1102) for Duchenne muscular dystrophy (DMD) failed to meet its primary endpoint, leading to a significant drop in share value. • The trial, involving wheelchair-bound boys, showed no statistically significant difference between avicursen and placebo in improving upper limb function at week 25. • Percheron plans a strategic review of its pipeline, exploring alternative indications for avicursen and considering new programs to restore shareholder value. • Despite the trial's failure, avicursen was reported to be safe and well-tolerated, prompting the company to explore its potential in other conditions.

Race Oncology's RC220 Phase 1 Trial Advances for Solid Tumors

6 months ago

• Race Oncology has submitted ethics and regulatory documents for a Phase 1 trial of RC220 with doxorubicin, targeting advanced solid tumors. • The trial, expected to begin in Q1 2025, will assess the safety and tolerability of RC220 in combination with doxorubicin across multiple sites. • The study includes two stages focusing on dose optimization, cardioprotective benefits, and anticancer efficacy of RC220. • Race Oncology also reported $18.78 million in cash reserves, with significant investment in R&D and drug manufacturing.

Opthea's Sozinibercept: Phase 3 COAST Trial Completes Patient Visits, Topline Results Expected Soon

6 months ago

• Opthea Limited has completed the final patient visit for the Phase 3 COAST trial of sozinibercept in combination with aflibercept for wet AMD. • Topline results from the COAST trial are anticipated in early Q2 CY25, with the ShORe trial results expected in mid-CY25. • Sozinibercept, a VEGF-C/D inhibitor, is being evaluated for its potential to improve visual outcomes in wet AMD patients when combined with anti-VEGF-A therapies. • The FDA has granted Fast Track Designation to sozinibercept, highlighting its potential to address an unmet need in wet AMD treatment.

Leqembi's EU Approval Faces Further Delay as EMA Re-evaluates Safety Data

6 months ago

• The European Commission has requested the EMA to re-examine Leqembi's safety data, potentially delaying its EU approval beyond the expected timeframe. • The CHMP will assess recent safety data to determine if an update to its positive opinion is needed, particularly regarding risk minimization measures. • Eisai and Biogen believe existing data support Leqembi's safety profile, reinforced by clinical use in the US and other approved regions. • Leqembi is already approved in the US, Japan, China and other countries, with a new once-monthly intravenous maintenance dose approved in the US.

Sozinibercept Shows Promise in Improving Visual Outcomes for nAMD Patients

6 months ago

• Sozinibercept, a novel VEGF-C/D inhibitor, is under investigation for neovascular age-related macular degeneration (nAMD) to improve visual acuity beyond current VEGF-A therapies. • Phase 2b trials showed that sozinibercept combined with ranibizumab led to a statistically significant additional gain of 3.4 letters in BCVA compared to ranibizumab alone at 24 weeks. • Ongoing Phase 3 trials (ShORe and COAST) are evaluating sozinibercept in combination with ranibizumab or aflibercept, with potential regulatory filings planned after 12-month efficacy analysis. • Next-generation nAMD therapies like sozinibercept aim to target multiple pathways beyond VEGF-A to enhance vision and quality of life for patients, addressing the limitations of current treatments.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.