XtalPi Inc. | November 25, 2022
XtalPi announced today that they are embarking on a strategic collaboration with CK Life Sciences, a member of the CK Hutchison Group. XtalPi and CK Life Sciences will leverage their respective expertise to jointly develop a novel AI tumour vaccine R&D platform to improve the discovery and design capabilities of tumour vaccines and accelerate the development of more vaccine types. The goal of this collaboration is to realize precision treatment for patients worldwide.
According to public information, there were nearly 20 million newly diagnosed cancer patients worldwide in 2021, of which about 4.5 million cases came from China. Many cancer types lead to detrimental outcomes, with high morbidity and mortality, and there remains a large unmet clinical need. Tumour vaccines targeting different tumour neoantigens, tumour-associated antigens and tumour-specific antigens in patients can be designed for use as immunotherapy, to activate the patient's own specific immune responses.
Currently, there are only two therapeutic tumour vaccines— sipuleucel-T for melanoma and Bacillus Calmette-Guérin for bladder cancer, as well as preventive tumour vaccines against human papillomavirus infection and hepatitis B infection approved by the U.S. Food and Drug Administration. Recently, several other tumour vaccines have entered clinical development and evidence of efficacy has begun to emerge.
According to Mordor Intelligence, the global cancer vaccine market size was US$6.79 billion in 2021 and will increase at a compound annual growth rate of 11.53% from 2022 to 2026. The expected market size by 2026 will be approximately US$12 billion.
Currently, the design and preclinical development process for tumour vaccines is complex and lengthy, hindering the efficiency and success rate of tumour vaccine research and development.
Incorporating XtalPi's industry expertise in AI computation and robotic automation, this collaboration aims to build an AI tumour vaccine R&D platform that applies advanced AI algorithms and high-precision molecular modeling to predict and design a variety of tumour vaccines that can activate specific immune responses to kill tumours. The tumour vaccines will be screened and verified through automated experiments, and through integrating algorithmic feedback to optimise activity and efficacy, the platform is expected to generate preclinical tumour vaccine candidate compounds with robust immune activity.
"As a company headquartered in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone, XtalPi is committed to realising the synergies between Shenzhen and Hong Kong by creating a new paradigm for innovation in the Greater Bay Area. Empowered by the latest technological advancements in automation, artificial intelligence is accelerating more innovative and diverse areas in drug research and development. Together with CK Life Sciences, we are committed to overcome conventional limitations and discover diverse applications for cutting-edge technologies. We believe the AI cancer vaccine platform jointly developed by CK Life Sciences and XtalPi will inspire the global scientific community to progress vaccine research and development and fast-track key development milestones for cancer vaccines. We are confident that this collaboration will significantly facilitate the scientific research exchange in the Greater Bay Area."
Dr. Shuhao Wen, co-founder and chairman of XtalPi
Dr. Melvin Toh, Vice President and Chief Scientific Officer of CK Life Sciences, comments: "The R&D of tumour vaccines is one of the key development directions of CK Life Sciences. The cooperation with XtalPi will apply XtalPi's AI algorithm, molecular modeling and automated experiments to speed up the R&D process, improve the success rate, and increase the efficacy of tumour vaccines."
Founded in 2014, XtalPi founders recognized a common hurdle in drug development having to do with solid polymorphism, which could be successfully tackled with quantum physics predictions. Since then, XtalPi has maintained its focus on identifying and then attacking traditional bottlenecks in biopharmaceutical R&D through innovative technologies. Through considerable capital investments in automation and personnel, XtalPi now has four locations worldwide and employs approximately 1000 employees. XtalPi has engaged in collaboration research with nearly all top-20 pharmaceutical companies in the world. Its ID4 platform combines physics-based simulations with experimental validation and refinement, automation for rapid synthesis, and machine learning to continuously improve prediction accuracy and process efficiency.
About CK Life Sciences
CK Life Sciences is listed on the Stock Exchange of Hong Kong. Bearing the mission of improving the quality of life, CK Life Sciences is engaged in the business of research and development, manufacturing, commercialisation, marketing, sale of, and investment in, products and assets which fall into three core categories - nutraceuticals, pharmaceuticals and agriculture-related. CK Life Sciences is a member of the CK Hutchison Group.
BriaCell Therapeutics Corp. | December 01, 2022
IPA an advanced biotherapeutic research and technology company, announced that BioStrand BV an AI in silico discovery subsidiary of IPA, has entered into a research collaboration and license agreement with BriaCell Therapeutics Corp. a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer.
The collaboration will leverage BioStrand’s LENSai™ software, built upon IPA’s proprietary HYFT™ Universal Fingerprint™ technologies, and will focus on in silico antibody discovery to generate relevant clinical molecules for potential development. Under the terms of the Agreement, BioStrand and BriaCell will collaborate on the design, discovery, and development of anti-cancer antibodies. Upon successful antibody discovery, BioStrand will receive an upfront payment of US$500,000, and will be eligible to receive future success-based development milestones, including those for the submission of Investigational New Drugs clinical milestone payments, and commercial royalties on net sales of products. Further terms are not disclosed.
“We are very excited to begin this program with BriaCell and apply our technology to the development of biologics that may have a huge clinical impact. Shortening timelines, while also integrating as much information as possible upstream to improve the efficiency of the process, is extremely important in the development of highly targeted therapies. It is a step towards realizing our long-term vision of significantly advancing precision medicine.”
Dr. Ingrid Brands, General Manager and co-founder of BioStrand
“We believe that BioStrand’s revolutionary AI-powered technology, combined with its cutting-edge protein engineering platform, will allow us to design and discover potent anti-cancer therapeutics,” stated Miguel A. Lopez-Lago, PhD, Chief Scientific Officer of BriaCell. “This approach would complement BriaCell’s current immunotherapy pipeline of innovative anti-cancer therapeutics.”
About BriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer.
ImmunoPrecise Antibodies Ltd.
ImmunoPrecise Antibodies Ltd. has several subsidiaries in North America and Europe including entities such as Talem Therapeutics LLC, Biostrand BV, ImmunoPrecise Antibodies Ltd. and ImmunoPrecise Antibodies B.V. The IPA Family is a biotherapeutic research and technology group that leverages systems biology, multi-omics modelling and complex artificial intelligence systems to support its proprietary technologies in bioplatform-based antibody discovery. Services include highly specialized, full-continuum therapeutic biologics discovery, development, and out-licensing to support its business partners in their quest to discover and develop novel biologics against the most challenging targets.
CELL AND GENE THERAPY
TEMBEXA and Smallpox | September 27, 2022
Emergent BioSolutions Inc. announced that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.
The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.
“The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.”
Paul Williams, SVP government/MCM business at Emergent
The 10-year contract valued at up to $680 million, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government, was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12 million.
Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix
An upfront payment of $238 million;
Potential milestone payments of up to $124 million contingent on the potential exercise by the U.S. government of procurement options following the base period;
15% royalty on gross profit from sales of TEMBEXA outside the U.S.;
20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and
Up to an additional $12.5 million upon achievement of certain development-based milestones.
TEMBEXA is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease.
The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a BOXED WARNING for increased risk for mortality when used for longer duration.
Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention variola virus is ranked in the highest risk category for bioterrorism agents due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.