Bio Platforms
Neurona Unveils Phase 3 EPIC Study for NRTX-1001 Cell Therapy in Epilepsy
Neurona Therapeutics recently announced plans to initiate the Phase 3 EPIC clinical trial for its lead product candidate, NRTX-1001. NRTX-1001 is the first investigational human cell…
Medigene AG Expands Patent Portfolio With Patent Grant for its JOVI Technology in the US
Medigene AG recently announced it has been issued a patent by the US Patent Office protecting its JOVI technology, a method allowing the enrichment of…
IMUNON Announces Translational Data from Phase 1/2 OVATION 2 Study of IMNN-001 in Advanced Ovarian Cancer
IMUNON, Inc. recently announced new translational data from ongoing analyses of results from the Company’s Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12)…
IN8bio Presents Positive Phase 1 Data Highlighting Durability of Remissions in High-Risk AML
IN8bio, Inc. recently presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in…
Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Bicara Therapeutics Inc. recently announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab…
Abcuro Announces $200 Million Financing to Advance its First-In-Class Medicine in Development for Inclusion Body Myositis
Abcuro, Inc. recently announced the closing of a $200-million Series C financing led by New Enterprise Associates (NEA) with Foresite Capital joining the round and…
FORMULATION FORUM - Nanoparticle Technologies for Oral Delivery of Peptides & Proteins
Jim Huang, PhD, and Shaukat Ali, PhD, examine various nanoparticle technologies in oral delivery of large molecules.
VACCINE DEVELOPMENT - Enhancing Pandemic Preparedness With Mosaic-8b Nanoparticles
Leonardo Magneschi, PhD, says although the mosaic-8b vaccine is still in early development, it has the potential to enable a broad and cross-reactive immunization strategy that could provide comprehensive protection against known and unknown sarbecoviruses.
Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer & Plans for FDA Alignment on Next-Stage Development
Ocean Biomedical recently announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI),…
Safi Biotherapeutics & ARMI BioFabUSA Initiate Collaboration to Support Large-Scale Development of mRBCs
Safi Biotherapeutics recently announced a collaboration focused on the manufacturing of Safi’s mRBCs to support regulatory requirements and initial clinical studies. “We are very excited…
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Biodexa Pharmaceuticals PLC recently announced the US FDA has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the…
Alumis & ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company
Alumis Inc. and ACELYRIN, INC. recently announced a definitive merger agreement under which Alumis and ACELYRIN will merge in an all-stock transaction. Martin Babler, President,…
Maze Therapeutics Doses First Patient in Phase 2 Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease
Maze Therapeutics, Inc. recently announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients…
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…
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).