TC BioPharm | November 23, 2022
TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia.
The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."
Bryan Kobel, CEO of TC BioPharm
TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients.
About TC BioPharm PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.
Astellas Pharma Inc. | September 20, 2022
Astellas Venture Management LLC a wholly-owned venture capital subsidiary of Astellas Pharma Inc. and Mission Bay Capital BioLabs a life-science incubator, today announced their collaboration on the "Astellas Future Innovator Prize" formerly known as the Astellas Golden Ticket competition. Building on over three successful years, the competition offers entrepreneurial scientists or emerging biotechnology start-ups one year's priority usage of MBC BioLabs' state-of-the-art lab facility and access to Astellas' research and development (R&D) capabilities and business leaders.
With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms. The 2022 competition will prioritize innovative research that compliment Astellas' Focus Area Approach and pipeline.
"We are truly thrilled to host the Astellas Future Innovator Prize again this year. Through our long-term collaboration with MBC BioLabs, we aim to create an environment that encourages innovation to thrive. The Astellas Future Innovator Prize enables us to provide biotech companies with expertise and capabilities to turn an innovative idea into a real solution, which could transform the lives of patients in need around the world."
William Watt, President, AVM
"We are pleased to continue our partnership with Astellas to uncover the innovators of tomorrow," said Douglas Crawford, MBC BioLabs General Manager. "The past winners of the Astellas Future Innovator Prize show what can be achieved by combining Astellas' support, advice and expertise with our laboratory incubator, and we are excited to see the result of our ongoing collaboration."
Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 4, 2022 to enter the Astellas Future Innovator Prize.
About the Astellas Future Innovator Prize at MBC BioLabs
Astellas is offering up to two prizes for pioneering scientists with innovative research that complements Astellas' areas of interest in alignment with its Focus Area Approach and pipeline, including Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, Cell Therapy, and other areas.
The 2021 Astellas Future Innovator Prize winners were Vcreate and Weatherwax Biotechnologies, chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas' Focus Area Approach.
About Astellas Venture Management LLC
AVM is the wholly-owned venture capital organization within Astellas, dedicated to supporting pre-clinical, cutting-edge science that can bring VALUE to patients. For over 15 years, AVM has provided equity investments to private, early-stage companies developing therapeutic programs and platform technologies, helping them to advance their innovations faster. AVM is a strategic investor, making investments in science that will enhance the current Astellas R&D pipeline or that could catalyze new directions in discovery research.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.
About MBC BioLabs
MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single bench and providing these entrepreneurial scientists with access to millions of dollars of equipment, MBC BioLabs allows companies to be fast, focused, and frugal. It has three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos, California. Each site has a complete molecular biology core facility that allows companies to do experiments on day one. MBC BioLabs has partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Since opening in 2013, MBC BioLabs has helped launch and grow 290 companies. These companies have brought 58 programs to the clinic, produced 13 approved diagnostics, and raised over $14 billion.
Eyenovia, Inc. | November 30, 2022
Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs.
Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off.
“We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.”
Michael Rowe, chief executive officer of Eyenovia
“We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund.
Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million.
About Eyenovia, Inc.
Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression.
About Avenue Venture Opportunities
The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.