Bio Platforms
Entasis Therapeutics Receives Acquisition Proposal From Existing Majority Stockholder Innoviva Inc.
Entasis Therapeutics Holdings Inc. recently announced its Board of Directors received a preliminary, non-binding proposal from its majority stockholder Innoviva, Inc. to acquire all….
Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the US & Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
Immunic, Inc. recently announced the company received a Notice of Allowance from the USPTO for patent application 16/644581 titled IL-17 and IFN-gamma inhibition for the…
ImCheck Announces First Patients Dosed in Phase 2 of EVICTION Trial for ICT01
ImCheck Therapeutics recently announced the first patients have been dosed in the Phase 2a monotherapy expansion arm in the ongoing Phase 1/2a EVICTION clinical trial…
Pardes Biosciences Announces FDA Clearance of IND Application for Oral Antiviral Drug Candidate for the Treatment & Prevention of SARS-CoV-2 Infections
Pardes Biosciences, Inc. recently announced its Investigational New Drug (IND) application for PBI-0451 has been cleared by the US FDA. “As we enter our third…
Arch Scientists Publish Data on the Mechanism of Action & Efficacy of Lead Drug Candidate LSALT Peptide in the Prevention of Acute Kidney Injury
Arch Biopartners Inc. recently announced a scientific team led by Dr. Daniel Muruve at the University of Calgary, and their collaborators, have published a paper…
Pharmazz Inc. Submits INDA to India Central Drugs Standard Control Organization for Phase 2 Clinical Trial of Sovateltide in Hypoxic-Ischemic Encephalopathy in Neonates
Pharmazz, Inc. recently announced it has submitted an Investigational New Drug Application (INDA) to the India Central Drugs Standard Control Organization (CDSCO) for a Phase…
Silo Pharma Extends Exclusive Option Agreement for Homing Peptides
Silo Pharma, Inc. recently announced it has extended its exclusive option agreement with the University of Maryland, Baltimore, to explore a novel invention generally known as….
Brickell Biotech Acquires Exclusive Global Rights to Portfolio of Novel STING Inhibitors Targeting Autoimmune & Inflammatory Diseases from Carna Biosciences
Brickell Biotech, Inc. and Carna Biosciences, Inc. recently announced they have entered into a licensing agreement, whereby Brickell will have the exclusive, worldwide rights to develop and commercialize….
QSAM Biosciences Receives Rare Pediatric Disease Designation From FDA for CycloSam in the Treatment of Osteosarcoma
QSAM Biosciences Inc. recently announced the US FDA has granted Rare Pediatric Disease Designation to QSAM’s clinical-stage drug candidate, CycloSam, for the treatment osteosarcoma, a…
PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA in Advanced Head & Neck Cancer
PDS Biotechnology Corporation recently announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer achieved its preliminary objective…
MaxCyte Signs Strategic Platform License With Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs
MaxCyte, Inc. recently announced the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell….
Polyplus Acquires e-Zyvec to Expand Expertise in Plasmid DNA Vector Engineering
Polyplus recently announced the acquisition of e-Zyvec, a provider of DNA design and production services for tailor-made DNA vectors for gene therapy, bio-manufacturing, and research.…
ANAVEX2-73 (Blarcamesine) AVATAR Phase 3 Trial Met Primary & Secondary Efficacy Endpoints for the Treatment of Adult Patients With Rett Syndrome
Anavex Life Sciences Corp. recently reported positive top-line results from the Phase 3 randomized, double-blind, placebo-controlled AVATAR trial of ANAVEX2-73 (blarcamesine) in adult female….
Biogen Exercises Option to Participate in the Development & Commercialization of a Late-Stage Bispecific Antibody
Biogen Inc. recently announced it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30-million one-time option fee…
Biofrontera Inc. provides Update on Patient Recruitment for Phase 3 Study for the Treatment of sBCC With Ameluz-PDT
Biofrontera Inc. recently provided an update on the patient recruitment for the Phase 3 clinical study for the treatment of superficial basal cell carcinoma (sBCC)…
Arcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals With Seborrheic Dermatitis
Arcutis Biotherapeutics, Inc. recently announced the enrollment of the last subject in its STRATUM Phase 3 pivotal trial for topical roflumilast foam in patients with….
Veru Enters Clinical Trial Collaboration & Supply Agreement With Eli Lilly & Company
Veru Inc. recently announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company. The objective of the collaboration is to evaluate the efficacy and safety of….
Aravive Announces First Patient Dosed in Phase 2 Study of Batiraxcept in Clear Cell Renal Cell Carcinoma
Aravive, Inc. recently announced it has dosed the first patient in the Phase 2 portion of the Phase 1b/2 study of batiraxcept for the treatment of clear cell renal cell carcinoma (ccRCC)…..
Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity
Altimmune, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for…
Viridian Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Development of VRDN-002, a Next-Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. recently announced the US FDA clearance of its investigational new drug (IND) application of VRDN-002. The Company’s next generation IGF-1R antibody, VRDN-002,…
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).