Vaxcyte
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2013-12-01
- Employees
- 254
- Market Cap
- $8.7B
- Website
- http://www.vaxcyte.com
- Introduction
Vaxcyte, Inc. engages in the development of vaccines for infectious diseases. It focuses on conjugate vaccines and protein-based vaccines developed through the Sutro Biopharma's Xpress CF Platform, a cell-free protein synthesis technology. The company was founded by Grant E. Pickering and Jeff Fairman on November 27, 2013, and is headquartered in San Carlos, CA.
Vaxcyte's VAX-24 Shows Promising Results Despite Phase 2 Serotype Misses in Infant Study
• Vaxcyte's Phase 2 study of VAX-24 pneumococcal vaccine missed four serotypes compared to Prevnar20 in infant data, causing a 50% drop in share price despite overall promising safety and immunogenicity profile.
• Evercore ISI maintains an "Outperform" rating on Vaxcyte, noting that three of the four serotype misses were narrow and likely to be resolved in the larger upcoming Phase 3 trial.
• The 24-valent pneumococcal conjugate vaccine candidate is designed to prevent invasive pneumococcal disease, with analysts suggesting timing of results coinciding with FDA official Peter Marks' resignation created additional market uncertainty.
Vaccinex to Delist from Nasdaq Despite Promising Alzheimer's Drug Results
• Vaccinex will delist from Nasdaq on March 17 after failing to meet equity requirements, despite reporting positive Phase II results for its lead Alzheimer's candidate pepinemab in 2024.
• The company's market capitalization has fallen to approximately $2.5 million, with cash reserves of just $2.9 million as of September 2024, reflecting financial challenges despite initial success raising $40 million in its 2018 IPO.
• Vaccinex plans to continue developing pepinemab for both Alzheimer's disease and oncology indications through partnerships, including ongoing collaborations with MSD and Merck KGaA for cancer trials.
Vaxcyte Nears Critical Phase II Readout for 24-Valent Pneumococcal Vaccine
• Vaxcyte is preparing to release crucial Phase II safety and immunogenicity data for VAX-24, their 24-valent pneumococcal conjugate vaccine, by the end of the current quarter.
• The comprehensive infant trial will provide initial safety, tolerability, and immune response data, with follow-up booster dose results expected by year-end.
• This development comes amid broader regulatory uncertainties in the vaccine sector, with potential implications for the pneumococcal vaccine landscape.
Dynavax Reports Strong Growth with HEPLISAV-B Revenue Up 26% in 2024, Advances Pipeline Programs
• HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market.
• Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense.
• The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.
Vaxcyte Advances 31-Valent Pneumococcal Vaccine to Final Phase II Stage in Infant Trial
• 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.
Merck's CAPVAXIVE Receives Positive EU CHMP Opinion for Pneumococcal Vaccine
• The European Medicines Agency's CHMP recommended CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumonia in adults 18 and older.
• CAPVAXIVE is designed to protect against Streptococcus pneumoniae serotypes responsible for the majority of invasive pneumococcal disease cases.
• The recommendation is supported by Phase 3 STRIDE trial results, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults.
• If approved, this would be the fourth authorization of CAPVAXIVE, having already been approved in the U.S., Canada, and Australia.
Vaxcyte's 31-Strain Pneumococcal Vaccine Shows Superior Immune Response Over Prevnar 20 in Phase 1/2 Trial
Vaxcyte's VAX-31 pneumococcal vaccine demonstrated stronger immune responses against 18 out of 20 serotypes compared to Pfizer's Prevnar 20 in Phase 1/2 trials. The promising results have prompted the company to advance to Phase 3 trials in 2025, potentially challenging Pfizer's dominance in the $10+ billion pneumococcal vaccine market.
Sling Therapeutics Appoints Andrew Guggenhime to Board as Linsitinib Advances in Phase 2b for TED
• Sling Therapeutics appointed Andrew Guggenhime to its Board of Directors, leveraging his extensive biopharma experience to advance clinical programs.
• Guggenhime's financial expertise will support Sling as it anticipates key milestones for linsitinib, an oral treatment for thyroid eye disease (TED).
• Linsitinib is currently in a Phase 2b clinical trial and aims to offer a more convenient, patient-centric option for TED, addressing an underserved market.
• TED affects approximately 70,000 people in the U.S. annually, and linsitinib targets the IGF-1R signaling pathway implicated in the disease.
Vaccine Updates: FDA Approves Self-Administered FluMist, Updated Novavax COVID-19 Vaccine
• The FDA has approved FluMist, a nasal spray flu vaccine, for self- or caregiver-administration, making it the first flu vaccine with this capability, indicated for individuals aged 2 to 49 years.
• Novavax's updated COVID-19 vaccine has received FDA emergency use authorization for individuals aged 12 years and older, set to be available in pharmacies and grocers across the United States.
• GSK reported positive topline data from a phase 3 study for co-administration of its RSV vaccine (Arexvy) with its shingles vaccine (Shingrix) in adults 50 years and older.
• The WHO has added the MVA-BN (Imvanex) vaccine to its prequalification list, marking the first mpox vaccine to receive this designation, indicated for adults and potentially for off-label use in younger populations.
Liraglutide Shows Promise in Pediatric Obesity, While Oncology Trials Face Setbacks
• Novo Nordisk's liraglutide demonstrated a significant reduction in BMI in a Phase III trial involving children aged 6-11, showing potential for pediatric obesity treatment.
• Vaxcyte's VAX-31 pneumonia vaccine showed positive Phase I/II topline data, increasing its Phase Transition Success Rate (PTSR) in streptococcal pneumonia.
• Pfizer terminated a Phase I trial of maplirpacept, leading to a decrease in its PTSR for peripheral T cell lymphoma and B cell Hodgkin lymphoma.
• Les Laboratoires Servier's oncology drug trial was terminated due to business reasons, impacting the PTSR of S-64315 and S-65487 in multiple myeloma and leukemia.
Vaxcyte's VAX-31 Shows Promise in Broad-Spectrum Pneumococcal Disease Prevention
• Vaxcyte's VAX-31 vaccine demonstrated a favorable safety profile and strong immune response against all 31 serotypes in adults aged 50 and older.
• The company's XpressCF platform enables the development of broad-spectrum vaccines that overcome the limitations of traditional cell-based approaches.
• VAX-31 is rapidly advancing to Phase 3 clinical trials, with potential FDA approval expected by late 2026 or 2027, positioning Vaxcyte as a leader in the pneumococcal vaccine market.
• Vaxcyte's robust financial position, with $2.8 billion in liquid reserves, supports its research and development efforts through FDA approval and commercialization.
OrsoBio Secures $67M for Obesity Drugs, Vor Bio's AML Therapy Shows Promise, and More
• OrsoBio, backed by Eli Lilly, raised $67 million to advance its portfolio of weight loss medicines targeting different mechanisms than GLP-1 therapies.
• Vor Bio's experimental AML therapy, trem-cel, demonstrated successful engraftment and protection against Mylotarg toxicity in a Phase 1 trial.
• Boehringer Ingelheim plans to advance its geographic atrophy drug into Phase 2 trials after positive Phase 1 safety data.
• Novartis has licensed a capsid from Voyager Therapeutics to develop a gene therapy for a rare neurological disease, expanding their collaboration.
FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump
• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older.
• Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older.
• Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.
Athira Pharma's Fosgonimeton Fails to Meet Primary Endpoint in Phase II/III Alzheimer's Trial
• Athira Pharma's fosgonimeton did not meet the primary endpoint in the Phase II/III LIFT-AD trial for mild-to-moderate Alzheimer's disease.
• The trial failed to show statistically significant improvement in cognition and function compared to placebo after 26 weeks of treatment.
• Subgroup analyses showed some improvements in cognition and function in patients with moderate Alzheimer's and APOE4 carriers.
• Despite the setback, Athira Pharma believes the data suggest potential benefits of HGF pathway modulation on neuronal health.
Sutro Biopharma and Merck Advance Novel Cytokine Derivative into Phase 1 for Solid Tumors
• Sutro Biopharma announces the dosing of the first patient in a Phase 1 study for a novel cytokine derivative therapeutic developed in collaboration with Merck.
• The therapeutic is designed for the treatment of advanced or metastatic solid tumors, marking a significant step in the collaboration between the two companies.
• Sutro Biopharma will receive a $10 million payment from Merck as a result of achieving this clinical milestone, per the 2018 agreement.
• The collaboration leverages Sutro's XpressCF® and Xpress CF+® platforms for cytokine derivative development, with Merck holding exclusive worldwide rights to resulting therapeutic candidates.
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