On December 10, 2018 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that investigators will present data via a poster presentation at the this year’s ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, IMV, DEC 10, 2018, View Source [SID1234534101]). The conference will take place on December 13 – 16 in Geneva Switzerland at the Palexpo, Geneva’s exhibition and congress center.

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Poster Session Details

Session Title: Poster Display Session
Location: Foyer, Geneva Palexpo
Poster ID: 87P; Abstract ID 262
Abstract Title: "New clinical data from the DeCidE1 trial: Results on DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with advanced recurrent epithelial ovarian cancer"
Date: December 14 – 15, 2018
Time: 12:30 p.m. – 13:00 p.m. (local time)
Presenter: Dr. Oliver Dorigo, DeCidE1 Clinical Investigator and Lead Author
Investor Call Information

IMV will host a webcast and conference call on Thursday, December 13 at 8:30 a.m. ET to provide an overview of its ESMO (Free ESMO Whitepaper)-IO presentation.

Dial-in: (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (International)

Conference ID#: 6192578

A live audio webcast and presentation will be available via this link, or by pasting this URL in an internet browser: View Source

About ESMO (Free ESMO Whitepaper) I-O

The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress works to increase the overall understanding of the potential of immunotherapy and its implications for clinical practice. The Congress keeps oncologists up-to-date in this rapidly evolving field and is the ideal platform for all

interested stakeholders. From the basics of immunotherapies to the latest research results; from understanding different treatment options to management of toxicities and interpretation of new data, the Congress builds the European community of immuno-oncology stakeholders.

On December 10, 2018 HiFiBiO Therapeutics, a world leader in the discovery of therapeutic antibodies through single-cell screening and analysis, reported the formation of Victa Biotherapeutics, a joint venture with Vikas P. Sukhatme, MD, Robert W. Woodruff Professor of Medicine and Dean of Emory University School of Medicine (Press release, HiFiBiO Therapeutics, DEC 10, 2018, View Source [SID1234532917]). The new open-innovation collaboration will look to expand on the immuno-oncology research pioneered by Dr. Sukhatme during his time at Beth Israel Deaconess Medical Center (BIDMC) and ultimately help accelerate the development of breakthrough standalone or complementary therapies for various cancers. Specific financial terms of the transaction were not disclosed.

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The new joint venture aims to validate surface molecules on myeloid-derived suppressor cells (MDSCs) that were previously discovered by Dr. Sukhatme and his team at BIDMC. Dr. Sukhatme brings his deep understanding of the targets and mechanisms of action and strong expertise about the connection between MDSCs and relevant cancer patients. HiFiBiO Therapeutics will use its biological expertise, unprecedented drug discovery engine, in-depth knowledge of pharmacology, and single-cell-based translational research capabilities to identify a repertoire of first-in-class antibody drugs for various forms of cancer. Victa Biotherapeutics has secured the option to exclusively license the intellectual property from BIDMC related to the target(s) of interest demonstrating significant clinical implications.

"This joint venture with HiFiBiO Therapeutics enables us to continue the important immuno-oncology research that we conducted for many years at BIDMC," said Dr. Sukhatme. "Victa can now leverage HiFiBiO Therapeutics’ state-of-the-art drug discovery and translational research engine to screen and interrogate our MDSC drug targets so that we can accelerate the development of more effective biotherapeutics and increase our probability of success."

"Vikas is a world-renowned physician-scientist and a true visionary for developing new approaches to treat advanced cancer," said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. "This new joint venture and licensing agreement is another high-impact initiative to demonstrate HiFiBiO Therapeutics’ expertise with immune modulation antibody therapies and to deepen our strong commitment to these open-innovation collaborations that are designed to transform treatment for complex diseases and diverse tumor types. Together, we will provide a unique single-cell translational approach to targeting the proper patient populations for many precision medicine applications."

On December 10, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, DEC 10, 2018, View Source [SID1234532259]).

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The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and will evaluate the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation.

"We are delighted the IND application was favorably reviewed by the FDA and brings us ever closer to delivering a novel endocrine treatment option for these women in great need," said Sermonix Chairman Dr. Anthony Wild. "This marks an important milestone in Sermonix’s effort to develop lasofoxifene as a precision medicine for women with advanced breast cancer."

A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments1.

"As ESR1 mutations are highly prevalent in ER+ metastatic breast cancer, we look forward to demonstrating lasofoxifene’s potential promise in this area of significant unmet medical need," said Dr. David Portman, Sermonix founder and chief executive officer. "Acceptance of the IND application allows us to maintain momentum in the important effort to bring lasofoxifene to patients who desperately need more options for this incurable disease, so we are thrilled to receive this news from the FDA."

1 Chandarlapaty S et al, JAMA oncology 2016 Oct 1;2(10):1310-1315)

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

On December 10, 2018 Nascent Biotech, Inc. (OTC: NBIO) reported that it Received US Food and Drug Administration (FDA) Clearance to begin Phase 1 Clinical Trials effective December 7th, 2018 (Press release, Nascent Biotech, DEC 10, 2018, View Source [SID1234532016]).

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Nascent CEO Sean Carrick stated, "On Friday December 7, 2018, Nascent Biotech received a letter from the FDA moving the Company’s IND filing from Full Clinical Hold to Partial Clinical Hold, which frees the Company to immediately begin Phase 1 Human Clinical Trials with its present drug lot." "There are additional product testing criteria required by the FDA, which we believe are very achievable and have already begun to respond," stated Executive Vice President Dr. Brandon Price.

Nascent founder, Dr. Mark Glassy, commented, "It is gratifying that the FDA will allow Nascent to test the value of Pritumumab in the treatment of advanced brain cancer – a disease with few treatment options and very poor outcomes."

On December 10, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that the U.S. Food and Drug Administration ("FDA") has cleared the Investigational New Drug ("IND") application for a humanized bispecific GD2 antibody (Press release, Y-mAbs Therapeutics, DEC 10, 2018, View Source [SID1234532006]). It is anticipated that a Phase 1/2 clinical trial will soon be initiated to begin screening patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy.

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This bispecific product candidate is a fully humanized IgG-scFv format antibody, licensed by Memorial Sloan Kettering to Y-mAbs, in which the anti-CD3 scFv is linked to naxitamab IgG1 and the Fc region is mutated to help prevent cytokine release as well as complement-mediated pain side effects. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "This is a novel bivalent tumor targeting bispecific antibody for the treatment of GD2 positive solid tumors in both pediatric and adult cancers. We believe that these bispecific antibodies have the potential to overcome many of the limitations associated with existing bispecific constructs."

Dr. Claus Møller, Chief Executive Officer further notes, "I am excited to see this bispecific antibody make its way towards the clinic, to establish the safety profile and to determine the maximum tolerated dose."