Bio Platforms
Gradalis Secures FDA Regenerative Medicine Advanced Therapy Designation for Investigational Personalized Immunotherapy for Advanced Ovarian Cancer
Gradalis, Inc. recently announced the US FDA has granted Gradalis’ personalized investigational cellular immunotherapy, Vigil (Gemogenovatucel-T) Regenerative Medicine Advanced Therapy (RMAT) designation based on favorable clinical…
Indaptus Therapeutics Receives Approval From Health Canada to Expand Clinical Trial of Decoy20
Indaptus Therapeutics, Inc. recently announced it has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This…
Annovis Announces First Patients Entered Into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease
Annovis Bio Inc. recently announced the first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early AD. "The launch…
Northstrive Biosciences Reports Positive Updates for Obesity Drug Candidates
Northstrive Biosciences Inc. recently announced an update for its innovative obesity treatment candidates, EL-22 and EL-32, both aimed at optimizing fat loss while preserving muscle…
BioNTech Completes Acquisition of Biotheus
BioNTech SE recently announced the completion of the acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to…
Purple Biotech Announces Research Collaboration With the Icahn School of Medicine at Mount Sinai
Purple Biotech Ltd. recently announced it has entered into a Research Collaboration Agreement with the Icahn School of Medicine at Mount Sinai (Icahn School of…
HCW Biologics Granted FDA Clearance to Evaluate One of its Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
HCW Biologics Inc. recently announced it has received clearance of its Investigational New Drug Application (IND) from the US FDA to initiate a first-in-human Phase…
Salarius Pharmaceuticals Announces Patient Enrollment to Resume in Investigator-Initiated Phase 1/2 Clinical Trial Using Seclidemstat With Azacitidine to Treat Hematologic Cancers
Salarius Pharmaceuticals, Inc. recently announced patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment…
Jupiter Neurosciences Announces Manufacturing Agreement With Catalent
Jupiter Neurosciences, Inc. recently announced it has entered into an agreement with Catalent Pharma Solutions, LLC for the production of JOTROL softgel capsules to support…
Nuvation Bio Announces Expanded Access Program in the US for Taletrectinib in Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. recently announced it has initiated an Expanded Access Program (EAP) for taletrectinib in the US for the treatment of patients with locally…
Jupiter Neurosciences Partners With Zina Biopharmaceuticals to Advance Phase 2a Parkinson’s Trial
Jupiter Neurosciences, Inc. recently announced a strategic partnership with Zina Biopharmaceuticals, LLC to support all aspects of Jupiter’s upcoming Phase 2a clinical trial for Parkinson’s…
Ocean Biomedical Advances Malaria Vaccine Research With New NIH Funding & Expedited Development Pathway
Ocean Biomedical recently announced its Scientific Co-founder, Dr. Jonathan Kurtis, MD, PhD, and his research team have received additional significant funding from the National Institutes…
March Biosciences Receives FDA Orphan Drug Designation for MB-105, a First-in-Class CD5 CAR-T Cell Therapy, for T-Cell Lymphoma
March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced that the U.S. Food and…
Silexion Therapeutics Reports Strong Tumor Growth Reduction From Systemic Administration of SIL-204 in Preclinical Pancreatic Cancer Models
Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced promising new…
Sonnet BioTherapeutics Further Expands Global Intellectual Property Portfolio With Issuance of Patent for Platform Technology
Sonnet BioTherapeutics Holdings, Inc recently announced that the European Patent Office (EPO) has granted Patent No. EP3583125 B1, titled Albumin Binding Domain Fusion Proteins, which covers…
GT Biopharma Announces First Patient Dosed in Phase 1 Trial of Second-Generation TriKE for the Treatment of Hematologic Malignancies
GT Biopharma, Inc. recently announced the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed…
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
Cartesian Therapeutics, Inc. recently announced it has received written agreement from the US FDA under the Special Protocol Assessment (SPA) process on the overall design…
Fortress Biotech Announces First Patient Dosed in Phase 2 Trial of Triplex Vaccination in Stem Cell Donors to Reduce CMV Events in Recipients of HSCT
Fortress Biotech, Inc. and its majority-owned subsidiary, Helocyte, Inc. recently announced the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical…
Aliri Launches qPCR to Complement Existing Lineup of Multi-Omics Platforms
Aliri Bioanalysis, a leading provider of advanced bioanalytical and spatial biology solutions for drug developers, is pleased to announce the addition of quantitative polymerase chain…
Attovia Therapeutics Announces First Participant Dosed in First-in-Human Phase 1 Study of ATTO-1310, its Novel Half-life Extended Anti-IL-31 ATTOBODY for the Treatment of Chronic Pruritus
Attovia Therapeutics recently announced the first subject has been dosed in a first-in-human Phase 1 study of ATTO-1310, a novel, subcutaneous (SQ), half-life extended (HLE)…
What are Bio Platforms?
Platforms (or asset-independent technologies to capture all kinds of capabilities that can be leveraged across many different drug candidate assets rather than just discovery tools that the term ‘platform’ immediately brings to mind) are ubiquitous in modern pharma. They are the product of an arms race, to secure access to the best capabilities in key areas.
Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform.
But it has often been said that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating these platforms.
Benefits of Bio Platforms
Platform technologies have the ability to radically improve upon current products and generate completely novel products. In this sense, they open up new arenas for drug discovery and development, potentially increasing the number of therapeutic options for patients. Once a single compound or therapeutic has been generated and demonstrates a clinical benefit in patients, it is more likely this platform technology can successfully be applied to other therapeutic areas, derisking future compounds/products.
Complex drugs by their very nature are challenging and costly to manufacture. This, in turn, translates into higher costs for patients and other payers. In order to provide safe and effective therapies at a reasonable price, it is necessary for the industry to develop manufacturing technologies that reduce costs and provide a consistent product. While the initial investment may be larger, manufacturing costs will be lower over time as the manufacturing process is solidified.
Scale and Investment of Bio Platforms
Despite the initial upfront costs, platform technologies inevitably provide pragmatic solutions to production challenges, while yielding safer and more effective therapeutic products. It has often been said that one of the key features that distinguishes “Big Pharma” from biotech is access to the latest technological platforms to aid efficient drug discovery and development.
These platforms range from vast chemical libraries, ultra-high throughput screening and huge genetic databases in discovery, to predictive toxicology platforms, cutting-edge ‘omics’ and even deep-seated knowledge of particular therapeutic areas in development. All these platforms have two things in common: They can be used on any (or many) development candidate assets, and they cost huge sums to establish in the first place, and in a few cases each time they are used as well. Hence their restriction to the largest pharmaceutical companies (and a few of the so-called “big biotechs” that are, in many ways, indistinguishable from the old-guard pharma).
Only when you have hundreds of active projects can you justify the cost of creating and operating these platforms. Or so the mantra goes. It is access to these platforms that keeps the big companies ahead in the race to discover and develop the best medicines (or at least counterbalance the disadvantages of being large and slow-moving, depending on your point of view). But is that just an assertion? How much evidence is there to support the proposition that the efficiency gains due to these platforms outstrips the cost of creating and maintaining them?
Keeping these technologies “cutting edge” has become so expensive that increasingly we hear pharma companies talking of “pre-competitive” approaches to develop the next generation. A group of companies might develop a platform capability they then share. The principle goal of such initiatives is to access even grander and more expensive tools than individual companies could afford, rather than to dramatically cut costs (although sharing platforms rather than developing the same thing in parallel in each silo should at least keep a lid on rising costs).