News

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.^[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.^[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a “silent killer” because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.²

BALTIMORE–(BUSINESS WIRE)–Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) — Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

ROCKVILLE, Md. and ST. LOUIS, Jan. 30, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue.

Application deadline is Feb. 15 for the pandemic network edition of “Make Your Medical Device Pitch for Kids!™

WASHINGTON, Jan. 29, 2024 (GLOBE NEWSWIRE) — The Alliance for Pediatric Device Innovation (APDI) and Pediatric Pandemic Network (PPN) have teamed up to provide a unique opportunity for innovators of pediatric medical devices, diagnostics and digital health solutions. The organizations are inviting submissions for a pitch competition that emphasizes the development of medical countermeasures (MCMs) – innovations designed to address the unique healthcare needs of children during pandemics and other disasters. MCMs play a pivotal role in bolstering readiness and response capabilities to disasters arising from a broad spectrum of threats.

Johns Hopkins University has launched an ambitious endeavor that the school’s leaders say will make Baltimore a hub of the booming artificial intelligence industry.

The new Data Science and Translation Institute, announced several months ago and planned for the western edge of the Homewood Campus, is expected to be “the leading academic hub for data science and artificial intelligence – a resource that will bring world-class experts to the Baltimore region and drive game-changing innovations,” said Rama Chellappa, interim co-director of the planned institute and a Bloomberg Distinguished Professor at the school.

Florence, Jan. 26, 2024 – PQE Group, the renowned Life Science consulting powerhouse, concludes the fiscal year 2023 with a 10% growth and an upwardly revised income exceeding 100 million euros in revenues. The Italian headquartered global firm, celebrated as a preferred advisor to pharma manufacturing and medical device corporations and SMEs globally, marks this success as a testament to its resilience, adaptability, and strategic vision amid the complex global landscape.

“At a time when many companies grapple with geopolitical challenges, crises, and inflation rates, PQE Group stands out not only for its resilience but for its ability to thrive in uncertain times, showcasing positive growth across all financial indicators,” stated Gilda D’Incerti, CEO & Founder of PQE Group. “This success is rooted in meticulous planning, strategic investments in cutting-edge technologies, and a corporate culture that values agility and innovation.”

ROCKVILLE, Md., Jan. 29, 2024 /PRNewswire/ — Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial.

“This is an important milestone for the company and patients suffering from rheumatoid arthritis” states Gary Fanger President and Chief Executive Officer of Rise Therapeutics. “This achievement reinforces our commitment to deliver innovative new medicines to the clinical community.”

Germantown, Maryland, and State College, Pennsylvania, Jan. 25, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a first-in-kind collaboration with Penn State University in the United States to create a shared research and education facility for the fast-developing microbiome sciences.

The university-industry partnership will serve as a beacon for this field by investigating research opportunities that address challenges and research gaps facing the microbiome, which involves the research into a community of microorganisms that can be found living together in any given environment, including the human body.

ROCKVILLE, Md., and SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Imugene, (ASX: IMU), a clinical-stage immuno-oncology and cell therapy company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Imugene obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue.