Bio Platforms
ARCA biopharma Announces Completion of Enrollment in Phase 2b ASPEN-COVID-19 Clinical Trial Evaluating rNAPc2 as a Potential Treatment for Patients Hospitalized With COVID-19
ARCA biopharma, Inc. recently announced that enrollment has been completed in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized…
Progenity Announces New Patent for Single-Molecule Detection Technology
Progenity, Inc. recently announced a new patent related to its single-molecule detection platform under development. The USPTO has issued U.S. Patent No. 11,186,863 titled Methods,…
SAB Biotherapeutics Announces SAB-176 Met its Primary Endpoint in Phase 2a Challenge Study in Adults Infected With Influenza Virus
SAB Biotherapeutics recently announced that SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and….
BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated With Schizophrenia & Bipolar Disorders
BioXcel Therapeutics, Inc. recently announced the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of….
2022 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
APTAMER TECHNOLOGY - From Postal Codes to GPS: Building Better Drug Conjugates With Aptamers
David Bunka, PhD, and Emily Robinson, PhD, focus on a new breed of affinity binders that can be used as an alternative to antibody therapeutics and has the potential to reshape the industry, delivering new medicines with improved safety and efficacy profiles and reduced healthcare costs.
Heat Biologics Unveils a Novel Cellular Vaccine Platform Targeting Known & Unknown Emerging Biological Threats
Heat Biologics, Inc. recently unveiled its new RapidVax cellular vaccine platform at the 2021 World Antiviral Congress. RapidVax is designed as a rapid programmable vaccine…
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH
Hepion Pharmaceuticals, Inc. recently announced the US FDA has granted Fast Track designation for the company’s lead drug candidate, CRV431, for the treatment of NASH.…
Akoya Biosciences Secures CLIA Lab Certification, a Milestone for Applying its Spatial Biology Technologies to Accelerating Precision Cancer Therapies
Akoya Biosciences, Inc., The Spatial Biology Company, recently announced its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, MA, has received its Certificate of Registration from the….
TARGETED ONCOLOGY THERAPIES - Harnessing Nature’s “Cues” to Selectively Activate the Immune System to Attack Cancer
Dan Passeri, MSc, JD, reviews a new class of synthetic biologic drugs engineered and designed to leverage the beneficial effect of IL-2 to selectively stimulate the proliferation and cytotoxic activity of disease-relevant T cells against cancer.
Gb Sciences Accelerates Drug Development Via Innovative Biopharma Technology & Strategic Partnerships
Recognizing the glacial pace of traditional drug research and development processes and the adverse effect of this on patients, biopharmaceutical company Gb Sciences has taken innovative steps to speed up….
RespireRx Pharmaceuticals Announces Publication of Preclinical Results Supporting the Use of AMPAkines in the Treatment of Human Spinal Cord Injury
RespireRx Pharmaceuticals Inc. recently announced the publication by Dr. David Fuller (University of Florida) and his colleagues of two new, scientific articles in major, peer-reviewed…
Adial Pharmaceuticals Announces Positive Preclinical Data for PNV2 as a Drug Candidate for Triple Negative Breast Cancer
Adial Pharmaceuticals, Inc. recently announced positive preclinical data for PNV2 in an animal model of triple negative breast cancer (TNBC). Based on the strength of…
Zealand Pharma Announces Successful Outcome of Phase 1b Clinical Trial With GLP1-GLP2 Dual Receptor Agonist
Zealand Pharma A/S recently announced topline results from its Phase 1b multiple ascending dose trial with dapiglutide. In this randomized, double-blind, placebo-controlled, multiple ascending dose…
Decibel Therapeutics Announces Extension of Research Term Under Strategic Collaboration With Regeneron to Discover & Develop Gene Therapies for Hearing Loss
Decibel Therapeutics recently announced that Regeneron has extended the research term of its collaboration with the company to discover and develop gene therapies for hearing loss…..
Apollomics Doses First Patient in Phase 3 Clinical Trial With APL-106 (Uproleselan Injection) in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia
Apollomics Inc. recently announced the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of…
Dave Palmer Promoted to Operations Manager Role for Micropore Technologies
With a burgeoning global client list following recent breakthroughs in the use of its unique crossflow technology for the production of lipid nanoparticles, UK-based Micropore…
Cytovia & Cellectis Expand Their TALEN Gene-Edited iNK Partnership to Enable Broader Collaboration in China
Cytovia Therapeutics, Inc. and Cellectis recently announced they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and….
Stanford Scientists First to Identify New Cellular Correlates of Protection Against Influenza for an Oral Flu Vaccine Developed by Vaxart
A new Stanford study published in Cell Host and Microbe has demonstrated that VXA-A1.1, an investigational oral tablet flu vaccine under development by Vaxart, Inc.,…
BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma
BioNTech SE recently announced the US FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111…
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).