On May 17, 2022 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, co-founder and chairman of the executive board, and Bart Van Rhijn, chief financial officer, will participate in the Jefferies Healthcare Conference in June 2022 (Press release, Nanobiotix, MAY 17, 2022, View Source [SID1234614741]).

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Event Details:

Jefferies Healthcare Conference

Presentation Date: Wednesday, June 8th, 2022
Time: 1:00 PM ET
A live webcast of the presentation will be available on the events page of the Investors section of the Company’s website. A replay will be available on the Nanobiotix website within 48 hours of the event. The Company’s corporate presentation can be downloaded here.

On May 17, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported the appointment of Janice Lu, M.D., Ph.D., as Chief Medical Officer of Ambrx (Press release, Ambrx, MAY 17, 2022, View Source [SID1234614758]). Dr. Lu is a distinguished clinical professor of medicine who has more than 18 years of experience in leading clinical trials and breast cancer drug development.

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"I am delighted to welcome Janice Lu to the Ambrx team and look forward to leveraging her insight in breast oncology to continue to progress ARX788 through the clinic," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "Janice has been a valuable asset as a principal investigator for multiple Ambrx trials, including the Phase 1 ACE-Pan Tumor-01 and Phase 2 ACE-Breast-03 clinical trials, and is the ideal candidate to take the role of CMO at our company. I look forward to leaning on Janice’s expertise to further our current research and development efforts in the treatment of oncology."

"I am impressed with the encouraging data from the ongoing clinical trials of ARX788 and Ambrx’s engineered precision biologics technology platform," said Dr. Lu. "I am excited to begin working with Ambrx in this new capacity, assisting with the ongoing development of their clinical development pipeline and overseeing the clinical operations. I believe our consorted efforts will potentially provide therapeutic treatment options that are less toxic and highly targeted to patients suffering from breast, gastric, and other solid tumors."

Dr. Lu has spent her career focused on managing the treatment of women with breast cancer. Prior to her role at Ambrx, Dr. Lu was a Clinical Professor of Medicine and Medical Director of the Breast Oncology Program at the Keck School of Medicine, University of Southern California Norris Comprehensive Cancer Center. Prior to her role at USC, Dr. Lu was an Associate Professor of Clinical Medicine in the Division of Hematology and Oncology at the University of California, Los Angeles. Dr. Lu, a board certified medical oncologist, began her career at SUNY Stony Brook where she served as the Director of Breast Medical Oncology for several years.

Dr. Lu received a M.D. from Peking University School of Medicine as well as a Ph.D. from Syracuse University focusing on epigenetics under the mentorship of Dr. David Allis (Rockefeller University). Dr. Lu completed her Hematology and Oncology Fellowship at New York University School of Medicine.

On May 17, 2022 Obsidian Therapeutics, Inc., a biotechnology company pioneering engineered cell and gene therapies, reported it will present enhancements to its proprietary cytoDRIVE technology during a poster presentation at the 25th ASGCT (Free ASGCT Whitepaper) Annual Meeting (Press release, Obsidian Therapeutics, MAY 17, 2022, View Source [SID1234614774]). The conference is being hosted in Washington, D.C., and virtually, May 16-19, 2022.

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The data to be presented outline next-generation advancements to Obsidian’s proprietary cytoDRiVE platform technology, which provides a way to precisely control the timing and level of protein function using FDA approved small molecules. Armoring cell therapies with potent cytokines such as IL12 is a promising approach to treating solid tumors, but uncontrolled constitutive expression of these payloads has limited their clinical use due to toxicity. The data to be presented demonstrate that Obsidian’s cytoDRiVE platform enables robust and reversible regulation of multiple cytokines such as IL12, IL23, IL2, and IFNα, potentially enabling their safe use in adoptive cell therapy applications.

"These advances in our regulation platform expand the versatility and breadth of potential applications for the cytoDRiVE technology," commented Jan ter Meulen, M.D., Ph.D., Chief Scientific Officer of Obsidian. "We look forward to continuing to leverage our technology to advance our pipeline of potential therapies designed to expand available treatment options and improve outcomes of patients using enhanced cell therapies, such as engineered tumor infiltrating lymphocytes."

Details of the poster presentation are as follows:

Poster Board Number: W-215
Session Title: Cancer – Immunotherapy, Cancer Vaccines III
Location: Hall D, Walter E. Washington Convention Center 801 Mt Vernon Pl NW Washington, D.C.
Date and Time: May 18, 2022, 5:30 p.m. to 6:30 p.m. ET
Title: Armoring T-cells with regulatable, membrane tethered cytokines using improved drug-responsive domain technology (cytoDRiVE)
Presenter: Dr. Dhruv K. Sethi, Director, Lead, Discovery & DRD Technologies, at Obsidian Therapeutics

Abstract Summary: Cytokines such as IL12 and IFNα have shown great promise in pre-clinical studies when expressed from genetically modified T-cells, however broad use is limited by toxicity from systemic exposure of constitutive expression. If concentration and localization of cytokines and other immunomodulators could be effectively regulated, they would strong candidates for armoring cellular therapies, such as chimeric antigen receptor T cells (CAR-T cells) or tumor infiltrating lymphocytes (TILs). Advancements to the cytoDRiVE platform, based on multimerization of DRDs with homologous or heterologous oligomerization domains to increase their degron effect, enable tight regulation with extremely low cell surface abundance in the absence of drug, and robust induction (10-20 fold) in the presence of drug. Design elements such as membrane-tethering to reduce risk of systemic toxicity and engineering of protease sites for controlled shedding enable fit-for-purpose engineering and potential to regulate multiple cytokines. cytoDRiVE provides full control of the abundance of IL12, IL23, IL2, and IFNα in genetically modified T-cells using a small molecule drug as the on/off switch for precise control of cytokine activity.

On May 17, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company focused on developing first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported the initiation of the Phase 2 portion of its ongoing study of CM24, a first-in-class monoclonal antibody with the potential to treat multiple cancers (Press release, Purple Biotech, MAY 17, 2022, View Source [SID1234614807]). The Phase 2 is an open-label, multicenter study in subjects with metastatic pancreatic cancer (PDAC) to evaluate the safety and tolerability of CM24 in combination with the PD-1 inhibitor Opdivo (nivolumab) and chemotherapy. The primary study endpoint is to evaluate preliminary efficacy in 2nd line PDAC.

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The phase 2 portion of the study (NCT04731467) is being conducted as part of Purple Biotech’s clinical collaboration with Bristol Myers Squibb. The companies together made the determination to prioritize PDAC over non-small cell lung cancer (NSCLC) based on the positive interim data. Accordingly, this decision will allow an increase in the number of subjects that will be participating, and will accelerate this part of the study, and the updated timeline to complete this trial is within 2023.

"Pancreatic ductal adenocarcinoma, or pancreatic cancer, has one of the highest mortality rates of all cancers and affects tens of thousands of patients each year. While progress has been made in understanding and treating pancreatic cancer, more effective treatments are needed. It is exciting to have CM24 and Opdivo showing a confirmed partial response in a patient with pancreatic cancer with an MSS tumor, where other immune checkpoint inhibitors have failed to show response to date. In addition, the safety profile of CM24 in combination with nivolumab and the positive efficacy signals in advanced patients with very poor prognosis in the study are encouraging, and support the advancement of the clinical study in patients with pancreatic cancer," said Erkut Borazanci, MD, Deputy Director Oncology and Clinical Investigator at HonorHealth Research Institute, Scottsdale, AZ.

"We are thrilled at the progress being made to help move this treatment forward in the clinical trial process for the potential benefit of patients with pancreatic cancer," said Gil Efron, President and CFO of Purple Biotech. "We are thankful for our partners at BMS for collaborating with us on this study and their support. Importantly, the decision to prioritize the PDAC study will extend the cash runway of Purple Biotech through the end of 2024," added Efron.

This announcement follows the release of interim safety and efficacy results from the Phase 1b portion of the study of CM24 in combination with Opdvio shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. Information shared demonstrated a favorable safety profile. Six Grade 3 adverse events (AEs) that were unrelated to CM24 or nivolumab and no Grade 4 AEs or deaths were reported. Encouraging signals of efficacy in advanced patients with PDAC were reported (n=8, ORR=12%, DCR=37%), with one confirmed partial response in a patient with metastatic pancreatic cancer, as well as three patients with stable disease, including two patients with pancreatic cancer and one patient with papillary thyroid cancer. All patients but one received two prior lines of treatment for their metastatic disease.

OPDIVO is a trademark of Bristol-Myers Squibb Company.

On May 17, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, reported it has entered into an asset purchase agreement with MannKind Corporation (Nasdaq: MNKD) to sell the V-Go insulin delivery device for $10 million and additional sales-based milestones. Certain inventory and employees are also included under the terms of the agreement (Press release, Zealand Pharmaceuticals, MAY 17, 2022, View Source [SID1234614910]).

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V-Go is a once-daily, wearable, insulin delivery device that helps provide blood sugar control for everyday lifestyles. Designed to be patient-friendly, V-Go is worn like a patch and eliminates the need for taking multiple daily shots.

"This transaction is an important step forward in executing on the strategic refocusing we outlined at the end of March, as we find partners for our commercial and late-stage assets and prioritize the research and development of innovative new peptide therapeutics," said Adam Steensberg, MD, Chief Executive Officer of Zealand Pharma. "We believe MannKind is the right partner to fully leverage the value of V-Go and ensure its continued availability for the patients and prescribers who need it."

"MannKind is committed to bringing innovative solutions to the diabetes patient community to potentially ease daily disease management," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Acquiring V-Go will help us to address an unmet need while strategically leveraging our infrastructure in the diabetes space and positioning MannKind’s endocrine business for additional growth."

The acquisition of V-Go by MannKind is anticipated to close in May 2022, subject to the satisfaction of certain closing conditions.

Today’s news does not impact Zealand Pharma’s Financial Guidance for 2022 as reiterated in the company’s Interim Report for the First Quarter 2022 announced on May 12, 2022.