On August 24, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported results from a new preclinical in vitro study for its highly selective CDK9 inhibitor, GFH009, in neuroendocrine prostate cancer (NEPC) (Press release, Sellas Life Sciences, AUG 24, 2022, View Source [SID1234618598]). The data shows that GFH009 demonstrated significant anti-tumor effects in the selected cell line at nanomolar concentrations and, in certain samples, complete growth inhibition with no viable cancer cells.

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NEPC, an aggressive variant of prostate cancer, is a rapidly growing indication which arises as a result of otherwise successful treatment of advanced prostate cancer. In up to 15 to 20 percent of patients treated with hormonal therapies for prostate adenocarcinoma, small-cell prostate cancer may develop in later stages of prostate cancer progression. This histologic transformation occurs as a mechanism of treatment resistance. Aggressive NEPC represents a lethal endpoint in the progression of prostate cancer from prostate adenocarcinoma to castration-resistant prostate cancer (CRPC) to NEPC. Median survival for NEPC patients whose cancer arose from prior prostate adenocarcinoma is estimated at only 5.4 months.

The conversion to NEPC is associated with recurrent genetic lesions including mutation or deletion of RB1 and TP53 as well as the overexpression and genomic amplification of MYCN. SELLAS believes that all forms of MYC may be susceptible to CDK9 inhibition and the data from the in vitro study, conducted at an independent, third-party contract research organization, Translational Drug Development (TD2), supported this supposition, resulting in 38 nM median IC50 value.

"We are very excited with this first confirmation of our hypothesis that GFH009 could address NEPC, a rapidly growing indication," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "About one in eight men will be diagnosed with prostate cancer during his lifetime and any significant change in the course of treatment for this cancer has potential for outsized consequences."

About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

On August 24, 2022 Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported the initiation of patient dosing in the U.S. for a Phase 1/2 study of RNK05047 (Press release, Ranok Therapeutics, AUG 24, 2022, View Source [SID1234618616]). The trial, entitled CHAMP-1, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RNK05047 in patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Ranok anticipates preliminary data from the study in the second half of 2023.

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"RNK05047 is Ranok’s first therapy based on our proprietary CHAMP technology, as well as the first BRD4 protein degrader in the pharmaceutical industry to enter clinical testing," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok. "RNK05047 is designed to selectively degrade BRD4 protein preferentially in tumors, thereby improving safety and efficacy, which differentiates it from other investigational therapies such as non-selective BET inhibitors."

"The BET bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types," said Manuel Hidalgo Medina, M.D., Ph.D., Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, Associate Director of Clinical Services at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a site Principal Investigator in the trial. "We are pleased to be participating in this trial and are hopeful that RNK05047 will provide a beneficial new therapeutic option for patients."

Additional information on this clinical trial (NCT05487170) can be found at www.clinicaltrials.gov.

About Ranok’s CHAMP platform

Ranok’s proprietary Chaperone-mediated Protein Degradation/Degrader (CHAMP) platform and Chaperone-Tether Library are based on our founders’ extensive backgrounds researching protein homeostasis. CHAMP technology takes advantage of the cellular chaperone network, which regulates the folding and stability of proteins, distinguishing it from other targeted protein degradation approaches. CHAMP has a number of unique advantages, such as the evasion of mechanisms of drug resistance, and is designed to improved safety and efficacy due to the selective targeting of disease tissues.

About RNK05047

RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase 1/2 trial of RNK05047 currently underway in the U.S. that will assess its safety, tolerability and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. Preliminary data is expected from the trial in the second half of 2023.

On August 24, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare and genetically defined diseases, reported that the company is scheduled to present at the following September investor conferences (Press release, Agios Pharmaceuticals, AUG 24, 2022, View Source [SID1234618599]):

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Wells Fargo Healthcare Conference on Wednesday, September 7, 2022 at 8:35 a.m. ET; and
Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 4:50 p.m. ET.
Live webcasts of the presentations can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. Replays of the webcasts will be archived on the Agios website for at least two weeks following each presentation.

On August 24, 2022 Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, reported that it has entered into a lease agreement to develop an approximately 83,000 square-foot Research and Development (R&D) and Manufacturing Center to expand its operations in Seattle and complement its existing R&D enterprise in South San Francisco (Press release, Sonoma Biotherapeutics, AUG 24, 2022, View Source [SID1234618617]). The state-of-the-art Center will support the R&D and manufacturing of Sonoma Bio’s pipeline of gene-modified Treg therapies for autoimmune and inflammatory diseases at scale.

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"Sonoma Bio is at the forefront of developing Treg therapies to treat autoimmune and inflammatory diseases by restoring balance to the immune system, and we are establishing robust and nimble infrastructure from end-to-end to deliver these cellular products," said Heidi Hagen, Chief Technical Officer of Sonoma Biotherapeutics. "Through the integration of our R&D engine with next-generation process development and cell therapy production tools, we will have the ability to quickly and efficiently deliver potentially transformative therapies to patients in need."

This R&D and Manufacturing Center will include the development and use of cutting-edge technologies and capabilities from cell selection and genetic modification to intelligent manufacturing automation and information technology systems. The integration of this infrastructure and scientific expertise will enable Sonoma Bio to move efficiently from molecular target identification to in-house full-scale production for multiple product candidates and indications in Phase 2 clinical trials and beyond. The Center will be located on the Seattle waterfront at 501 Elliott Avenue West, a property owned by Office Properties Income Trust and being redeveloped by The RMR Group into Unison Elliott Bay.

"Seattle has an established legacy of delivering many firsts in the cell therapy field for cancer, and we are building upon those insights to advance our pipeline of engineered Treg therapies for autoimmune and inflammatory diseases," said Jeff Bluestone, Ph.D., Co-Founder and CEO of Sonoma Biotherapeutics. "This Center will create highly-skilled scientific, engineering and manufacturing jobs in the Seattle area, taking advantage of the deep local capabilities and expertise. As we move into the next phase of growth at Sonoma Bio, we want to unite talent across the thriving life science communities of Seattle and San Francisco."

On August 24, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC) (OTC:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported its participation in the following upcoming conferences (Press release, Ensysce Biosciences, AUG 24, 2022, View Source [SID1234618600]):

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PAINWeek Conference 2022, September 6 – September 9, 2022, in Las Vegas, NV. Dr. Lynn Kirkpatrick, Chief Executive Officer, to chair a symposium and panel, entitled, "Severe Pain, Strategic Perspectives." The symposium will be held on September 9th from 12:30 p.m. – 1:30 p.m. Pacific time.
H.C. Wainwright 24th Annual Global Investment Conference, September 12 – September 14, 2022, at the Lotte New York Palace Hotel, New York, NY.
Lake Street 6th Annual Best Ideas Growth Conference, Wednesday, September 14, 2022, at The Yale Club, New York, NY.
New Product Planning Summit, September 19-20, 2022, in Boston, MA. Geoff Birkett, Chief Commercial Officer, to chair the meeting and speak on his prior experience launching several major neuroscience and pain products.
The Company’s Chief Executive Officer, Dr. Lynn Kirkpatrick, and Chief Financial Officer, Dave Humphrey, will be available for one-on-one meetings during both the H.C. Wainwright and Lake Street conferences. For more information about the events or to schedule a one-on-one meeting with Ensysce’s management, please contact Ensysce’s Investor Relations at [email protected].