Bio Platforms
SAB Biotherapeutics Novel DiversitAb Platform Proven to Develop Anti-Idiotype Antibodies to Help Treat Autoimmune Diseases
SAB Biotherapeutics recently announced results from a project in collaboration with global biotechnology leader CSL confirming that SAB’s DiversitAb platform can generate functional fully human anti-idiotype polyclonal….
Ovid Therapeutics Dosed Healthy Volunteers With OV329 in Phase 1 Trial
Ovid Therapeutics Inc. recently dosed healthy volunteers with OV329 in late December 2022, as part of a Phase 1 study. The company is conducting the…
IMUNON Enters Collaborative Research Agreement With The Wistar Institute’s Vaccine & Immunotherapy Center to Research IMUNON’s PLACCINE Vaccine Platform
IMUNON, Inc. and The Wistar Institute recently announced the signing of a first collaborative research agreement to research and develop new vaccine formulations utilizing IMUNON’s PLACCINE modality for the….
Purple Biotech & Mor Research Applications Announce Research Collaboration to Identify Promising Investigational Oncology Treatments
Purple Biotech Ltd. recently announced a research collaboration with Mor Research Applications that provides Purple Biotech first access to early stage oncology product candidates owned by….
HRA Pharma Rare Diseases Registers the first Cushing’s Syndrome Treatment in Colombia
HRA Pharma Rare Diseases, an affiliate of HRA Pharma, a Perrigo Company, recently announced the registration of the first ever treatment for Cushing’s syndrome, Metopirone,…
Oncorus Announces Research Collaboration With Daewoong Pharmaceutical for the Development of Lipid Nanoparticle Formulations for mRNA Drug Candidates
Research collaboration leverages Oncorus’ proprietary ionizable amines, PEG lipids, LNP formulations, process development and manufacturing together with Daewoong’s mRNA expertise….
Kala Pharmaceuticals Announces FDA Acceptance of IND Application for the Treatment of PCED
Kala Pharmaceuticals, Inc. recently announced the US FDA has accepted an investigational new drug (IND) application for the company’s lead product candidate, KPI-012, a human…
Gilead to Acquire All Remaining Rights to Potential First-In-Class Immunotherapy
Gilead Sciences, Inc. and Jounce Therapeutics, Inc. amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buyout remaining contingent payments potentially due under….
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Valneva SE recently announced it has completed rolling submission of the Biologics License Application (BLA) to the US FDA for its single-shot chikungunya vaccine candidate, VLA1553.…
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV Technologies recently announced that the US FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety,…
Jazz Pharmaceuticals & Zymeworks Announce Jazz has Confirmed Opt-In & Advances Partnership
Jazz Pharmaceuticals plc and Zymeworks Inc. recently announced Jazz has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks’ zanidatamab in key markets….
atai Life Sciences Initiates Phase 2b Proof-of-Concept Trial of RL-007 for Cognitive Impairment Associated With Schizophrenia
The Phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS)…..
Carrick Therapeutics & The Menarini Group Announce Clinical Trial Collaboration
Carrick Therapeutics and the Menarini Group recently announced a clinical trial collaboration and supply agreement that covers the execution of a Phase 2 clinical trial to evaluate the novel combination of….
Paratek Pharmaceuticals Announces Positive Top Line Data From Pilot Efficacy Study for the Treatment of Pulmonary Anthrax & Acceptance of the Second Procurement of NUZYRA Under BARDA Project BioShield
Paratek Pharmaceuticals, Inc. recently announced positive top line data from a pilot rabbit efficacy study evaluating NUZYRA’s effectiveness in the treatment of pulmonary anthrax. In the study, a 100% survival rate….
Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates
Assembly Biosciences, Inc. recently announced promising interim efficacy, safety and pharmacokinetic (PK) results from two ongoing clinical studies of its investigational next-generation HBV core inhibitors,…
Adagene Announces Clinical Trial Collaboration to Evaluate Anti-CTLA-4 SAFEbody ADG126 in Combination With Roche’s Standard-of-Care for First-Line Advanced Liver Cancer
Adagene Inc. recently announced a clinical trial collaboration with Roche to evaluate the triple combination of Adagene’s ADG126 with Roche’s atezolizumab and bevacizumab in first-line treatment of….
Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart
Ocugen, Inc. recently announced the US FDA agreed to Ocugen’s proposed control and overall design for the Phase 3 study of NeoCart, a regenerative cell…
Synlogic Announces Achievement of Proof of Concept for SYNB8802 in Enteric Hyperoxaluria Based on Urinary Oxalate Lowering in Phase 1b Study
Synlogic, Inc. recently announced that SYNB8802 has demonstrated proof of concept through clinically significant lowering of urinary oxalate in a Phase 1b study in patients…
Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina
Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research Triangle, to offer comprehensive stand-alone…
MoonLake Immunotherapeutics Screens First Patient in Phase 2 Study of the Nanobody Sonelokimab in Active Psoriatic Arthritis
MoonLake Immunotherapeutics AG recently announced the first subject has been screened in the US in a Phase 2 clinical study of the Nanobody sonelokimab in patients with….
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).