On September 13, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported the appointment of Norman LaFrance, M.D. to the position of Chief Medical Officer and Senior Vice President (Press release, Cytori Therapeutics, SEP 13, 2021, View Source [SID1234587617]).

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"We are delighted to have Dr. LaFrance onboard as he brings several decades of highly relevant clinical, regulatory and commercial expertise to the Plus Therapeutics management team," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "His proven track record in radiotherapeutics and drug development coupled with his commercial experience will be invaluable as we expand our pipeline, move key programs to late stage clinical development and best position the company for long-term regulatory and commercial success."

Dr. LaFrance’s appointment begins on or around December 8, 2021 and he joins the Company with nearly 40 years of experience as a nuclear medicine physician and as an executive in the pharmaceutical and healthcare industries. Dr. LaFrance has a particular expertise in radiotherapeutic drug research and development as well as commercialization of molecular imaging, diagnostic and therapeutic products. He was most recently Chief Medical Officer, Senior Vice President, at Jubilant Pharma Ltd, responsible for all Pharma Medical & Regulatory Affairs activities.

"I am excited to join a company which reflects my passion to make an impact on patients with significant unmet medical needs," said Norman LaFrance, M.D. "From an industry perspective, it is clear that Plus Therapeutics’ focus on radiotherapeutics positions it firmly for long-term growth, and I am excited to lead development and expansion of its promising pipeline."

Prior to Jubilant Pharma, Ltd., Dr. LaFrance served as Global Chief Medical Officer at IBA Molecular from 2010 to 2012, and as Senior Vice President, Clinical Development and Chief Medical Officer at Molecular Insight Pharmaceuticals from 2007 to 2010. Prior to industry, Dr. LaFrance practiced medicine and held academic faculty appointments at Johns Hopkins University School of Medicine in the departments of medicine and radiology and the Department of Radiological Sciences in the John Hopkins School of Hygiene and Public Health. He is Double Board Certified with Fellowship status both in internal medicine and nuclear medicine, maintains active medical licensure in the U.S. along with active, professional society membership.

Dr. LaFrance received his bachelor of science and master of engineering degrees in nuclear engineering and science from Rensselaer Polytechnic Institute, and his medical degree from the University of Arizona, College of Medicine, Tucson.

On September 13, 2021 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported that results from patient stratification studies using the Cellworks Computational Omics Biology Model (CBM) and Biosimulation Platform to predict drug and immunotherapy responses within non-small cell lung cancer (NSCLC) patient tumors will be featured in four poster presentations at the IASLC 2021 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and held virtually September 8-14, 2021 (Press release, Cellworks, SEP 13, 2021, View Source [SID1234587632]).

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The studies address the need for a personalized treatment approach that matches NSCLC patients with appropriate chemotherapy or immunotherapy using Cellworks Personalized Therapy Biosimulation. Personalized therapy biosimulation begins by optimizing the uniqueness of each patient’s cancer by utilizing their multiomic data to create a patient-specific protein network map or ‘personalized disease model’ using Cellworks proprietary Computational Omics Biology Model (CBM). The Cellworks Personalized Therapy Biosimulation Platform uses the personalized disease model to identify disease-biomarkers unique to each patient and biosimulate the therapy regimens to get drug response on patients.

Poster Presentations

Featured Poster Presentation FP16.05 – Computational Omics Biology Model (CBM) Identifies Novel Biomarkers to Inform Combination Platinum Compound Therapy in NSCLC.

Poster Presentation P70.20 – Impact of KRAS and Co-Occuring Mutations of NSCLC Master Regulator Network as Determined by Computational Omics Biology Model.

Poster Presentation P70.03 – Computational Omics Biology Model (CBM) Identifies Amplifications of Chromosome 6p to Predict Chemotherapy Response.

Poster Presentation P12.06 – Computational Omics Biology Model (CBM) Identifies PD-L1 Immunotherapy Response Criteria Based on Genomic Signature of NSCLC.

"Often single biomarker based approaches do not capture the true biological complexity of a NSCLC patient’s cancer and have limitations in their ability to predict clinical benefit and duration of response with treatments," said Dr. Vamsidhar Velcheti, Associate Professor, Department of Medicine at NYU Grossman School of Medicine; Director, Thoracic Medical Oncology Program; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "Study results show that biosimulation using the Cellworks CBM can identify novel biomarkers in NSCLC patients and inform the optimal drug combination for platinum-based therapies, which are used to treat a variety of malignancies including lung cancer. In another study, Cellworks biosimulation identified a unique chromosomal signature which permits a stratification of NSCLC patients that are most likely to not respond to gemcitabine and platinum treatments even though they have key response criteria. These important studies show how the Cellworks Biosimulation Platform can advance Personalized Oncology for NSCLC patients."

"In NSCLC patients, expression of the PD-L1 immune protein is used to predict the outcome of targeted treatment," said Dr. Apar Kishor Ganti, Professor in the Department of Internal Medicine, Division of Oncology/Hematology, at the University of Nebraska Medical Center; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "However clinical benefits of using PD-L1 to predict patient outcomes do not occur uniformly. In our study, biosimulation using the Cellworks CBM captured a holistic picture of the tumor microenvironment using tumor omics – revealing that alterations of the adenosine and STING pathways play key roles in determining benefit from PD-1/L1 targeting. Study results show that the Cellworks Biosimluation Platform can improve therapy response predictions for NSCLC patients beyond PD-L1 testing and improve outcome in specific patients."

"KRAS is a frequent oncogenic driver in NSCLC, but co-occurrence of other mutations alters the signaling pathways and the key transcription factors involved in the disease network," said Dr. Vamsidhar Velcheti, Associate Professor, Department of Medicine at NYU Grossman School of Medicine; Director, Thoracic Medical Oncology Program; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "Biosimulation using the Cellworks CBM identified the key transcriptional mediators and kinase of KRAS mutations and how they are shuffled by the presence of co-mutations in other common oncogenes. Study results show that Cellworks Biosimulation Platform can be used to identify the regulatory network in the cancer, which lays the foundation for new therapeutic strategies targeting key master regulators."

On September 13, 2021 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright 23rd Annual Global Investment Virtual Conference on September 13-15, 2021 (Press release, Palatin Technologies, SEP 13, 2021, View Source [SID1234587647]).

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On September 13, 2021 Alkermes plc (Nasdaq: ALKS) reported two poster presentations related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place Sept. 16-21, 2021 (Press release, Alkermes, SEP 13, 2021, View Source [SID1234587585]). The presentations will include a trial-in-progress poster for ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy, with or without anti-CTLA-4 therapy, and a poster showing data from a preclinical study that evaluated the anti-tumor efficacy of a mouse ortholog of nemvaleukin as monotherapy and in combination with chemotherapy in a murine model of small cell lung cancer.

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"We’re pleased to share updates from the nemvaleukin development program with the scientific and medical community at ESMO (Free ESMO Whitepaper). This year’s posters include information on our ongoing ARTISTRY-6 clinical trial in melanoma, which is designed to support potential registration in mucosal melanoma, and data from a preclinical study that investigated the potential of nemvaleukin in combination with chemotherapy," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We look forward to continuing to explore nemvaleukin’s potential as a novel, differentiated therapy for patients with high unmet need across a wide array of tumor types."

Details of the presentations are as follows:

Abstract: 834
Title: ARTISTRY-6: Nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma
Presenter: Richard D. Carvajal, M.D., Director of Experimental Therapeutics and Director of the Melanoma Service at Columbia University Medical Center
Presentation Date: The poster presentation will be available on demand to attendees beginning Sept. 16, 2021.

Abstract: 3326
Title: Anti-tumor efficacy and immune profiling of the mouse ortholog of nemvaleukin alfa, a novel engineered IL-2 fusion protein, in an orthotopic mouse model of small cell lung cancer alone or in combination with standard chemotherapy
Presenter: Yuanwang Pan, Ph.D., Postdoctoral Fellow, Immuno-Oncology, Laura and Isaac Perlmutter Cancer Center, New York University Grossman School of Medicine, NYU Langone Health
Presentation Date: The poster presentation will be available on demand to attendees beginning Sept. 16, 2021.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

On September 13, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, reported that Valneva SE has received a termination notice from the United Kingdom Government in relation to Valneva’s supply agreement for its COVID-19 vaccine candidate, VLA2001 (Press release, Dynavax Technologies, SEP 13, 2021, View Source [SID1234587600]). Valneva stated that they intend to continue clinical development of VLA2001 and the pivotal Phase 3 trial for VLA2001, Cov-Compare, remains ongoing at Public Health England. Based on its portfolio of COVID-19 collaborations Dynavax reiterates its belief that its CpG 1018 supply contracts continue to represent an approximately $300 – $400 million dollars aggregate revenue opportunity in 2021.

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Valneva recently announced that its Phase 3 results for VLA2001 are expected to be available early in the fourth quarter of 2021 and these results are expected to form part of Valneva’s planned rolling submission for conditional approval of VLA2001 with the UK’s Medicines and Healthcare products Regulatory Agency ("MHRA"). Subject to these data and MHRA approval, Valneva has indicated that it believes initial approval for VLA2001 could be granted in late 2021.

Ryan Spencer, Chief Executive Officer of Dynavax commented, "Valneva is one of a number of companies developing COVID vaccines using CpG 1018 as an adjuvant and we continue to look forward to the upcoming Phase 3 clinical trial results for Valneva’s inactivated COVID-19 vaccine adjuvanted with CpG 1018. The first COVID-19 vaccine that uses CpG 1018 was recently authorized by regulatory authorities and we look forward to the potential authorization of additional Dynavax-enabled COVID-19 vaccines in the months and quarters ahead."

Under Dynavax’s existing supply agreement for CpG 1018, purchase orders submitted by Valneva are cancellable if the UK Government reduces or terminates its order for VLA2001, in which case, Valneva would not be obligated to pay Dynavax the final portion of an outstanding purchase order. Valneva has not yet cancelled any outstanding purchase orders for CpG 1018. Dynavax has the right to retain any portion of the purchase price for CpG 1018 made in advance by Valneva as well as any CpG 1018 manufactured but not yet delivered.

Dynavax intends to continue to monitor the situation but can make no assurances regarding the outstanding orders. If Valneva’s existing purchase orders are cancelled, Dynavax will work to reallocate CpG 1018 inventory to its other COVID-19 collaborators. Dynavax’s revenue opportunity associated with its CpG 1018 commercial supply agreements in 2021, as well as its corresponding profit margin, are contingent on many variables including continued success of each of Dynavax’s partners’ programs and timing of product delivery.

About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.