Scandion Oncology initiates part 3 of the CORIST phase II trial

On October 10, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it has as planned initiated part 3 of the CORIST phase II trial studying Scandion’s lead compound SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC) (Press release, Scandion Oncology, OCT 10, 2022, View Source,c3645573 [SID1234621863]). The first of up to 36 patients has been enrolled as the development of SCO-101 seamlessly continues with the momentum from the ongoing part 2 of the trial maintained.

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CORIST part 3 expands the development program to best exploit SCO-101’s potential in mCRC, adding a new schedule for combining SCO-101 and chemotherapy (FOLFIRI), which will be evaluated in patients with both RAS wild-type and RAS mutated tumors. Part 2 of the trial only includes patients with RAS wild-type tumors.

The new optimized dosing schedule for CORIST part 3 is based on evidence about safety and pharmacokinetics gathered so far from part 2 of the trial. This schedule is expected to provide a potentially improved modality for combining SCO-101 and FOLFIRI.

"We are pleased to initiate part 3 of CORIST in accordance with our plans and communicated timeline. SCO-101 has potential to improve treatment options in mCRC and we are excited to continue the work to best harness this potential to the benefits of patients, health care professionals and Scandion", says Johnny Stilou, acting Chief Executive Officer of Scandion.

New administration schedule

CORIST part 3 will evaluate the safety and tolerability of SCO-101 in combination with FOLFIRI when administered once daily on day 1 to day 6 and FOLFIRI administered on day 2 to day 4 of each treatment cycle. Based on pharmacokinetics and pharmacodynamics data this new schedule is expected to be better both in term of efficacy and tolerability.

CORIST part 3 is planned to include up to 36 patients, however the number of patients will vary according to the observed tolerance. Topline results from CORIST part 3 are currently expected in the third quarter of 2023, but timelines may change depending on number of patients enrolled.

Following completion of part 3, Scandion expects to expand the CORIST trial with a part 4. Here, up to 24 patients will be enrolled to assess the preliminary activity of SCO-101 in combination with FOLFIRI administered at the optimal dose found in part 3. After completion of part 4, the overall study results will be analyzed to choose the best schedule and the appropriate patient population for further development of SCO-101 in mCRC.

Kineta Announces Participation in Upcoming October 2022 Investor Conferences

On October 10, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that the Company’s management team will participate in the following investor conferences in October 2022 (Press release, Kineta, OCT 10, 2022, View Source;utm_medium=rss&utm_campaign=kineta-announces-participation-in-upcoming-october-2022-investor-conferences [SID1234621862]):

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Needham Virtual Biotech Private Company 1×1 Forum
Format: Virtual one-on-one meetings
Date: October 19-20, 2022

Opal Group Family Office & Private Wealth Management Forum West
Format: Live Presentation
Presentation Title: Building Next-Generation Immunotherapies and Investor Value
Date/Time: October 19, 2022 at 11:20-11:40 A.M. Pacific Time
Location: Napa, California

Jenny Sundqvist new CEO of InDex Pharmaceuticals

On October 10, 2022 InDex Pharmaceuticals Holding AB (publ) reported that the Board of Directors has named Jenny Sundqvist as new CEO (Press release, InDex Pharmaceuticals, OCT 10, 2022, View Source [SID1234621861]). Jenny comes from a position as Chief Commercial Officer at Isofol Medical AB and has broad experience from leading positions within the pharmaceutical industry. Johan Giléus, who has been acting CEO since April 2022, will continue as CFO in the company.

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"We are very pleased to welcome Jenny Sundqvist as the new CEO of InDex Pharmaceuticals. Jenny’s knowledge and experience in pharmaceutical development and business management will be of great benefit for further development of the company, and I also want to take the opportunity to thank Johan for his appreciated and valuable contributions to the company as acting CEO," said Wenche Rolfsen, Chairman of InDex Pharmaceuticals.

Jenny Sundqvist has an impressive track record of developing companies and creating value. She has broad experience in leading successful research organizations in combination with commercial experience in marketing of approved medications. Jenny has previously, among other things, worked as Chief Commercial Officer at Isofol Medical AB, been responsible for AstraZeneca’s global research portfolio in oncology, worked as Site Director for AstraZeneca’s research unit in Gothenburg and been global brand manager for AstraZeneca’s asthma product Symbicort.

"I am very grateful to have been entrusted by the Board of Directors to lead InDex on this exciting journey of taking cobitolimod through phase III and towards the market. I look forward to working with the Board of Directors and the competent employees at InDex with the goal of improving the quality of life for patients while building value for the shareholders," said Jenny Sundqvist.

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 13:30 CET on October 10, 2022.

ITI Announces Presentation on Nucleic Acid-Based UNITE® Vaccine Platform at Vaccines Summit 2022

On October 10, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that it will present at the Vaccines Summit 2022 at the Sheraton Reston Hotel in Reston, VA on October 11-13 (Press release, Immunomic Therapeutics, OCT 10, 2022, View Source [SID1234621860]). Associate Director, Vaccine Discovery, Wei Shen, Ph.D., will present a talk entitled, "Nucleic Acid-Based UNITE Vaccine Platform Provides Novel Treatment Options for Unmet Medical Needs in Oncology, Allergy and Infectious Diseases," at 2:00PM EDT on October 13, 2022.

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Presentation details are as follows:

Presenter: Dr. Wei Shen, Ph.D.
Title: Nucleic Acid-Based UNITE Vaccine Platform Provides Novel Treatment Options for Unmet Medical Needs in Oncology, Allergy and Infectious Diseases
Date and Time: Thursday, October 13, 2022, 2:00PM EDT
Where: Room A

About UNITE
ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

IconOVir Bio Appoints Julia Maltzman, M.D., as Chief Medical Officer

On October 10, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported the appointment of Julia (Julie) Maltzman, M.D., as its Chief Medical Officer (Press release, IconOVir Bio, OCT 10, 2022, View Source [SID1234621859]). Dr. Maltzman brings over three decades of experience as a distinguished medical oncologist with deep scientific and clinical knowledge of drug development in the oncology space and significant leadership experience overseeing all aspects of clinical, medical and regulatory affairs. At IconOVir, Dr. Maltzman will lead all activities associated with the clinical development of the IconOVir’s emerging OV-based therapeutic pipeline, including clinical development, clinical operations, medical affairs and pharmacovigilance activities.

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"We are thrilled to welcome Julie to our team as we prepare to advance ICVB-1042, our lead product candidate, into first-in-human Phase 1 studies next year," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. "Julie is an accomplished leader in oncology drug development, and we believe that her extensive clinical experience, coupled with her background as a medical oncologist, will be instrumental in our efforts to unlock the full potential of ICVB-1042, while also supporting the growth of our broader OV-based therapeutic pipeline. We look forward to benefiting from Julie’s leadership as we finalize the design of our Phase 1 trials, continue preparations to become a clinical-stage biopharmaceutical company and advance our mission to cure cancer and restore life to every patient, everywhere."

Dr. Maltzman joins IconOVir from Genentech, where she most recently served as Franchise Head, Vice President and Global Head of Gastrointestinal (GI) and Cancer Immunotherapy. In this role, Dr. Maltzman provided enterprise-level strategic and operational development leadership for late-stage GI and cancer immuno-oncology combinations across all tumor types worldwide. Prior to joining Genentech, she was a Vice President of Clinical Development at Nektar Therapeutics, where she led clinical development and pharmacovigilance, setting strategy and direction for several clinical development teams in oncology. Before that, Dr. Maltzman held positions of increasing responsibility at Gilead Sciences, Morphotek, Inc. and Glaxo Smith Kline, in addition to holding a faculty appointment at the University of Pennsylvania. Dr. Maltzman received her B.A and M.D. from the University of Colorado. She completed her internship and residency in internal medicine at the University of Chicago Hospital, and her fellowship in hematology/oncology at the Hospital of the University of Pennsylvania.

"It is an honor to join IconOVir at such a pivotal time in its growth as it prepares to initiate Phase 1 clinical trials evaluating ICVB-1042 in patients with solid tumors," said Dr. Maltzman. "IconOVir’s unique modular approach to developing the next generation of OV therapy has the potential to transform the landscape of cancer therapy and the lives of countless patients currently suffering from these diseases. I look forward to bringing my experience as a medical oncologist and drug developer to IconOVir and supporting the expansion and acceleration of IconOVir’s pipeline to bring novel therapies to the patients that inspire our work."