Bio Platforms
INTRATUMORAL DELIVERY - Combining Local & Systemic Treatments: Could Immuno-Oncology Finally Enable Local Intratumoral Delivery?
Lewis H. Bender, MA, MBA, says cancer is a local and systemic disease, and new forms of local treatment, such as intratumoral dosing coupled with systemic immunotherapy, are being explored.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 2
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
EXECUTIVE INTERVIEW - Noxopharm: Introducing a Novel & Potentially Transformative Drug Candidate in the Treatment of Cancer
Graham Kelly, Founder, Executive Chairman, and CEO of Noxopharm, discusses the company’s innovative approach to cancer treatment.
Novavax Advances Development of Novel COVID-19 Vaccine
Novavax, Inc. recently announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19….
Arecor Achieves Second License Milestone Payment From Global Pharmaceutical Partner
Arecor Ltd recently announced it has achieved an important second, contractual milestone with one of its pharmaceutical partners….
TrakCel & Ori Biotech Sign Collaboration Agreement
TrakCel and Ori Biotech Ltd recently announced a non-exclusive strategic partnership to achieve supply chain orchestration within closed system manufacturing for the cell and gene therapy sector.…
Spring Bank Announces New Clinical Collaboration With Roche
Spring Bank Pharmaceuticals, Inc. recently announced a new clinical collaboration with Roche to explore the co-administration of SB 11285, Spring Bank's intravenously (IV)-administered STING (STimulator…
Cue Biopharma’s Therapeutic Immuno-STAT Platform to be Featured in Merck Presentation
Cue Biopharma, Inc. recently announced the company’s therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) platform is scheduled to be featured in a Merck…
leon & Nucleus Medical Announce Collaboration to Develop & Manufacture Novel Transplantation Medicine
This license agreement enables Nucleus to utilize proprietary MicroJet Reactor (MJR) nanotechnology to improve stability, increase solubility and enhance bioavailability of its lead asset in…
Aravive Announces Dose Escalation of AVB-500 in Recurrent Platinum Resistant Ovarian Cancer Phase 1b Trial
Aravive, Inc. recently announced that the independent Data Monitoring Committtee (DMC) has reviewed the open-label data following the first 28-day treatment cycle for the three…
Mustang Bio Announces First Subject Treated in Phase 1/2 Trial
Mustang Bio, Inc. recently announced that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration…
Diasome Announces Positive Results from Phase 2 OPTI-1 Study
Diasome Pharmaceuticals, Inc. recently announced positive results from its Phase 2 OPTI-1 study of injectable hepatocyte directed vesicle (HDV) added to mealtime insulin in people with…
Annovis Issued Patent for Method of Treating Parkinson’s Disease & Other Lewy Body Diseases
Annovis Bio Inc. was recently issued a patent (US 10,383,851) in August 2019 for a method of treating Parkinson’s disease, Lewy body dementia, and other…
Alkahest Announces Initiation of Phase 2b Clinical Trial
Alkahest, Inc. recently announced the initiation of a Phase 2b clinical trial of its orally administered small molecule CCR3 inhibitor, AKST4290. The company has dosed the first….
Cocrystal Pharma's Structure-Based Technology Demonstrated Broad Utility
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics using its proprietary structure-based drug discovery platform technology to create first-and…
Oculis Announces Positive OCS-01 Phase 2 Data
Oculis S.A. recently reported positive data from a phase 2 study of OCS-01, a novel eye drop formulation of dexamethasone, in development for the treatment…
Zumutor Biologics & Catalent Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors
Catalent recently announced it has signed an agreement with Zumutor Biologics, Inc., to manufacture Zumutor’s lead candidate, ZM008, for the treatment of solid tumors. Zumutor…
BeyondSpring’s Plinabulin Stimulates Both the Adaptive & Innate Immune System
BeyondSpring Inc. recently announced that new clinical data on the company’s first-in-class, late-stage asset, Plinabulin, shows its ability to potently stimulate the innate immune system.…
Biologics Patent Expiry Trend Expected to Have Positive Impact
Expectations for biosimilars are high in 2020, and the drug class will finally begin to make its mark in the US, says GlobalData, a leading…
AskBio Announces First Patient Dosed in Phase 1 Trial
Asklepios BioPharmaceutical (AskBio) and its NanoCor Therapeutics subsidiary recently announced that the first patient has been dosed in a Phase 1 clinical trial of NAN-101.…
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).