Bio Platforms
Biora Therapeutics Announces New Patent for its NaviCap Targeted Oral Delivery Platform
Biora Therapeutics, Inc. recently announced it received an Issue Notification from the US Patent and Trademark Office for a patent related to the treatment of…
Nectin Therapeutics Adds Combination Therapy Arm & Expands Sites in Phase 1 Clinical Trial of Its First-in-Class Anti-PVR Immune-Oncology Agent
Nectin Therapeutics Ltd. recently announced it has progressed its Phase 1 clinical trial of NTX1088 to include a combination therapy arm with the immune-oncology drug…
Ethris Initiates First-in-Human Dosing in Phase 1 Study for the Treatment of Virus-Induced Asthma
Ethris GmbH recently announced the dosing of the first healthy participant in its first-in-human study of lead candidate ETH47, which was developed using Ethris’ Stabilized…
Successful Transfer of NDA Acknowledged by FDA From Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch
Emergex Vaccines Holding Limited recently announced the company has transferred ownership, as of May 2023, of the existing US FDA New Drug Application (NDA) of the investigational MAP originally intended….
Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
Unicycive Therapeutics, Inc. recently announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC…
POINT Biopharma & Lantheus Announce Positive Topline Results From Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer
POINT Biopharma Global Inc. and Lantheus Holdings, Inc. recently announced statistically significant topline results from the pivotal….
Roche Completes Acquisition of Telavant From Roivant, Including Rights to Novel TL1A Directed Antibody for Inflammatory Bowel Disease Treatment
Roivant recently announced the completion of the previously announced acquisition by Roche of Telavant, for an upfront payment of approximately $7.1 billion…..
Aeterna Zentaris & Ceapro Announce Merger to Create Diversified Biopharmaceutical Company
Aeterna Zentaris Inc. and Ceapro Inc. recently announced they have entered into a definitive agreement to combine operations in an all-stock merger of equals transaction…..
Rani Therapeutics Announces Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist
Rani Therapeutics Holdings, Inc. recently announced pharmacodynamic data of an incretin triagonist of the GLP-1, GIP, and glucagon receptors delivered transenterically, which mimics the RaniPill…
Aptamer Group Signs Material Agreement With Genetic Medicines Company
Aptamer Group plc, the developer of novel Optimer binders to enable innovation in the life sciences industry, recently announces it has entered into a material…
Clene Announces Publication Describing CNM-Au8 Brain Target Engagement in Neurodegenerative Diseases
Clene Inc. and its wholly owned subsidiary Clene Nanomedicine Inc. recently announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8, the…
ReciBioPharm Partners With Acuitas Therapeutics to Provide Rapid Technology Transfers & cGMP Manufacture of LNP Formulations
ReciBioPharm, the advanced and emerging therapies business unit within Recipharm, and biotechnology firm Acuitas Therapeutics have recently announced they are taking their partnership to the next level….
ADMA Biologics Announces FDA Approval for BIVIGAM in the Pediatric Patient Setting for Those 2 Years of Age & Older
ADMA Biologics, Inc. recently announced the US FDA has approved the company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service…
Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors With RAF or RAS Mutations
Immuneering Corporation recently announced the US FDA has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate…
Abzena Partners With ProteoNic to Offer Enhanced CHO Cell Line
Abzena, the leading end-to-end bioconjugate and complex biologics CDMO, recently announced a partnership with ProteoNic Biosciences BV to license their premium protein expression….
Coya Therapeutics & Dr. Reddy’s Laboratories Enter Development & Commercialization Agreement for ALS Treatment
Dr. Reddy’s Laboratories SA and Coya Therapeutics, Inc. recently announced they have entered into a development and license agreement for the development and commercialization of COYA 302, an investigational combination therapy for….
AbbVie Announces FDA & EMA Updates for Epcoritamab for the Treatment of Relapsed/Refractory Follicular Lymphoma
AbbVie recently announced updates from the US FDA and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed…
Sermonix Pharmaceuticals Announces Publication of ELAINE-1 & ELAINE-2 Trial Results
Sermonix Pharmaceuticals Inc. recently announced results of its two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies were published in Annals of Oncology,…
Sana Biotechnology Highlights Preclinical Data Supporting Tumor Control & Immune Evasion Capabilities of Hypoimmune-Modified Allogeneic CAR T Cells
Sana Biotechnology, Inc. recently announced preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP)…
TILT Biotherapeutics Announces Positive Clinical Data in Checkpoint0Resistant Metastatic Melanoma Phase 1 Trial
TILT Biotherapeutics recently presented safety and efficacy data from its international Phase 1 trial in patients with metastatic melanoma (NTC04217473), in an oral presentation at…
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).