Catalent and MigVax Sign Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19

On June 7, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, and MigVax, an Israeli biopharmaceutical company developing an oral subunit vaccine against COVID-19, reported that they have signed a development agreement to leverage Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine (Press release, Catalent, JUN 7, 2022, https://www.catalent.com/catalent-news/catalent-and-migvax-sign-agreement-to-develop-an-orally-disintegrating-freeze-dried-tablet-vaccine-against-covid-19/ [SID1234615689]).

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MigVax’s lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests, and in November 2021. As an oral formulation, MigVax-101 could offer significant potential advantages in low-and middle-income countries over today’s first-generation injected vaccines, including ease of administration, transport and storage, the potential to tackle future variants, and applicability to a broader population. In addition, MigVax’s oral approach may allow for mucosal protection, a benefit that may prove important in preventing infection.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is recognized as one of the world’s best-performing ODTs, offering multiple advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. Utilizing the Zydis ODT technology, Catalent’s innovative Zydis Bio facilitates the oral delivery of macromolecules. Under the terms of the agreement, Catalent will undertake a feasibility study to formulate MigVax-101 into a Zydis Bio ODT dose form and evaluate its preclinical performance and stability properties. Work will be carried out at Catalent’s Zydis facility in Swindon, U.K.

"We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine," commented Mr. Ran Amir, MigVax’s CEO. "Once our vaccine can be transported using the Zydis Bio technology, in unrefrigerated vehicles and stored in standard warehouses, it will be much easier and cost-effective for countries everywhere to roll out mass-vaccination programs. We believe this is a major step forward that will help society cope with the viruses in our midst as we continue returning to the ‘new normal’."

"Zydis Bio technology offers numerous potential benefits to this program, and has previously been used to successfully deliver antigens to the oral mucosae," commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. He added, "In addition, the ease of administration and the potential for removal of the need for cold chain storage and transport means that the oral vaccine would have significantly fewer restrictions in terms of global distribution, compared with current cold chain injectable vaccines."

Catalent’s 250,000-square-foot site in Swindon, U.K., houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.

Immatics and Editas Medicine Enter Strategic Research Collaboration and Licensing Agreement to Combine Gamma-Delta T Cell Adoptive Cell Therapies and Gene Editing for the Treatment of Cancer

On June 7, 2022 Immatics N.V. (Nasdaq: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, reported that the two companies have entered into a strategic research collaboration and licensing agreement to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer (Press release, Immatics, JUN 7, 2022, View Source [SID1234615687]). As part of the licensing agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property. Editas Medicine is the exclusive licensee of Harvard and Broad Institute’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines.

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By combining Editas Medicine’s gene editing technology with Immatics’ ACTallo allogeneic, off-the-shelf adoptive cell therapy platform based on gamma-delta T cells, gamma-delta T cells can be redirected to cancer cell targets with the goal of creating cells with enhanced tumor recognition and destruction.

"Engineered cell therapies have the potential to significantly impact the treatment paradigm for cancer, and our partnership with the esteemed team at Editas Medicine will provide us with further versatility and flexibility in how we engineer our ACTallo cell therapies based on a specific tumor target," said Rainer Kramer, Ph.D., Chief Business Officer, Immatics. "It has always been our focus to deliver innovative science to cancer patients and this collaboration with Editas Medicine will enable us to access CRISPR technologies and apply them to our off-the-shelf gamma-delta T cell platform."

"We believe that our gene editing technology can modulate and enhance the potential of cell therapies to deliver transformative medicines for the treatment of cancer. We are excited to work with the team at Immatics to develop new experimental medicines with enhanced tumor fighting abilities to help patients with cancer," said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine.

Under the terms of the agreement, Editas Medicine will be eligible to receive an undisclosed upfront cash payment as well as additional milestone payments based on development, regulatory, and commercial milestones. In addition, Immatics will pay royalties on future net sales on any products that may result from this collaboration.

Zumutor Receives FDA Response on Pre-Investigational New Drug (PIND) Application

On June 6, 2022 Zumutor Biologics, a next generation Tumor-Directed IO therapeutics reported that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its novel monoclonal antibody ZM008 developed to treat various locally advanced or metastatic solid tumours (Press release, Zumutor Biologics, JUN 6, 2022, View Source [SID1234616460]).

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The Company plans to initiate actions on the FDA’s recommendations and follow up with the FDA with an Investigational New Drug (IND) application by the Q3 of 2022 followed by Phase I studies.

Ms Kavitha Iyer Rodrigues Chief Executive Officer of Zumutor, commented, "We appreciate the FDA’s thoughtful guidance on the proposed chemistry, manufacturing and control (CMC), nonclinical and clinical development program of our novel monoclonal antibody ZM008. We intend to address the recommendations made by the FDA and are committed to the successful completion of the required clinical trials of ZM008 to provide an effective and safe therapy for various solid tumors."

TriSalus Life Sciences to Present at the Society of Interventional Radiology’s 2022 Annual Scientific Meeting

On June 6, 2022 TriSalus Life Sciences, an interventional immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, reported that it will present a series of events at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting, held June 11-16, 2022, at the Boston Convention and Exhibition Center (Press release, TriSalus Life Sciences, JUN 6, 2022, View Source [SID1234615767]).

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The TriSalus clinical leadership team will be on-site to discuss the company’s FDA-cleared TriNav Infusion System as well as ongoing research with the interventional radiology (IR) community, including two presentations on new pre-clinical data that inform the company’s immunotherapeutic platform approach.

The company is pioneering an integrated platform approach that aims to overcome immunosuppression and delivery barriers by combining an investigational toll-like receptor 9 agonist, SD-101, with innovative drug delivery technology. The TriNav Infusion System utilizes the Pressure-Enabled Drug Delivery (PEDD) method of administration with SmartValve to overcome intratumoral pressure and improve delivery of therapeutic agents during outpatient interventional radiology procedures.

Additional activities, including a Monday evening reception, are highlighted below.

ON-SITE TRISALUS SPOKESPERSONS

Steven C. Katz, MD, FACS, Chief Medical Officer

David B. Jaroch, PhD, Senior Principal Scientist

Alexander Y. Kim, MD, Director of Interventional Oncology Clinical Strategies

Mikael Trollsas, PhD, Senior Vice President of Research and Development

CONFERENCE ACTIVITIES

Sunday, June 12 – Tuesday, June 14

TriNav Exhibition, Booth #605

Visit Booth #605 to see a replica of the TriNav Infusion System and learn how the device is engineered to improve tumor response, increase therapeutic delivery, and target tumors more precisely.

Sunday, June 12

Hands-on Workshop, Interventional Oncology: Embolization, 3:00 – 4:30pm ET, Exhibit Hall C

During this interactive workshop, attendees can experience what makes the TriNav Infusion System different from standard delivery approaches.

Monday, June 13

Taste of New England: An Evening Reception, Presented by TriSalus Life Sciences, 6:30-8:00pm ET

Westin Boston Seaport – Marina Ballroom II

Join the TriSalus team for an evening networking and education reception, complete with New England favorites. (Media RSVP for the event by emailing [email protected].)

Wednesday, June 15

(Scientific Sessions listed below are part of the SIR 2022 CME-accredited scientific program and not a TriSalus-sponsored activity.)

Scientific Session: IO Frontiers 2, 3:18-3:27pm ET, Room 253B

Abstract Title: Improved Delivery of a TLR-9 Agonist to Liver Tissue by Intravascular Pressure Enabled Drug Delivery (PEDD) Compared with Direct Needle Injection

Hear TriSalus Senior Principal Scientist David B. Jaroch, PhD highlight promising results from a pre-clinical study comparing local injection of labeled SD-101 into hepatic tissue versus using the PEDD method.

Scientific Session: Venous Disease and Sampling, 4:21-4:30pm ET, Room 258A

Abstract Title: Comparison of Pancreatic Tissue Uptake of Oxaliplatin Delivered by Systemic Circulation and by Pancreatic Retrograde Venous Infusion (PRVI)

TriSalus Senior Principal Scientist David B. Jaroch, PhD will present on the development of a trans-venous approach for regional treatment of pancreatic tumors, using a catheter capable of modulating pressure and flow within the organ to promote drug uptake.

Horizon Therapeutics plc to Present at the Goldman Sachs 43rd Annual Global Health Care Conference

On June 6, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in June (Press release, Horizon Therapeutics, JUN 6, 2022, View Source [SID1234615710]):

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Goldman Sachs 43rd Annual Global Health Care Conference

Date: Tuesday, June 14, 2022
Presentation Time: 11 a.m. ET
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for one year following the event.