On November 12, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that its Board of Directors authorized a share repurchase program of up to $3 billion of the Company’s outstanding common stock (Press release, Regeneron, NOV 12, 2021, View Source [SID1234595406]).

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"With the strength of our balance sheet and our business, we see this as an opportunity to continue to invest in Regeneron," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "This share repurchase program is part of our broader capital allocation strategy to maximize shareholder value for years to come."

Repurchases may be made from time to time at management’s discretion through a variety of methods, such as open-market transactions (including pre-set trading plans), privately negotiated transactions, accelerated share repurchases, and other transactions in accordance with applicable securities laws. The program has no time limit and can be discontinued at any time. No shares have been repurchased under the program to date. There can be no assurance as to the timing or number of shares of any repurchases. As of November 12, 2021, $1.8 million remained available for share repurchases under the prior $1.5 billion share repurchase program authorized in January 2021.

On November 12, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that a poster presentation describing the adaptive Phase 1/2 trial of LYT-200 for the potential treatment of difficult-to-treat solid tumors will be given at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th annual meeting (Press release, PureTech Health, NOV 12, 2021, View Source [SID1234595405]).

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The scientific poster to be presented at SITC (Free SITC Whitepaper) details the Company’s adaptive Phase 1/2 clinical trial of LYT-200, an investigational monoclonal antibody targeting galectin-9, which is an immunosuppressive protein prominently expressed in multiple difficult-to-treat cancers, including, but not limited to, pancreatic cancer, cholangiocarcinoma, and breast cancer. The clinical study includes a dose finding/dose escalation phase (part 1) and an expansion cohort phase (part 2) in patients with relapsed and refractory metastatic solid tumors. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of LYT-200 both as a single agent and in combination with either BeiGene’s tislelizumab or chemotherapy. Topline results from the Phase 1 portion of the study are now expected in the first half of 2022 to allow for continued dose escalation as a maximum tolerated dose has not yet been reached.

"PureTech’s preclinical data package elegantly supports the significance of galectin-9 as a therapeutic target, showing it is a multifaceted immunosuppressor in cancer biology and potential biomarker of prognosis," said Zev Wainberg, M.D., Professor of Medicine at UCLA and Co-director of the UCLA GI Oncology Program and the lead primary investigator of the study.

"High galectin-9 levels in patients have been associated with a worse prognosis, and our anti-galectin-9 research candidates outperformed approved immunotherapies in multiple preclinical models of difficult-to-treat cancers, giving us confidence as we moved into the clinical phase to establish key safety and therapeutic parameters and initial insights into efficacy," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech.

Part 1 is a dose-finding study being conducted using a reassessment method to evaluate safety and establish the recommended Phase 2 dose. Two to six patients per treatment cohort are assigned to receive sequentially higher intravenous infusions of LYT-200 every two weeks on day one and day 15 of each 28-day cycle, starting at a dose of 0.2 mg/kg, with escalating dose cohorts up to 16 mg/kg. Part 1 will be completed when six consecutive patients have received the optimal biologic dose and/or the maximal tolerated dose. The study is currently evaluating patients enrolled in the fourth cohort of part 1 at an active dose measuring 6.3 mg/kg. The Phase 2 portion of the study is currently planned to enroll patients with a range of solid tumor types, including pancreatic cancer and other GI solid tumor types.

The U.S. Food and Drug Administration (FDA) recently granted orphan drug designation for LYT-200 for the treatment of pancreatic cancer. The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S. if the drug is approved.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, that are difficult to treat and have poor survival rates. PureTech has presented preclinical data demonstrating high expression of galectin-9 across breast cancer, pancreatic and cholangiocarcinoma samples and found that the highest levels of galectin-9 correlated with shorter time to disease relapse and poor survival. These data suggest that galectin-9 could be significant both as a therapeutic target for a range of cancers and as a cancer biomarker. Preclinical animal and patient-derived organoid tumor models also showed the potential efficacy of LYT-200 and the importance of galectin-9 as a target. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial, and results from the Phase 1 portion of the dose escalation trial are expected in the first half of 2022.

On November 12, 2021 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and nine months ended September 30, 2021 (Press release, ProMIS Neurosciences, NOV 12, 2021, View Source [SID1234595404]).

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"We are pleased to be ramping up our efforts to advance our lead asset, PMN 310, closer toward the clinic," said Gene Williams, ProMIS’ Chairman and CEO. "The financing we secured earlier this year is enabling us to unlock the potential of our platform, which we believe could have significant impact on the treatment of several neurological diseases, including Alzheimer’s Disease (AD), Parkinson’s Disease and ALS. The strengthening of our management team and Board this quarter has also enabled us to leverage worldwide development and patent expertise and strengthen our overall competitive position."

Corporate Highlights

On July 2, 2021, the Company announced the voting results of its annual meeting of shareholders held on June 30, 2021, in Vancouver, British Columbia, Canada. All resolutions described in the Management Proxy Circular and placed before the meeting were approved by the shareholders.
On July 8, 2021, the Company announced that it had filed and obtained a receipt for the Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec.
On August 25, 2021, we announced the closing of a public offering for gross proceeds of US$20,125,000 (CDN$25,522,525).
On October 7, 2021, we announced that we would hold a special general meeting of shareholders (the "Special Meeting") on December 1, 2021. We set October 18, 2021, as the record date for the Special Meeting. The purpose of the Special Meeting is to ask shareholders to grant the Board of Directors the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States.
People

On September 1, 2021, the Company appointed Josh Mandel-Brehm to the board of directors. Mr. Mandel-Brehm has held various key business development and operations leadership roles at leading biotechnology companies.
On September 23, 2021, the Company appointed Maggie Shafmaster, JD, PhD, to the board of directors. Dr Shafmaster has approximately 30 years of experience providing intellectual property advice to biotechnology and pharmaceutical industries.
On October 22, 2021, the Company announced the expansion of its senior management team. The following changes were announced:

Eugene Williams, formerly Executive Chairman, takes on the role of Chairman and Chief Executive Officer ("CEO"), with immediate effect.
Dr. Elliot Goldstein resigned from his current role as CEO with immediate effect and continues to support us as President and special consultant to the CEO.
Gavin Malenfant joins our senior management team as Chief Operating Officer. Mr. Malenfant brings more than 30 years of biopharmaceutical experience to our team, with special focus on providing expert management and oversight of drug development programs. The top priority in the near term will be to support the timely development of the PMN310 program to completion of IND enabling activities, anticipated in the second half of 2022. He will be working with Mr. Williams and the leadership of the PMN310 project team, whose key members include:
Michael Grundman, MD, Senior Medical Adviser. Prior to joining the pharmaceutical industry, Dr. Grundman was Associate Director of the Alzheimer’s Disease Cooperative Study at the University of California, San Diego ("UCSD") and is currently an Adjunct Professor of Neurosciences at UCSD. Dr. Grundman previously served on the FDA Peripheral and Central Nervous System Advisory Committee.
Ernest Bush, PhD, Head of Pharmacology/Toxicology. Dr. Bush has 35 years of experience working in the field of biomedical research and development, driving development of innovative therapies for treatment of human diseases. He has served as a consultant in non-clinical development providing advice and insight into Investigational New Drug ("IND") enabling programs, pre-clinical data-set analysis for due diligence and evaluation and audits of Good Laboratory Practices ("GLP") bioanalytical and toxicology facilities and studies.
Dennis Chen, PhD, Head of Manufacturing. Dennis has more than 25 years of prior pharmaceutical experience in working with companies from virtual to global and all phases of development. Dennis provides Regulatory Affairs, Chemistry, Chemistry, Manufacturing and Controls ("CMC") and Biopharmaceutical Development support to ProMIS with expertise in peptides, proteins and oligonucleotides.
Financial Results

Results of Operations – Three months ended September 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020

On November 12, 2021 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that new study data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Phio Pharmaceuticals, NOV 12, 2021, View Source [SID1234595403]). The data from this study in an in vivo hepatocarcinoma model shows that PH-762 administered locally clears untreated distal tumors, indicating a systemic immune response.

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"We are very excited with this new data on PH-762, our lead product candidate," said Dr. Simon Fricker, Phio’s VP of Research & Development. "These new results, along with a growing body of mechanistic data collected thus far, provide a compelling argument for the clinical potential of PH-762. It furthermore continues to show the potential of our INTASYL platform in various applications, including direct therapeutic use."

The Company has previously presented data showing that local administration of PH-762, our PD-1 targeting INTASYL compound, produces a robust silencing of PD-1 and changes in the tumor microenvironment associated with anti-tumor activity. In this new study, tumors were implanted in mice and treated locally with PH-762. In addition, to determine an abscopal effect or systemic immune response, tumors were also implanted on the opposite side of the original tumor and left untreated. Results showed that PH-762 significantly inhibited growth of treated tumors, but furthermore, the growth of the untreated tumor was also significantly reduced, resulting in 80% of these untreated tumors becoming completely cured. These data indicate that local treatment with PH-762 provides a robust anti-tumor efficacy to both locally treated tumors and to untreated distal tumors, suggesting an abscopal effect, due to a systemic immune response. As such, the results indicate that INTASYL therapeutic use can represent an alternative to systemic antibody checkpoint therapy with potential for improved efficacy and reduced systemic toxicity. This systemic anti-tumor response toward distant tumors and metastases will be investigated in our upcoming Phase 1 clinical trial for locally administered PH-762 in patients with melanoma.

Phio’s presentation detailing the data presented at SITC (Free SITC Whitepaper) titled, "Locally administered immunotherapy self-delivering RNAi PH-762 results in abscopal clearance of untreated distal tumors, suggesting systemic immune response, in a murine hepatocarcinoma model" will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here).

On November 12, 2021 Nimbus Therapeutics, a biotechnology company designing and developing breakthrough medicines through structure-based drug discovery, reported the first patient dosed in the first-in-human Phase 1/2 study of their small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, NDI-101150 (Press release, Nimbus Therapeutics, NOV 12, 2021, View Source [SID1234595402]). HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, making it a high-priority target in immuno-oncology.

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"We are proud to expand our clinical development program with the initiation of this first-in-human trial. The preclinical evidence we’ve seen for our HPK1 inhibitors to date, including in vivo data shared at the 2021 AACR (Free AACR Whitepaper) Annual Meeting, has shown significant tumor growth inhibition, both as a single agent and in combination with anti-PD1, and robust and durable effects on immune memory," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "New approaches to expand the promise of immuno-oncology to solid tumors are greatly needed and we’re eager to explore the potential of NDI-101150 to help address this unmet need."

The Phase 1/2 trial is a multicenter, open-label study that will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. It is planned to enroll approximately 106 subjects.

"HPK1 is an important therapeutic target in immuno-oncology because of its role in multiple adaptive immune system components, including T cell, B cell and dendritic cell-mediated immune responses. We are pleased to have progressed a highly-selective HPK1 inhibitor into the clinic," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "Development of this agent was made possible by Nimbus’ computational drug discovery approach, which continues to provide opportunities to develop new medicines in diseases with high unmet medical need."