On September 22, 2020 AIM ImmunoTech Inc. (NYSE American:AIM) reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands (Press release, AIM ImmunoTech, SEP 22, 2020, View Source [SID1234569679]).

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Prof. Casper van Eijck, MD, PhD, oncologist and a global leading expert in pancreatic cancer

Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Prof. van Eijck states, "The overall survival of the experimental group was compared to a large historical control cohort matched for age, gender, stage of disease, and number of cycles of Folfirinox chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. These results were obtained with a very high degree of statistical significance. Based on these data, I see the potential for Ampligen as a meaningful extension of the standard of care for advanced pancreatic cancer, which we are planning to investigate further." A detailed clinical report and an article for publication are being prepared by Prof. van Eijck and his team at Erasmus MC.

AIM CEO Thomas K. Equels states: "We started this program in January 2017. These exceptional results from Erasmus exceed even our most optimistic expectations. I am deeply grateful to Prof. Casper van Eijck, his team at Erasmus, and Ronald Brus, MD, the guiding hand at myTomorrows, for their vision and careful diligence in implementing this important analysis of Ampligen as a single-agent therapy for late-stage pancreatic cancer. I extend deep gratitude to the government of the Netherlands for its pioneering support and commitment to advancing a critical medical innovation in a deadly cancer with very limited medical interventions. Medical advances in lethal unmet medical needs depend on this sort of outstanding clinical and governmental cooperation and support. We could not have accomplished this but for the support of the Netherlands."

AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA "fast-track" and possibly even FDA "breakthrough" designations and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States. AIM also plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If granted, this serves to extend a company’s exclusivity rights once a drug reaches market.

On September 22, 2020 Lantern Pharma, a clinical-stage biopharma company using its proprietary RADR AI platform to improve drug discovery & development and identify patients who will benefit from its targeted oncology therapeutics, reported that it has announced a collaboration and research agreement with Fox Chase Cancer Center for the further development of Lantern’s LP-184 in pancreatic cancer (Press release, Lantern Pharma, SEP 22, 2020, View Source [SID1234565612]). Based in Philadelphia, Fox Chase is a research center for pancreatic cancers and one of the four original cancer centers to receive comprehensive cancer center designation from the National Cancer Institute (NCI).

The Fox Chase collaboration will focus on advancing the targeted use of LP-184 in molecularly-defined sub-types of pancreatic cancer. The goal of the collaboration is to create a more biologically relevant and robust gene signature in preparation for future clinical trials, enabling pancreatic cancer patients to potentially benefit from a more effective and personalized cancer therapy.

"Collaborations with world-leading cancer centers are an essential part of our strategy to rapidly advance the insights driving our therapeutic programs and grow our RADR A.I. platform by adding millions of new, unique, and proprietary data points," said Panna Sharma, CEO of Lantern Pharma. "This relationship with Fox Chase will allow us to use state-of-the-art models and biological methods to add more physiologically relevant data and insights into the mechanisms of LP-184, and will further shape our algorithms for how certain compounds interact with specific tumor types. The unique insights we gain will equip Lantern with critical advantages in our aim of accelerating LP-184’s path to clinical trials and ultimately commercialization, while saving millions of dollars in development costs. This data-enabled, and biomarker-based approach has the potential to meaningfully bend the cost curve of cancer drug development and help bring personalized cancer therapies to patients with reduced economic burden, and greater efficacy."

The research will be led by Igor Astsaturov, MD, Ph.D., a researcher in gastrointestinal cancers at the Molecular Therapeutics Program at Fox Chase where he specializes in investigating signaling pathways that inform the choice of biomarkers and innovative therapy combinations in clinical trials.

LP-184 is a DNA-damaging small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including pancreatic cancer. As a next-generation alkylating agent that preferentially damages DNA in cancer cells that overexpress certain biomarkers, LP-184 has the potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs.

"We are very pleased to partner with Lantern Pharma in establishing a collaboration that will play an important role in our research," said Astsaturov. "Our advanced research approach using patient-derived cancer models will provide us with critical insights into the efficacy of LP-184 in pancreatic cancers. We look forward to sharing these results with the broader scientific community and hopefully bringing this drug to cancer patients that can best benefit from this compound."

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Research Goals

The research program is at the forefront of translational cancer medicine and will use patient-derived cancers that are grown in the lab and transformed into physiologically relevant 3D organoids and PDx models. This innovative approach allows researchers to more precisely understand the biology of what actually happens inside the cancer tumor, which will more accurately establish the precise biomarker signatures and help provide data-driven insight into additional mechanisms that can be leveraged in the fight against pancreatic cancer.

Among several objectives, the research will determine whether the overexpression of the gene PTGR1, a biomarker that has been linked to cancer cell proliferation, will indicate heightened sensitivity to LP-184 and a more favorable response rate and efficacy as compared to standard of care agents. LP-184 has been advanced using Lantern’s proprietary RADR A.I. platform that leverages over 500 million data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and genomic and biomarker signatures that correlate to drug response in cancer patients.

Although significant recent advances have been made in the use of targeted and biomarker-based therapies in cancer, pancreatic cancer remains an area that has not experienced significant improvement in patient outcomes. The overall five-year survival rate for pancreatic cancer across all stages remains at only 10.0% in the US and 8.2% globally, and pancreatic cancer is expected to become the 2nd leading cause of cancer death in the USA in 2020 behind lung cancer according to the National Cancer Institute’s SEER Stat Database.

On September 22, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported that it will announce its first half-year 2020 financial results and new corporate strategy following market close on Wednesday, September 30, 2020 (Press release, Genfit, SEP 22, 2020, View Source [SID1234565521]). The press release will be followed by two conference calls hosted by GENFIT management to discuss the results and new strategy:

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Conference Call in English on September 30, 2020 at 4:30pm EDT / 22:30 CEST, and in French on October 1, 2020 at 1:30am EDT / 07:30am CEST

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 877-407-9167 (toll-free U.S. and Canada), 201-493-6754 (international) or 0 800 912 848 (France) five minutes prior to the start time (no passcode needed). A replay will be available shortly after the call.

On September 22, 2020 BioCanRx, Canada’s Immunotherapy Network, reported funding of $10M for 14 cancer immunotherapy research projectsand eight core and biomanufacturing facilities (Press release, BioCanRx, SEP 22, 2020, View Source [SID1234565514]). In addition to BioCanRx’s investment, matching partner contributions of $16.5M increase the total investment in Canadian translational cancer immunotherapy research and manufacturing facilities to $26.5M.

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Cancer is one of the biggest health challenges facing Canadians. Nearly 1 in 2 Canadians is expected to develop cancer in their lifetime. BioCanRx is working to turn the tide and improve outcomes for patients by accelerating the development of promising immunotherapy treatments which could be more effective, affordable and safe than conventional cancer therapies.

"We’re collaborating and building teams across Canada to find new ways for the body’s immune system to outsmart and kill cancer. This new funding is helping to bridge the research gap between lab discoveries and clinical trials to ultimately benefit patients," said Dr. John Bell, BioCanRx’s Scientific Director and a senior cancer research scientist at The Ottawa Hospital and the University of Ottawa.

BioCanRx’s investments in the development of novel therapies continue to be guided and benchmarked by its Research Management Committee composed of internationally renowned academics and industry leaders in the field of cancer immunotherapy. The focus of the newly funded projects includes highly innovative and novel approaches to cancer treatment, targeting difficult to treat cancers where current options are limited. The project investment portfolio includes cross-disciplinary teams from across the country working on new, rational combination approaches and unique cell, vaccine/virus-based and antibody immunotherapies.Investments in Canada’s biomanufacturing capacity also feature prominently and additional sites across the country will be added to our point-of-care cell manufacturing network to enhance access to life-saving therapies to patients across the country.

On September 22, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported that Pierre Belichard, Chief Executive Officer, and Christophe Bonny, Chief Scientific Officer, will present at the Jefferies Virtual Next Generation IBD Therapeutics Summit, which will take place September 23-24, 2020 (Press release, Enterome, SEP 22, 2020, View Source [SID1234565504]).

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The presentation, in the form of a live fireside chat, will take place on Wednesday, September 23, at 11:30-12:10 Eastern Daylight Time.