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Anti-Cancer Potential of Rencofilstat Expanded with Results from Preclinical Multiple Myeloma Studies

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– Synergistic activity demonstrated with rencofilstat in combination with first line multiple myeloma drug, bortezomib –

EDISON, N.J., Jan. 18, 2023 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced positive results of preclinical studies examining rencofilstat as a potential therapeutic for multiple myeloma (“MM”).

Rencofilstat exerted anti-cancer activity across a large panel of MM cell lines, and most potently, in combination with bortezomib, a proteosome inhibitor and first-line treatment for MM. These results strengthen Hepion’s oncology initiatives and further support rencofilstat’s poly-indication potential.

The combination of rencofilstat and bortezomib produced 100% cytotoxicity in cell culture experiments across all 16 MM cell lines, including three lines that are characterized as bortezomib-resistant. The cytotoxic activity of rencofilstat plus bortezomib was synergistic in every cell line, showing greater cytotoxicity in combination than the sum of the two drugs individually. Rencofilstat administered individually resulted in reduced cell numbers in most cell lines, and the suppressive effect of rencofilstat correlated to reduced gene expression levels of cyclophilins A and D, two of the known targets of rencofilstat. Most of the experiments were performed by Diag2Tec (Montpellier, France), a contract research organization with expertise in MM.

These results were consistent with an independent study that reported that cyclophilin A inhibition should be considered as a therapeutic strategy for resistant MM.1 They were also similar to recent studies showing that a combination of rencofilstat and another proteosome inhibitor, ixazomib, synergistically killed prostate cancer cells. Together, they provide strong rationale for considering a rencofilstat-proteosome inhibitor combination for clinical investigation in MM or other cancers.

“These results provide further support for the development of rencofilstat as a therapeutic agent in oncology and other indications,” said Daren Ure, PhD, Hepion’s Chief Scientific Officer. “They validate years of research from the academic community documenting many therapeutic effects of cyclophilin inhibition. Rencofilstat’s antifibrotic activity is strongly linked to cyclophilin B inhibition, whereas its anti-cancer activity in the MM studies appears to depend on cyclophilins A and D. Interestingly, another entirely different mode of anti-cancer activity was previously highlighted in preclinical liver cancer studies, where rencofilstat exerted a synergistic, anti-tumor effect in combination with the checkpoint inhibitor, anti-PD1 antibody. Rencofilstat’s ability to target multiple processes as a single drug is one of its main advantages. Another key benefit is rencofilstat’s favorable safety profile in clinical trials to date, which creates opportunities for combining it with other drug therapies.”

Hepion has now documented beneficial effects of rencofilstat in experimental models of fibrosis in multiple organs, liver cancer, prostate cancer, thrombosis-related platelet activation, viral infections, lung injury, and MM.

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, “While our two active Phase 2 clinical trials in NASH are Hepion’s major current focus, these latest results afford us the opportunity to continue to create a ‘pipeline within a product.’ Thorough scientific and strategic analyses are being conducted to characterize the growing list of disease indications that are possible candidates for rencofilstat treatment. At the same time, we are exploring additional business development initiatives and non-dilutive funding to support clinical trials in oncology, as recently announced.”

Reference

1Nature Medicine, 2021 27(3):491-503. doi: 10.1038/s41591-021-01232-w

About Hepion Pharmaceuticals

The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.

Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to rencofilstat, potentially shortening development timelines and increasing the observable differences between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat to expand the company’s footprint in the cyclophilin inhibition therapeutic space.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]  

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Ancoris Recognised as Top Place to Work for Second Year Running by The Sunday Times

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May 21, 2024

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Ancoris recognised for fostering a sense of empowerment and respect within the workplace91% of Ancoris employees feel empowered at work93% of employees say that are treated with respectLONDON, May 21, 2024 /PRNewswire/ — Ancoris, a UK-based Google Cloud services provider, has been named a Top Medium Business in The Sunday Times 2024 Best Places to Work list. The accolade has been awarded for the second year in a row, and recognises Ancoris’ focus on DEI; its commitment to empowerment, reward, and recognition; and its wellbeing policies and frameworks.

“I am so pleased to see Ancoris recognised, once again, as a top place to work!” says Andre Azevedo, Ancoris CEO. “Ancoris is a place where we try our best to foster collaboration, empowerment, innovation, and respect – so to have our employees echo this and respond in the way they have is amazing.”
The Sunday Times survey captured Ancoris employees’ responses in a number of categories: Reward and Recognition, Information Sharing, Empowerment, Wellbeing, Instilling Pride, and Job Satisfaction. The independently managed survey showed Ancoris scoring “excellent” across all six engagement categories, with top scores in Empowerment, Wellbeing, Reward & Recognition. In response, 93% of employees say they are treated with respect; 92% feel trusted and able to make decisions; and 91% of employees feel empowered at work.
“We’ve seen a lot of change over the last 12 months. The rise of Generative AI has caused shifts in our market and  economic conditions are causing customers to really qualify where they make technology investments. These pivots undoubtedly have an impact on our employees and how people feel at work,” Azevedo continues. “I truly believe, however, the innovative work we are doing for our customers has helped us maintain and create an even stronger sense of collaboration and pride for our team members. We’re lucky to have so many smart people within our business, so continuing to give them interesting, challenging, and rewarding problems to solve for our customers is really key.”
About AncorisAncoris is a leading Google Cloud Services Provider, headquartered in the UK, on a mission to become the most innovative Google Cloud partner in the ecosystem. Ancoris leverages its strong problem solving skills and continuous improvement approach to help customers become AI Native and stay ahead of their competition. Ancoris has extensive experience in Google Cloud technologies helping enterprises integrate AI-native solutions into their business through expertise in Data & AI, Application and Infrastructure Modernisation, Workspace, and Maps. Ancoris was recognized as a Rising Star for Data, Analytics, and Machine Learning in the ISG Provider™ Lens for Google Cloud Partner Ecosystem in 2022 and 2023 consecutively, and awarded Google Cloud’s 2024 EMEA Public Sector Partner of the Year award. Ancoris employs the best in the business and was named in the Top 10 Sunday Times Best Places to Work 2023, and a Top Place to Work in 2024.
Contact: Holly [email protected]
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Department of Health – Abu Dhabi Partners with Roche Pharmaceuticals Middle East to Elevate Research, Clinical Trials, and Real-World Data

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May 21, 2024

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ABU DHABI, UAE, May 21, 2024 /PRNewswire/ — The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate, signed a Memorandum of Understanding (MoU) with Roche Pharmaceuticals Middle East during Abu Dhabi Global Healthcare Week (ADGHW). Under the MoU, the two entities will advance critical research using real-world data to study and assess the spinal muscular atrophy burden in Abu Dhabi, as well as assessing potential conduction of research and the facilitation of real-world data collection to monitor Duchenne Muscular Dystrophy (DMD) disease.

 
 
In the presence of Dr. Rashed Alsuwaidi, the Executive Director of the Healthcare Workforce Planning Sector at DoH and Michael Oberreiter, Head of Global Access at Roche Pharmaceuticals, the MoU was signed by Dr. Asma Al Mannaei, the Executive Director of the Research and Innovation Centre at DoH and Mohamed Elshaarawy, General Manager Roche Pharmaceuticals, UAE.
Dr. Asma Ibrahim Al Mannaei, Executive Director of the Research and Innovation Center at the at DoH said: “Abu Dhabi has a track record of excellence and fast-growing, future-forward, data-enabled services. Serving as a hub for healthcare data, Abu Dhabi’s substantial computing power enables it to harness the potential within this data, transforming it into valuable information. This, in turn, allows us to innovate and develop novel approaches to shift healthcare towards prediction, prevention, and treatment, thereby accelerating the future of healthcare, not only for Abu Dhabi but for the global community. Through international collaborations, Abu Dhabi seeks to lead research groups supported by global partners to explore the resilience and sustainability of the healthcare sector worldwide as well as expand access to quality care for patients around the world.”
The two entities will work together to support the evolution of real-world data collection frameworks in Abu Dhabi. Enhancing DoH’s ability to track and monitor outcomes of therapies will support DoH in making informed clinical and policy decisions for better optimisation of patient outcomes. Furthermore, DoH and Roche will strengthen the research network across Abu Dhabi and improve accrual for potential clinical trials.
Mohamed Elshaarawy, General Manager Roche Pharmaceuticals, UAE said: “This MoU underscores our collaboration with the DoH which is fuelled by a shared vision of harnessing the power of data to drive informed decision-making within the healthcare system. Data-driven healthcare systems hold immense potential to revolutionise patient care and outcomes. Through the generation, utilisation, and realisation of data, healthcare professionals and policymakers can unlock valuable insights, identify trends, and make evidence-based decisions. This data-driven approach enables us to optimise resource allocation, personalise treatment approaches, and ultimately achieve better patient outcomes. By harnessing the full potential of data, we can improve the overall efficiency and effectiveness of the healthcare system, ensuring that every patient receives the highest quality of care tailored to their specific needs. We are sincerely grateful for the trust, confidence, and empowerment the DoH has placed in establishing this effective public-private partnership with Roche in the UAE.”
Held under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of Abu Dhabi Executive Council, ADGHW is a major government initiative by the DoH, which took place from the 13th -15th May 2024.
For more information please visit: https://www.adghw.com/
About Department of Health – Abu Dhabi (DoH):
The DoH is the regulatory body of the healthcare sector at the Emirate of Abu Dhabi and ensures excellence in healthcare by monitoring the health status of the population. DoH defines the strategy for the health system, monitors and analyses the health status of the population and performance of the system. In addition, DoH shapes the regulatory framework for the health system, inspects against regulations, enforce standards, and encourages adoption of world-class best practices and performance targets by all healthcare service providers in the Emirate. DoH also drives programmes to increase awareness and adoption of healthy living standards among the residents of the Emirate of Abu Dhabi in addition to regulating scope of services, premiums and reimbursement rates of the health system.
For further information on DoH, visit https://www.doh.gov.ae/ and follow on X, Instagram, Facebook, LinkedIn and YouTube.
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Biopharma Leaders Shape the Future of Drug Development at Veeva R&D and Quality Summit Europe

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May 21, 2024

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Ascendis, Bayer, Boehringer Ingelheim, Jazz Pharmaceuticals, Novo Nordisk, Sanofi, and Teva to keynote sharing innovations to drive better patient outcomes
BARCELONA, Spain, May 21, 2024 /PRNewswire/ — Veeva Systems (NYSE: VEEV) today announced that leaders from Ascendis Pharma A/S, Bayer, Boehringer Ingelheim, Jazz Pharmaceuticals, Novo Nordisk, Sanofi, and Teva will be keynote speakers at Veeva R&D and Quality Summit, Europe, June 4-5 in Madrid, Spain. Life sciences professionals across the industry will come together to share how connected technologies across clinical, regulatory, safety, and quality are advancing innovations for patients.

As one of the largest gatherings of biopharma leaders in Europe, Veeva R&D and Quality Summit will bring together over 1,000 industry professionals to share learnings across more than 100 sessions. Bayer and Jazz Pharmaceuticals will join Rik Van Mol, senior vice president of Veeva Development Cloud, and Avril England, general manager of Veeva Vault, for the opening keynote to explore the future of development for new medicines and therapies.
The event’s zone keynotes include:
Ascendis and Bayer, sharing strategies to reduce costs and accelerate trials with a connected platform.Boehringer Ingelheim, detailing its shift toward data-centric regulatory information management.Novo Nordisk, showing how it uses data and AI to transform clinical research.Sanofi, explaining its innovative approach to advance quality through operational excellence.Teva, providing insight into its rapid journey from disparate safety systems into one streamlined global solution.A panel with Elpida Therapeutics CEO Terry Pirovolakis and Veeva experts will close the event with a discussion on how the industry can best accelerate the development of life-saving rare disease gene therapies.
“Connecting clinical, regulatory, safety, and quality is key to advancing the product lifecycle and delivering better outcomes for patients,” says Rik Van Mol, senior vice president of Veeva Development Cloud. “At Veeva R&D and Quality Summit, biopharma leaders can connect, exchange ideas, and share new strategies to advance the industry forward together.”
Veeva R&D and Quality Summit is open exclusively to life sciences professionals. Register and review the agenda at veeva.com/eu/Summit.
Additional InformationConnect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
About Veeva SystemsVeeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com/eu.
Veeva Forward-looking StatementsThis release contains forward-looking statements regarding Veeva’s products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-K for the fiscal year ended January 31, 2024, which you can find here (a summary of risks which may impact our business can be found on pages 9 and 10), and in our subsequent SEC filings, which you can access at sec.gov.
Contact:
Jeremy WhittakerVeeva [email protected]
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