GBS vaccine(Minervax ApS)

New investment from EQT Life Sciences and OrbiMed with participation from existing investors MinervaX will hold financial reserves of more than €125 million, following the financing The financing supports the Company's efforts to commence a Phase III clinical trial of its Maternal Vaccine against Group B Streptococcus COPENHAGEN, Denmark, Oct. 11, 2023 /PRNewswire/ -- MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has today announced the completion of a EUR 54 million upsized financing. The financing includes investment from new investors EQT Life Sciences and OrbiMed, with participation from existing investors Novo Holdings, Pureos Ventures, Sanofi Ventures, Trill Impact Ventures, Adjuvant Capital, Wellington Partners, Industrifonden, Sunstone LifeScience Ventures, and LF Invest. Vincent Brichard of EQT Life Sciences and Tal Zaks of OrbiMed will join the MinervaX Board of Directors. GBS is a leading cause of life-threatening infections in newborns as well as adverse pregnancy outcomes such as preterm delivery and stillbirths. Current prophylactic measures provide insufficient protection, meaning there is an urgent need to accelerate the development of a GBS vaccine. A video describing the unmet medical need for a GBS vaccine and details of MinervaX's novel GBS maternal vaccine can be found on the Company's website, here: . The Company is currently progressing two Phase II clinical trials in 470 pregnant persons across Denmark, United Kingdom, Uganda and South Africa. Initial data from these clinical trials are highly positive and demonstrate that the vaccine has an acceptable safety profile, is highly immunogenic and gives rise to functionally active antibodies. Details of MinervaX's clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578. In addition to pregnant persons, MinervaX is also pursuing Phase I development of its novel GBS vaccine in Older Adults, under identifier NCT05782179. This financing will enable MinervaX to progress its novel GBS vaccine towards Phase III clinical trials in 2024. Per Fischer, CEO of MinervaX, said: "The addition of EQT Life Sciences and OrbiMed to our existing investor consortium further strengthens the Company's resolve to advance our novel GBS vaccine towards Phase III clinical trials in pregnant persons. It also provides additional validation and recognition of the acceptable safety profile and strong data demonstrated in the Phase II clinical trials. We are delighted to welcome Vincent Brichard and Tal Zaks to the board of directors, who will bring invaluable vaccine expertise as we continue to address the pressing need for the development of a novel vaccine to address the unmet medical burden of Group B Streptococcus." Vincent Brichard, Venture Partner EQT Life Sciences, commented: "EQT Life Sciences is thrilled to take an active part in the MinervaX prophylactic vaccine against GBS with the hope to save newborns' lives. We are impressed by the clinical data achieved so far, the quality of the team and the near-term milestones enabling MinervaX to start a registration trial." Tal Zaks, Partner at OrbiMed, added: "We recognize the unmet need for better protection against GBS disease for vulnerable populations and the potential for MinervaX's vaccine to provide best-in-class efficacy. I look forward to working with the MinervaX team to support the full development of this program." About MinervaX MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and now also for vaccination of older adults, with Phase II data suggesting superior efficacy compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX's vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX's vaccine will confer protection against virtually 100% of all GBS isolates. About Group B Streptococcus (GBS) GBS is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and, in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death. Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which cannot comprehensively prevent GBS infection in utero and do not protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings. Finally, it carries the risk for increasing antibiotics resistance, a recognized worldwide health threat. The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by several public health organizations including the WHO. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need. About EQT Life Sciences EQT Life Sciences was formed in 2022 following an integration of LSP, a leading European life sciences and healthcare venture capital firm, into the EQT platform. As LSP, the firm raised over EUR 3.0 billion (USD 3.5 billion) and supported the growth of more than 150 companies since it started to invest over 30 years ago. With a dedicated team of highly experienced investment professionals, coming from backgrounds in medicine, science, business, and finance, EQT Life Sciences backs the smartest inventors who have ideas that could truly make a difference for patients. More info: Follow EQT on LinkedIn, Twitter, YouTube and Instagram About OrbiMed OrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed's team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, London and other key global markets. More info: SOURCE MinervaX

Pfizer's pursuit of group B strep vaccine comes as prevention efforts have lowered case rates over the last 20-plus years. Given the challenges of running an efficacy study for a group B streptococcus (GBS) vaccine, Pfizer's top vaccine executive hopes that regulators will allow an immunogenicity study for approval instead, just as they have for the New York pharma's meningitis B and pneumococcal vaccines.  That’s according to Annaliesa Anderson, Ph.D., Pfizer’s head of vaccine R&D in a recent interview with Fierce Biotech. Since GBS rates are quite low, she says the company is working on a phase 3 study design that would focus on the product and transfer of antibodies from the mother to the baby.  “Efficacy studies will be extremely large and complicated,” Anderson said, noting that Pfizer’s meningitis B and pneumococcal vaccine were licensed using just serological data.  “And then once they're licensed, we then do studies to demonstrate the effectiveness," Anderson said. She added that this is an effective method of getting a vaccine of this type, called a polysaccharide conjugate vaccine, licensed. This type of vaccine wields the same sugar molecules that coat bacteria to help mount a protective immune defense.  It’s unclear how large of a market Pfizer may ultimately be tapping into for the GBS shot. Andersen underscored that the goal remains to gain access to major markets and that she had “not seen a pathway” for any Pfizer vaccine to be developed if its target was not ultimately the U.S. and/or Europe. Prevention guidelines and screening have significantly reduced cases of GBS in the U.S., from about 1.7 per 1,000 live births in 1993 to 0.2 cases per 1,000 live births in 2020, according to the CDC. Anderson says those measures have been less helpful at preventing disease in babies older than a week old. “And so there's still important value for this vaccine to be able to potentially prevent disease up to 90 days of life, which is really the window of which you see disease for group B strep.”  The bacterial infection can cause meningitis and bloodstream infections, with 4-6% of babies that contract the disease ultimately dying.  Pfizer's phase 3 plans follow midstage data released in July showing that the vaccine induced antibody production in pregnant people that transferred to babies. The ratio of antibody transferred from 0.4-1.7 depending on the serotype. The trial recruited 360 healthy pregnant people who received one of three doses, and compared the findings to a parallel natural history study among 18,000 enrolled people who were pregnant. Rates of adverse events were similar following the administration of the vaccine compared to placebo.  The ongoing clinical development has been financially buoyed by grants from the Bill & Melinda Gate Foundation, including $100 million for phase 3 development provided in May 2022. The funding will also help expand access in lower-income countries.