Bio Platforms
Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate
Celsion Corporation recently announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for….
Biogen Reaches Agreement With Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 Billion
Biogen Inc. recently announced it has entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to….
Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program
Cocrystal Pharma, Inc. has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19…..
Provectus Biopharmaceuticals Provides Update on Research into PV-10 Immunotherapy as an Immune Adjuvant for Making Vaccines Work Better
Provectus recently provided an update on research of its investigational immunotherapy PV-10 (rose bengal sodium, a halogenated xanthene small molecule) as an immune adjuvant in…
Allergy Therapeutics Announces FDA Clearance of IND Application for Novel Peanut Allergy Vaccine Candidate
Allergy Therapeutics recently announced the US FDA has cleared the Group’s Investigational New Drug application (IND) for its novel virus-like particle (VLP)-based peanut allergy vaccine…
Evaxion Biotech Announces Publication of Clinical Data of EVX-01 Heading Into Phase 2b in Collaboration With Merck
Evaxion Biotech A/S recently announced the publication of a paper on personalized therapy with EVX-01 in patients with metastatic melanoma in the open access, peer-reviewed….
Cyclerion Therapeutics Announces Initiation of Patient Dosing in CY6463 Phase 2a Study in Alzheimer’s Disease With Vascular Pathology
Cyclerion Therapeutics, Inc. recently announced patient dosing has begun in its Phase 2a study in Alzheimer’s Disease with Vascular Pathology (ADv). “The need for effective…
Hepion Pharmaceuticals’ Rencofilstat, in Combination With an Immune Checkpoint Inhibitor, Demonstrates Synergistic Anti-Tumor Activity in a Nonclinical Liver Cancer Study
Hepion Pharmaceuticals, Inc. recently announced the results of a nonclinical research study showing that its clinical phase drug candidate, rencofilstat (CRV431), synergistically decreased liver tumor….
Tony O’Neill Joins Ajinomoto Bio-Pharma Services’ Leadership Team as Vice President of Compliance
Ajinomoto Bio-Pharma Services, a leading global provider of bio-pharmaceutical contract development and manufacturing services, is pleased to announce that Tony O’Neill has joined Aji Bio-Pharma…
INmune Bio, Inc. Announces Research Collaboration With Chinese University of Hong Kong to Evaluate INKmune in Nasopharyngeal Cancer
INmune Bio, Inc. recently announced the company has entered into a preclinical research collaboration with Chinese University of Hong Kong (CUHK) to evaluate INKmune -…
Athira Pharma Announces Initiation of Patient Dosing in SHAPE, a Phase 2 Clinical Trial of ATH-1017 for the Treatment of Parkinson's Disease Dementia & Dementia with Lewy Bodies
Athira Pharma, Inc. recently announced patient dosing has begun in SHAPE, a Phase 2 clinical trial of ATH-1017 for the treatment of Parkinson’s disease dementia and Dementia with Lewy bodies….
Monte Rosa Therapeutics & Yeda Announce License & Research Collaboration to Accelerate Discovery of Novel Covalent Molecular Glue Degraders
Monte Rosa Therapeutics, Inc. recently announced a license and research collaboration agreement with Dr. Nir London and the Yeda Research and Development Company Ltd., the…
Biomea Fusion Announces First Patient Dosed
Biomea Fusion, Inc. recently announced the first patient has been dosed in its Phase 1 clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with….
Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma
Checkpoint Therapeutics, Inc. recently announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as…
Genezen Appoints Senior Director of Business Development to Support Rapid Growth
Genezen, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early phase process development, GMP vector production and analytical testing…
SAB Biotherapeutics Reports Positive Phase 2 Virology Data Demonstrating SAB-185 Met Criteria for Advancement to Phase 3 in NIH ACTIV-2 Trial for Treatment of COVID-19
SAB Biotherapeutics recently reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required for advancement to Phase 3 in the…
Masonic Cancer Center at the University of Minnesota Receives FDA Clearance to Proceed With Phase 1 Clinical Trial in Solid Tumors for HCW9218, HCW Biologics’ Novel Bifunctional Fusion Protein
HCW Biologics Inc. recently announced the Masonic Cancer Center, University of Minnesota was cleared by the US FDA to proceed to evaluate the company’s lead…
Kura Oncology Receives FDA Authorization to Proceed With Phase 1b Study of KO-539 in Acute Myeloid Leukemia
Kura Oncology, Inc. recently announced the US FDA has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with…
ASLAN Pharmaceuticals Initiates Phase 2b Study of ASLAN004 (Eblasakimab) in Moderate-to-Severe Atopic Dermatitis
ASLAN Pharmaceuticals recently announced it has screened the first patient in its Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis…
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…
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).