On March 16, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported it has received notification from the U.S. Food and Drug Administration ("FDA") that the FDA’s Clinical Hold on AIM’s investigational new drug ("IND") application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted and the Company may proceed with the study (Press release, AIM ImmunoTech, MAR 16, 2022, View Source [SID1234610150]).

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"Based on the data we’ve seen to date, we believe Ampligen has the potential to offer an important treatment option to patients living with pancreatic cancer. This is a significant milestone for the Company and further positive Phase 2 confirmation of these results would demonstrate the potential of Ampligen as an effective therapy option. We are incredibly pleased and grateful to the FDA for its authorization, which enables us to proceed with further clinical evaluation. Our team is focused on commencing our Phase 2 study which we believe brings us another step closer to providing a potentially effective therapy after systemic chemotherapy in patients with advanced pancreatic cancer," commented Thomas Equels, Chief Executive Officer of AIM.

The AMP-270 clinical trial is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. We plan to enroll approximately 90 subjects across up to 30 centers in the U.S. and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites. Amarex Clinical Research will manage the AIM-sponsored Phase 2 study.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, states, "The longer median Progression Free Survival and overall survival rates of our patients treated with Ampligen that we have seen already are very encouraging and warrant further evaluation. With this devastating disease where there remains a need for more effective therapies, we are excited to advance the development of this important asset that has shown promise in addressing that need. I believe Ampligen has the potential to be a meaningful extension to the standard of care for advanced pancreatic cancer and I look forward to seeing the results of this next trial."

Prof. Michael A. "Tony" Hollingsworth, PhD, of the Buffett Cancer Center at UNMC, states "We are excited to undertake this clinical trial and associated correlative studies to better understand the mechanism by which Ampligen may extend survival of pancreatic cancer patients. The development of new therapeutic options is of utmost importance to the pancreatic cancer community, as we have so few options for patients."

Prof. Kelsey Klute, MD, of the Buffett Cancer Center at UNMC, stated, "Ampligen has shown promising activity in treating pancreatic cancer in the Erasmus Program and in preclinical models. This is an important step toward formally testing its activity in patients affected by this devastating disease."

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies. Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials — both underway and planned — at major cancer research centers around the country. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

On March 16, 2022 EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, reported that it entered a non-exclusive, worldwide license agreement with Boston Children’s Hospital (BCH) for intellectual property related to methods and compositions for increasing fetal hemoglobin levels by disrupting BCL11A expression at the genomic level to treat hemoglobinopathies (Press release, EdiGene, MAR 16, 2022, View Source [SID1234610138]).

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There is scientific evidence that suggests one way to address hemoglobinopathies is to upregulate the production of fetal hemoglobin to compensate for the genetic mutations that affect the proper production and function of hemoglobin. Fetal hemoglobin is naturally shut down after birth but can be reactivated by disrupting the BCL11A gene expression during erythropoiesis.

"In β-thalassemia patients with hereditary persistence of fetal hemoglobin (HPFH), naturally occurring genetic variants lead to higher fetal hemoglobin level and significantly alleviate symptoms, suggesting the potential of this therapeutic approach," said Dong Wei, Ph.D., CEO of EdiGene. "The license is an important component of our strategy to develop ET-01, an innovative gene-editing therapy for patients with transfusion-dependent β-thalassemia, in an effort to advance rapidly evolving technology into therapeutics for patients with unmet needs."

The terms of the agreement were not disclosed.

Founded in 2015, EdiGene has developed integrated capabilities and boosts a growing pipeline that extends across four gene-editing platforms. In January 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved the company’s Investigational New Drug (IND) application for ET-01, autologous CD34+ hematopoietic stem/progenitor cells with the elytroid-specific enhancer of the BCL11A gene modified by CRISPR/Cas9, for patients with transfusion-dependent β-thalassemia. A multi-center Phase I clinical trial is ongoing in China.

On March 15, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported the appointment of Dr. Xiong Zikai as the senior vice president (SVP) to be fully responsible for the company’s BD affairs (Press release, ImmuneOnco Biopharma, MAR 15, 2022, View Source [SID1234655641]).

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Dr. Zikai Xiong has extensive experience in various fields of biomedicine. Before joining ImmuneOnco, Dr. Xiong Zikai was in charge of strategic and innovative drug business development in Bayer Pharma, Lunsheng Pharma, Dino Pharma and other companies in Germany, and worked as a corporate strategic management consultant in Roland Berger, Germany. He also participated in the early entrepreneurial development of companies such as Genetron Health, an oncology in vitro diagnostic company.

Dr. Zikai Xiong holds a PhD in Cancer Molecular Genetics from the University of Cambridge, UK and a BS in Cell Biology and Genetics from Peking University.

Chairman and CEO, Dr. Tian, Wenzhi said: "I am very happy and sincerely welcome Dr. Xiong Zikai to join the ImmuneOnco team. I believe that, with his extensive professional experience, he will definitely help the company to develop rapidly. We also look forward to his joining to promote the business development of the company. ImmuneOnco accelerates the realization of the great vision of ‘developing first-class medicines for the benefit of cancer patients’". "We will work with all colleagues in the company to build the company into a world-renowned biopharmaceutical company and develop first-class new drugs for cancer patients around the world.

On March 15, 2022 EPFL spin-off Leman Biotech has raised USD 11 million for its protein that can improve the effectiveness of immunotherapy drugs used to treat some types of cancer (Press release, Leman Biotech, MAR 15, 2022, View Source [SID1234628394]).

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Immunotherapy is a promising new weapon in the fight against some types of cancer. It involves enhancing the ability of a patient’s own immune system to identify and destroy tumor cells. However, this form of treatment fails in around two thirds of patients because their T cells – the main cancer-killing lymphocytes – become exhausted. One option scientists are currently studying to improve the efficacy of immunotherapy is to add a protein that gives a boost to tired T cells. That’s the path being explored by EPFL spin-off Leman Biotech.

Its researchers have tested one such protein and found it has a nearly 90% efficacy rate on mice. "We ran several more preclinical trials these past few months using different types of human tumors transplanted into mice," says Prof. Li Tang, EPFL Professor and Co-Founder of Leman Biotech. "The results were just as encouraging, and the mice went on to have normal life expectancies."

The company just raised USD 11 million in its first funding round. The next step will be to complete the preclinical trials and then enter the clinical phase, which the start-up hopes to do within two years.

"For a first funding round, USD 11 million is a hefty sum," said Natalia Giovannini of the EPFL’s Technology Transfer Office (TTO). "Leman Biotech’s success in attracting capital reflects the considerable interest in its innovation."

The company will use the proceeds to quickly ramp up its operations. "We’ve already opened two research labs – one in the Superlab Suisse, at the Biopôle in Epalinges, and the other in southern China where our co-founder is based," concludes Tang.

On March 15, 2022 Emmanuelle BETTENDORF reported that it will participate in BioEurope Spring from March 28 to 31, 2022 and will be available to meet with you on partnership opportunities (Press release, Vect-Horus, MAR 15, 2022, View Source [SID1234610700]).

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