On November 12, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported the poster presentation of preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually (Press release, Rubius Therapeutics, NOV 12, 2021, View Source [SID1234595408]).

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"The preclinical data presented at SITC (Free SITC Whitepaper) indicate that RTX-224 stimulates both adaptive and innate immune responses, leading to an antitumor effect in our surrogate models," said Laurence Turka, M.D., chief scientific officer and head of research & translational medicine of Rubius Therapeutics. "Our preclinical model of RTX-224 demonstrated significant activation of CD4+ T cells, CD8+ T cells, antigen-presenting cells and NK cells as well as potent anti-tumor activity in a melanoma model, giving us confidence that RTX-224 may be an effective treatment for advanced solid tumors. The U.S. FDA recently cleared our Investigational New Drug application for RTX-224, and we expect to begin dosing patients during the first quarter of 2022."

Poster Title: RTX-224, An Engineered Allogeneic Red Cell Therapeutic Expressing 4-1BBL and IL-12, Activates Immune Cells in Blood and Spleen to Promote Tumor Growth Inhibition in Mice

RTX-224 is an allogeneic cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface. RTX-224 is designed as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior responsiveness to checkpoint inhibitors.

Data Summary

The mouse surrogate of RTX-224, mRBC-224, demonstrated potent anti-tumor activity in B16F10 melanoma models, intravenously and subcutaneously, that was associated with pharmacodynamic changes in the tumors, including activated CD8+ T cells, NK cells and macrophages.
mRBC-224 distributed mainly in the spleen of tumor-bearing mice 24 hours after one dose.
mRBC-224 treatment in mice promoted activation of NK cells, CD8+ T cells and monocytes/macrophages in the blood and spleen of naïve and tumor-bearing mice.
RTX‑224 (in vitro) and mRBC‑224 (in vivo) stimulate adaptive (CD8+ T cells and CD4+ T cells) and innate (NK cells and macrophages) immune responses.
The combined enhancement of both adaptive and innate immune responses leads to a productive antitumor response as demonstrated in preclinical studies.

On November 21, 2021 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported updated interim data from the Phase 1 data from RP2 alone and in combination with Opdivo that continues to provide strong support for the next stage development of RP2 (Press release, Replimune, NOV 12, 2021, View Source [SID1234595407]). The poster will be presented November 12-14, 2021 at 7:00 a.m. ET to 5:00 p.m. ET at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held November 10-14, 2021.

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Updated RP2 data shows compelling durability of response as single agent and in combination with Opdivo providing additional evidence of the clinical utility of RP2 in patients with hard-to-treat, anti-PD1 failed cancers.

RP2 leverages Replimune’s platform to express an anti-CTLA-4 antibody, in addition to GALV-GP R- and GM-CSF which is expressed by RP1. The Company has now fully enrolled the 30-patient cohort evaluating RP2 combined with Opdivo following previously completing enrolment of the 9-patient cohort evaluating RP2 as monotherapy. The Phase 1 clinical trial population comprised patients with advanced cancers having failed, or being ineligible for, standard of care options.

The updated interim data shows:

In the nine-patient monotherapy cohort with RP2, two of the initial three patients who achieved response remain in response, these being a patient with esophageal cancer (partial response; previously anti-PDL1 failed) at 22 months from entering the trial and a patient with mucoepidermoid carcinoma (complete response) at 19 months from entering the trial. As previously reported, the third responding patient with uveal melanoma with a partial response (Yervoy/Opdivo failed) progressed at 15 months from entering the trial.
Updated data from the 30-patient cohort of RP2 in combination with Opdivo shows durable responses ongoing at out to >425 days.
To date, seven of the 30 patient (23.3%) cohort of RP2 in combination with Opdivo have achieved partial responses, with additional patients still on study with the opportunity to achieve a response. Six of the seven responses are ongoing with depth of response having been maintained or deepened over time.
The responding patients are four of nine patients with cutaneous melanoma (all anti-PD1 or anti-PD1 and anti-CTLA-4 failed), two of eight patients with uveal melanoma (anti-PD1 or anti-PD1 and anti-CTLA-4 failed) and one of three patients with squamous cell carcinoma of the head and neck (anti-PD1 failed).
Biomarker data continues to demonstrate substantial increases CD8 T cells and PD-L1 expression, with T cell receptor sequencing and Nanostring expression analysis further indicating potent and broad activation of an anti-tumor immune response.
No correlation has been observed between the degree of anti-tumor response and the baseline levels of PD-L1 expression, in line with the intended mechanism of action for RP2 of turning immunologically ‘cold’ tumors ‘hot’.
Overall the data, including the durability of the responses, continues to support that oncolytic immunotherapy-mediated expression of anti-CTLA-4 from RP2 provides potent & systemic anti-tumor effects, without substantial additional toxicity as compared to the oncolytic backbone (RP1), including without evidence of the side effects associated with systemic ipilimumab.
Based on the observation of durable clinical responses in patients with liver metastases following treatment with both RP1 and RP2, the Company has amended the clinical trial protocol to enrol an additional 24 patients with liver metastases from lung cancer, gastrointestinal cancers, breast cancer and uveal melanoma.
Replimune will also be presenting three additional Trial in Progress presentations at this year’s SITC (Free SITC Whitepaper) Annual Meeting

Abstract Title: ARTACUS: An open-label, multicenter, phase 1b/2 study of RP1 in solid organ transplant recipients with advanced cutaneous malignancies (Trial in Progress presentation)
Abstract Number: 550
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E

Abstract Title: CERPASS: A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (Trial in Progress presentation)
Abstract Number: 547
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E

Abstract Title: IGNYTE: An open-label, multicenter, phase 1/2 (Ph 1/2) clinical trial of RP1 ± nivolumab in patients with advanced solid tumors (Trial in Progress presentation)
Abstract Number: 506
Session Date and Time: November 12-14, 2021 from 7:00 AM ET- 5:00 PM ET
Location: Hall E

The full posters will be posted to the presentations section of the Replimune website at View Source

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