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Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

The Maryland Industrial Partnerships (MIPS) program announced that it is providing matching grants for 17 technology product development projects in Maryland.

Each project pairs University System of Maryland faculty members with Maryland-based companies to develop new technology products or processes. Projects are jointly funded by both MIPS and participating companies. All funding goes to the university research.

Ascentage Pharma and AstraZeneca Enter into Clinical Collaboration on the Registrational Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Combination with BTK Inhibitor Acalabrutinib in Treatment-Naïve Patients with First-Line CLL/SLL

SUZHOU, China, and ROCKVILLE, Md., Oct. 15, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has entered into a clinical collaboration with AstraZeneca Investment (China) Co., Ltd. (or “AstraZeneca”). The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Published: 10/10/2023

With an increasing number of U.S. biopharmaceutical firms feeling the financial constraints imposed by the Inflation Reduction Act (IRA) and subsequently shutting down or suspending their research programs in the rare disease domain, hundreds of millions of patients in both the U.S. and India face the grim prospect of not receiving a breakthrough treatment for their condition within their lifetimes. IndoUSrare, a US-based nonprofit committed to stanching rare diseases, launches the inaugural Bridging RARE conference to forge a path for affordable clinical innovation via strengthened Indo-US collaborations and more inclusive clinical trials for minimizing the devastating health consequences arising from this policy shift.

(HERNDON, Va.) October 10, 2023: Rare diseases, as defined by the World Health Organization (WHO), refer to some 10,867 medically significant conditions, each with a prevalence of one or less per 1,000 individuals. With only about 8% of them being treatable,¹ rare diseases include congenital malformations, autoimmune disorders, lysosomal storage disorders, thalassemia, muscular dystrophies, and infrequent forms of cancer and infections. Despite substantial progress during the 40 years since the enactment of the Orphan Drug Act of 1983, which incentivized the U.S. private sector to develop 1,100 FDA-approved orphan treatments,² the global thrust against rare diseases is on the verge of losing steam.

VaxTRIALS Adds a New Latin America Base and Greater Vaccine Research Depth

Rockville, MD, October 5, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the acquisition of VaxTRIALS. Headquartered in Panama City, Panama, VaxTRIALS’ 160+ staff members manage and monitor vaccine clinical trial activities throughout Latin America.

“Today’s clinical trials are both more complex and more global in nature than ever before,” said Emmes Executive Chairman Sastry Chilukuri. “Combining VaxTRIALS’ depth of expertise in Latin America and Emmes’ strengths, particularly in technology, biostatistics and data management, will give clients an unmatched partnership experience in conducting their clinical trials.”

Imagine a world where unhealthy organs are replaced with transplants constructed with a 3D printer using the patient’s own cells. No more agonizing waits and desperate searches for a suitable donor organ, and, because the printed organs use cells from the patients themselves, no more fear of organ rejection. It might sound like science fiction set in the far off future, but thanks to the pioneering work of United Therapeutics , it may become a reality a lot sooner than you think, and it’s happening here in Maryland.

Co-headquartered in Silver Spring, United Therapeutics was founded in 1996 by Dr. Martine Rothblatt, a mom who wanted to save her 7 year-old daughter Jenesis who’d been diagnosed with a rare and serious disease called pulmonary arterial hypertension. Twenty seven years later, Jenesis has defied the odds and works at the company her mother founded to save her life.