IMV Inc. to Present at Three Investor Conferences in September

On September 1, 2021 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company pioneering a novel class of immunotherapies against difficult-to-treat cancers, reported that members of IMV’s executive management team will be presenting at three investor conferences in September (Press release, IMV, SEP 1, 2021, View Source [SID1234587091]).

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2021 Virtual Wells Fargo Healthcare Conference

Fireside chat, Thursday, September 9, 2021

9:20 a.m. ET

HC Wainwright 23rd Annual Global Investment Conference

On-demand starting September 13, 2021

7:00 a.m. ET

Cantor Global Healthcare 2021 Conference

Fireside chat, Wednesday, September 29, 2021

11:20 a.m. ET

Webcasts of IMV’s presentations will be accessible in the ‘Events, Webcasts & Presentations’ section of IMV’s website. These webcasts will then be archived following the live presentation and a copy of the presentation will be available at www.imv-inc.com.

Asher Bio Closes $108 Million Series B Financing

On September 1, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the closing of an oversubscribed Series B financing, which raised $108 million (Press release, Asher Biotherapeutics, SEP 1, 2021, View Source [SID1234587090]). The financing was led by Wellington Management Company LLP, and included new investors RA Capital Management, Janus Henderson Investors, Logos Capital, Marshall Wace and Alexandria Venture Investments, and, along with existing investors Third Rock Ventures, Invus, Boxer Capital of Tavistock Group, Mission BioCapital, and other undisclosed institutional investors.

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"We are pleased to announce this Series B financing and we are tremendously grateful to our new and existing investors for their support and commitment to our goal of delivering a new class of biotherapeutics, with superior selectivity and broad applicability across multiple tumor types, as well as infectious and autoimmune diseases," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Since our founding, we have made significant progress validating the modularity and broad applicability of our cis-targeting platform, achieving preclinical proof-of-concept for our first three pipeline programs and building our team into a sustainable organization, with the depth and capabilities to exploit the full potential of our novel immunotherapies. This funding will enable us to accelerate the development of AB248, while continuing to drive our additional programs forward with urgency, as we aim to restore hope, health and happiness in the lives of patients."

Asher Bio aims to advance a portfolio of cis-targeted therapies derived from diverse cytokines and cell-types, each designed to address the challenge of pleiotropy that limits the efficacy and tolerability of many immunotherapies. By engaging two receptors on the same cell for activation, an immunomodulatory receptor for therapeutic action and a specific target receptor for directing the therapy to the desired cell type, Asher Bio’s cis-targeted immunotherapies seek to offer a new level of selectivity, with the potential to deliver superior clinical outcomes and an improved safety profile.

"We are encouraged by Asher Bio’s tremendous progress since launch, including the generation of new preclinical data that further validates the company’s unique cis-targeting approach," said Jeffrey Tong, Ph.D., Partner at Third Rock Ventures. "We believe cis-targeted immunotherapies may be able to overcome the selectivity challenges that prohibited first-generation cytokine immunotherapies from achieving their full therapeutic potential, ultimately providing better outcomes to patients by offering improvements in both efficacy and safety. We are pleased to continue supporting the Asher team as it applies its platform to address some of the most significant unmet needs in oncology, infectious and autoimmune diseases."

Proceeds from this financing will enable Asher Bio to fund its lead cis-targeted immunotherapy, AB248, through clinical proof-of-concept, while advancing a second program through investigational new drug (IND)-enabling studies and continuing to invest in its cis-targeting platform. Asher Bio expects to file an IND application for AB248 with the U.S. Food and Drug Administration in the third quarter of 2022. AB248 is an engineered interleukin-2 (IL-2) immunotherapy designed to specifically target CD8+ effector T cells. In preclinical and IND-enabling studies, AB248 has evidenced a highly differentiated profile, selectively expanding CD8+ T-cells, while avoiding immune cell subtypes associated with toxicities and immunosuppressive effects, resulting in enhanced anti-tumor efficacy and improved tolerability. The Series B funding will also support Asher Bio’s development of additional targeted immunotherapies, including a CD8+ T‑cell cis-targeted STAT3 cytokine and a CAR-T cis-targeted IL-2, both of which have demonstrated preclinical proof-of-concept.

"We designed our cis-targeting platform to leverage a systematic, modular process, which can be applied across an array of immunomodulatory molecules and cell types," said Ivana Djuretic, Ph.D., Co-Founder and Chief Scientific Officer of Asher Bio. "This enables us to continuously apply learnings from our research and development efforts across our earlier-stage portfolio, rapidly creating and de-risking additional programs. With this financing, we will be able to invest more aggressively in our next wave of novel therapeutic candidates, accelerating not only the development of AB248, but the advancement of our second program through IND-enabling studies."

ZepzelcaTM (lurbinectedin) approved in United Arab Emirates (UAE) for the treatment of metastatic Small Cell Lung Cancer (SCLC)

On September 1, 2021 Immedica Pharma AB reported that the United Arab Emirates Ministry of Health and Prevention has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, SEP 1, 2021, View Source [SID1234587088]).

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"Small cell lung cancer is a disease with limited treatment options. The approval of Zepzelca in United Arab Emirates represents an important treatment option for patients whose metastatic SCLC has progressed after traditional chemotherapy such as platinum-based therapy," said Anders Edvell, CEO at Immedica Pharma.

Immedica has a strategic alliance/partnership with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.

Ashraf Attia, Regional Director in the Middle East at Immedica said: "Today’s announcement marks a significant milestone for Immedica’ s ambition to expand our presence in oncology in the Middle East region."

The approval of Zepzelca by United Arab Emirates Ministry of Health and Prevention is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.

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ImmunityBio Announces Oral Presentation of Phase 2/3 Clinical Trial Results of Patients with BCG-Unresponsive Bladder Cancer Carcinoma at the Upcoming American Urological Association’s Annual Meeting

On September 1, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported Karim Chamie, M.D., Associate Professor of Urology, UCLA Department of Urology, will be presenting the Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer at the American Urological Association’s Annual Meeting on Sept. 10th (Press release, ImmunityBio, SEP 1, 2021, View Source [SID1234587087]).

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Updated data will be presented as a follow-up to Dr. Chamie’s oral presentation at ASCO (Free ASCO Whitepaper) GU in February 2021 in which 72 subjects in Cohort A of the QUILT 3.032 trial were evaluated. Eighty-one subjects are now fully enrolled in Cohort A and evaluable with median follow-up of over 20 months.

The full oral presentation, titled "PD09-05: Phase 2/3 clinical results of IL-15RαFc superagonist N-803 with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) patients," will be available in the Events section of ImmunityBio’s Investor Relations website on Friday, Sept. 10 at 10:10 a.m. PDT.

QUILT 3.032 is an open-label, three cohort multicenter Phase 2/3 study of intravesical BCG plus Anktiva (N-803) in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) and was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. The FDA had granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met.

Rubius Therapeutics to Participate in the Morgan Stanley 19th Annual Global Healthcare Conference and H.C. Wainwright 23rd Annual Global Investment Conference in September 2021

On September 1, 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 that the Company’s executive management team will participate in the Morgan Stanley 19th Annual Global Healthcare Conference on September 9-13, 2021, and the H.C. Wainwright 23rd Annual Global Investment Conference on September 14, 2021 (Press release, Rubius Therapeutics, SEP 1, 2021, View Source [SID1234587086]).

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Pablo J. Cagnoni, M.D., president and chief executive officer will provide a corporate update through a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 10, 2021, at 9:30 a.m. EDT. A live audio webcast will be available within the Investors & Media section of the Rubius Therapeutics website. An archived replay will be accessible for 90 days following the event.

Members of the executive management team will host meetings with investors at the H.C. Wainwright 23rd Annual Global Investment Conference on September 14, 2021.