CORRECTING and REPLACING Circle Pharma Raises $45 Million in Series B Financing

Business Wire | March 17, 2020

Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, today announced that it has raised $45 million in a Series B financing. The financing was led by The Column Group, with participation by Nextech Invest. All investors from the prior round – ShangPharma, LifeForce Capital, and the Berkeley Catalyst Fund – joined the financing. In conjunction with the financing, Peter Svennilson, founder and managing partner of The Column Group, and Thilo Schroeder, Ph.D., partner at Nextech Invest were appointed to the board. John Josey, Ph.D., formerly President and CEO of Peloton Therapeutics, was appointed to the board as Chairman. Proceeds from the investment will be used to advance Circle’s work to develop inhibitors of Cyclin A and Cyclin E, and to expand the company’s pipeline.

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Farmacon Global Partners With Validcare for Performance-Based Clinical Research Solutions

Validcare | February 17, 2022

“Validcare’s partnership with Farmacon Global will literally redefine clinical trial success from patient-centric design through database lock,” said Patrick McCarthy CEO Validcare. The Validcare platform accommodates site-based, hybrid and decentralized clinical trials and establishes key performance indicators to ensure study success. “Partnering with Validcare allows our sponsors to quickly identify and implement ROI generating activities like increased patient enrollment and site set up, while facilitating easier communication with principal investigators and on-going participation. This is especially critical for clinical trials in Latin America where Farmacon Global is uniquely positioned for delivering on-time and on-budget studies. Our focus has always been on the voice of the patients enrolled in a study. Today through our Validcare partnership we can offer the empirical results of better access and data integrity with our trial participants through e-CRF, e-diaries and more efficient RWE data being applied at a whole new level,” Tylosky concluded. Sara Tylosky CEO Farmacon Global Validcare will provide critical infrastructure to power Farmacon Global along with relevant metrics and KPIs. “Together, we provide proven processes, tools and technology to overcome the obstacles that typically cause clinical trial delays and failures,” said McCarthy. “We are excited to reset sponsor expectations and execute clinical trials on time and on budget.” About Validcare Founded by experts with more than 20 years of industry experience, Validcare offers the leading solution for best practices in streamlining research for regulatory compliant, life-improving products. Validcare brings a decade of experience powering clinical trials and value-based care models spanning pharma, med device and supplement market segments. About Farmacon Global Farmacon Global is a strategic CRO of medical consultants, providing solutions to accelerate clinical trials in emerging markets – with a specialty in Latin America and emerging markets with in-place medical associates and KOL alliances. Specialties include rare disease, cancer, immunology and infectious disease

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Telix Granted FDA Orphan Drug Designation for Bone Marrow Conditioning Treatment

Telix Pharmaceuticals Limited | March 29, 2022

Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs. Bone marrow conditioning is performed prior to HSCT, a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells (cells that can develop into different types of cells), to encourage production of new bone marrow that produces healthy blood cells. Traditional conditioning regimens are associated with morbidity and mortality from chemotherapy, limiting their use particularly in pediatric and rare diseases.[1] TLX66 has the potential to add to the depth of conditioning, thereby removing additional disease-causing cells. In addition, TLX66's potential to reduce the toxicity of existing conditioning regimens could increase the number of patients that are eligible for transplant. HSCT is being used increasingly in malignant hematological conditions, such as multiple myeloma and acute myeloid leukemia, and in non-hematological malignancies and rare / immune-mediated diseases.[2] In 2018, 22,729 HSCTs were performed in the United States.[3] During 2021, the Company reported initial results for safety and tolerability for the Targeted Radiotherapy for AL-amyloidosis, a Phase I trial conducted at the University of Southampton, United Kingdom.[4] The study found that TLX66 was well-tolerated in patients with systemic amyloid light chain amyloidosis, enabling successful engraftment of the patients' own transplanted stem cells without the need for toxic chemotherapy in this rare immune condition with a poor prognosis. "The granting of an Orphan Drug Designation by the FDA for TLX66, combined with recent encouraging data from prior studies in hematological malignancies and autoimmune disease provides a strong impetus to advance our development plans for TLX66. This treatment has potential application in a number of hematological cancers and rare diseases and potentially also in the future for conditioning for cell and gene therapies." Telix Chief Medical Officer, Dr Colin Hayward TLX66 has also previously been granted ODD status by the European Medicines Agency in Europe for treatment in hematopoietic stem cell transplantation. TLX66 has not received a marketing authorisation approval in any jurisdiction. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

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FDA Grants Direct Biologics Regenerative Medicine Advanced Therapy (RMAT) Designation for the use of ExoFlo in COVID-19 Related ARDS

Direct Biologics | April 13, 2022

Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle platform drug technology, announced that the U.S. Food and Drug Administration has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clinical evidence indicating the ability to address an unmet medical need for a serious life-threatening disease or condition. Under the RMAT designation, the FDA provides intensive guidance on drug development and post-market requirements through early and frequent interactions. Additionally, an RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications. "After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicenter, double blinded, placebo controlled randomized clinical trial, the FDA has recognized ExoFlo as a lifesaving treatment for patients suffering from Acute Respiratory Distress Syndrome (ARDS) due to severe or critical COVID-19. The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US," he said. Mark Adams, Chief Executive Officer "We are very pleased that the FDA has recognized the lifesaving potential of our platform drug technology ExoFlo. The RMAT has provided a pathway to expedite our drug development to achieve a BLA in the shortest possible time," said Joe Schmidt, President. "I am very proud of our team. Everyone has been working around the clock for years in our mission to save human lives taken by a disease that lacks treatment options, both in the US and abroad. We are grateful for the opportunity to accelerate development of ExoFlo under the RMAT designation as it leads us closer to our goal of bringing our life saving drug to patients who desperately need it." ExoFlo is an acellular human bone marrow mesenchymal stem cell derived extracellular vesicle product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC. Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com. About Direct Biologics Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in San Antonio, Texas. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust EV platform technology. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving segment of next generation regenerative biotherapeutics. Direct Biologics has obtained and is pursuing multiple additional clinical indications for ExoFlo through the FDA's investigational new drug (IND) process.

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Stallergenes Greer Strengthens Precision Medicine Approach in Allergen Immunotherapy With Imperial College London Research Collaboration

Stallergenes Greer | January 17, 2022

Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that the company has entered into a research collaboration on the discovery of biomarkers of AIT efficacy with Imperial College London, a global top ten university with a world-class reputation in science, engineering, business and medicine. This long-term research collaboration, which combines the long-standing expertise of Stallergenes Greer in AIT with the prestigious research capabilities of Imperial College London, aims to push the boundaries of allergic patient care by identifying biomarkers of AIT efficacy and expanding the knowledge of the pathophysiology of allergic diseases and their treatment with AIT. “We are thrilled about this collaboration with Imperial College London which will contribute to both deciphering the mode of action of AIT and identifying key markers that can be used in the routine practice of allergology for the benefit of patients and healthcare practitioners. Based on the understanding of specific phenotypes and the responses of patients with allergies, allergologists will be able to tailor treatment modalities with the right dosing at the right time for each individual. This underscores our commitment to advancing precision medicine for allergy sufferers”, Amer Jaber, Executive VP Operations Europe and International and President of Stallergenes SAS “This research collaboration is a remarkable opportunity for a fruitful partnership between Imperial College London, a pioneer and world-leading university in the biomarker field, and Stallergenes Greer. It will build on the recent advances of biomarker research to further develop precision medicine in AIT for the benefit of patients with allergic diseases,” said Dr Mohamed Shamji, Head of the Immunomodulation and Tolerance Group, Imperial College London. The results of this research collaboration will be shared in international congresses and peer review publications. About Allergen Immunotherapy Allergies are the most prevalent and fastest growing chronic diseases in the industrialised world, affecting over one billion people worldwide. Allergen immunotherapy uniquely alters the natural course of respiratory allergies. It is the only therapeutic class capable of modifying disease progression and potentially preventing the onset of the disease by inducing tolerance in the immune system. About Stallergenes Greer Headquartered in London (UK), Stallergenes Greer Ltd is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer Ltd is the parent company of Greer Laboratories, Inc. About Imperial College London Imperial College London is one of the world's leading universities. The College's 20,000 students and 8,000 staff are working to solve the biggest challenges in science, medicine, engineering, and business. Imperial is University of the Year 2022 in the Times and Sunday Times Good University Guide. It is the world’s fifth most international university, according to Times Higher Education, with academic ties to more than 150 countries. Reuters named the College as the UK's most innovative university because of its exceptional entrepreneurial culture and ties to industry.

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