Bio Platforms
Zealand Pharma Completes Enrollment in EASE-SBS 1 Phase 3 Trial Assessing Glepaglutide in Patients With Short Bowel Syndrome
Zealand Pharma A/S recently announced completion of patient enrollment in its pivotal Phase 3 trial (EASE-SBS 1) of glepaglutide, the company’s long-acting GLP-2 analog, for…
F-star Announces Issuance of US Patent Protecting FS118, a Bispecific Antibody Targeting PD-L1 & LAG-3
F-star Therapeutics, Inc. recently announced the USPTO has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors…..
Compass Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study of CTX-009, a Bispecific Antibody That Simultaneously Targets Delta-like Ligand 4 (DLL4) & Vascular Endothelial Growth Factor A (VEGF-A)
Compass Therapeutics, Inc. recently announced the US FDA has cleared its IND application for CTX-009, enabling the company to initiate a global Phase 2 clinical…
Kinnate Biopharma Inc. Announces FDA Clearance of Investigational Drug Application for KIN-3248
Kinnate Biopharma Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation….
Treadwell Therapeutics Engages Genezen to Advance its T cell Receptor-Based Cell Therapy Pipeline
Treadwell Therapeutics and Genezen have recently confirmed a partnership agreement to accelerate the production of T cell receptor (TCR)-based candidates to address unmet needs in cancer patients…..
HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 & Pembrolizumab for Treatment of Head & Neck Cancer & Reports FDA’s Fast Track Designation
HOOKIPA Pharma Inc. recently announced the first patient has been dosed with HB-200 in combination with pembrolizumab for the treatment of first-line advanced/metastatic Human Papillomavirus 16….
Resverlogix Announces Commencement of Patient Enrollment & Dosing in a Phase 2b Trial for a Promising Canadian-Developed COVID-19 Treatment
Resverlogix Corp. recently announced enrollment and dosing of patients has commenced in a Phase 2b study at a site at the University of Alberta Hospital in Edmonton. The trial will evaluate the safety and efficacy of apabetalone….
Artizan Biosciences Selects Lead Product Candidate for Inflammatory Bowel Disease Therapeutic Development Program
Artizan Biosciences, Inc. recently announced the selection of its lead product candidate, ARZC-001, for the treatment of inflammatory bowel disease (IBD). Discovered internally and….
Evaxion Biotech Receives Regulatory Clearance to Initiate Phase 2 Trial of EVX-01 in Combination with KEYTRUDA for Treatment of Melanoma
Evaxion Biotech A/S recently announced it has received clearance from the Australia Therapeutic Goods Administration to initiate a Phase 2b trial of its patient specific cancer immunotherapy EVX-01 in combination with….
EQRx Announces Two Lancet Oncology Publications of Positive Phase 3 Results of Sugemalimab in Stage III & Stage IV Non-Small Cell Lung Cancer
EQRx, Inc. recently announced data from its partner CStone Pharmaceuticals’ two pivotal Phase 3 studies of the anti-PD-L1 monoclonal antibody sugemalimab for the treatment of…
EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
Evelo Biosciences Presents Data on EDP1815 Mechanism of Action & Supporting Ongoing Clinical Development for Inflammatory Diseases
Evelo Biosciences, Inc. recently announced data for EDP1815, the company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis…..
EXECUTIVE INTERVIEW - GATC Health & Liquid Biosciences: Faster, Cheaper, More Effective Drug Discovery
Ian Jenkins, Director of Science, and Jeff Moses, CMO at GATC Health, discuss the combined benefits of their MAT platform and Liquid Biosciences’ Emerge mathematical evolution platform to help identify the right biology sooner and focus on a smaller set of potential compounds early in the pre-clinical development process to enable pharma companies to develop drugs with more efficiency and a higher success rate.
GALECTIN INHIBITORS - Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?
Pol F. Boudes, MD, explains how development of a galectin-3 inhibitor could play a significant role in treating liver diseases, such as non-alcoholic steatohepatitis (NASH) and its complication, liver cirrhosis.
BIOMARKERS - Biomarkers: The Guiding Light for R&D in Heterogeneous Diseases
Thomas Turi, PhD, says while biomarkers have been a long-standing part of R&D and a mainstay of clinical practice for the characterization and diagnosis of disease for decades, they are increasingly playing a crucial role in guiding decisions to improve efficacy and efficiency of clinical trials.
Imcyse Reports Positive Immune Response from Interim Analysis of Phase 2 IMPACT Type 1 Diabetes Study
Imcyse recently reported positive biomarker data from a planned interim analysis of its Phase 2 study, IMCY-0098 Proof of ACtion in Type 1 Diabetes (T1D) (IMPACT), evaluating the company’s lead candidate….
Brooklyn ImmunoTherapeutics Provides Update on Regenerative Medicine Intellectual Property Portfolio
Brooklyn ImmunoTherapeutics, Inc. recently announced 18 new patents were issued and 17 new patent applications were filed in 2021. The intellectual property is owned by…
Q-VANT Biosciences Launches to Solve the Pharmaceutical Industry Problem of Limited Quillaja Saponin-Based Adjuvants for Life-Saving Vaccines
Q-VANT Biosciences has launched as the first company to achieve a 100% sustainable way to meet the growing global vaccine market demand for Quillaja saponin-based adjuvants including QS-21. QS-21 is considered the “Gold Standard” adjuvant for enhancing immune….
HUTCHMED Receives Breakthrough Therapy Designation in China for HMPL-523 for Treatment of Primary Immune Thrombocytopenia
HUTCHMED (China) Limited recently announced the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to HMPL-523,…
COVAXIN (BBV152) Booster Shown to Neutralize Both Omicron & Delta Variants of SARS-CoV-2
Ocugen, Inc.and its partner, Bharat Biotech recently announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of candidate vaccine….
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).