On September 8, 2021 ISA reported the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo (cemiplimab) in advanced HPV16 positive oropharyngeal cancer (Press release, ISA Pharmaceuticals, SEP 8, 2021, View Source [SID1234587393]). This new study is the third with active recruitment under ISA Pharmaceuticals’ strategic immuno-oncology collaboration with Regeneron.

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The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.

The other studies testing the combination of ISA101b and Libtayo are:
A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.
A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for this study are expected in the second half of 2022.

ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA’s proprietary Synthetic Long Peptide (SLP) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."

Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe(1) and 46,000 new cases and 9,000 deaths in the US(2).

On September 8, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that Frances L. Johnson MD, Chief Executive Officer and Co-Founder of Viewpoint, will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Viewpoint Molecular Targeting, SEP 8, 2021, https://viewpointmt.com/viewpoint-molecular-targetingr-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference/ [SID1234587411]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand beginning Monday, September 13, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Company’s website (viewpointmt.com). The webcast replay will be archived for 90 days following the event.

On September 8, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported the initiation of a Phase 1/2 clinical trial to evaluate JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent prior to allogeneic transplant in patients with GATA2-related myelodysplastic syndromes (MDS) (Press release, Jasper Therapeutics, SEP 8, 2021, View Source [SID1234587429]). Jasper Therapeutics and the National Cancer Institute (NCI), part of the National Institutes of Health, have entered into a clinical trial agreement in which NCI will serve as the Investigational New Drug (IND) sponsor for this study.

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"As we seek to make stem cell transplants safer and expand the indications for which JSP191 could be used as a less toxic, more effective conditioning regimen in patients undergoing curative transplant, we look forward to collaborating with the NCI on this Phase 1/2 clinical trial in patients with GATA2-related MDS," said Wendy Pang, M.D., Ph.D., vice president, research and translational medicine, of Jasper Therapeutics. "The results may provide us with key insights about the use of JSP191, a highly differentiated anti-CD117 monoclonal antibody, as a conditioning agent for this patient population."

MDS are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i Some patients with MDS have mutations in the GATA2 gene, which plays a role in the production and maintenance of hematopoietic stem cells, which give rise to all blood and immune cells.ii Each year, about 2,500 patients with MDS in the G7 countries receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) are currently enrolling. Enrollment in four additional studies is expected to begin in 2021 in patients with severe autoimmune disease, sickle cell disease, chronic granulomatous disease or Fanconi anemia who are undergoing hematopoietic cell transplantation.

On September 8, 2021 ATP, a leader in life sciences venture capital, reported the launch of Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer, and treat autoimmune and inflammatory disorders and other diseases, using self-replicating RNA (srRNA) (Press release, Replicate Bioscience, SEP 8, 2021, View Source [SID1234587380]). Replicate will use $40 million in committed Series A funding from ATP to advance multiple novel srRNA programs into clinical development.

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"Next-generation srRNA agents are taking RNA therapeutics into many more areas of disease treatment, and what Replicate is doing to define and expand this field is completely new and exciting," said Michael Ehlers, M.D., Ph.D., Chief Scientific Officer of ATP and a venture partner at the firm. "ATP is investing in Replicate because we see the company’s technology as a quantum leap in RNA therapeutics."

Self-replicating RNAs, or srRNAs, work by copying themselves inside cells of the body and instructing the cells to make, and keep making, therapeutic proteins. Replicate uses synthetic biology, original molecular design principles, and a diverse, proprietary repertoire of virally derived vectors to engineer custom srRNAs that offer unique advantages compared to other RNA or srRNA therapeutic approaches. These advantages include lower dosing levels by several orders of magnitude; increased duration of therapeutic effect; and selectively programmed ability to either activate or evade the immune system.

Nathaniel Wang, Ph.D., Replicate Bioscience Chief Executive Officer, said: "We started Replicate to build a best-in-class srRNA platform from scratch—to pursue our vision of a better way to make srRNAs that we are convinced can solve life-threatening medical problems, from drug resistance in cancer to autoimmune and inflammatory disorders and more. We are thrilled to partner with ATP, to accelerate our progress towards realizing that vision for patients."

Dr. Wang and Andrew Geall, Ph.D., Replicate Chief Development Officer, previously collaborated on srRNA technologies at Synthetic Genomics and at Novartis Vaccines and Diagnostics. They joined with a former colleague, Herbert Kim Lyerly, M.D., and Zachary Hartman, Ph.D., both professors of cancer research and immunology at Duke University, to develop an srRNA application capable of preventing or removing drug-resistant cancer mutations—a tactic they dubbed "synthetic immune lethality." Replicate Bioscience is developing synthetic immune lethality srRNAs for concurrent administration with targeted therapies in solid tumors. Beyond cancer, Replicate is developing different types of srRNAs for autoimmune and inflammatory disorders, and the company’s versatile technology platform also lends itself to deployment in other disease areas.

The Replicate Bioscience Board of Directors is chaired by Dr. Ehlers and includes as members Dr. Wang; Seth Harrison, M.D., founder and managing partner of ATP; and Joseph A. Yanchik III, a venture partner at ATP. The company’s Scientific Advisory Board includes Drs. Lyerly and Hartman; Philip Santangelo, Ph.D., a spatial biologist and professor of biomedical engineering at Georgia Institute of Technology and Emory University; and Jeffrey Ulmer, Ph.D., former head of preclinical R&D at GlaxoSmithKline and former global head of external research at Novartis. The company is headquartered in San Diego, California.

On September 8, 2021 BeyondSpring Inc. ("BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported that management will present at and participate in the Morgan Stanley 19th Annual Global Healthcare Conference and R.W. Baird’s 2021 Global Healthcare Conference (Press release, BeyondSpring Pharmaceuticals, SEP 8, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-to-participate-in-the-upcoming-september-conferences [SID1234587570]). Details for both conferences are below:

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Morgan Stanley 19th Annual Global Healthcare Conference
Date: Tuesday, September 14th 2021
Time: 11:45am ET
Format: Fireside Chat
Management will also be available for 1×1 meetings on September 9th-15th, 2021. If you would like to request a meeting, please contact [email protected].

R.W. Baird’s 2021 Global Healthcare Conference
Date: Wednesday, September 15th 2021
Time: 4:55pm ET
Format: Presentation
Management will also be available for 1×1 meetings on September 14th-15th, 2021. If you would like to request a meeting, please contact [email protected].