BioBiz: Johnson & Johnson COVID-19 Vaccine stopped; Repertoire gets $189M infusion; Agenus presents clinical data; Solo-Dex launches and more

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Both the FDA and Centers for Disease Control have decided to stop administering Johnson & Johnson’s Covid-19 vaccine after reviewing data involving six reported cases of a rare and severe type of blood clot in individuals in the US after receiving the vaccine.

CDC has announced a meeting of its Advisory Committee on Immunization Practices for tomorrow to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Marks said in a media call that the probable cause may be a similar mechanism seen in other adenovirus vector vaccines, like the AstraZeneca Covid-19 vaccine, which underwent a similar safety review in Europe. He said one person has died and one person is in critical condition from the blood clots.

Repertoire Immune Medicines, a clinical-stage biotech company decoding the immune synapse to create novel immune therapies for cancer, immune disorders, infectious disease, and other serious diseases, completed a $189 million Series B financing. Joining Flagship Pioneering, Repertoire’s institutional founder and principal backer, are new and existing investors including Softbank Vision Fund 2i, the Public Sector Pension Investment Board (PSP Investments), the Alaska Permanent Fund, Invus, and others. Proceeds from this financing will support further expansion of the company’s proprietary DECODE discovery platform, accelerate its clinical and preclinical pipeline, expand Repertoire’s team, and enhance its manufacturing capabilities. Founded by Flagship Pioneering, Repertoire has raised more than $350 million in the aggregate to date.

Earlier this week, Agenus presented new clinical data on AGEN1181, its next-generation anti-CTLA-4 antibody, at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 10 – 15, 2021.

“The preclinical and translational data in conjunction with our updated clinical data with AGEN1181 alone or in combination with our PD-1, balstilimab, continue to strongly support and differentiate our next-generation CTLA-4 antibody,” said Steven O’Day, MD, Chief Medical Officer of Agenus.

 “AGEN1181 is showing activity in patients with tumors which typically do not respond to first-generation CTLA-4 and PD-1 antibodies. Equally important, the safety data continues to show no immune mediated hypophysitis, pneumonitis, or hepatitis to date. Given the efficacy and favorable safety profile, we have expanded AGEN1181 into Phase 2 in colorectal cancer patients as a first step in our efforts to expand to additional important cancer indications,” adds O’Day.  In two separate presentations at AACR, Agenus showcased the optimal performance of AGEN1181 in relevant models. In addition, as the clinical data matures, additional responses as well as a conversion from a partial response to a complete response, have been observed.

Solo-Dex, a developer and distributor of medical catheters, announces the national availability of its Facile® continuous peripheral nerve block (cPNB catheter for managing pain before, during and after surgery. All Solo-Dex products are currently US FDA cleared and CE marked for Europe.

With Facile®, anesthesiologists can place and activate the facile continuous nerve block catheter quickly and safely for common procedures such as shoulder repair, hip and knee replacement as well as general surgical procedures.  Facile leads the field in ease-of-use placement. The SOLO-DEX Fascile® simplifies and accelerates cPNB placement, improving patient comfort and post-procedure pain management. Patients report the need for opioids is drastically reduced and often eliminated altogether.

Life365, a leading virtual care platform provider, announced its intention to participate in offering a comprehensive suite of solutions to healthcare providers in the relaunched $250M COVID-19 Telehealth program appropriated by Congress and offered by the FCC to qualified applicants by offering a comprehensive RPM and telehealth platform that qualifies under the program’s eligible expenses. Their goal is to help qualified applicants quickly supply the necessary information in order to receive the much-needed Telehealth and RPM resources to service their patients and communities. Life365 has launched an easy-to-use website http://www.covid19-telehealth-program.com to provide applicants with information regarding the program and help facilitate the submission of their applications with a comprehensive listing of key resources.

“This is yet another once in a lifetime opportunity for qualified healthcare providers to accelerate the rollout of Telehealth and Remote Patient Monitoring (RPM) connected solutions to their surrounding and remote communities”, said Kent Dicks, CEO of Life365. “Before COVID-19, Telehealth and RPM were slowly increasing in adoption, with numerous pilots and limited rollouts. Telehealth had an approximately 13% market penetration in the US prior to COVID-19, but with the pandemic, utilization shot to over 70% – It was the only way patients could safely see their doctors. The first round of FCC funding helped stimulate and accelerate adoption during the pandemic. This second round will help facilitate building a permanent bridge to remote care services, normalizing remote care as an everyday experience.”