Bio Platforms
CordenPharma & pHLIP Announce Strategic Alliance to Develop pHLIP LNP Targeted Delivery Platform for RNA & Gene Therapies
CordenPharma International and pHLIP, Inc. recently announce their strategic alliance to collaborate in developing and commercializing the pHLIP-LNP targeted delivery platform for RNA-based and genetic…
Sitryx Announces Collaboration Partner Lilly Has Commenced Phase 1 Study of SIT-011 for Chronic Autoimmune & Inflammatory Diseases
Sitryx Therapeutics recently announced Eli Lilly & Company has commenced a Phase 1 first-in-human study of SIT-011, a post-translational modification modulator program for chronic autoimmune and….
Rhythm Pharmaceuticals & LG Chem Life Sciences Enter Agreement for Rhythm to Acquire Global Rights to Oral MC4R Agonist LB54640
Rhythm Pharmaceuticals, Inc. recently announced it has entered into a global licensing agreement with LG Chem, Ltd. for LB54640, an investigational oral small molecule melanocortin-4…
Boehringer Ingelheim Licenses Multiple Dark Antigens From Enara Bio to Develop Off-the-Shelf Immunotherapies for Non-Small Cell Lung Cancer
Enara Bio recently announced Boehringer Ingelheim has exercised its option to license a number of cancer antigens discovered and validated through the ongoing collaboration using…
Avenue Therapeutics Reaches Final Agreement with the FDA for Phase 3 Safety Study for IV Tramadol
Avenue Therapeutics, Inc. recently announced it has reached final agreement with the US FDA on the Phase 3 safety study protocol and statistical analysis approach,…
BriaCell Images Confirm Robust Anti-Tumor Activity in Patient with “Eye-Bulging” Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently released transformational images of the recently reported remarkable responder in the Phase 2 study of BriaCell’s Bria-IMT combination regimen…..
OBI Pharma Announces US FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992
OBI Pharma recently announced the US FDA has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its…
Ampersand Biomedicines Acquires AbCheck to Accelerate Platform and Product Development
Acquisition amplifies Ampersand’s in-house capabilities to generate AND-Body Therapeutics – programmed biologics across a broad range of diseases….
4DMT & Arbor Biotechnologies Establish Partnership to Co-Develop & Co-Commercialize Next-Generation Genetic Medicines for CNS Diseases
Partnership brings together two leaders in next-generation genetic medicines to engineer, co-develop and co-commercialize (50:50 profit share) AAV-delivered CRISPR/Cas-based therapeutics for up to six product candidates in CNS….
Sanara MedTech Inc. Announces Exclusive License Agreement for Patented Collagen Peptides
Sanara MedTech Inc. recently announced it has signed an exclusive license agreement with Tufts University to develop and commercialize patented technology covering 18 unique….
Intensity Therapeutics Provides Business Update Reflecting Progress in Phase 3 Sarcoma Program
Intensity Therapeutics, Inc. recently announced a business update reflecting progress in its Phase 3 sarcoma clinical program. In the fourth quarter of 2023, the company…
GeoVax Announces Issuance of Malaria Vaccine Patent
GeoVax Labs, Inc. recently announced the US Patent and Trademark Office has issued Patent No. 11,857,611 to GeoVax, pursuant to the company’s patent application No.…
Healis Therapeutics Announces Supply Agreement With CKD Bio to Develop CKDB-501 for Neuropsychiatric Indications
Healis Therapeutics recently announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein. CKD Bio is…
Avenue Therapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial for the Treatment of Spinal & Bulbar Muscular Atrophy
Avenue Therapeutics, Inc. recently announced all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar…
4DMT Receives FDA Regenerative Medicine Advanced Therapy Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD
4D Molecular Therapeutics recently announced the US FDA has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet…
BriaCell Reports Unprecedented Preliminary Survival & Clinical Benefit in Antibody-Drug Conjugate Refractory Patient Subset
BriaCell Therapeutics Corp. recently reported unprecedented preliminary survival and clinical benefit data in a new subset of advanced breast cancer patients treated with BriaCell’s Bria-IMT…
ImmunoScape & MiNK Therapeutics Collaborate to Accelerate Novel TCR Identification & Therapeutic Development
ImmunoScape and MiNK Therapeutics, Inc. recently announced a collaboration agreement to discover and develop next-generation TCR therapies against novel targets in solid tumors. The combined efforts…
Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress & Key Milestones Accomplished
Lipella Pharmaceuticals Inc. recently celebrated its first anniversary as a publicly traded entity. Based in Pittsburgh, PA, the company has made substantial strides over the past year, achieving critical milestones….
Enlivex Announces Completion of Enrollment of its Phase 2 Trial Evaluating Allocetra in Patients With Sepsis
Enlivex Therapeutics Ltd. recently announced it has completed enrollment of all 120 patients in its Phase 2 trial of Allocetra in patients with sepsis. The…
Kronos Bio Announces Pipeline Update & p300 KAT Inhibitor Development Candidate
Kronos Bio, Inc. recently announced an update on its pipeline. After a review of data from the Phase 1b portion of its Phase 1b/2 trial…
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).