On October 10, 2019 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company reported that originated and continues to develop collagenase-based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, named life sciences industry veteran Kevin Buchi chief executive officer of BioSpecifics. He will also serve on the company’s board of directors (Press release, BioSpecifics Technologies, OCT 10, 2019, https://www.prnewswire.com/news-releases/biospecifics-technologies-corp-names-j-kevin-buchi-as-chief-executive-officer-300936191.html [SID1234540925]).

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"We are extremely pleased to have Kevin join BioSpecifics as chief executive officer. The board of directors believes that Kevin’s diversified life sciences leadership experience and business acumen will drive transformative vision and strategy for generating both near- and long-term shareholder value," said Jenn Chao, Chair of the Executive Search Committee.

"I am thrilled to be joining BioSpecifics. This is a unique company with very significant opportunities to further advance its collagenase-based therapies both commercially and clinically," said Mr. Buchi. "There are several key milestones on the near-term horizon including a potential third marketed indication for XIAFLEX, with the BLA filing submitted in early September for the treatment of cellulite, and the continued growth of the XIAFLEX commercial franchise and development portfolio."

Mr. Buchi is currently the chairman of the board of directors at Dicerna Pharmaceuticals and a director of Amneal Pharmaceuticals and Benitec Biopharma Ltd. Mr. Buchi was most recently president and chief executive officer at TetraLogic Pharmaceuticals from 2012 to 2016. Previously, he served as Impax Laboratories’ interim President and chief executive officer from December 2016 to March 2017. Earlier, he served as corporate vice president of Global Branded Products at Teva Pharmaceutical from 2011 to May 2012. Mr. Buchi also served as chief executive officer of Cephalon, which was acquired by Teva in October 2011. He had been at the company since 1991. Mr. Buchi holds a Masters of Management degree from the J.L. Kellogg Graduate School of Management from Northwestern University and a B.A. in Chemistry from Cornell University.

On October 10, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled in a phase I study to investigate the safety and tolerability of a combination treatment of birinapant and radiation therapy in patients with recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (Press release, Medivir, OCT 10, 2019, View Source [SID1234540942]). The initiative for the study came from researchers at the US National Cancer Institute (NCI). The study is sponsored and financed as part of NCI’s Cancer Therapy Evaluation Program (CTEP). Medivir provides birinapant and will be afforded full access to all reports from the study under its Cooperative Research and Development Agreement with NCI for birinapant. The primary goals of which are to evaluate the safety of the combination treatment and to establish a maximum tolerated dose for further studies. The potential signs of a treatment response in the patients are also investigated. Medivir’s decision to support this study was based on preclinical data from NCI showing good effects from birinapant in combination with radiotherapy in models of various types of cancer of the head and neck region [1]). Further information on the study can be found at clinicaltrials.gov with the reference number NCT03803774.

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"We believe that birinapant has the potential to form part of several different combination treatments for various types of cancer," says Uli Hacksell, PhD., CEO of Medivir. "The birinapant-radiation therapy combination treatment yielded impressive results in the preclinical cancer models, and we are eagerly awaiting the results of the phase I study, which will be a good complement to the ongoing phase II combination study of birinapant and Keytruda.

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, mobile: +46(0)8-5468-3100

About Head and Neck Squamous Cell Carcinoma (HNSCC)
HNSCC is diagnosed in about 550,000 individuals worldwide annually. Of these around 63,000 cases occur in the United States, where around 13,000 patients die from the disease each year. Locoregionally advanced recurrent disease in patients who have had prior chemoradiation therapy has a poor prognosis, with a two year survival rate of less than 50%.

About birinapant
Birinapant is being developed to enhance responses, and extend survival, of patients with solid tumors where existing treatments do not provide sufficient survival benefit, or where patients no longer have treatment options. Based on its unique design and mechanism, birinapant has the potential to enhance patients’ responses in combination with other treatments. Medivir’s initial focus is on developing birinapant in combination with an immuno-oncology agent.

On October 10, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a research collaboration agreement with the University of California Los Angeles (UCLA) to conduct preclinical studies evaluating the Company’s Lm technology in mouse tumor models of glioblastoma multiforme (GBM) (Press release, Advaxis, OCT 10, 2019, View Source [SID1234540926]). Specifically, the collaboration with Dr. Vaithi Arumugaswami’s group at UCLA’s Department of Molecular and Medical Pharmacology will investigate anti-tumor immunity and anti-tumor responses generated by Lm vaccines that express diverse glioblastoma neoantigens.

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"We are excited that Dr. Arumugaswami and his colleagues at UCLA will investigate the potential of our Lm technology platform in GBM, one of the deadliest cancers," said Andres Gutierrez, Executive Vice President and Chief Medical Officer of Advaxis. "Contrary to other tumor types, GBM has not seen much success in targeting by immunotherapeutic agents due to a low tumor mutation burden, high tumor heterogeneity and presence of the blood brain barrier, among other factors. Hence, Dr. Arumugaswami’s characterization of the neoantigen landscape and immune responses to Lm- constructs may lead to the development of novel therapies with clinical activity in this elusive cancer."

On October 10, 2019 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its third quarter 2019 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 29, 2019 (Press release, Incyte, OCT 10, 2019, View Source [SID1234540927]).

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The schedule for the press release and conference call/webcast is as follows:

Q3 2019 Press Release:

October 29, 2019 at 7:00 a.m. ET

Q3 2019 Conference Call:

October 29, 2019 at 8:00 a.m. ET

Domestic Dial-In Number:

877-407-3042

International Dial-In Number:

201-389-0864

Conference ID Number:

13695247

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13695247.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

On October 10, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will present updates of clinical data from the MANIFEST clinical trial of CPI-0610 in oral and poster presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting on December 9 (Press release, Constellation Pharmaceuticals, OCT 10, 2019, View Source [SID1234540945]). Two abstracts reflecting MANIFEST data have been accepted by ASH (Free ASH Whitepaper) and will be published on November 6. Updated data will be presented at the meeting.

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ASH Oral Presentation

Title: MANIFEST, a Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Domain Inhibitor (BETi), as Monotherapy or Add-On to Ruxolitinib, in Patients with Refractory or Intolerant Advanced Myelofibrosis

Oral Session: 634. Myeloproliferative Syndromes: Clinical: JAK Inhibitors and Combination Therapies

Date and Time: December 9, 11:15 AM

Location: Orange County Convention Center, W311EFGH, Orlando, FL

Dr. John Mascarenhas, Associate Professor of the Icahn School of Medicine at Mount Sinai and an investigator in the MANIFEST clinical trial, will give the oral presentation with interim data from MANIFEST.

ASH Poster Presentation

Title: Preliminary Report of MANIFEST, a Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Domain Inhibitor (BETi), in combination with Ruxolitinib, in JAK Inhibitor (JAKi) Treatment Naïve Myelofibrosis Patients

Session: 634. Myeloproliferative Syndromes: Clinical: Poster III

Date and Time: Monday, December 9, 2019, Poster Display: 10:00 AM-8:00 PM EST, Poster Presentation: 6:00 PM-8:00 PM EST

Location: Orange County Convention Center, Hall B, Orlando, FL

Investor Event

Constellation will host an investor meeting and webcast conference call at 12:30 PM EST on December 9 at the Rosen Centre Hotel in Orlando to discuss the interim data from the MANIFEST oral presentation and poster at ASH (Free ASH Whitepaper). Further details will be provided later. If you would like to attend, please contact Ron Aldridge, Senior Director of Investor Relations, at [email protected].