Enlivex and Mount Sinai Health System Announce Research Collaboration for the Development of Allocetra in Combination with Immune Checkpoint Inhibitors

On March 1, 2021 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, and Mount Sinai Health System, one of the world’s leading academic health systems, reported a new research collaboration for the development of clinical strategies for Allocetra with checkpoint inhibitors (Press release, Enlivex Therapeutics, MAR 1, 2021, View Source [SID1234575892]). Allocetra is a macrophage-reprogramming immunotherapy product candidate currently in clinical development by Enlivex for the potential treatment of life-threatening immune-mediated diseases.

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Under the strategic collaboration agreement, the parties have agreed to develop and execute a pre-clinical program to investigate the potential synergies between Allocetra and commercially approved checkpoint inhibitor therapies for select solid cancers.

Carlos Cordon-Cardo, M.D., Ph.D., Irene Heinz Given and John LaPorte Given Professor and Chair of the Lillian and Henry M. Stratton-Hans Popper Department of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai, commented, "We are impressed with the data supporting the immunotherapeutic effects of Allocetra in preclinical cancer models. The scientific rationale supporting AllocetraTM-checkpoint inhibitor combination therapies is intriguing, as preclinical studies suggest Allocetra may reverse the immunosuppressive tumor microenvironments that often hamper checkpoint inhibitors by reprogramming anti-tumor macrophages to their homeostatic state. We look forward to the further development of Allocetra-checkpoint inhibitor combination therapies through this newly formed collaboration."

A pioneer of the oncologic molecular pathology discipline, Dr. Cordon-Cardo has helped establish a deeper understanding of the mechanisms of human cancers and new targets for cancer diagnosis and therapeutics, enhancing the vision of personalized medicine. Dr. Cordon-Cardo is one of the "Highly Cited Authors" by the Institute of Scientific Information, one of the "Highly Influential Biomedical Researchers" (one of the top 400 over 15,153,100 author identifiers) by the European Society for Clinical Investigation; and one of the top "List of 500 Most Highly Cited Researchers Worldwide," Google Scholar, Citations 101,185; h-index 158; i10-index 521 (Google Scholar-2020). Dr. Cordon-Cardo is the recipient of numerous honors and awards, including "Roll of Honour" of the International Union Against Cancer; Gold Medal of the Swedish Society of Physicians; Distinguished Alumnus Award, Weill-Cornell Graduate School of Medical Science, Cornell University; Fellow, Royal Society of Medicine.

Dror Mevorach, M.D., Chief Medical Officer of Enlivex, commented, "We are excited to collaborate with the distinguished research and clinical teams at Mount Sinai. Allocetra may have a rebalancing effect on the typically immunosuppressive tumor microenvironment, potentially by facilitating the conversion of pro-tumor macrophage populations to anti-tumor populations. Together, we plan to investigate the potential of AllocetraTM to synergistically combine with commercially available checkpoint inhibitors for the treatment of solid tumors."

Oren Hershkovitz, Ph.D., CEO of Enlivex, stated, "The researchers and clinicians at Mount Sinai are world-class and ideal partners as we work toward the realization of Allocetra’s potential. We are pleased with the decision of Mount Sinai to formulate a strategic collaboration with Enlivex for the development of Allocetra as a potentially key component of combination therapies for solid tumors."

Allocetra is currently in clinical development for acute life-threatening immune-mediated diseases such as sepsis and COVID-19. Enlivex recently reported positive top-line results in 21 patients from Phase Ib and Phase II investigator-initiated trials in COVID-19 patients in severe/critical condition. The Company has also previously reported positive results from a Phase Ib investigator-initiated trial in 10 sepsis patients and plans to initiate a controlled, randomized, Phase IIb study in sepsis during the first quarter of 2021.

Emergent BioSolutions to Participate in Investor Conferences

On March 1, 2021 Emergent BioSolutions Inc. (NYSE: EBS) repoted that members of the company’s senior management team will participate in the following investor conferences (Press release, Emergent BioSolutions, MAR 1, 2021, View Source [SID1234575891]):

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Jefferies Inaugural Global Plasma Summit
March 11, 2021
Company fireside chat scheduled at 12:50 pm EST

KeyBanc Life Sciences & MedTech Investor Forum
March 24, 2021
Company fireside chat scheduled at 1:15 pm EST
Chardan 4th Annual Manufacturing Summit
April 26-27, 2021
Fireside chat date and time will be updated on the Emergent website as the information becomes available.
Truist 7th Annual Life Sciences Summit
May 4-5, 2021
Presentation date and time will be updated on the Emergent website as the information becomes available.
For conferences where a presentation is planned, the company’s webcast presentation may include a discussion of the company’s recent business developments as well as its financial results and guidance. The webcasts will be available both live, if possible, and by replay, and will be accessible from the Emergent website.

Oncorena Receives Approval of First in Patient Trial with Orellanine as a Potential Breakthrough Therapy in Metastatic Renal Cancer Patients

On March 1, 2021 Oncorena, dedicated to developing a unique and potential breakthrough therapy for metastatic renal cancer, reported the Swedish Medical Products Agency’s approval of the Phase 1/2 of First in Patient trial of the first-in-class compound, orellanine in patients with metastatic renal cancer in dialysis (Press release, Oncorena, MAR 1, 2021, View Source [SID1234575884]).

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Preclinical evidence shows that orellanine, a well known fungus toxin, specifically exerts powerful anti-tumor effects on metastatic renal cancer in different preclinical models. Orellanine has a unique mode of action. All preclinical activities have been completed and the Swedish Medical Products Agency has approved Oncorena’s first clinical trial in patients with metastatic renal cancer on dialysis.

"Evaluating orellanine in patients with metastatic renal cancer is a key milestone in our efforts to demonstrate the clinical features of this promising compound," said Lars Grundemar M.D., Ph.D., Chief Executive Officer of Oncorena.

"I am thrilled that Oncorena now is transforming into a clinical stage company. The scientific advances Oncorena has made during the years can be crucial for patients in the future. In the same way, the progress is crucial for the company’s continued development and enables new ventures in the field of kidney cancer," said Andreas Segerros, Oncorena’s Chairman of the Board of Directors.

About the clinical Phase 1/2 trial
The Phase 1/2 multicenter, open-label, clinical trial of orellanine, to be conducted at the Centre for Clinical Cancer Studies at the Karolinska University Hospital, Stockholm, Sweden, will enrol patients with metastatic renal cancer already on dialysis due to renal failure. Orellanine will be given intravenously. The trial is divided into a dose escalation part followed by a repeated dose expansion part to examine safety, tolerability, pharmacokinetics and signs of anti-tumor effects. The Phase 1/2 trial will include up to 40 patients and will be expanded also to other countries.

About orellanine
Orellanine is a well known nephrotoxin from the Cortinarius family of mushrooms. Since many people have inadvertently ingested the mushroom the effects of orellanine are well documented and are limited to the kidneys. Experimental studies have shown powerful anti-tumor effects on metastatic renal cancer. Orellanine has a novel mechanism of action. The target group for the potential orellanine treatment is patients with metastatic kidney cancer who are undergoing dialysis. These patients have renal failure, however, they have an urgent need for treatment of the metastatic disease and may potentially benefit from treatment effect of orellanine.

About kidney cancer
Approximately 400,000 patients are affected by kidney cancer globally and more than 131,000 die of the disease every year, source WHO. 80% of the patients are between 40 and 69 years of age when they are diagnosed. The disease can often be cured by surgery if detected in time, but unfortunately the diagnosis is often made when the tumor has already spread to other organs. The prognosis is then considerably less favorable and certain groups have a median survival of less than two years. Today the disease is treated with various types of targeted and immuno-active drugs, often with severe side effects, and standard chemotherapy drugs have only very limited effect. There is therefore an urgent and high unmet medical need for new, effective and safe drugs.

CARsgen Therapeutics Receives Orphan Medicinal Product Designation from the European Medicines Agency for CT041 CLDN18.2 CAR T Cells for the Treatment of Gastric Cancers

On March 1, 2021 CARsgen Therapeutics Holdings Limited, a clinical-stage biopharmaceutical company, reported that the European Commission (EC) has granted orphan designation for CT041, CARsgen’s first-in-class Claudin 18.2 (CLDN18.2) targeted CAR-T product candidate for the treatment of gastric cancer (Press release, Carsgen Therapeutics, MAR 1, 2021, View Source [SID1234575883]). CT041 consists of the patient’s own T cells, genetically modified to express a humanized anti-CLDN18.2 chimeric antigen receptor (CAR) to treat patients with CLDN18.2-positive tumors.

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"The orphan medicinal product designation of CT041 by the EC is another important recognition of CARsgen’s commitment to the development of CAR T-cell treatment for patients with advanced gastric cancer," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, over one million new cases of gastric adenocarcinoma are expected each year, and it is the seventh most prevalent cancer type worldwide [1]. Despite the development of novel therapies, gastric cancer is still a disease with one of the highest unmet medical needs. We reaffirm our long-standing commitment to cancer patients worldwide by expanding upon our CT041 clinical trial data to advance novel, safe and effective immunotherapies."

The EC grants orphan drug designation to investigational treatments for rare conditions, those affecting fewer than five in 10,000 people in the European Union. Treatments that meet the European Medicines Agency’s orphan designation criteria qualify for incentives to encourage advancement of drug development.

CT041 is the first CLDN18.2-targeted CAR T-cell treatment that has received Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China. Three open-label, multicenter, Phase 1b clinical trials (NCT04404595, NCT04581473, and NCT03874897) to evaluate the safety and efficacy of autologous CT041 cell treatment in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma are currently underway.

IDEAYA to Participate in Upcoming March 2021 Investor Relations Events

On March 1, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the following upcoming investor relations events (Press release, Ideaya Biosciences, MAR 1, 2021, View Source [SID1234575882]).

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Investor Relations Events

H.C. Wainwright Global Life Sciences Conference 2021 (Virtual)
Corporate Presentation
Tuesday, March 9th, 2021 at 7:00 am ET
Citi’s 2021 Winter West Coast Biotech Virtual Bus Tour (Virtual)
Fireside Chat with Analyst Mohit Bansal
Tuesday, March 16th, 2021 at 3:00 pm ET
Oppenheimer’s 31st Annual Healthcare Conference (Virtual)
Company Presentation
Wednesday, March 17th, 2021 at 2:30 pm ET
Roth 33rd Annual Conference (Virtual)
Company Panel hosted by Analyst Zegbeh Jallah: "Highly Attractive Small Molecule
Oncology Platforms" with Arvinas, IDEAYA Biosciences and Turning Point Therapeutics
Wednesday, March 17th, 2021 at 5:00 pm ET
A live audio webcast of selected events will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of selected webcasts will be available for 30 days following the live event.