CELL AND GENE THERAPY, MEDICAL
Be The Match BioTherapies® | January 18, 2023
On January 17, 2023, Be The Match BioTherapies, a company that provides solutions for organizations that develop and commercialize cell and gene therapies, introduced its offering of CIBMTR® clinical research organization services (CRO services), which significantly reduces the time needed to launch and execute high-impact clinical trials.
These CRO services are the outcome of a collaboration between Be The Match BioTherapies and CIBMTR, resulting in expertise and access to unmatched research, sites, donors, partnerships, scientific and operational knowledge, and other resources.
CIBMTR CRO services offer unique capabilities such as
Established relationships with over 225 clinical locations domestically
Nearly 20 years of expertise in transplant and cellular therapy trials and study management, as well as clinically-trained staff
On-staff transplant physicians provide direct contact with patients and donors for clinical and research insights.
A link to the CIBMTR outcomes database for over 575,000 patients
The new CRO services offer turn-key solutions, including protocol development and approval oversight, site selection, project management, site start-up, research sample/laboratory coordination, data management, study monitoring, patient-reported outcomes, statistical analysis, and financial administration. For certain services, such as data analysis, surveys, site selection and administration, and sample management, businesses may instead rely on the expertise of CIBMTR CRO services.
About Be The Match BioTherapies®
Be The Match BioTherapies is the sole supplier of cell and gene therapy solutions with fully configurable services to assist the cell therapy supply chain. It is committed to accelerating patient access to life-saving cell and gene treatments by delivering the best-quality cellular source material from Be The Match Registry®, the most-varied registry of prospective blood stem cell donors in the world, with over 7 million potential blood stem cell donors. Through global collaborations with apheresis, bone marrow collection, and transplant centers, the firm creates, onboards, trains, and maintains extensive collection networks to advance cell treatments.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Exelixis | February 14, 2023
On February 13, 2023, Exelixis, Inc., a leading global oncology firm innovating next-generation medicines and regimens at the forefront of cancer care and Sairopa B.V. (Sairopa), a renowned firm developing novel therapeutics for cancer by modulating the patient's immune system, announced that FDA has approved Sairopa's Investigational New Drug (IND) Application to assess the pharmacokinetics and safety of ADU-1805 in adults with advanced solid tumors.
ADU-1805, being a monoclonal antibody active against all human SIRPα alleles, has the potential to reach a broader patient population than existing SIRPα-directed therapeutics.
ADU-1805 has the potential to boost the immune system's ability to combat tumors by suppressing SIRPα, an important immuno-suppressive component of the tumor microenvironment. When compared to other SIRP family members, ADU-1805 has been designed to bind preferentially to SIRPα, which may improve its capacity to stimulate immune cells.
In accordance with the clinical development and option agreement announced in November 2022, Exelixis has the option to obtain an exclusive, global license to commercialize and develop ADU-1805 and other anti-SIRPα antibodies after reviewing data from predetermined phase 1 clinical studies of ADU-1805 to be conducted by Sairopa during the option period. This IND approval results in a $35 million milestone payment to Sairopa to be paid in the first quarter of 2023.
Founded in 1994, Exelixis is a leading global oncology firm at the vanguard of cancer care, developing next-generation drugs and regimens. Fueled by bicoastal centers of research and development expertise, its clinically distinct pipeline of small molecules, antibody-drug conjugates, and other biotherapeutics is quickly expanding its product portfolio to address a growing spectrum of tumor types and indications. In addition, the company has demonstrated an excellent track record of endurance in the face of adversity after working in the competitive biotech industry for over 25 years. Its main product's success has provided it with a robust commercial basis, allowing re-energizing research activities and team expansion in clinical development, drug discovery, and commercial areas.
MEDTECH, INDUSTRIAL IMPACT
BioNTech and InstaDeep | January 12, 2023
BioNTech and InstaDeep Ltd. recently signed an agreement wherein the former is set to acquire InstaDeep, a worldwide leader in AI and ML technologies.
The acquisition involves a total upfront payment of about £362 million in cash, while BioNTech shares will be used to buy the remaining 100% of InstaDeep shares, excluding those currently held by BioNTech.
The acquisition strengthens BioNTech's aim to establish world-leading abilities in AI-driven drug discovery and develop vaccines as well as next-generation immunotherapies to treat diseases with significant unmet medical needs. In addition, the company will enhance its network of worldwide research collaborators and expand its presence in many talent hubs throughout the United States, the Middle East, Africa, and Europe due to the acquisition.
With the acquisition of InstaDeep, BioNTech's proven and new AI- and ML-based models will be added to all of its discovery platforms and linked to an automated lab infrastructure through InstaDeep's DeepChainTM platform.
MD, CEO and Co-Founder of BioNTech, Prof. Ugur Sahin, said, "Since the inception of BioNTech, we have focused on leveraging computational solutions to create personalized immunotherapies that can reach a wide patient population."
(Source: Globe Newswire)
Adding to this, CEO and Co-Founder of InstaDeep, Karim Beguir, stated, "AI is progressing exponentially and our mission at InstaDeep has always been to make sure it benefits everyone. We are very excited to join forces and become one team with BioNTech, with whom we share the same culture of deep tech innovation and focus on positive human impact."
(Source: Globe Newswire)
BioNTech is a fully-integrated and worldwide leader in immunotherapy. It has been focusing on automating and digitizing processes and developing capacities for the specialized production of individual vaccinations and large-scale goods, such as the COVID-19 vaccine. As immunotherapy pioneers, the company believes that science and innovation can make a difference for humankind. Therefore, since the beginning, it has focused on harnessing the immune system's total capacity to combat cancer and infectious diseases.