Bio Platforms
Nanexa Signs Continuation of Feasibility Agreement With Major Pharmaceutical Company to Investigate PharmaShell Long-Acting Formulations in a Multi-Billion US Market
Nanexa has recently announced the signing of an extension of a feasibility agreement with a major pharmaceutical company to investigate the use of Nanexa´s proprietary…
Assembly Biosciences Reports Positive Interim Results From Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate Showing Reductions in Viral Shedding Rate & Genital Lesion Rate in Recurrent Genital Herpes
Assembly Biosciences, Inc. recently announced positive interim antiviral activity, clinical outcomes, safety, and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-5366, an investigational…
Genmab Announces Phase 3 Trial Met Dual Primary Endpoints in Patients With Relapsed/Refractory Follicular Lymphoma
Genmab A/S recently announced positive results of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab andlenalidomide (R2) versus…
Cardurion Pharmaceuticals Completes Enrollment in Phase 2 Trials Evaluating a Novel PDE9 Inhibitor in Heart Failure
Cardurion Pharmaceuticals, Inc. recently announced it has completed enrollment in two global, multi-center, Phase 2 clinical trials assessing the safety and efficacy of CRD-750 in…
Moleculin Biotech Reports Promising Preclinical Data of Annamycin in Liver Cancer Treatment
Moleculin Biotech, Inc. recently announced the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which…
Porosome Therapeutics Announces Breakthrough Alzheimer's Discoveries
Porosome Therapeutics, Inc. recently announced key advancements in its first-in-class, disease-modifying neurological platform, which will transform Alzheimer’s Disease (AD) research and treatment by offering a…
Elicio Therapeutics Announces Positive Recommendation to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Elicio Therapeutics, Inc. recently announced that following the Independent Data Monitoring Committee’s (IDMC) pre-specified interim review of the unblinded safety and efficacy data in the…
Pioneering LNP Expert Dr. Pieter Cullis Joins Hongene’s Scientific Advisory Board
Hongene, a global CDMO focused on nucleic acid raw materials and medicines, has appointed Dr. Pieter Cullis, a renowned innovator in lipid nanoparticle…
SERB Pharmaceuticals Agrees to Acquire Y-mAbs Therapeutics
SERB Pharmaceuticals and Y-mAbs Therapeutics, Inc. recently announced they have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead…
Yatiri Bio Acquires NGeneBioAI to Expand AI-Powered Proteomics Platform & Advance Precision Biomarker Discovery
Yatiri Bio, Inc. recently announced the successful acquisition of NGeneBioAI, Inc., a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics. The acquisition strengthens Yatiri…
Medicus Pharma Announces MoU With Helix Nanotechnologies to Develop Thermostable Infectious Disease Vaccines
Medicus Pharma Ltd. and Helix Nanotechnologies Inc. recently announced they have entered into a non-binding memorandum of understanding (MoU) in respect of their shared mutual interest…
XOMA Royalty Enters Agreement to Acquire LAVA Therapeutics
XOMA Royalty Corporation and LAVA Therapeutics N.V. recently announced they have entered a definitive share purchase agreement whereby XOMA Royalty will acquire LAVA for (i)…
Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety & Depression
Artelo Biosciences, Inc. recently announced that it has received written scientific advice from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on the nonclinical development…
Silexion Therapeutics Announces New Preclinical Data Showing Up to 97% Inhibition of Cancer Cell Growth, Including New Evidence Against New Previously Untested KRAS Mutation
Silexion Therapeutics Corp recently announced groundbreaking new preclinical data revealing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and almost 90% in…
Pancreatic Cancer Phase 2a Study With Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone
Can-Fite BioPharma Ltd. recently announced that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer. The Phase…
Incannex Reports Positive Topline Results From RePOSA Phase 2 Trial of IHL-42X
Incannex Healthcare Inc. recently announced positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep…
FDA Provides Trethera Clearance to Initiate Clinical Trial in Healthy Volunteers to Study Food Effect & Biomarkers
Trethera Corporation recently announced the US FDA has cleared a clinical trial evaluating its novel drug, TRE-515, in healthy volunteers. TRE-515, a clinical-stage drug in…
Merck Advances Neuroscience Pipeline With Novel Therapies in Phase 2 Studies for Treatment of Alzheimer’s Disease
Merck, known as MSD outside of the US and Canada, a premier research-intensive biopharmaceutical company, is initiating two Phase 2 clinical studies for MK-2214 and…
Centauri Therapeutics Receives an Additional $5.1 Million From CARB-X to Progress ABX-01 Lead Compound to First-in-Human Clinical Trials
Centauri Therapeutics Limited recently announced CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) has provided an additional $5.1 million in funding for the development of their lead…
BriaPro Therapeutics Files Patent Application for Immuno-Oncology Platform With Novel Multitargeting Agents
BriaCell Therapeutics Corp. and its majority owned subsidiary, BriaPro Therapeutics Corp., recently announce BriaPro is developing novel multivalent agents for cancer treatment. BriaPro has filed…
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).