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Alpha Cognition Announces Positive Neuroprotection Data from Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury

Alpha Cognition Inc. | February 23, 2022

Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI.

These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.”

Denis Kay, the Company’s Chief Scientific Officer 

In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison.

Compared to vehicle treatment, ALPHA-1062

  • Demonstrated statistically significant reduction in lesion size measured at 35 days after injury.
  • Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression.
  • Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment.

Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation.
Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.”

About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options.

ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.

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Alnylam Announces 3-Month Extension of Review Period for New Drug Application for Vutrisiran

Alnylam Pharmaceuticals, Inc. | April 05, 2022

Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration has extended the review timeline of the New Drug Application for vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated amyloidosis, to allow for the review of newly added information related to the new secondary packaging and labeling facility. Alnylam recently learned that the original third-party secondary packaging and labeling facility the Company planned to use for the vutrisiran launch was recently inspected and the inspection requires classification for the FDA to take action on the vutrisiran NDA. The inspection observations were not directly related to vutrisiran. In order to minimize delays to approval, Alnylam has identified a new facility to pack and label vutrisiran and submitted an amendment to the NDA for review by the FDA. The updated Prescription Drug User Fee Act goal date to allow for this review is July 14, 2022. No additional clinical data have been requested by the FDA. “We are committed to working with the FDA and the new facility to bring this important treatment option as quickly as possible to patients living with the polyneuropathy of hATTR amyloidosis, an inherited, progressively debilitating, and fatal disease. We are confident in our regulatory application and the body of data supporting the efficacy and safety of vutrisiran.” Pushkal Garg, M.D., Chief Medical Officer & EVP, Development and Medical Affairs Vutrisiran is also under review by the European Medicines Agency the Brazilian Health Regulatory Agency and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). We aim to minimize the impact of this issue on these reviews through timely resolution of the matter or utilization of an alternative facility for one or more of these regions. Vutrisiran has been granted Orphan Drug Designation in the U.S. and the European Union (EU) for the treatment of ATTR amyloidosis, and in Japan for transthyretin type familial amyloidosis with polyneuropathy. About Vutrisiran Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, which encompasses both hATTR and wild-type ATTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of wild-type and variant transthyretin protein before it is made. Quarterly, and potentially biannual, administration of vutrisiran may help to reduce deposition and facilitate the clearance of TTR amyloid deposits in tissues and potentially restore function to these tissues. Vutrisiran utilizes Alnylam’s Enhanced Stabilization ChemistryGalNAc-conjugate delivery platform, designed for increased potency and high metabolic stability that may allow for infrequent subcutaneous injections. About Alnylam Pharmaceuticals Alnylam has led the translation of RNA interference into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding 20 years ago, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO®, GIVLAARI® (givosiran), OXLUMO® and Leqvio® being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefitingpatients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

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OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform

OptimizeRx Corporation | March 16, 2022

OptimizeRx Corp. a leading provider of point-of-care technology solutions helping patients start and stay on therapy, announced a definitive agreement to acquire the EvinceMed platform and related assets. EvinceMed is a leader in delivering end-to-end automation for specialty pharmaceutical transactions. The acquisition includes the full Market Access Management Platform supporting pharma manufacturers, hub providers and pharmacies to improve patient access, speed to therapy and activation of affordability programs. With the EvinceMed platform, OptimizeRx will be able to help patients get access to the drugs they need by simplifying the prescribing process for specialty products, automating manual steps to determine drug eligibility and affordability, and introducing electronic enrollment and medical documentation within workflow across the OptimizeRx network of over 300 electronic health record (EHR) systems, ePrescribing platforms, and account-based marketing technologies spanning more than 700 thousand providers. The integration of the EvinceMed and OptimizeRx platforms has already begun with an exclusive collaboration that began last year. Full integration of the technology assets will further the Company’s ability to help patients start and stay on therapy. While specialty drugs account for only 2.2% of total prescription volume in the U.S, they accounted for over 45% of total pharmacy spend, or $218.6 billion in 2019 1,2. The cost and increasing use of specialty medications has exposed unique barriers to the prescription and patient access process. Manufacturer support programs provide much-needed services to prescription medication access, affordability, and adherence. However, a recent survey of 10,000 patients across multiple therapeutic areas found that only 20% of patients were aware of such programs3. Doctors and their staff can assist patients with enrollment into these programs, yet the enrollment process is often time-consuming, and doctors remain dissatisfied with current patient support options available. In addition, less than 10% of patient enrollment into these support programs is currently completed electronically4. “We are thrilled to have EvinceMed transition from an exclusive technology partner over the last year to being part of the team. Given the success we saw working together, this combination strengthens our position to serve our pharma customers across the full HCP network and throughout the patients’ journeys – from the moment the doctor logs into their EHR right through the point of dispense at the pharmacy. This acquisition offers significant high margin cross-selling opportunities across our growing customer base of leading life science companies, while further fortifying our business through vertical integration, and helping drive upward momentum to our key performance indicators. We expect this acquisition to benefit revenue growth in 2023 as we further develop our network around connectivity to additional partners.” William Febbo, CEO of OptimizeRx David Jackson, CEO of EvinceMed commented, “We are very excited to be joining the OptimizeRx team. The impact of our combined technologies and the reach and scale that OptimizeRx has with pharmaceutical manufacturers is a game-changer to patient access to specialty medications. By automating the processes and tasks required to be completed prior to the fill and dispense of specialty medications, we can get patients on treatment much faster and at a lower overall cost.” OptimizeRx chief commercial officer, Steve Silvestro, added, “Our commitment to leveraging technology to assist providers and patients in accessing the tools they need to improve outcomes is a mission-driven effort. The EvinceMed assets give us additional resources to accomplish that while also expanding the network’s reach to point-of-dispense, a goal we have long pursued. Prescribing support through automation for providers will both accelerate workflows and remove barriers to the specialty prescribing process ensuring patients are able to readily access the life-changing innovative therapies that they need.” OptimizeRx is committed to investing in innovation to bring more digital in-workflow solutions to execute against the commercialization goals of life science organizations. OptimizeRx currently provides solutions to 19 of the 20 largest pharma manufacturers and seeks to continue driving long-term, sustainable ROIs for its clients while supporting initiatives that improve health outcomes. Recent market research commissioned by OptimizeRx revealed specialty drug access support as being a $12B+ market. This acquisition further diversifies OptimizeRx revenue streams as the Company scales to address the client needs in this space.

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Iktos Announces Collaboration With Galapagos in AI For Drug Design

Iktos, | June 29, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a collaboration with Galapagos, a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines, to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of Galapagos drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya™, its AI-based retrosynthesis analysis and planning tool Spaya™, and its know-how in computational drug design to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. Galapagos scientists will benefit from direct access to Makya™ and Spaya™ as part of the collaboration. Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. Iktos has also diversified its R&D efforts into the development of an AI technology for retrosynthesis and has developed the AI-based retrosynthesis analysis and planning tool Spaya™ enabling systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled and proud to join forces with Galapagos with the aim to discover optimised lead compounds for one of Galapagos undisclosed small molecule drug discovery projects. Pleased to have earned Galapagos trust, we are confident that together with Galapagos established R&D team, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The insights and feedback from Galapagos research team will be highly valuable to guide us into improving our technology and products.” Yann Gaston-Mathé, President and CEO of Iktos About Iktos Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.

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invoX Pharma to Acquire F-star Therapeutics, Inc. a Pioneering Next Generation Bispecific Discovery Platform and Clinical Programs

F-star Therapeutics, Inc. | June 24, 2022

invoX Pharma a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that the companies have entered into a definitive agreement whereby invoX will acquire all of the issued and outstanding shares of F-star common stock for $7.12 per share. The proposed acquisition values F-star at approximately $161 million. The transaction has been unanimously approved by the invoX and F-star Boards of Directors and is expected to close in the second half of 2022. F-star’s proprietary platform technology pioneers the use of tetravalent (2+2) bispecific antibodies that enable the simultaneous targeting of two different antigens and a unique set of pharmacology to deliver focused, potent and safe immune activation in the tumor microenvironment. Four programs are progressing in clinic, three based on F-star’s tetravalent platform and one next generation STING agonist, with multiple further undisclosed programs in development. These programs represent potentially first- and best-in-class drug candidates for many areas of unmet medical need, including patients with cancer and other serious diseases who have few other options available. Leveraging its modular antibody technology, F-star has forged collaborations with major international biopharma companies across a wide range of therapeutic areas including oncology, immunology and neurology. invoX, established in 2021 in the United Kingdom, is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. F-star will form a key element of invoX’s strategy to accelerate Sino Biopharm’s development of innovative medicines to transform the lives of patients worldwide, complementing its existing R&D platforms and pipeline. “Today’s proposed acquisition is aligned with invoX’s strategy to become a fully integrated biopharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs, worldwide. We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform.” Ben Toogood, Chief Executive Officer of invoX Eliot Forster, Chief Executive Officer of F-star said: “We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development.” About invoX Pharma invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, the Company aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. The Company’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star Therapeutics, Inc. F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The Company has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. The Company has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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