On July 18, 2023 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Cancer Research Horizons, the innovation engine at the core of one of the world’s largest private funders of cancer research, Cancer Research UK (CRUK), reported an agreement under which Cancer Research Horizons will license the entire Twist Biopharma Solutions Library of Libraries (Press release, Twist Bioscience, JUL 18, 2023, View Source [SID1234633305]).

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"Teaming up with Cancer Research Horizons to support exploratory drug discovery efforts, validating and de-risking biological targets has the potential to be groundbreaking for patients," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Cancer Research Horizons acts as a conduit between academia and industry, with our collaboration enabling early-stage antibody identification through access to our ‘Library of Libraries.’ With two mission-driven organizations aligning behind innovative technology solutions to improve health to make the world a better place, the opportunity to identify new biotherapeutics offers tremendous hope to those who need it most."

"We’re delighted to partner with Twist Bioscience, an exciting technology platform company who will enhance our antibody discovery capabilities with their highly diverse phage display libraries," said Hamish Ryder, CEO of Therapeutic Innovation at Cancer Research Horizons. "We look forward to using this technology to accelerate the delivery of high-quality therapeutics and diagnostics to cancer patients, in collaboration with our academic and industrial partners."

Under the terms of the agreement, Cancer Research Horizons will license Twist’s Library of Libraries, an expansive collection of synthesized antibody libraries designed based on naturally occurring sequences that harness innovative structural and developability features to cover a wide range of antibody drug targets, for a period of five years. Twist will receive a library access fee and will be eligible to receive annual maintenance fees as well as a share of revenue from any assets sold or transferred.

On July 18, 2023 ENB Therapeutics, Inc., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, reported that the company has completed enrollment of its international Phase 1 ENBOLDEN-101 trial investigating the safety and efficacy of lead product ENB-003 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, ENB Therapeutics, JUL 18, 2023, View Source [SID1234633304]). The Phase ½a study is a multicenter, open-label study conducted in the US and Australia and is comprised of two parts. Part 1 recruited 46 patients and was a dose-escalation study to determine the recommended dose for the Part 2 expansion phase of the study. The results of this study will be presented by ENB Therapeutics in a poster titled, "ENB-003, an ETBR antagonist, in combination with pembrolizumab for refractory advanced solid tumors: Topline data from the ENBolden-101 Phase 1B study" at the Immuno-oncology Summit which is being held August 7-9, 2023 in Boston, Massachusetts.

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ENB-003 in combination with pembrolizumab was well tolerated in the dose escalation study and demonstrated no DLTs across the 6 dosing cohorts. The most common treatment emergent adverse events irrespective of grade or causality included fatigue (28.2%), constipation (26.1%), abdominal pain (26.1%), nausea (23.9%), anemia 17.4%, diarrhea (17.4%). Serious adverse events, grade 3 and above considered possibly related to study treatment included fatigue (n=4), diarrhea (n=3), dyspnea (n=3) constipation (n=2), rash (n=2). 15 patients with evaluable disease were enrolled in cohorts 1-5 (ENB-003 dose range 150ug-1000ug) and 15 patients with evaluable disease were enrolled in the 6th cohort (ENB-003 dose 2000ug). The dosing frequency for cohort 6 was doubled to 6 doses every 3 weeks from 6 doses every 6 weeks in cohort 1-5. The DCR across all cohorts irrespective of ETBR status was 33% (1 PR, 9 SD, 20 PD). The DCR in ETBR-Hi patients was 33% in cohorts 1-5 (4 SD, 1 PR, 10 PD) and 83% in cohort 6 (5 SD, 1 PD). The DCR for ETBR-Lo patients in cohort 6 was 0% (9 PD). ETBR-Lo patients were not enrolled in cohorts 1-5. For microsatellite stable (MSS) platinum refractory/ resistant ovarian cancer there was an 80% DCR across all cohorts (1 PR, 3 SD, 1 PD) with a trend for durable responses at higher doses of ENB-003. A platinum refractory MSS ovarian cancer patient experienced a 95% PR of 12-month duration. The sample size was not powered for statistical significance.

"The completion of enrollment of the Phase 1 ENBOLDEN-101 first-in-man study is a significant milestone for our Company. We are extremely encouraged by the results in heavily treated cancer patients refractory to standard of care treatment," stated Sumayah Jamal, MD-PhD, President, Chief Scientific Officer and Co-Founder of ENB Therapeutics. "Our data suggest potential efficacy in patients that do not historically respond to immunotherapy and support further clinical development. We are grateful to our patients and their families for their participation in our study. "

Part 2 is a dose expansion study at the recommended dose designed to evaluate the safety, tolerability and efficacy of ENB-003 in combination with pembrolizumab in cancers refractory to standard of care including MSS R/R ovarian cancer, MSS pancreatic cancer, anti-PD1 refractory HNSCC, anti-PD1 refractory melanoma and anti-PD1 refractory TNBC. For more information on this Phase 1/2a study, see NCT04205227.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ENB-003

ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhances efficacy of CAR-T and anti-PD-1 in solid tumors across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first half of 2024. The trial will enroll microsatellite stable platinum refractory and primary platinum resistant ovarian cancer patients, as well as microsatellite stable pancreatic cancer patients that have failed standard of care.

On July 18, 2023 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported the signing of a supply agreement for the therapeutic medical radioisotope, actinium-225 (Ac-225) with Bayer (Press release, NorthStar Medical Radiostopes, JUL 18, 2023, View Source [SID1234633303]). Under the terms of the agreement, NorthStar will provide Bayer with its environmentally preferred, non-carrier added (n.c.a.) Ac-225. NorthStar’s Ac-225 will be used by Bayer for several of its radiopharmaceutical programs.

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Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells while limiting damage to nearby healthy tissue due to the short range of alpha radiation. NorthStar is positioned to be the first commercial-scale producer of n.c.a. Ac-225 for advancing clinical research and commercial radiopharmaceutical products. The Company will use its environmentally preferred electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.

"We are very pleased to enter this Ac-225 supply agreement with Bayer, a global healthcare leader, and we look forward to working with them moving forward," said Frank Scholz, Ph.D., President and Chief Executive Officer, NorthStar Medical Radioisotopes. "Our companies share a vision of developing and delivering innovative technology and compounds to drive research and ensure clinical availability of targeted radiopharmaceutical therapies for patients with cancer and other serious diseases. As a company at the forefront of U.S. radioisotope production, we are applying our proven accelerator technology expertise with molybdenum-99 (Mo-99) and copper-67 (Cu-67) to rapidly advance large-scale production of n.c.a. Ac-225. The electron accelerator is installed and construction is progressing on schedule on our dedicated, state-of-the-art Actinium-225 Production facility, with initial production of radiochemical grade Ac-225 planned in 2024. NorthStar expects to submit a Drug Master File to the FDA as quickly as possible thereafter, which, upon acceptance by the FDA, will allow it to provide cGMP grade Ac-225."

On July 18, 2023 Therapeutic Solutions International, Inc. (TSOI), reported that its breast cancer focused immuno-oncology subsidiary, Res Nova Bio, Inc., has identified and filed a patent on a novel mechanism of action of its immunotherapy-enhancing product FloraStilbene (Press release, Therapeutics Solutions International, JUL 18, 2023, View Source [SID1234633302]).

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The Company has demonstrated that administration of FloraStilbene, which is a proprietary combination of pterostilbene and the active ingredient in the abortion pill, mifepristone, suppresses loss of T cell activity caused by growing breast cancer. In a series of experiments, it was demonstrated that FloraStilbene stopped degradation of a protein called "T cell receptor zeta chain" which has previously been shown to be inactivated by the enzyme caspase-31. Breast cancer patients with higher levels of T cell receptor zeta chain have been reported to possess superior survival as compared to patients with lower levels2.

"Breast cancer takes an incredible toll on patients, which I have witnessed firsthand," said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor on the patent. "The data presented today, which is the basis for our proposed clinical trial, potentially will help to enhance efficacy of the brand-new type of medicine called ‘immunotherapy’ which to date has resulted in many cures of cancers which were previously considered incurable."

"Therapeutic Solutions International has a long history of advancing the field of cancer immunotherapy, dating back to 2015 when we filed our now issued patent # 9682047 entitled ‘Augmentation of oncology immunotherapies by pterostilbene containing compositions’ which covers the utilization of pterostilbene and various derivatives in increasing the therapeutic index of immunotherapy," said Timothy Dixon, President, and CEO of Therapeutic Solutions International and co-inventor. "I am honored to see the work led by Ms. Ramos which has advanced our science to the point where it is close to initiating clinical trials."

"Immunology has revolutionized cancer therapy. Now that the concept has been established that the immune system can be trained to kill cancer, it is time to optimize the existing medications whether they be proteins, cells, or oncolytic viruses," said Famela Ramos, President and CEO of Res Nova Bio and co-inventor. "Overcoming systemic immune defects induced by the cancer seems to us to be the first step in the optimization of immunotherapy. This is what we are aiming to accomplish in the clinical development of FloraStilbene.

On July 18, 2023 Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, reported that the National Medical Products Administration (NMPA) approved its clinical trial application for the product QN-019a (Press release, Qihan Biotech, JUL 18, 2023, View Source [SID1234633301]). It is the first IND approved in China for a gene-edited iPSC-derived cell therapy product.

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Qihan Biotech utilizes multiplexable genome editing technology to modify human Induced Pluripotent Stem Cells (iPSCs) and differentiate them into natural killer (NK) cell therapy product QN-019a, targeting CD19-positive B-cell lymphoma. The clinical indication for QN-019a is CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. According to the official website of the Center for Drug Evaluation, NMPA, the clinical trial application for QN-019a cell injection has received approval as of July 18, 2023.

"The approval of our application for the clinical trial is a result of our team’s collaborative efforts and also signifies Qihan entering a new phase in its evolution. The IND approval is the first step in a long drug development journey, and we will adhere to scientific rigor and fully use our genome editing technology and in-depth biological knowledge to continue our research," said Dr. Luhan Yang, the founder and CEO of Qihan Biotech. "We look forward to developing Off-the-Shelf cell therapy products with long-term efficacy for patients and realizing the vision of Qihan."