PHARMACY MARKET

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

TC BioPharm | November 23, 2022 | Read time : 02:00 min

TC BioPharm
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.

Spotlight

Capsule dosage form is a new dosage form developed after tablets, injections, oral liquids, etc. It is divided into hard capsules and soft gel capsule.

Spotlight

Capsule dosage form is a new dosage form developed after tablets, injections, oral liquids, etc. It is divided into hard capsules and soft gel capsule.

Related News

RESEARCH, PHARMA TECH

Alliance Pharma Opens State-of-the-Art Bioanalytical Laboratory in Brisbane

Alliance Pharma | December 08, 2022

Alliance Pharma a global leader providing bioanalytical, DMPK, and CMC testing services in the pharmaceutical and biopharmaceutical industry, has opened its new 20,000-square-foot bioanalytical laboratory, Alliance Pharma Pty, Ltd., in Brisbane, Australia. The new Australia facility, which the company announced plans for earlier this summer, includes an expansive lab to provide much-needed small and large molecule bioanalytical services for a region with limited choices for bioanalytical support. “Alliance Pharma’s expanded presence in Australia affirms our commitment to combining scientific talent and technology to deliver global drug development solutions. In this new purpose-built laboratory, our talented teams will use their diverse experience and expertise to provide high-quality bioanalytical services.” Alliance CEO, Patrick Bennett “Our new state-of-the-art science facility in Brisbane will further strengthen our global bioanalytical capabilities. It will allow biotech companies to work with us in Australia in the early phase and then transfer the knowledge on these assays to other regions to support the later development phases. Our objective is to accelerate the growth of our best-in-class portfolio and deliver industry-leading drug development service for our worldwide clients,” said Alliance Pharma Site President, Australia, Jason Wang, Ph.D. About Alliance Pharma Founded in 2008, Alliance is a contract research organization with bioanalytical, DMPK, and CMC testing labs in Malvern, PA, Brisbane, AU, Cambridge, U.K., and Sandwich, U.K. The labs specialize in advanced research services for all drug molecules, cell and gene therapies, and drug metabolism studies to support pharmaceutical and biotechnology companies’ drug discovery and development programs. Alliance’s mission is to build a trusted partnership with our clients to support their successful drug development programs. Our business philosophy is based on a foundation of trust, professional ethics, scientific excellence, and regulatory compliance.

Read More

VIEWS AND ANALYSIS, PHARMACY MARKET

MedRhythms Recognized for Advancements in Prescription Digital Therapeutics from CB Insights, Reuters Events Pharma and Fast Company

MedRhythms | December 12, 2022

CB Insights today announced that, for the second year in a row, MedRhythms has been named to its annual Digital Health 150, a list that showcases the 150 most promising private digital health companies. This recognition comes a week after MedRhythms received the Most Valuable Digital Therapy award at the Reuters Events Pharma Awards ceremony and less than a month after MedRhythms was named a Fast Company Next Big Things in Tech honoree for the progress that the company has made on its products and their potential to improve access to high quality care. "From reimagining clinical care, to leveraging tech like AR/VR to improve surgical training, this year's Digital Health 150 winners are transforming the future of healthcare with digital technology. This increasingly global cohort, representing more than 18 countries across five continents, is not only driving better patient outcomes, but making healthcare more accessible. We are excited to follow the meaningful impact and continued success of this year's winners." Brian Lee, SVP of CB Insights' Intelligence Unit "Being recognized as a leader in the industry by CB Insights, Reuters Events Pharma and Fast Company is an incredible honor and is a testament to our entire team's commitment to our mission to positively impact the lives of those living with neurologic injury and disease," said Brian Harris, CEO and Co-Founder of MedRhythms. "These recognitions serve as validation of our team's progress to date and, more importantly, as motivation to keep advancing as we push the envelope in healthcare by building next-generation neurotherapeutics that leverage the power of music to bring important interventions to patients around the world." Utilizing the CB Insights platform, the research team selected these 150 winners from a pool of over 13,000 private companies, including applicants and nominees. They were chosen based on factors including R&D activity, proprietary Mosaic scores, market potential, business relationships, investor profile, news sentiment analysis, competitive landscape, team strength, and tech novelty. The research team also reviewed over 3,000 Analyst Briefings submitted by applicants. MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, MedRhythms announced an oversubscribed Series B financing round of $27M co-led by Morningside Ventures and Advantage Capital. Since raising the Series B financing, MedRhythms has announced that the company has entered into collaborations with Universal Music Group (UMG), the world's largest record label for music content and data, and Biogen, one of the first global biotechnology companies. MedRhythms' most advanced product, which addresses gait impairment in chronic stroke, received Breakthrough Device designation from the U.S. Food and Drug Administration. Earlier this year, MedRhythms finalized a worldwide licensing agreement worth up to $120M with Biogen for the company's second product, which targets gait impairment in multiple sclerosis. In addition to these two assets, the company has a strong pipeline in large markets with high unmet needs and is conducting feasibility studies in collaboration with some of the world's leading clinicians and researchers. About Fast Company Fast Company is the only media brand fully dedicated to the vital intersection of business, innovation, and design, engaging the most influential leaders, companies, and thinkers on the future of business. The editor-in-chief is Brendan Vaughan. Headquartered in New York City, Fast Company is published by Mansueto Ventures LLC. About Reuters Events Pharma More open so that the strongest ideas and insights are brought to the fore in a transparent, trustworthy manner. More valued by having an authentic approach to building products and services that matter to patients. About MedRhythms MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. The company's pipeline product for chronic stroke walking deficits received Breakthrough Device designation in 2020 and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

Read More