Weekly Quick Hits (BioHealth Capital Region) – Week of June 26, 2023

The BioHealth Capital Region, which includes Washington, DC, Maryland and Virginia, has generated a lot of life science news this week. Here’s a look.

By Mark Terry
June 30, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

Innovent Bio and RemeGen Enter Partnership for ADCs in Solid Tumors in China

Rockville, Md.-based Innovent Biologics entered a partnership with Suzhou, China’s RemeGen Co. Innovent will provide clinical drug supplies of Tyvyt (sintilimab injection) during the clinical trial collaboration and RemeGen will run the Phase I/IIa studies of Tyvyt with RC88 or RC108 in Chinese patients with advanced solid tumors.

In the Clinic

BioNTech and OncoC4 Launch Pivotal Metastatic Lung Cancer Phase III Trial

BioNTech (Main, Germany) and OncoC4 (Rockville, Md.) dosed the first patient with non-small cell lung cancer (NSCLC) in a Phase III trial of anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The PRSERVE-003 study will evaluate the efficacy and safety of the therapy alone compared to standard-of-care chemotherapy (docetaxel) in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor therapy.

New Products

Thermo Fisher Launches New-Gen, (S)TEM Metrology Solution

Thermo Fisher Scientific introduced the Thermo Scientific Metrios 6 Scanning Transmission Electron Microscope ((S)TEM), a new-generation, fully automated (S)TEM metrology solution to help enhance productivity and deliver data quality assurance for high-volume semiconductor manufacturing. The company also introduced Gibco OncoPro Tumaroid Culture Medium kit. It is specifically developed for the expansion of patient-derived tumoroids, or cancer organoids, from multiple cancer indications.

New Patents

OpGen Reports Ares Genetics’ Patent Successfully Maintained

Rockville, Md.-based OpGen reported its subsidiary, Ares Genetics, announced that one of its key patents under opposition was successfully maintained. The patent, “Genetic Resistance Prediction Against Antimicrobial Drugs in Microorganism Using Structural Changes in the Genome” was granted in Europe in 2021 and in China in 2023. In September 2021, opposition was filed by a Swedish company against the patent in Europe.

Research Roundup

Johns Hopkins Research: New Standard for Graft-Versus-Host Disease Prevention

Researchers at Johns Hopkins Medicine have a new standard for graft-versus-host disease (GVHD) prevention after allogeneic hematopoietic stem cell transplantation. They published results from a Phase III study in the New England Journal of Medicine. The method used cyclophosphamide, tacrolimus, and mycophenolate mofetil and compared it against the standard of care, a calcineurin inhibitor (tacrolimus or cyclosporine) and methotrexate.

NIH Research:  3D Model of Ovarian Cancer Tumors

Researchers with the National Institutes of Health (NIH)/National Center for Advancing Translational Sciences (NCATS) used 3D models of ovarian cancer tumors and found differences in gene activity based on where a cell is in a tumor. Gene activity in cells at or near a tumor’s surface was different from that of cells closer to the tumor center.

Johns Hopkins Research: Nanoparticle to Improve mRNA Cancer Vaccines

Researchers at Johns Hopkins Medicine believe they may have developed a nanoparticle that can improve delivery of mRNA vaccines for infectious diseases and non-infectious diseases such as cancer. The degradable, polymer-based nanoparticle carrying an mRNA-based vaccine traveled to the spleen and activated certain cancer-fighting immune cells in laboratory mice.

UMSOM Research: Analysis from Genetically-Modified Pig Heart Transplant

Researchers with the University of Maryland School of Medicine (UMSOM) published data from the most extensive analysis so far on what caused eventual heart failure in the world’s first successful transplant of a genetically-modified pig heart into a human patient. The procedure was performed in January 2022 and 57-year-old David Bennett, Sr., showed early strong cardiac function, but two months later sudden onset of heart failure led to his death.

On the Hill – Regulatory and Advocacy

American Diabetes Association Releases Updates to 2023 Standards of Care in Diabetes

The American Diabetes Association, based in Arlington, Va., published updates to the Standards of Care in Diabetes-2023 on the use of teplizumab in delaying the onset of type 1 diabetes. Teplizumab is a monoclonal antibody targeting the immune system that can delay the onset of type 1 diabetes in high-risk individuals. The ADA also released a guideline update in Non-alcoholic fatty liver disease (NAFLD).

FDA: New Publications on Real-World Data, Draft Guidance on Orthopedic Implants and More

The FDA published several relevant materials, including “Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative” and draft guidance, “Patient-Matched Guides to Orthopedic Implants.” The agency also issued final guidance for industry entitled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.”

FDA: Approves 1^st Cellular Therapy for Type 1 Diabetes

The FDA announced the first allogeneic (donor0 pancreatic islet cellular therapy made from deceased donor pancreatic cells to treat type 1 diabetes. The treatment, Lantrida, developed by CellTrans,  is approved for adults with type 1 diabetes who are unable to approach target average blood glucose levels because of current repeated episodes of severe low blood sugar.

FDA: 1^st Gene Therapy for Adults with Severe Hemophilia A Approved

The FDA approved BioMarin’s Octavian, the first adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to AAV serotype 5. It is a one-time gene therapy administered as a single dose by IV infusion. The therapy carries a gene for clotting Factor VIII.

People on the Move

Emergent BioSolutions Announces CEO Transition

Gaithersburg, Md.-based Emergent BioSolutions announced Robert G. Kramer Sr. plans to retire as President, CEO and board member effective immediately. Haywood Miller was appointed interim CEO while it runs a search for a permanent replacement.

Kaleo Expands Executive Team

Kaleo, based in Richmond, Va., named George Parise as CFO and Steve Gaeth and Vice President and Controller. Pariase was previously CFO at Pharmaceutical Associates. Gareth was previously Senior Director and Controller at Kaleo.