Encephalitis, Japanese

Sept. 10, 2024 -- Alopexx, Inc., a clinical-stage biotechnology company focused on developing novel, broad-spectrum immune-mediated therapeutics for the prevention and treatment of bacterial, fungal, and parasitic infections, today announced a collaboration with Bharat Biotech for the co-development and commercialization of Alopexx’s proprietary broad-spectrum anti-microbial vaccine, AV0328, in India and other low income and lower middle-income countries. Bharat Biotech is a pioneering biotechnology company known for its world-class research and development and manufacturing capabilities. As part of the collaboration, the companies will co-develop and commercialize AV0328, a synthetic vaccine targeting poly N-acetyl glucosamine (PNAG), in India and other licensed territories. Alopexx would be entitled to a one-time upfront payment and milestone payments, as well as royalties on future sales of AV0328 in the licensed territories. “We are excited to enter into this collaboration with Bharat Biotech,” said Dr. Daniel Vlock, CEO of Alopexx. “To partner with a company with such vast experience and expertise in vaccine development is a significant validation of the value and potential of Alopexx’s technology. This collaboration brings us one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial solutions, especially in low-and middle-income countries.” Dr. Vlock added, “We also deeply appreciate the collaborative support provided by Bharat Biotech. This support is not only crucial for the advancement of AV0328, but will also significantly bolster our overall clinical programs. The broad and breakthrough potential of our platforms in treating a wide array of bacterial, fungal, and parasitic infections represents a transformative approach to combating infectious diseases on a global scale.” Dr. Krishna Ella, Executive Chairman of Bharat Biotech, commented, “We are proud to collaborate with Alopexx to bring AV0328 to the regions where it is most needed. Our goal is to develop solutions to reduce anti-microbial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally.” AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG), a substance found on the surface of a wide range of bacterial, fungal, and parasitic pathogens. In pre-clinical studies, targeting PNAG has shown effectiveness in preventing and treating infections caused by over 15 different pathogens. A phase I, first-in-human trial has been completed, demonstrating that AV0328 is well-tolerated with no serious adverse events observed. The vaccine induced antibodies capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution. Bharat Biotech (BBIL) is a biotech company in Genome Valley, Hyderabad, India. BBIL is a global leader with 145 patents, ~20 vaccines and bio-therapeutics, and registrations in 125 countries. These vaccines were developed through clinical trials in more than 20 countries worldwide and have been published in more than 100 peer-reviewed journals. The company has manufactured and supplied more than 9 billion doses of vaccines globally, saving millions of lives and livelihoods annually. The company has world-class vaccine and bio-therapeutics research, product development, manufacturing, and distribution facilities. BBIL has developed vaccines for infectious diseases, including Hepatitis B, Pentavalent (DPT+HepB+Hib), Rabies, Typhoid, polio, H1N1 influenza, Japanese Encephalitis (JENVAC®), India’s first Rotavirus vaccine, the world’s first Typhoid conjugate vaccine, TYPBAR TCV®, novel vaccines for COVID-19 such as COVAXIN® and INCOVACC®. BBIL introduced WHO pre-qualified vaccines, namely BIOPOLIO®, ROTAVAC®, ROTAVAC 5D®, and TYPBAR TCV®, in several countries worldwide. BBIL has a strong pipeline of innovative vaccines against malaria, tuberculosis, Para Typhi A, non-typhoidal salmonella, chikungunya, and Zika. The acquisition of Chiron Behring Vaccines has positioned Bharat Biotech as one of the world's largest rabies vaccine manufacturers with CHIRORAB® and INDIRAB®. To learn more about BBIL, visit www.bharatbiotech.com. Alopexx is a clinical-stage biotechnology company targeting novel immune therapeutics for the prevention and treatment of bacterial, fungal and parasitic microbial infections. The target of our therapeutics, poly N-acetyl glucosamine (PNAG), has been found in a wide range of pathogens. Our vaccine candidate, AV0328, has been shown to induce protective antibodies against a wide range of PNAG-expressing pathogens in a Phase I trial. F598, our fully human monoclonal antibody, has been shown to be safe and well tolerated in phase I and pilot trials. Following a single infusion, it can provide protection for 2-3 months. Our goal is to develop a broad-spectrum, non-antibiotic therapeutic platform for the treatment and prevention of microbial infections. These immune therapeutics will reduce reliance on antibiotics and the development of antimicrobial resistance. For more information, please visit www.Alopexx.com. The content above comes from the network. if any infringement, please contact us to modify.

Shigella4V’s story began at LimmaTech, which spun out from GlycoVaxyn after its 2015 acquisition by GSK. Valneva has added to its growing arsenal of vaccines by handing over 10 million euros ($10.7 million) upfront to LimmaTech for the global license to a Shigella candidate that once formed part of a GSK partnership.There is no vaccine approved for Shigella, the second leading cause of fatal diarrheal disease worldwide. LimmaTech’s asset, dubbed Shigella4V, is a tetravalent bioconjugate vaccine that produced some positive interim data from a phase 1/2 trial in February.As well as the upfront fee, LimmaTech will be in line for an undisclosed amount of milestone payments and low double-digit royalties on sales should Shigella4V make it to market. The deal means that LimmaTech will be responsible for conducting a pair of phase 2 trials launching later this year: a controlled human infection model and a pediatric study in low- and middle-income countries, which are worst affected by Shigella. “We are very pleased to partner with LimmaTech to advance a promising program in an area of high unmet medical need,” Valneva CEO Thomas Lingelbach said in the August 1 release.“The Shigella vaccine candidate enables a potential first-in-class vaccine solution for both [low and middle-income countries] and travelers and, as such, represents a potentially highly synergistic product for Valneva,” Lingelbach continued. “The anticipated development path follows a staggered and risk-mitigated strategy, and hence allows an efficient capital allocation in line with our communicated plan of having a new R&D program in phase 3 by 2027.” Shigella4V’s story began at LimmaTech, which spun out from GlycoVaxyn after its 2015 acquisition by GSK. When GSK acquired GlycoVaxyn, the candidate was added to the pipeline and LimmaTech was offered a research agreement to develop new bioconjugate antigen-based vaccines in partnership with the U.K.'s non-profit Wellcome Trust. A year ago, GSK handed back the candidate, citing plans to prioritize its own vaccine for the bacteria.“Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we achieved to date, we are excited to accelerate the program with our partnership with Valneva,” LimmaTech CEO Franz-Werner Haas said in the August 1 release.Having missed the boat with a COVID-19 vaccine that was only approved in the U.K. in 2022, Valneva has been expecting more success with the rollout of its chikungunya virus vaccine this year. The French biotech also markets shots for cholera and Japanese encephalitis, with candidates for Lyme disease and Zika in the clinic.

Valneva has forged a strategic alliance and an exclusive licensing pact with LimmaTech Biologics to secure the latter’s vaccine candidate Shigella4V (S4V) against shigellosis. “The Shigella vaccine candidate enables a potential first-in-class vaccine solution…and, as such, represents a potentially highly synergistic product,” said Thomas Lingelbach, chief executive of Valvena. As part of the deal announced Thursday, LimmaTech stands to receive €10 million ($10.8 million) upfront and is eligible for regulatory, development and sales-based milestone payments, alongside low double-digit sales royalties. LimmaTech will lead two mid-stage studies of S4V, likely to commence later this year, while Valneva will take charge of all further development and regulatory activities, and manage global commercialisation of the vaccine if approved. Lingelbach noted that the company intends to have a Phase III programme in place by 2027.LimmaTech partnered with GSK in 2015 to develop the tetravalent bioconjugate vaccine candidate, subsequently in-licensing it last year. Positive interim Phase I/II data reported in February this year demonstrated favourable safety, tolerability and immunogenicity of S4V against the four most common pathogenic Shigella serotypes.Valneva’s portfolio currently includes approved jabs for Japanese encephalitis, cholera and traveller's diarrhoea, and hepatitis B, in addition to the chikungunya vaccine Ixchiq recently approved in the US, Canada and EU. The company’s developmental pipeline includes VLA15 for Lyme disease in partnership with Pfizer and VLA1601 for Zika virus.