Bio Platforms
Moderna Announces First Participant Dosed in Phase 1 Study of its Epstein-Bar Virus Vaccine
Moderna, Inc. recently announced the first participant has been dosed in the Phase 1 study of mRNA-1189, the Company's Epstein-Barr Virus (EBV) vaccine candidate. The study…
Pfizer & BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine
Pfizer Inc. and BioNTech SE recently announced a new research, development, and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles….
Rain Therapeutics & Roche to Collaborate on Clinical Trial of Milademetan Combination With Anti-PD-L1 Immunotherapy for Various Solid Tumor Indications
Rain Therapeutics Inc. recently announced a clinical supply agreement with Roche for the supply of the anti-Programmed Death Ligand-1 (PD-L1) monoclonal antibody, atezolizumab…..
F-star Therapeutics Announces Merck KGaA, Darmstadt, Germany Exercises a Fourth Licensing Option in Immuno-Oncology Collaboration
F-star Therapeutics, Inc. recently announced that Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany, has exercised a fourth licensing option to develop another…
Cue Biopharma & LG Chem Life Sciences Announce Development Milestone in Immuno-STAT Biologics Collaboration for CUE-102
Cue Biopharma, Inc. and LG Chem Life Sciences recently announced a key milestone in the selection of a clinical product candidate has been reached in their collaboration for CUE-102, an Immuno-STAT biologic, jointly developed to….
Curia Unveils Comprehensive mRNA Solution
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, recently unveiled its messenger RNA (mRNA) solution, which includes discovery, process development and mRNA drug substance production, through….
Santhera Enters Exclusive License Agreement With Sperogenix for Vamorolone in Rare Diseases in the Greater China Region
Santhera Pharmaceuticals recently announced it has entered into an exclusive license agreement with Sperogenix Therapeutics, a China-based company specializing in orphan diseases. Under this agreement….
Viridian Therapeutics Submits IND Application for VRDN-002 to the US FDA
Viridian Therapeutics, Inc. recently announced the submission of an investigational new drug (IND) application to the US FDA for VRDN-002, a humanized monoclonal antibody that…
TCR² Therapeutics & Arbor Biotechnologies Establish Collaboration to Advance Allogeneic TRuC-T Cell Therapies
TCR2 Therapeutics Inc. and Arbor Biotechnologies recently announced the two companies have entered into a strategic research collaboration and non-exclusive license agreement focused on the…
Biogen Exercises Option With Ionis to Develop & Commercialize Investigational ASO for SMA
Biogen Inc. and Ionis Pharmaceuticals, Inc. recently announced that Biogen exercised its option to obtain from Ionis a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306…..
Vaccinex Reports Phase Ib KEYNOTE B84 Combination Study of Keytruda & Pepinemab in Patients With Advanced, Recurrent, or Metastatic Head & Neck Squamous Cell Carcinoma Passes Planned Interim Safety Analysis
The Phase 2 segment of the study is now expected to begin enrollment and is expected to accelerate patient accrual…..
Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones
Assembly Biosciences, Inc. recently outlined anticipated progress and milestones for its development pipeline in 2022…..
Allarity Therapeutics & Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib & Stenoparib
Allarity Therapeutics, Inc. and Oncoheroes Biosciences, Inc. recently announced they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates….
US FDA Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children
Immix Biopharma, Inc. recently announced the US FDA has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of…
UAB & Mereo Announce Positive Top-line Results From Phase 1b/2 Trial of Alvelestat in Hospitalized Patients With COVID-19 Respiratory Disease
The University of Alabama at Birmingham (UAB) and Mereo BioPharma Group plc recently announced top-line data from a Phase 1b/2 clinical trial evaluating alvelestat, a…
Cocrystal Pharma’s COVID-19 Oral & Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron Variant
Cocrystal Pharma, Inc. recently announced in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against the Omicron variant…..
Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval for dovitinib for the third-line…
Heat Biologics Announces Planned Acquisition of Elusys Therapeutics
Heat Biologics, Inc. recently announced it has executed a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM (obiltoxaximab) Injection,….
Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
Hepion Pharmaceuticals, Inc. recently announced the US FDA has accepted its investigational new drug (IND) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the…
Novartis Strengthens Immunotherapy Pipeline With Option, Collaboration & License Agreement With BeiGene
Novartis recently announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company’s research and development activities in immuno-oncology….
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).