On February 8, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company will host a virtual R&D Day at 10:00 am – 1:30 pm ET / 7:00 – 10:30 am PT on Wednesday, February 22, 2023 (Press release, Poseida Therapeutics, FEB 8, 2023, View Source [SID1234626978]).

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Poseida’s third-annual R&D Day will feature its executive leadership and scientists for a morning of presentations and fireside chats with special guest speakers exploring the future of cell and gene therapy. The program will highlight the Company’s proprietary genetic engineering platform technologies, differentiated allogeneic CAR-T programs, and novel approaches to gene therapy as well as ongoing collaborations with Roche and Takeda.

External speakers will include George M. Church, Ph.D., a pioneer in the fields of genetics and synthetic biology and Chair of Poseida’s Gene Therapy Scientific Advisory Board; Madhu Natarajan, Ph.D., Head of the Rare Diseases Drug Discovery Unit at Takeda; and Christine Brown, Ph.D., Professor, City of Hope, a CAR-T cell expert and member of Poseida’s Immuno-Oncology Scientific Advisory Board.

Registration for this virtual event and access to the live webcast will be available on the Investors & Media section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for 90 days following the presentation.

On February 8, 2023 ReviR Therapeutics, a privately held developer of a suite of small molecule RNA-targeting technologies for cancer and other genetically-defined diseases, and Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that they have entered into a research collaboration and option-to-license agreement aimed at discovering and developing innovative treatments for genitourinary (GU) tumors and other related serious diseases, leveraging ReviR’s proprietary RNA-targeted technologies (Press release, Asieris Pharmaceuticals, FEB 8, 2023, View Source [SID1234626977]).

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The collaboration will include multiple oncology targets, with the goal of improving patient outcomes. According to the agreement, Asieris will be utilizing ReviR’s innovative RNA modulation technologies, named BindeR and SpliceR, to identify and develop new therapeutics that target RNA to treat cancer.

ReviR combines computational and high throughput drug discovery technologies with the goal of delivering next generation medicines to patients. Its VoyageR AI platform integrates computational approaches to drug traditionally undruggable RNA targets. Initially, ReviR’s focus is in CNS, oncology, and genetically defined disease indications.

"We are pleased to be collaborating with ReviR, an innovative biopharmaceutical company focused on the development of RNA-targeting small molecule therapies,” said Alice Chen, Ph.D., Vice President, Discovery Biology and Head of Translational Research, at Asieris. "We believe that our in-house R&D expertise on small molecule oncology drug discovery, combined with ReviR’s proprietary RNA-targeted technologies, will speed the benefit to patients. We will continue to adhere to our differentiated R&D strategy, focus on genitourinary tumors and related diseases, expand global reach of our innovation to deliver novel drug products for patients in China and globally."

"Asieris is a global biopharma company specialized in the development of GU oncology therapies, and we are excited to be working with them to discover new treatments for indications of interests," stated Paul August, Ph.D., Chief Scientific Officer of ReviR Therapeutics. "Our BindeR and SpliceR platform technologies have the potential to advance therapeutics for undruggable cancer targets, and we believe this collaboration will accelerate the discovery of new treatments for patients."

"The cooperation with Asieris will provide ReviR with access to the specialized knowledge, and specialized resources to validate the effectiveness of our RNA targeted small molecule platforms." said Peng Yue, Ph.D., CEO of ReviR Therapeutics. "Importantly such a collaboration will enable us to partake in synergistic endeavors with a highly proficient team of seasoned experts at Asieris, which would undoubtedly lead to novel discoveries and breakthroughs in the small molecule, RNA targeting field. As the first of many partnerships to come for ReviR, we believe that collaboration will greatly augment our efforts to enhance patient outcomes and further the field of cancer research."

On February 8, 2023 ImmVira’s first intratumoral injected OV product MVR-T3011 IT has shown positive efficacy in the course of clinical studies in the U.S. and China as of January 2023, with which the monotherapy treatment significantly prolonged PFS to a median of 12.9 months among melanoma patients who had failed previous immune-oncology treatment. Currently, late-stage melanoma faces poor prognosis (Press release, Immvira, FEB 8, 2023, View Source [SID1234626975]). Clinical studies have found that median PFS of only 1.7 months for stage IV patients, second-line mono immunotherapy achieved median PFS of 2.8 and 3.6 months, combination therapy of PD-1 Ab and VEGF inhibitor achieved median PFS of 4.2 months.

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This Phase II clinical study commenced in mid-2021 in the U.S. and China. 19 patients with advanced melanoma who had failed prior PD-1 or PD-1/CTLA-4 combination treatment received MVR-T3011 IT monotherapy, and nearly 90% of subjects had distant metastasis and over 50% of subjects had baseline target lesion diameters that added up to more than five centimeters. After receiving local monotherapy of MVR-T3011 IT, the confirmed ORR and DCR (including low dosage cohorts in dose-escalation stage) was 21.1% (4/19) and 47.4% (9/19), respectively. Median PFS was 12.9 months, and 12-month PFS rate was 51.5%. Median PFS significantly increased, also showing MVR-T3011 IT’s potential in reversing resistance of immune checkpoint inhibitors.

In the clinical studies KEYNOTE-151 and POLARIS-01, the ORR of PD-1 Ab (pembrolizumab/ toripalimab) in Chinese subjects with advanced melanoma treated with second-line monotherapy was 17.6% and 17.3%, respectively, with the median PFS of 2.8 months and 3.6 months, respectively. In LEAP-004, a Phase II study of second-line subjects with recurrent or metastatic melanoma who had failed prior PD-1 or PD-1/CTLA-4 treatment, the combination of VEGF inhibitor (lemvastinib) and PD-1 Ab (pembrolizumab) had an ORR of 21% and a median PFS of 4.2 months. Compare with the clinical studies in patients at a similar stage, the efficacy of MVT-T3011 IT monotherapy topical administration demonstrated encouraging results.

The inspiring efficacy results of MVR-T3011 IT monotherapy on melanoma clinically validated the unique design of packaging PD-1 Ab and IL-12 into the product, and it also enhanced our confidence in the combination treatment clinical trials with Roche’s MEK inhibitor Cobimetinib in melanoma in the United States.

About Melanoma

Melanoma is an aggressive and fatal form of skin cancer that results from the malignant transformation of melanocytes in the basal layer of the skin epidermis. Clinical studies have found that the median progression-free survival (PFS) is only 1.7 months for stage IV patients. In advanced melanoma cases that have metastasized, the one-year survival rate drops to 35% to 62%.

About MVR-T3011

MVR-T3011, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.

On February 8, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the SVB Securities 2023 Global Biopharma Conference on Tuesday, February 14, 2023 at 2:20 p.m. EST / 20:20 CET (Press release, Affimed, FEB 8, 2023, View Source [SID1234626974]).

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A live webcast of the presentation will be accessible on Affimed’s website at View Source
A replay of the call will be archived on Affimed’s website for 30 days after the call.

For more information on the conference or to schedule a one-on-one meeting with Affimed management, please contact your conference representative or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

On February 8, 2023 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, aTyr Pharma, FEB 8, 2023, View Source [SID1234626973]). In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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RBC Capital Markets is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

aTyr intends to use the net proceeds from the offering primarily for general corporate purposes, including the ongoing development of efzofitimod and the expansion of its clinical development program to include a planned Phase 2 study of efzofitimod in patients with systemic sclerosis (SSc, or scleroderma)-associated interstitial lung disease (SSc-ILD), in 2023, based on recent clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration, and for working capital.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by aTyr that was declared effective by the Securities and Exchange Commission ("SEC") on April 8, 2022. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]; or H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone at (212) 856-5711 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.