VIEWS AND ANALYSIS

CMIC and Lokavant Collaborate to Deploy Machine Learning-Powered Clinical Trial Intelligence Platform

CMIC | June 25, 2021

CMIC Co., Ltd., a leading Japanese Contract Research Organization (CRO), and Lokavant, a leading clinical trial intelligence company, announced today that they have agreed to use Lokavant's predictive analytics capabilities to assist CMIC's clinical operations. This strategic collaboration, Lokavant Oversight, monitoring, and operational risk management platform, will be implemented throughout CMIC studies.

CMIC was the first firm in Japan to provide CRO services, and the company has over 28 years of pharmaceutical development expertise in the Asia-Pacific (APAC) area. CMIC Group supports more than 80% of new drug research in Japan. CMIC and Lokavant are some of the first predictive analytics collaborations for clinical trial operations in the rapidly expanding APAC region.

Trial management has gotten more complex and inefficient as the quantity of data points gathered in clinical trials has increased rapidly. The procedure for detecting and managing risks in clinical trials is still largely manual, and it is often too delayed to prevent severe consequences. The collaboration between CMIC and Lokavant goes beyond conventional risk-based monitoring by implementing an end-to-end solution backed by Lokavant's past operational data and CMIC's data. This will enable CMIC to perform next-generation risk-based monitoring, which will be capable of predicting data quality problems, research schedule delays, and budget overruns. CMIC clinical teams will be proactive, rather than reactive, in reducing problems and eventually enhancing trial results by using historical data to predict future issues. Lokavant and CMIC will also collaborate to create data-driven metrics to track study success across previous and current CMIC trials, delivering critical insights to CMIC's 1,200+ clinical trial operators.

About Lokavant
Lokavant's data-driven solutions, including its flagship product, Lokavant Oversight, a tech-enabled risk-based monitoring solution, and Lokavant Insight, a clinical operations benchmarking tool, allow next-generation clinical trials. Lokavant Oversight collects and distributes real-time data from various trial data sources, anticipates problems throughout clinical development to reduce trial risks, and empowers monitoring teams by displaying critical research data. Lokavant Insight enables clinical teams to assess clinical trial performance and analyze critical trial success and failure indicators.

About CMIC Group
CMIC Group was established in 1992 as Japan's first Contract Research Organization (CRO). CMIC Group is now Japan's biggest clinical CRO with a worldwide presence, offering complete services in drug development, clinical site management, clinical to commercial GMP manufacturing, regulatory consultancy, and contract sales and marketing solutions. CMIC Group assists pharmaceutical, biotech, and medical device firms in entering the Japanese market, conducting clinical trials in Asia, and bridging drug development and manufacturing requirements in the United States, Europe, Japan, and the rest of Asia. CMIC Group employs approximately 7,000 people and operates from 25 locations across the globe.

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BUSINESS INSIGHTS

Athira Pharma Advances Phase 2/3 LIFT-AD Clinical Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Patients

Athira Pharma, Inc. | October 18, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The committee also determined that, with the additional enrollment of fewer than 150 patients for a total enrollment of less than 300 patients without background therapy the study will be well powered for the primary endpoint given the preliminary effect size observed. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition and function. Results from the completed exploratory ACT-AD Phase 2 study showed a favorable safety profile and suggested positive effects on measures of cognition function and neurodegeneration in patients taking fosgonimeton without background therapy. Guided by these results, the Company proactively amended LIFT-AD to focus on patients not on background therapy. The unblinded interim analysis was then conducted in approximately 100 patients not on background therapy to corroborate observations from ACT-AD and ensure LIFT-AD is well powered to determine the effect of fosgonimeton on clinically meaningful and commercially relevant endpoints. “The results from the data monitoring committee’s unblinded analysis give us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes. This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.” Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira “We are very excited by the results of this independent review as we believe they mitigate the risk of the fosgonimeton development plan, support the potential clinical benefit of fosgonimeton and inform the sample size needed to achieve success with LIFT-AD,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We are now targeting to complete enrollment in mid-2023 and report topline data in early 2024. Importantly, we have a strong balance sheet to execute our plans through key data readouts and beyond. Moving forward, we remain keenly focused on advancing this novel investigational therapy with the hope of positively impacting the lives of millions of Alzheimer’s patients. “Our goal with fosgonimeton is to demonstrate its ability to improve cognition and function and to ultimately provide neuroprotection. The ACT-AD study suggested these benefits, and the results of the LIFT-AD interim analysis corroborate those findings,” added Dr. Litton. “We believe any drug that can demonstrate neuroprotection could become a treatment of choice for mild-to-moderate Alzheimer’s patients.” About the LIFT-AD Clinical Study LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease. Patients are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale and function. Additional information on the LIFT-AD study can be found at: NCT04488419. About Fosgonimeton Fosgonimeton is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain. The ACT-AD trial was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health. About Athira Pharma, Inc. Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies and neuropsychiatric indications.

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BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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PHARMACY MARKET

Jacobio Pharma to Collaborate with Merck on Clinical Trial of JAB-21822 in Combination with Cetuximab

Jacobio Pharma | October 13, 2022

Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®. This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement. "Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck," Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio About JAB-21822 JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab. About ERBITUX®. ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells. ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998. About Jacobio Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.

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