Ligand Announces the Close of its Acquisition of Vernalis

On October 10, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its acquisition of Vernalis plc has successfully closed and Vernalis will now operate as a subsidiary of Ligand (Press release, Ligand, OCT 10, 2018, View Source [SID1234529847]). Vernalis is a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations. In conjunction with this event, Ligand announced that its portfolio now contains more than 178 shots on goal.

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"We welcome the Vernalis team into the Ligand family and are pleased to add its expertise in structure-based drug discovery to our discovery technology platforms that we offer partners. The Vernalis team has proven its ability to generate novel drug candidates for its partners, including the leading partnerships with Verona and Corvus for COPD and oncology," said John Higgins, Chief Executive Officer of Ligand. "As we advance the Ligand business model, we will continue to evaluate a variety of business, royalty and technology acquisitions, all with the objective of adding shots on goal to our portfolio and creating potential for long-term, diversified and sustainable cash flows for our investors."

Under the terms of the acquisition, Ligand paid Vernalis shareholders approximately $42.3 million, offset by approximately $32 million of net cash on hand at Vernalis, after deal costs.

As previously announced, the acquisition of Vernalis provides Ligand with the following:

A portfolio of more than 8 fully-funded partnered programs, or shots on goal, including:
RPL554, a Phase 2, novel treatment for COPD, which is partnered with Verona Pharma;
CPI-444, a Phase 1, adenosine A2A receptor antagonist for treatment of solid tumors, which is partnered with Corvus Pharmaceuticals.
A 70-person R&D team based in Cambridge, England focused on fragment- and structure-based drug discovery and partnering, with an active portfolio of collaboration agreements generating over $8 million per year of service revenue matched by a comparable level of costs, and partnerships that have the potential to generate additional near-term shots on goal. Ongoing collaboration partners include Servier, Daiichi Sankyo, Asahi Kasei and others.
An established compound library and additional early-stage, unpartnered programs in oncology, CNS and other areas that will provide business development out-licensing and corporate formation opportunities.
England-based operations that provide a platform to more efficiently pursue investment and acquisition opportunities in Europe and the United Kingdom.
Ligand 2018 Financial Outlook

As previously announced, revenue and operating expense impact from Vernalis in 2018 is currently expected to be small and mostly offset each other. Beyond 2018, research business revenue is expected to approximate expenses with longer-term milestones and royalties being accretive to future Ligand earnings.

Advisors

MTS Securities, LLC and finnCap Ltd. served as financial advisors and Latham Watkins LLP served as legal advisor to Ligand in this transaction.

Incyte presents the data for pemigatinib, its selective inhibitor of FGFR, which will be announced at the 2018 ESMO conference

On October 10, 2018 Incyte (Nasdaq: INCY) has reported that the Phase 2 intermediate data of its selective inhibitor of FGFR1 / 2/3 in the clinical research phase, pemigatinib (INCB54828), will be will present at the next European Congress of Oncology (ESMO) (Free ESMO Whitepaper) 2018 that will take place in Munich, Germany, from October 19 to 23, 2018 (Press release, Incyte, OCT 10, 2018, View Source [SID1234529846]).

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The information that will be announced in ESMO (Free ESMO Whitepaper) 2018 includes poster presentations on the FIGHT-202 study of pemigatinib in patients with advanced cholangiocarcinoma (cancer of the bile duct) and previously treated / metastatic or surgically unresectable with a genetic alteration of the factor of fibroblastic growth (FGF) / FGFR, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (cancer of the bladder) carrying an alteration of the FGF / FGFR gene.

"We are pleased that pemigatinib data – part of our portfolio of targeted treatments – have been selected for presentation at this year’s ESMO (Free ESMO Whitepaper) conference," said Steven Stein, MD, medical director, Incyte. "We are keen to share the latest intermediate data from the ongoing FIGHT-202 trial for pemigatinib in patients with cholangiocarcinoma, who continue to support our project to submit the new drug registration request in 2019 for this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which supports the recruitment for the continuous administration cohort of this trial ».

The summaries were made public today on the ESMO (Free ESMO Whitepaper) congress website, at View Source .

Poster details:

Intermediate results of FIGHT-202, an open and multicenter Phase 2 study of INCB054828 in patients (pts) with advanced and previously treated / metastatic or surgically unresectable cholangiocarcinoma (CCA) with / without alterations of the fibroblast growth factor (FGF) gene / FGF receptor (FGFR) (summary No. 756P, poster presentation session)

Sunday, October 21, 2018 from 12:45 pm Spanish Peninsular Time until 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in the Pavilion A3 – Poster Area Networking Hub
Intermediate results of FIGHT-202, an open-label multicentre study in Phase 2 of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) carrying the genetic alterations (GA) of fibroblast growth factor (FGF) / FGF receptor (FGFR) (summary No. 900P, poster presentation session)

Monday, October 22, 2018 from 12:45 pm Spanish Peninsular Time at 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in Hall A3 – Poster Area Networking Hub
The details of the full session and the data submission lists for ESMO (Free ESMO Whitepaper) 2018 can be found at:

View Source .

About the FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFR) play an important role in the proliferation of tumor cells and in survival, migration and angiogenesis (formation of new blood vessels). The mutations, translocations and activating gene amplifications of the FGFRs are closely correlated with the development of various types of cancer.

Pemigatinib is a potent selective inhibitor of isoforms 1, 2 and 3 of FGFR that, in preclinical studies, has shown a selective pharmacological activity against cancer cells with alterations in FGFR. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy for various neoplasms due to FGFR are underway. The FIGHT clinical trial program (FIbroblast Growth factor receptor in oncology and Hematology Trials) currently comprises the FIGHT-201 study in patients with metastatic or surgically unresectable bladder cancer, including activating alterations of FGFR3; the FIGHT-202 study in patients with metastatic or surgically unresectable cholangiocarcinoma who did not respond to previous treatment, including activating translocations of FGFR2; and the FIGHT-203 study in patients with myeloproliferative neoplasms with activating translocations of FGFR1.

Epizyme to Present Updated Data on Tazemetostat from Full Phase 2 Study Cohort in Epithelioid Sarcoma at ESMO

On October 10, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported that updated efficacy and safety data from the fully enrolled cohort of epithelioid sarcoma (ES) patients in its ongoing Phase 2 trial of tazemetostat will be presented in a poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress to be held October 19-23 in Munich, Germany (Press release, Epizyme, OCT 10, 2018, View Source [SID1234529845]). Tazemetostat is the company’s potent, selective, orally available, first-in-class EZH2 inhibitor.

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The Phase 2 study ES cohort completed enrollment in 2017 with a total of 62 patients. Detailed data will be presented at the Congress, including objective response rate (ORR), the study’s primary endpoint, and other important endpoints in this disease including duration of response, overall survival (OS), disease control rate and safety. For the first time, an analysis of ORR, durability and OS will be presented in both treatment-naive patients and in relapsed and/or refractory patients from the fully enrolled study cohort. Data will be presented by the study’s primary investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Service, and assistant professor, Memorial Sloan Kettering Cancer Center.

"We are excited to share these updated efficacy and safety data on tazemetostat in patients with epithelioid sarcoma, a rare and deadly cancer," said Robert Bazemore, president and chief executive officer of Epizyme. "We remain committed to bringing this potential therapy to patients living with ES, and are confident as we progress towards our first NDA submission in the first half of 2019."

In addition to the ES data, Epizyme will present data from the company’s Phase 2 study of tazemetostat in adult patients with INI1-negative tumors in two additional poster discussions and during one oral session at ESMO (Free ESMO Whitepaper). A complete list of the tazemetostat presentations at ESMO (Free ESMO Whitepaper) are listed below:

Epithelioid Sarcoma Poster Discussion Session
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults: (epithelioid sarcoma cohort)
Abstract No.: 1615PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Mrinal Gounder, M.D.

Proffered Paper (Oral Presentation) Session
Title: Molecular characterization of epithelioid sarcoma (ES) tumors derived from patients enrolled in a phase 2 study of tazemetostat
Abstract No.: 1892O
Date: Saturday, October 20, 2018; 11:12 a.m. – 11:24 a.m. CEST
Location: Hall B3 – Room 21
Presenter: Mrinal Gounder, M.D.

Poster Discussion Sessions
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (INI1-negative tumors cohort)
Abstract No.: 1611PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Silvia Stacchiotti, M.D.

Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (rhabdoid tumor cohort)
Abstract No.: 1612PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Robin L. Jones, MRCP, M.D.

Conference Call Information
Epizyme Management will host a conference call on Monday, October 22, 2018 at 8:30am EDT. To participate in the conference call, please dial 877-844-6886 (domestic) or 970-315-0315 (international) and refer to conference ID 8780088. The webcast can be accessed in the Investor Relations section of the company’s website at www.epizyme.com. The replay of the webcast will be available in the investor section of the company’s website for 60 days.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

Merck to Hold Third-Quarter 2018 Sales and Earnings Conference Call on October 25

On October 10, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its third-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Thursday, Oct. 25 (Press release, Merck & Co, OCT 10, 2018, View Source [SID1234529843]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 2169459. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 2169459. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

Heat Biologics to Present at the 2018 BIO Investor Forum

On October 10, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that the company is scheduled to present at the 2018 BIO Investor Forum Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that the company is scheduled to present at the 2018 BIO Investor Forum. The Forum will be held on October 17th and 18th at the Westin St. Francis Hotel in San Francisco, California.

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Jeff Wolf, Founder and Chief Executive Officer of Heat Biologics, will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the forum.

Presentation Date: Wednesday, October 17, 2018
Time: 3:45 PM, PT
Location: Elizabethan A Room

. The Forum will be held on October 17th and 18th at the Westin St. Francis Hotel in San Francisco, California.

Jeff Wolf, Founder and Chief Executive Officer of Heat Biologics, will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the forum.

Presentation Date: Wednesday, October 17, 2018
Time: 3:45 PM, PT
Location: Elizabethan A Room