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Immunomic250

Immunomic Therapeutics Doses First Patient in its Phase 1 Clinical Trial of ITI-1001, a pDNA Vaccine for the Treatment of Glioblastoma Multiforme

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Immunomic250ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

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Horizon250

MM+M: Roche, Horizon lead way for pharma reputation among rare disease patient groups

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Horizon250Horizon Therapeutics and Roche rank among the top pharma companies in terms of reputation among rare disease patient groups, according to a recent report compiled by U.K. consultancy PatientView. 

Published Tuesday, the 2022 Corporate Reputation of Pharma survey asked 426 rare disease patient groups representing some 3.3 million patients to assess the performance of 34 drugmakers in the space.

The report noted that pharma has steadily improved its reputation among rare disease patient groups over the past five years. Most respondents praised drugmakers’ abilities to provide products that are beneficial to patients and innovating on breakthrough treatments.

Still, the industry scored lower in 2022 for key activities that are meaningful to these patient populations, including fair pricing policies and access to medicines.

Out of the 34 companies, Horizon was ranked first among rare disease patient groups familiar with the brand, followed by Roche and Takeda Pharmaceuticals. Out of 31 companies, Roche was assessed as the top company by rare disease patient groups working with the company.

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Gillian Henker

CANVASREBEL: Q&A with Gillian Henker, President & Co-Founder, Sisu Global Health.

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Gillian HenkerWe’re excited to introduce you to the always interesting and insightful Gillian Henker. We hope you’ll enjoy our conversation with Gillian below.

Hi Gillian, thanks for joining us today. So let’s jump to your mission – what’s the backstory behind how you developed the mission that drives your brand?

At Sisu Global, we set our vision for a world where medical technology enables access to healthcare in every community. In 2010 at Komfo Anokye Teaching Hospital (KATH), I set out to create medical devices to fit the unmet needs of those in resource-limited settings — medical devices that are simple in nature yet impactful in design, serve as a lifesaving intervention for patients, and directly influence the entire healthcare ecosystem.

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HHS logo

Project NextGen Awards Over $1.4 Billion to Develop the Future of COVID-19 Vaccines and Therapeutics

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HHS logoFunding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.

The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.

“Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” said HHS Secretary Xavier Becerra. “These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

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TEDCONOSTO

TEDCO Invests in Nostopharma, LLC

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TEDCONOSTOCOLUMBIA, Md. (August 17, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Social Impact Builder Fund investment of $250,000 into Nostopharma, LLC., a small business developing treatments to restore the health of orthopedic patients.

“Nostopharma is on a mission to revolutionize orthopedic surgery. We hope to offer a complication-free future for trauma patients, athletes and chronic inflammation victims and are developing treatments to help surgeons control trauma complications, including trauma induced abnormal bone growth, a problem that the first application of our platform is looking to solve,” said Ekaterina Vert-Wong, cofounder and CEO of Nostopharma. “We are creating products that minimize abnormal bone growth from the start, helping patients avoid painful and costly revision surgeries.”

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Zalgen Labs

Frederick’s Zalgen Immunotherapeutic Confers Complete Protection Against Advanced Multilineage Lassa Infections in Nonhuman Primates

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Zalgen LabsFREDERICK, Md.Aug. 18, 2023 /PRNewswire/ — Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, including Lassa Fever (LF), today announced publication of data demonstrating that Arevirumab-3®, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages. 

The study emanated from an extensive and ongoing research collaboration of Zalgen, Tulane University (Tulane), UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) [www.vhfc.org] and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) [www.vhfimmunotherapy.org] working on advanced alternatives to treat Lassa fever and other hemorrhagic viral infections.

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Japanvisit

International Delegation from Japan Visits BioHealth Innovation, Inc. in a Bid to Strengthen Biotech Ties

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JapanvisitOn August 16th, BioHealth Innovation, Inc. (BHI) in Rockville, Maryland, hosted a distinguished group of professionals from Japan, representing the International Visitor Leadership Program (IVLP) in collaboration with the U.S. Department of State. This visit marked a significant step towards fostering international relations in the biotechnology sector.

The delegation from Japan arrived with specific objectives for their visit. They aimed to deepen their understanding of technology transfer and the best practices in commercialization. Additionally, they sought to forge strong ties with U.S. technology transfer experts, laying the groundwork for future collaborations. A significant focus was on amplifying biotechnology research and fostering commercial partnerships between the U.S. and Japan. They also aspired to strengthen Japan’s bioeconomy sector, envisioning it as a global epicenter for biotech products and ensuring its biotechnology ecosystems resonate with democratic principles. Furthermore, the delegation intended to heighten the interest of U.S. investors in early-stage biotechnology towards Japanese startups and to broaden the horizons for Japanese companies in the global venture capital arena.

The esteemed group from Japan comprised:

  • Dr. Rei Uematsu, Deputy Director, R&D Division, Industrial Science, Technology and Environment Policy Bureau, Ministry of Economy, Trade, and Industry (METI)
  • Dr. Jun Sato, Attending Physician, Department of Experimental Therapeutics, National Cancer Center Hospital of Japan
  • Dr. Eriko Ogawa, Manager, R&D Division, Amino Up Co., Ltd.
  • Dr. Noriyuki Nishimura, Principal Scientist, National Agriculture and Food Research Organization (NARO)
  • Dr. Masahiro Taniguchi, R&D General Manager, KAICO Ltd.
  • Dr. Minako Sumiyoshi, Regulatory Affairs Officer, Sanatech Seed Co., Ltd.

Representing BioHealth Innovation were Rich Bendis, President and CEO; Luis Gutierrez, Executive in Residence; Albine Martin, Entrepreneur in Residence; and Ethel Rubin, Entrepreneur in Residence.

The visit provided an opportunity for the delegation to learn more about BHI’s mission and services, fostering a deeper understanding and potential for future collaborations.

Rich Bendis, President and CEO of BHI, remarked, “It’s always an honor to host international delegations, especially one as esteemed as this group from Japan. Collaborative efforts like these pave the way for global advancements in biotechnology. We look forward to a future filled with shared knowledge and mutual growth.”

This visit underscores the importance of international collaboration in the biotechnology sector. As the world becomes more interconnected, partnerships like these will be crucial in driving innovation and ensuring the global community benefits from advancements in biotechnology.

MyMD250

FDA Accepts Baltimore’s MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)

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MyMD250BALTIMORE–()–MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept).The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication.

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10XAdd

Addimmune, a Clinical Stage Hiv-Focused Gene Therapy Company, to go Public Through Business Combination With 10x Capital Venture Acquisition Corp. III

By News, News Archive

10XAddNEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) — NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

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Georgiamune

Gaithersburg’s Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing

By News, News Archive

GeorgiamuneGAITHERSBURG, Md.Aug. 9, 2023 /PRNewswire/ — Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

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