Bio Platforms
Inozyme Pharma Announces FDA Fast Track Designation for INZ-701 in ABCC6 Deficiency
Inozyme Pharma, Inc. recently announced the US FDA has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency. “Through Fast Track designation,…
Alvotech Announces Positive Topline Results for a Proposed Biosimilar for Prolia & Xgeva
Alvotech recently announced positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia (denosumab) and Xgeva (denosumab). The study met…
Touchlight & LenioBio Collaborate to Accelerate Development of Protein Therapeutics for Pandemic Response
LenioBio and Touchlight recently announced a supply agreement aimed at leveraging the revolutionary capabilities of Touchlight’s rapid enzymatic doggybone DNA (dbDNA) to achieve unprecedented speed…
Ovid Therapeutics & Graviton Bioscience Announce Topline Data From Phase 1 Clinical Trial Studying a Potential First-In-Class Therapy for Cerebral Cavernous Malformations
Ovid Therapeutics Inc. and Graviton Bioscience Corporation recently announced the results from their Phase 1 healthy volunteer study evaluating the safety, tolerability, and pharmacokinetic (PK)…
Syncromune Granted FDA Fast-Track Designation for the Treatment of Metastatic Castrate-Resistant Prostate Cancer
Syncromune Inc. recently announced the US FDA has granted Fast Track designation for SYNC-T SV-102 therapy, its lead candidate for the treatment of patients with metastatic…
Artelo Biosciences Presents Preclinical Data on ART26.12 in Breast Cancer-Induced Bone Pain
Artelo Biosciences, Inc. recently announced Professor Saoirse O’Sullivan, Vice President of Translational Sciences at Artelo, presented preclinical data related to ART26.12, Artelo’s novel fatty acid binding…
WEBINAR - Development of Orally Delivered GLP-1 Therapeutics…From Diabetes to Obesity and Beyond
Join Quotient Sciences’ experts on July 18 as we explore the latest developments in orally-delivered GLP-1 agonists, the potential for these therapeutics and overcoming the manufacturing challenges.
NeOnc Technologies Completes $18.5-Million Financing, Advances Phase 2 Clinical Trials for Enhanced Method of Delivering Novel Therapeutics to the Brain Under FDA Fast-Track Status
NeOnc Technologies Holdings, Inc. has completed an $18.5-million financing to support the ongoing development and Phase 1 and 2 clinical studies of its novel drug…
Nxera Pharma Receives $10 Million From AbbVie as Collaboration Targeting Neurological Diseases Achieves First R&D Milestone
Nxera Pharma Co. Ltd recently announced it has reached an important R&D milestone under its multi-target discovery collaboration with AbbVie targeting neurological diseases, resulting in…
GRI Bio Announces Patent Granted for Proprietary Natural Killer T Cell Modulators
GRI Bio, Inc. recently announced the Korean Intellectual Property Office (KIPO) has granted Patent No. 10-2665487 titled Prevention and Treatment of Inflammatory Conditions. The granted…
Inmagene Announces Positive Topline Results of a Multiple Ascending Dose Study of a Non-Covalent Reversible BTK Inhibitor With Once- Daily Dosing Potential
Inmagene Biopharmaceuticals recently announced positive topline results from the multiple ascending dose (MAD) portion of its randomized, double-blind, placebo-controlled Phase 1 study of IMG-004, a…
GT Biopharma Announces FDA Clearance of IND Application for NK Cell Engager for Treatment of CD33+ Leukemia
GT Biopharma, Inc. recently announced FDA clearance of its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is…
Agile Therapeutics Announces Definitive Merger Agreement With Insud Pharma
Agile Therapeutics, Inc. recently announced it has entered into a definitive merger agreement with Insud Pharma, S.L. pursuant to which Insud, through its US subsidiary,…
Emmes Partners With ILiAD Biotechnologies to Conduct Phase 3 Clinical Trials of BPZE1, the Leading Next-Generation Pertussis Vaccine
ILiAD Biotechnologies, LLC recently announced the selection of Emmes Group, a global contract research and technology organization, to conduct upcoming Phase 3 studies of its lead…
Immutep Signs Exclusive License Agreement With Cardiff University for Next-Generation Anti-LAG-3 Molecules for Cancer
Immutep Limited recently announced a license agreement with Cardiff University granting the company exclusive rights to develop and commercialize anti-LAG-3 small molecules. A number of…
Ethris Announces Positive Initial Phase 1 Data Demonstrating Nasal Delivery of mRNA Lead Candidate
Ethris GmbH recently announced preliminary positive data from its Phase 1 dose escalation clinical trial evaluating the safety, tolerability, and target engagement of lead mRNA…
Kane Biotech Signs Worldwide License Agreement With I-MED Pharma
Kane Biotech Inc. recently announced it has entered into a worldwide license agreement with I-MED Pharma Inc. for the DispersinB technology. Biofilm is a known…
BioNTech & DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate in Prostate Cancer
BioNTech SE and Duality Biologics recently announced the US FDA granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic…
TFF Pharmaceuticals Provides Regulatory Update on Tacrolimus Inhalation Powder Clinical Program for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals, Inc. recently announced a regulatory update on its TFF TAC clinical program following its recent interaction with the US FDA. In April 2024,…
Checkpoint Therapeutics Announces Alignment With FDA Enabling Upcoming Cosibelimab BLA Resubmission
Checkpoint Therapeutics, Inc. recently announced it has reached alignment with the US FDA on its biologics license application (BLA) resubmission strategy for cosibelimab. Accordingly, Checkpoint…
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).