On December 10, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported an update of the ProSTAR study, its ongoing Phase 1b/2 clinical trial of CPI-1205 in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Constellation Pharmaceuticals, DEC 10, 2018, View Source [SID1234532000]).

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The ProSTAR study is evaluating CPI-1205, Constellation’s potent and highly selective small-molecule EZH2 inhibitor, in combination with either enzalutamide or abiraterone / prednisone ("abiraterone"), in mCRPC patients who experienced disease progression while receiving the other ARS inhibitor. Based on encouraging results from the Phase 1b portion of ProSTAR, the Company has initiated dosing in the randomized Phase 2 portion studying CPI-1205 in combination with enzalutamide versus enzalutamide alone. Constellation has also decided to expand the Phase 2 portion of the study by adding an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting.

"We are pleased that CPI-1205 achieved its Phase 1b endpoints in ProSTAR, demonstrating an encouraging safety profile and evidence of clinical activity in both arms," said Adrian Senderowicz, Chief Medical Officer of Constellation

Pharmaceuticals. "As we advance into the Phase 2 portion of the study, we believe combination therapy with CPI-1205 may provide a meaningful second-line treatment option to patients with metastatic castration-resistant prostate cancer, an area of significant unmet medical need. We are excited about expanding our opportunity to include an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting, given that very few patients experience a 50% reduction in PSAs on second-line treatment with abiraterone and that time to progression in this setting is typically short."

Initiation and Expansion of Phase 2 Portion of ProSTAR

As planned, Constellation has already begun dosing patients in the Phase 2 portion of the study, evaluating CPI-1205 in combination with enzalutamide versus enzalutamide alone. The Company continues to expect enrollment of up to 35 patients in both the treatment and the control arms.

Additionally, Constellation is expanding the trial to include a separate Phase 2 arm evaluating CPI-1205 in combination with abiraterone in up to 30 mCRPC patients who progressed on prior enzalutamide therapy. This arm, which will soon begin dosing patients, will not be randomized against a control arm due to the low response rate and lack of durability seen with abiraterone in the second-line setting.

In a recent randomized cross-over trial, only 4% of patients taking abiraterone after disease progression on enzalutamide, and only 31% of patients taking enzalutamide after disease progression on abiraterone, achieved a 50% reduction in PSA levels. Time to PSA progression was only 1.3 months and 2.7 months, respectively. Time to disease progression was only 1.6 months and 2.7 months, respectively.1

Constellation continues to expect to determine proof of concept for CPI-1205 in mid-2019.

1 D. Khalaf et al, Phase 2 randomized cross-over trial of abiraterone + prednisone (ABI) vs enzalutamide (ENZ) for patients (pts) with metastatic castration resistant prostate cancer (mCRPC): results for 2nd-line therapy, poster presented at 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

About mCRPC

mCRPC is an advanced form of prostate cancer and is defined by disease progression despite treatment with androgen depletion therapy (ADT). mCRPC may present as one or any combination of the following: a continuous rise in serum levels of PSA, progression of known metastases, or appearance of new metastases. Prognosis is associated with several factors, including the

ability to perform certain daily activities and the presence of bone pain. Additional symptoms commonly include anemia (low healthy red blood cell levels), weight loss, fatigue, hypercoagulability (abnormal blood coagulation), and increased susceptibility to infection. mCRPC presents as a spectrum of disease ranging from patients without symptoms but rising PSA levels despite ADT, to patients with metastases and significant debilitation.

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 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 QED Therapeutics reported that it has entered into an agreement with Foundation Medicine to develop a companion diagnostic for infigratinib, an FGFR1-3 selective tyrosine kinase inhibitor, in patients with cholangiocarcinoma (Press release, QED Therapeutics, DEC 10, 2018, View Source [SID1234576269]). The companion diagnostic, which will include detection of activating FGFR2 fusions, is expected to be incorporated into FoundationOneCDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that includes multiple companion diagnostics.

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"While targeted therapies have transformed the treatment landscape for multiple cancers, such as lung cancer, cholangiocarcinoma has not yet benefitted from these advances," noted Susan Moran, M.D., M.S.C.E., chief medical officer of QED Therapeutics. "Given infigratinib’s demonstrated promise in FGFR2 fusion-driven cholangiocarcinoma, a companion diagnostic is critical to help physicians reliably identify which patients might be candidates for treatment."

On December 10, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. Mr. O’Day is currently the CEO of Roche Pharmaceuticals (Press release, Gilead Sciences, DEC 10, 2018, View Source;p=irol-newsArticle&ID=2380022 [SID1234531986]). He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe.

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The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until Mr. O’Day’s start date of March 1, 2019. Mr. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer.

"Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future," said John C. Martin, PhD, Chairman, Gilead Sciences Board of Directors. "He is uniquely qualified to take on this role given his track record of success in highly scientific and competitive therapeutic areas, deep understanding of the evolving healthcare environment around the world, and unwavering commitment to driving innovation across all aspects of a business, which will serve Gilead and our stakeholders well. Additionally, Dan brings expertise and values that are aligned with our organization, and I, along with Gilead’s entire Board, am confident in his ability to work alongside our talented leadership team and deliver on our ambitious goals."

After joining Roche Pharmaceuticals in 1987, Mr. O’Day held various positions in the United States before moving to Roche headquarters in Switzerland in 1998. During his time in Switzerland, he held leadership roles in Global Marketing and Lifecycle Management. In 2001, he moved to Tokyo to become Head of Corporate Planning for Roche Pharmaceuticals in Japan and later moved to Denmark to serve as General Manager. He became President of Roche Molecular Diagnostics in California in 2006 and subsequently returned to Roche headquarters to lead the Diagnostics Division before assuming his current position. He is a member of the corporate executive committee of F. Hoffmann La Roche AG and a member of the boards of Shanghai Roche Pharmaceuticals Ltd., Roche (China) Holding, Roche Pharma Schweiz AG, Genentech, Inc., Chugai Pharmaceuticals Co., Ltd., Flatiron Health, Inc., and Foundation Medicine, Inc. Additionally, he has served as a member of the board of the European Federation of Pharmaceutical Industries and Associations. Mr. O’Day holds a Bachelor of Science in Biology from Georgetown University in Washington, D.C. and an MBA from the Columbia Business School at Columbia University in New York.

"I have long admired Gilead for its work to develop medicines that have fundamentally changed the way HIV and viral hepatitis are treated. The company has successfully grown into a global organization, providing access to people around the world, while maintaining its focus on innovative science," said Mr. O’Day. "Together with the Board, leadership team and Gilead’s 11,000 employees, I look forward to building on this in ways that I believe will – in keeping with Gilead’s mission – transform the lives of millions of individuals."

As previously announced, Dr. Martin will step down from the company’s Board of Directors, effective March 1, 2019, Mr. O’Day’s first day of employment. Also as previously announced, John F. Milligan, PhD, will step down from his role as President and Chief Executive Officer and as a member of the Board at the end of 2018.