On May 16, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that new data from the epithelioid sarcoma and follicular lymphoma cohorts of the company’s ongoing Phase 2 clinical trials of tazemetostat will be reported during oral presentations at medical meetings in June (Press release, Epizyme, MAY 16, 2019, View Source [SID1234536447]).

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Updated data from the fully enrolled cohort of epithelioid sarcoma patients in the company’s molecularly defined solid tumor program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting in Chicago. Updated data from the fully enrolled cohorts of patients with follicular lymphoma, both with and without EZH2 activating mutations, will be reported at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. The company will also report findings from its follicular lymphoma natural history study during a poster session at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam.

"The updated data to be presented at these upcoming meetings showcase tazemetostat’s potential to positively impact patients in need of new treatment options and, importantly, support the two planned NDA submissions this year," said Robert Bazemore, president and chief executive officer of Epizyme. "We remain on track to submit our epithelioid sarcoma NDA to the U.S. FDA in the second quarter, followed by our planned NDA submission for follicular lymphoma patients, both with and without EZH2 mutations, in the fourth quarter of this year. We look forward to these data presentations and continuing our work to execute these pivotal milestones."

Details of the presentations are listed below:

ASCO Oral Presentation
Title: Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients (pts) with epithelioid sarcoma (ES) (NCT02601950)
Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Tumori, Milan
Abstract No.: 11003
Date: Monday, June 3, 2019; 9:00 – 9:12 a.m. CDT
Location: E450

EHA Poster Discussion
Title: EZH2 gain-of-function mutations are not associated with more favorable prognosis in relapsed/refractory follicular lymphoma: a preliminary analysis on 590 patients
Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Presenter: Neil R. Michaud, director, translational medicine, Epizyme, Inc.
Abstract No.: PS1247
Date: Saturday, June 15, 2019; 5:30 – 7:00 p.m. CEST
Location: Poster Area

ICML Oral Presentation
Title: Interim update from a Phase 2 multicenter study of tazemetostat, an EZH2 inhibitor, in patients with relapsed or refractory follicular lymphoma
Presenter: Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire de Lille, France
Abstract No.: 105
Date: Friday, June 21, 2019; 2:45 – 3:00 p.m. CEST
Location: Room A

On May 16, 2019 Tempest Therapeutics Inc., a clinical-stage biotechnology company developing a broad portfolio of first-in-class immunomodulatory small molecules targeting diverse cancers, reported that the first patient has been dosed with TPST-1120 in a Phase I/Ib trial to treat advanced solid tumor malignancies (Press release, Tempest Therapeutics, MAY 16, 2019, View Source [SID1234536446]).

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PPAR (peroxisome proliferator-activated receptor) alpha is a nuclear transcription factor that regulates fatty acid oxidation and lipid metabolism in the tumor microenvironment (TME). TPST-1120 is a PPAR alpha antagonist that has a two-pronged mechanism, targeting both tumor cells and suppressive immune cells in the TME dependent on fatty acid metabolism, driving a metabolic shift to glycolysis and facilitating the development of a tumor-specific effector immune cell response. In extensive animal studies, TPST-1120 therapy used as a single agent or in combination with other anti-cancer drugs resulted in significant reductions in tumor growth and stimulation of durable anti-tumor immunity.

The U.S. Phase I trial (NCT03829436) is enrolling patients with advanced solid tumors. The open-label, dose-escalation and dose-expansion study is testing oral twice-daily TPST-1120 as monotherapy and in combination with marketed cancer drugs such as PD-1 inhibitors, anti-EGFR antibodies or chemotherapy. Primary outcome measures of the trial include assessing safety and tolerability and establishing a dose range for expanded studies at specified TPST-1120 doses. Secondary outcome measures include pharmacokinetics, mechanism-based biomarkers and objective response rate.

"Today represents an exciting moment for Tempest, as we transition to a clinical-stage company that is advancing first-in-human therapies targeting new pathways to induce anti-cancer immunity. Ultimately, we hope that our new approaches to treat cancer will provide benefit to patients," said Ginna Laport, MD, CMO of Tempest.

To help facilitate the transition to a clinical-stage company, Tempest has made key appointments to its board of directors with the appointment of Mike Raab, and to its scientific advisory board with the appointment of Benjamin Cravatt, Ph.D.

Mr. Raab is president and CEO of Ardelyx Inc., a publicly traded biotechnology company focused on cardiorenal diseases. He previously was a partner at New Enterprise Associates, where he spent 15 years in commercial and operating leadership roles in the biotech and pharmaceutical industries. Before NEA, he was SVP of therapeutics and general manager of the renal division at Genzyme Corp. where he launched and oversaw the sales growth of sevelamer, the leading phosphate binder to treat hyperphosphatemia, with over $1 billion in worldwide sales in 2013. Mike also was instrumental in the worldwide launch of Genzyme’s therapies for Gaucher disease, Ceredase and Cerezyme.

Dr. Cravatt is a professor in the Skaggs Institute for Chemical Biology and Gilula Chair Chemical Biology at The Scripps Research Institute. His research group is interested in understanding the roles that enzymes play in physiological and pathological processes, especially as pertains to the nervous system and cancer. Dr. Cravatt is a co-founder and scientific advisor of multiple biotechnology companies.

"Mike Raab and Ben Cravatt are widely recognized leaders in pharma and biotechnology drug development, and each will provide significant guidance and insights to facilitate Tempest’s continuing success," said Tom Dubensky, Ph.D., president and CEO of Tempest.

On May 16, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published an abstract on the Company’s clinical study evaluating its lead candidate, DPX-Survivac, in recurrent advanced ovarian cancer (Press release, IMV, MAY 16, 2019, View Source [SID1234536445]). The abstract was released online on the ASCO (Free ASCO Whitepaper) website yesterday in advance of ASCO (Free ASCO Whitepaper)’s annual meeting in Chicago, Illinois, taking place May 31 – June 4, 2019.

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The final conference poster presentation will include additional data collected between the abstract submission cutoff date of February 12, 2019, and the presentation itself.

Conference Call and Webcast Information

IMV will host a webcast and conference call to provide an overview of its ASCO (Free ASCO Whitepaper) presentation on Sunday, June 2, 2019 at 9:00 a.m. ET. The conference line is (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International), and the conference ID# is 8579285. A live audio webcast and presentation will be available via this link and through the ‘Events and Presentations’ page of IMV’s website.

IMV ASCO (Free ASCO Whitepaper) 2019 Presentation Detail

Poster Title: "DPX-Survivac and intermittent low-dose cyclophosphamide (CPA) with or without epacadostat (E) in the treatment of subjects with advanced recurrent epithelial ovarian cancer (DeCidE1 trial): T cell responses and tumor infiltration correlate with tumor regression."
Abstract Number: 5576
Session Title: Gynecologic Cancer
Date and Time: June 1, 2019, 1:15 – 4:15 p.m. CT

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication. It is currently being evaluated in multiple Phase 1b/2 clinical trials.

On May 16, 2019 Oncorus, Inc., an oncolytic virus therapeutics company focused on driving innovation to transform outcomes for cancer patients, reported that its President and Chief Executive Officer, Ted Ashburn, M.D., Ph.D., will provide a company overview and pipeline update at the following upcoming healthcare investor conferences in New York City (Press release, Oncorus, MAY 16, 2019, View Source [SID1234536444]):

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UBS Global Healthcare Conference on Tuesday, May 21, 2019 at 1:30 p.m. ET
Jefferies 2019 Healthcare Conference on Wednesday, June 5, 2019 at 9:30 a.m. ET

On May 16, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that ALX148 clinical results have been selected for presentation in the Poster Discussion Session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, May 31 – June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, ALX Oncology, MAY 16, 2019, View Source [SID1234536443]).

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ALX148 Presentation Information

Title: A phase 1 study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy (Abstract #2514).

Poster Discussion Session: Developmental Immunotherapy and Tumor Immunobiology, Advances in Immune Checkpoint Inhibition

Date: Saturday, June 1

Time: 1:15 p.m. – 1:27 p.m.

Location: Hall D1

Poster Display Session: Developmental Immunotherapy and Tumor Immunobiology

Date: Saturday, June 1

Time: 8:00 a.m. – 11:00 a.m.

Location: Hall A