On October 9, 2018 Fresenius Kabi reported that it has reached a milestone on the road to approval for another biosimilar (Press release, Fresenius, OCT 9, 2018, View Source [SID1234530131]) . MSB11455, a biosimilar candidate for Neulasta (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.

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On October 9, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that data will be presented from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) (Press release, Dynavax Technologies, OCT 9, 2018, View Source [SID1234530122]). Data will be presented in three individual sessions with data for advanced melanoma patients who are naïve to anti-PD-1 therapy being presented as a late-breaking abstract poster discussion, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, being held October 19-23, 2018 in Munich Germany.

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The details of the poster presentations and discussion sessions are as follows:

Phase Ib/II, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

Poster Discussion Session: Head and Neck Cancers
Final Publication Number: 1050PD
Discussion Session Date/Time: Saturday, October 20, 2018, 3:00 PM – 4:15 PM CEST
Discussion Session Location: Hall B3 – Room 23, ICM München, Munich Germany
Poster Session Date/Time: Saturday, October 20, 9:00 AM CEST to Monday, October 22, 5:00 PM CEST
Poster Session Location: Hall B4 – ICM München, Munich Germany

Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy

Poster Discussion Session: Melanoma and Other Skin Tumours
Final Publication Number: LBA45
Discussion Session Date/Time: Saturday, October 20, 2018, 2:45 PM – 4:05 PM CEST
Discussion Session Location: ICM – Room 14b, ICM München, Munich Germany
Poster Session Date/Time: Saturday, October 20, 2:45 PM CEST to Monday, October 22, 5:00 PM CEST
Poster Session Location: Hall B4 – ICM München, Munich Germany

Phase Ib/II study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who had progressive disease on or after prior anti-PD-1 therapy

Poster Session: Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Final Publication Number: 1265P
Poster Session Date/Time: Sunday, October 21, 12:45 PM – 1:45 PM CEST
Poster Session Location: Hall A3 – Poster Area Networking Hub, ICM München, Munich Germany

On October 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that interim results of its ongoing Phase 1b study of navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer will be presented in a poster presentation on October 20, 2018 at the European Society for Medical Oncology meeting to be held in Munich, Germany (Press release, OncoMed, OCT 9, 2018, View Source [SID1234530050]).

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Poster 951P/
Abstract 1389: A Phase 1b Study of Navicixizumab & Weekly Paclitaxel in Heavily Pre-Treated Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Date and Time: Saturday, October 20, 2018 from 12:30 pm to 1:30 pm CEST

Location: Hall A3 – Poster Area Networking Hub
About Navicixizumab
OncoMed’s anti-DLL4/VEGF bispecific antibody, navicixizumab, is designed to inhibit the function of both DLL4 and VEGF and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. Navicixizumab was developed utilizing OncoMed’s BiMAb bispecific platform technology, which enables the design of bispecific antibodies comparable to traditional monoclonal antibodies but possessing dual target-binding specificity. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. Further, in preclinical studies dual inhibition of DLL4 and VEGF appeared to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity. In a Phase 1a study with single-agent navicixizumab published in Investigational New Drugs, 19 of 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy

On October 9, 2018 Oblique Therapeutics, a biotech focused on new medicines for severe diseases with large unmet medical needs, reported that it will present new promising preclinical data for the drug candidate OT-1096 in triple-negative breast cancer (TNBC) at the largest oncology congress in Europe, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held 19-23 October in Munich, Germany (Press release, Oblique Therapeutics, OCT 9, 2018, http://obliquet.com/oblique-therapeutics-present-tumor-growth-inhibition-and-treg-lowering-data-for-ot-1096-in-humanized-mouse-tnbc-model-at-oncology-congress-esmo/ [SID1234530026]).

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The new data of the first-in-class anti-cancer agent OT-1096 shows promising preliminary results with improved tumor growth inhibition compared to pembrolizumab, one of the blockbuster drugs within immunooncology. The humanized TNBC PDX mouse-model, used in this study, allows for the growth of a breast cancer derived from a patient, in the presence of a human immune system. The results suggest that OT-1096 reduces tumor growth by two associated mechanisms; direct cancer cell killing activity by redox system modulation that, in turn, results in a beneficial immunomodulatory action through lowering of regulatory T-cells within the TIL* population as compared to controls. The results warrant further investigations of OT-1096 in TNBC and other aggressive cancers. Treatment with OT-1096 shows no safety or tolerability concerns.

"First of all, it is an honor to be recognized by ESMO (Free ESMO Whitepaper), and we are thrilled to exhibit our promising results for OT-1096 for the first time. Even more so, being part of changing the treatment landscape for cancer at this time is exciting for us: the 2018 Nobel Prize in Medicine was awarded for pioneering work in immunooncology and we see more and more traction and exciting results from novel immunomodulatory small molecules, such as ours, with the capacity to favorably change the immune system inside tumors ," said Prof. Owe Orwar, CEO at Oblique Therapeutics.

TNBC is an aggressive subtype of breast cancer associated with poor prognosis and limited treatment options, and new effective medicines are needed. Globally, two million people are diagnosed with breast cancer every year; of which 10-13 percent has TNBC.

Prof. Owe Orwar, CEO at Oblique Therapeutics, will present a poster (441P) with the title: "OT-1096, a first-in-class immunoactivating small molecule that targets the thioredoxin reductase/thioredoxin axis causes strong tumor growth inhibition by downregulating intratumoral Tregs in a humanized TNBC-PDX model" on Monday 22 October 2018 at 12:45-13:45. The abstract is available through esmo.org: View Source (search: 441P)

For more information, please contact:
Prof. Owe Orwar, CEO
Email: [email protected]

About OT-1096
OT-1096 is a next-generation first-in-class small molecule immunomodulator with anti-cancer activity. The initial clinical focus is on targeting advanced triple-negative breast cancer (TNBC) but the program will be extended to include other forms of metastatic and advanced cancer that fits to the mechanism of action of OT-1096.

On October 9, 2018 Pfizer Inc. (NYSE:PFE) reported its executive team that will report to Albert Bourla, incoming Chief Executive Officer, coincident with the commencement of his new role effective January 1, 2019 (Press release, Pfizer, OCT 9, 2018, View Source [SID1234529943]).

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"We are at a pivotal moment in Pfizer’s history, with Ian Read having positioned the company with a strong portfolio of marketed products, a deep pipeline and the clear potential to accelerate our revenue growth,"
said Bourla. "Given this opportunity to realize this accelerated growth potential, we are creating an executive team that has a proven record of success, an unwavering commitment to the patients we serve, and a clear
value creation initiative. I look forward to working with these outstanding leaders to achieve the full potential of our pipeline and deliver our next stage of growth."

Frank D’Amelio – Chief Financial Officer and Executive Vice President, Global Supply and Business Operations, will also assume the leadership for our manufacturing operations, Pfizer Global Supply (PGS).

Mikael Dolsten – Global President, Worldwide Research and Development, and Medical, will also assume oversight of the Chief Medical Officer’s role.

Michael Goettler – Global President, Established Medicines. As previously announced Michael will lead the Established Medicines business that will operate as an autonomous, stand-alone unit within Pfizer.

Angela Hwang – Group President, Pfizer Innovative Medicines, will become the Group President of Pfizer’s science-based Innovative business responsible for the entire portfolio of innovative medicines.

Rady Johnson – Executive Vice President, Chief Compliance, Quality and Risk Officer, will continue in his role as the Company’s Chief Compliance Officer.

Doug Lankler – Executive Vice President, General Counsel, will continue in his role as the company’s General Counsel.

Freda Lewis-Hall – Executive Vice President, Chief Patient Officer, will assume a new role as Pfizer’s Chief Patient Officer, deploying the resources of the company to advocate on behalf of all patients who rely on Pfizer to deliver new therapies and vaccines.

Rod MacKenzie – Executive Vice President, Chief Development Officer, will expand his responsibilities to include Pfizer’s regulatory affairs function in addition to all late stage development activities.

Dawn Rogers – Executive Vice President, Chief Human Resources Officer, will continue to lead the Human Resources team.

Sally Susman – Executive Vice President, Chief Corporate Affairs Officer, will continue to lead the Corporate Affairs function.

John Young – Group President, Chief Business Officer, will assume a new role, responsible for strategy, business development, portfolio management and valuation activities; business analytics; global commercial operations; and Patient and Health Impact, among others. Pfizer’s Consumer Healthcare business will also report to John.

Given the growing strategic importance of deploying digital technologies in research, discovery and business processes, Pfizer is appointing a Chief Digital Officer responsible for creating and implementing a strategy that accelerates and improves our digital capabilities so we can deliver more value to patients. Lidia Fonseca will join Pfizer’s
Executive Leadership Team in January 2019, as Executive Vice President, Chief Digital and Technology Officer. She is currently the Chief Information Officer and Senior Vice President at Quest Diagnostics.
Previously, she served as SVP at Laboratory Corporation of America, Executive Vice President of Global Operations and Technology at Synarc Incorporated, and held several positions of increasing responsibility at Philips Healthcare.

Executive Vice President and President, PGS, Dr. Kirsten Lund-Jurgensen, will retire at the end of the year after 19 years at Pfizer, and Executive Vice President, Strategy & Commercial Operations, Laurie Olson, will retire effective January 1, 2019, after 32 years at Pfizer.