1stOncology™: Cancer Intelligence Service – Page 15633 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Bellicum Pharmaceuticals Appoints Dr. William Grossman as Chief Medical Officer

On February 5, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported the appointment of William Grossman, M.D., Ph.D., as Chief Medical Officer, effective February 5 (Press release, Bellicum Pharmaceuticals, FEB 5, 2018, View Source [SID1234523720]). Dr. Grossman joins Bellicum from Genentech/Roche.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We are excited to have Bill join Bellicum. His expertise in the development of cancer immunotherapies and combinations will strengthen our team as we advance and expand our CAR T and TCR pipeline and prepare for the regulatory filing and potential commercialization of BPX-501 in Europe," said Bellicum’s President & CEO Rick Fair.

Commented Dr. Grossman: "I am thrilled to join Bellicum at this exciting time. Cellular immunotherapies are transforming how we treat cancer. Bellicum’s novel platform for controlling the activity of immune cells may help us improve upon the current generation, extending the benefit of these life-saving immunotherapies to more types of cancer."

In his most recent role at Genentech, Dr. Grossman served as the Group Medical Director, Cancer Immunotherapy, where he led the global clinical development of TECENTRIQ in gastrointestinal cancers and of cancer immunotherapy combinations across all solid tumor types. Among other accomplishments in this role, Dr. Grossman conceived and led the development of the Phase 1b/2 MORPHEUS platform to evaluate cancer immunotherapy combinations more rapidly and efficiently. Previously, he served as Senior Vice President, Research & Clinical Development at Biothera, where he oversaw all discovery and clinical development efforts in oncology and immunology. Dr. Grossman has also held leadership positions in research, clinical development, and medical affairs at AbbVie, Baxter Healthcare, and Merck & Co., where he was involved in the development and clinical study of cancer vaccines, immunomodulatory agents, and small molecules/biologics in oncology.

Prior to joining the industry, Dr. Grossman held various positions with the Medical College of Wisconsin and the Children’s Hospital of Wisconsin, and was Founder and Medical Director of the Clinical Immunodiagnostic and Research Laboratory, Professor for Microbiology and Genetics, and Director of the Hematology/Oncology/Bone Marrow Transplant Division for the Immunodeficiency Transplant Program. Dr. Grossman earned his M.D. and Ph.D. degrees from Washington University School of Medicine and completed his medical training in the Division of Pediatric Biology/Medicine at the Washington University School of Medicine.

Inducement Awards

The Compensation Committee of the Board of Directors has approved inducement awards to Dr. Grossman, which will be granted effective on his start date. The inducement awards consist of a stock option to purchase up to 175,000 shares of the Company’s common stock priced at the closing price of the Common Stock on the grant date of February 5, 2018, and a restricted stock unit for 30,000 shares of common stock. The stock option and restricted stock unit award will be granted subject to the terms of the Company’s 2014 Equity Incentive Plan. One-fourth of the shares subject to the stock option award will vest on the one-year anniversary of Dr. Grossman’s start date and the remainder of the shares will vest in a series of 36 successive equal monthly installments thereafter, and 25% of the shares subject to the restricted stock unit award will vest on each anniversary of Dr. Grossman’s start date, in each case subject to his continuous service with the Company through each such vesting date and subject to potential vesting acceleration under certain circumstances pursuant to the terms of Dr. Grossman’s employment agreement with the Company.

DEVELOPING A DOWNSTREAM BIO-CONJUGATION PROCESS

On February 4, 2018 ADC BIO reported the development of a revolutionary, ‘downstream bio-conjugation’ method that will present a new paradigm in Antibody Drug Conjugate (ADC) development and manufacturing (Press release, ADC BIO, FEB 4, 2018, View Source [SID1234526749]). In contrast to the existing approaches – which undertake bio-conjugation after both the mAb and cytotoxic have been manufactured – this new approach moves the conjugation step into the later stages of the downstream processing (DSP), with conjugation and antibody purification carried out concurrently.

"The major benefit, and the reason this approach will prove so disruptive, is that it will save several months of manufacturing time and up to 25% of the overall costs. But it will require much of the industry, with its current ingrained manufacturing methods, to re-evaluate exactly how it structures the supply chain that often uses three CMOs," commented Charlie Johnson, CEO of ADC Bio.

Using this ‘downstream bio-conjugation’ approach, potentially means less time at the antibody manufacturer (i.e. less time in traditional downstream processing), with the remaining downstream processing and conjugation service both transferring to the bio-conjugation CMO. The result is a refined, simpler and much more efficient system – saving up to three months of development time and resources plus creating large cost savings.

Under the Company’s new process, the starting point for the conjugation will no longer be post-creation of purified antibodies and will instead begin with antibody supernatants. This persuasive approach forgoes the need for extensive chromatographic purification techniques to deliver purified antibody.

The Company’s groundbreaking production technique – yet to be formally named – would also remove the need for expensive Protein A resins, instead replacing them with capture resins that are at the heart of the Company’s core ‘Lock-Release’ technology. In ADC manufacturing, the Protein A capture step is the most costly in downstream processing, delivering semi-purified antibody. Now, starting from antibody supernatant, ADC Bio’s unique approach will see their patented ‘Lock-Release’ technology facilitate both the antibody capture step and subsequent conjugation to the ADC payload – essentially replacing the Protein A resin and assembling the ADC in an efficient manner. The subsequent viral inactivation, removal and polishing will then occur post-conjugation.

The benefits of eliminating the need for proteinaceous A & G resins extends beyond substantial cost savings. Incidental leaching of these proteins from their purification media increases the impurities in a biopharmaceutical drug product – all of which have to be removed in subsequent chromatography polishing steps before an antibody can be used for any therapeutic application. Moreover, Protein A is known to cause immunogenic responses in humans and has proven toxic in a number of clinical studies – thus its removal is mandatory.

Keryx Biopharmaceuticals to Host Conference Call of Fourth Quarter and Full Year 2017 Financial Results on Wednesday, February 7, 2018

On February 2, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported that it will host a conference call and webcast on Wednesday, February 7, 2018 at 8:00 a.m. ET to discuss its fourth quarter and full year 2017 financial results (Press release, Keryx Biopharmaceuticals, FEB 2, 2018, https://keryx.gcs-web.com/news-releases/news-release-details/keryx-biopharmaceuticals-host-conference-call-fourth-quarter-1 [SID1234523749]).

To participate in the conference call, please dial 1-888-396-2320 (U.S.), 1-774-264-7560 (international) and refer to conference ID: 3697815. The call will be webcast live with slides and accessible through the Investors section of the company’s website at www.keryx.com for a period of 15 days after the call.

Keryx Biopharmaceuticals will announce its financial results for this period in a press release to be issued prior to the call.

CYTOKINETICS TO ANNOUNCE FOURTH QUARTER RESULTS ON FEBRUARY 15, 2018

On February 2, 2018 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that it is scheduled to report fourth quarter results on February 15, 2018 at 4:00 PM Eastern Time (Press release, Cytokinetics, FEB 2, 2018, View Source [SID1234523748]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 3665278.

An archived replay of the webcast will be available via Cytokinetics’ website until February 22, 2018. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 3665278 from February 15, 2018 at 7:30 PM Eastern Time until February 22, 2018.

TESARO to Announce Fourth-Quarter 2017 Financial Results on February 27, 2018

On February 2, 2018 TESARO, Inc. (NASDAQ:TSRO) reported its fourth-quarter 2017 financial results on Tuesday, February 27, 2018, after the close of the U.S. financial markets (Press release, TESARO, FEB 2, 2018, View Source [SID1234523718]). During the conference call and live audio webcast at 4:15 p.m. ET on February 27, 2018, TESARO’s senior management team will discuss the Company’s operating results in greater detail, as well as the status of its development programs and commercial products. For the month of December, ZEJULA achieved approximately 60% market share in the U.S. among PARP inhibitors utilized in patients with ovarian cancer, according to IntrinsiQ. This market-leading share position in ovarian cancer is consistent with the share ZEJULA achieved in prior months. Additional details will be discussed on the February 27, 2018 webcast.

This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

******************CONFERENCE CALL & WEBCAST INFORMATION******************

TESARO will host a conference call and live audio webcast to discuss its fourth-quarter financial results.

WHEN: Tuesday, February 27, 2018 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com

A replay will be available for 30 days at www.tesarobio.com.