BioNTech | MedPath

FDA Expands Warning for mRNA COVID-19 Vaccines Due to Heart Side Effect Risk in Young Males

a day ago

• The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses. • New warnings cite data from the FDA's safety surveillance system and a 2023 study showing that while clinical courses were generally mild, myocardial injury was common among affected individuals. • Health officials maintain that these heart conditions remain rare complications, with CDC data indicating they typically resolve quickly, though studies are ongoing to determine potential long-term effects.

Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug

2 days ago

• 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.

FDA Demands Additional Trial for Novavax COVID-19 Vaccine, Delaying Full Approval

12 days ago

• The FDA has requested an additional clinical trial for Novavax's protein-based COVID-19 vaccine (NVX-CoV2601) before granting full approval, despite promising Phase 2/3 results showing a 5.8-fold increase in neutralizing antibodies. • Novavax's stock dropped approximately 8% following the regulatory setback, raising concerns about the company's ability to compete with established mRNA vaccines in the market. • The timing of FDA's request coincides with HHS Secretary Robert F. Kennedy Jr.'s appointment, suggesting potential political influence in the regulatory process as Novavax negotiates the scope of the additional trial.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

UK Government Unveils Life Sciences Strategy to Strengthen Post-Brexit Industry

a month ago

• The UK government has revealed a comprehensive life sciences strategy led by Professor Sir John Bell, aiming to strengthen the sector after Brexit through increased funding and policy reforms. • Key proposals include £160 million in new funding, improved clinical trial capabilities, implementation of the Accelerated Access Review, and benchmarking the UK to be in the top quartile for innovative medicine adoption by 2023. • Industry leaders from pharmaceutical companies, biotech firms, and healthcare organizations collaborated on the strategy, which addresses challenges in NHS funding constraints while seeking to create a globally competitive life sciences ecosystem.

CureVac Wins Key Patent Validity Decision in Ongoing mRNA Litigation Against BioNTech

2 months ago

• European Patent Office largely upholds CureVac's patent EP 3 708 668 B1 for split poly-A tail technology, a foundational mRNA innovation, dismissing BioNTech's opposition challenge. • The ruling represents a significant milestone in the broader patent dispute between the two companies, with an infringement hearing scheduled for July 1, 2025, at the Regional Court Düsseldorf. • CureVac seeks recognition and compensation for its pioneering contributions to mRNA technology that enabled the development of COVID-19 vaccines.

FDA Budget Cuts Under Trump Administration Threaten Drug Development Pipeline

3 months ago

• Pharmaceutical companies warn in SEC filings that Trump administration's FDA staffing and budget cuts could significantly delay or halt new drug approvals and commercialization processes. • Recent layoffs of hundreds of FDA employees have sparked industry-wide concerns about disruptions to clinical trials, grant applications, and regulatory oversight activities. • Multiple biotech firms, including Xenon Pharmaceuticals and Rezolute, report that reduced FDA capacity could negatively impact their drug development timelines and business operations.

AIM Vaccine's mRNA RSV Vaccine Advances to U.S. Clinical Trials with Superior Preclinical Results

4 months ago

• AIM Vaccine has submitted its novel mRNA RSV vaccine for FDA clinical trials, demonstrating superior humoral and cellular immunity compared to existing marketed products in preclinical studies. • The company's mRNA RSV vaccine development comes at a crucial time, with the global RSV vaccine market projected to reach USD 16.7 billion by 2030 and no approved vaccines currently available in China. • Multiple financial institutions, including FOSUN INTERNATIONAL SECURITIES and SDICSI, have issued "Buy" ratings for AIM Vaccine, citing strong product pipeline and international growth potential.

Vir Biotechnology's Dual-Masked T-Cell Engagers Show Promise in Early Cancer Trials

4 months ago

• Vir Biotechnology's VIR-5818 demonstrated tumor shrinkage in 50% of HER2-expressing cancer patients at doses ≥400 µg/kg. • VIR-5500 showed PSA reductions in 100% of mCRPC patients at initial doses ≥120 µg/kg, with a 58% confirmed PSA50 response. • Both VIR-5818 and VIR-5500 exhibited promising safety profiles with minimal cytokine release syndrome and manageable adverse events. • The PRO-XTEN™ masking technology may enable tumor-specific activation and a wider therapeutic index for T-cell engagers.

Sarepta Seeks Accelerated Approval for DMD Gene Therapy SRP-9001

5 months ago

• Sarepta Therapeutics has submitted SRP-9001 (delandistrogene moxeparvovec) to the FDA for accelerated approval to treat ambulatory Duchenne muscular dystrophy (DMD) patients. • The filing is based on positive data from early-stage studies, showing improvements in clinical function and a consistent safety profile, while awaiting Phase 3 EMBARK results. • SRP-9001, a one-time gene therapy, delivers a shortened dystrophin gene via an AAV vector, addressing the underlying genetic defect in DMD patients. • If approved, SRP-9001 would offer a one-time treatment option for DMD, contrasting with Sarepta's existing chronic exon-skipping therapies.

mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy

5 months ago

• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment. • BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab. • Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers. • The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.

BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer

5 months ago

• 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.

FDA Approves Astellas' Vyloy (Zolbetuximab) for Advanced Gastric and GEJ Adenocarcinoma

8 months ago

• The FDA has approved zolbetuximab (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma. • Approval was based on SPOTLIGHT and GLOW trials, demonstrating statistically significant improvements in progression-free and overall survival compared to chemotherapy alone. • The VENTANA CLDN18 (43-14A) RxDx Assay from Roche was also approved as a companion diagnostic to identify patients eligible for Vyloy treatment. • Vyloy is now approved in five markets worldwide, offering a new targeted therapy option for a subset of gastric and GEJ cancer patients.