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.

On October 9, 2018 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported its important new long-term clinical trial results from the Company’s 146 patient Phase IIb NX03-0040 Fexapotide (FT) U.S. study for low grade localized prostate cancer (Press release, Nymox, OCT 9, 2018, View Source [SID1234529926]). All patients in the 78 month study had greater than or equal to 56 months from the time of enrollment, with a range of 56 to 78 months. After 78 months, the data shows that men who received the high dose Fexapotide 15mg single dosage treatment had a 73% reduction in the need for surgery or radiotherapy associated with much more favorable biopsy Gleason results compared to controls (p=.0024). There were 5% patients in the entire Fexapotide group (high dose and low dose) who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037).

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In the low grade localized prostate cancer trial reported today, Fexapotide triflutate (FT) was administered by a single painless injection directly into the prostate in a simple procedure requiring several minutes or less in an office setting without sedation or anesthesia, and guided by routine ultrasound. FT was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040. The patients were then biopsied after 6 weeks and then every 18 months, along with serial PSA measurements and long-term follow-up. After 78 months of study, high dose FT 15mg single treatment resulted in 73% less surgery or radiotherapy associated with Gleason grade progression (p=.0024), and both doses of FT (15mg and 2.5mg) as a group were overall effective (p=.0037). The 15mg dose was more effective than the lower dose. There were 5% patients in the entire FT group who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037). After 78 months all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 65.4% (p=.0014) in FT 15mg treated patients compared to the randomized control group. Numerous other parameters were significantly better in the FT treated groups compared to controls. Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. with 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer.

The Company expects to publish full details from this prostate cancer trial in peer review publications as well as participation in upcoming scientific presentations.

Paul Averback, CEO of Nymox, said, "These exciting new results confirm and expand the evidence for the beneficial long-term effect of a virtually painless and safe minimal administration of Fexapotide Triflutate to men with low grade localized prostate cancer. The risk of prostate cancer progression is very significantly reduced in these U.S. clinical trials, based on objective evidence from biopsies and surgery. It is important to emphasize that Fexapotide has also been shown to be associated with a major reduction in the incidence of new prostate cancer in men suffering from BPH (benign prostatic hyperplasia). This additional evidence comes from patients who received FT for their BPH in Nymox’s long-term studies of 977 men with BPH in the U.S. as part of Nymox’s pivotal Phase 3 BPH clinical program. Both 1) the long-term data reported here today involving treatment of biopsy established low grade localized cancers, and 2) the long-term prevention of new confirmed cancer in BPH patients reported previously, together indicate that FT has shown significant efficacy in men for the treatment and prevention of prostate cancer, without the risks and undesirable side effects generally associated with treatment of these conditions."

Dr. Averback added, "These strong results clearly support Management’s ongoing efforts to advance both of the Company’s 2 major clinical programs towards marketing goals. Nymox has taken the first steps toward an anticipated meeting with regulatory authorities concerning planning for registration trials for low grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable risks and often permanent side effects of current treatments."

The Company recently published and reported on the long-term safety of re-administration of Fexapotide based on re-injection studies NX02-0020 and NX02-0022 involving 344 men given Fexapotide re-injections in 2 Phase 3 multi-year re-injection safety trials. Re-injection safety data is a key necessity for injection treatments. It is expected for prostate cancer treatment that follow-up and intermittent re-treatments will be needed and desirable for many if not the majority of men who require treatment.

Low grade localized prostate cancer (T1c) represents approximately half of prostate cancers that are diagnosed, and is a very common treatment problem. The Nymox study reported today involves patients with initially Gleason grade 3+3 or lower. These patients are found to have these tumors by biopsy which is usually instituted after finding abnormalities in PSA levels, and/or after abnormal digital rectal examination of the prostate, and/or after the patient has experienced lower urinary tract symptoms or other changes.

Low grade localized prostate cancer represents a therapeutic challenge. Because of its slow growth and low initial level of malignancy, doctors and patients are often reluctant to proceed to invasive surgical treatments or radiotherapy due to the unpleasant and often permanent side effects these treatments cause in the genitourinary tract, such as sexual functional issues and/ or urinary issues. Eventually if and when the tumor progresses, invasive surgical and/or radiotherapeutic procedures become necessary, with greater risk due to the progression. Occasionally the tumors become highly malignant after variable lengths of time. These risks cause understandable anxieties and distress and many men prefer to advance to invasive therapy before running these risks of higher grade cancers.

It is widely acknowledged that a treatment alternative that can destroy or ablate the low grade cancers of the prostate without the dreaded side effects and morbidities, would be a great addition to the armamentarium of the urologist for the benefit of these patients. FT is the leading contender to deliver chemical ablation of low grade localized cancers of the prostate, without major safety risks, and to be capable of safe multiple treatments when necessary. Low grade cancers of the prostate are frequently multifocal and should be expected to require retreatments for the different cancer foci; for cancer foci that are not fully ablated; and for new cancerous foci that develop.

FT is Nymox’s first in class injectable treatment for BPH and low grade localized prostate cancer. The drug is given as a virtually painless injection with no anesthesia, analgesia or catheterization, and is an office procedure which takes a few minutes to administer. FT has been in development for BPH (prostate enlargement) for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with BPH to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical BPH program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover FT in the trial, as compared to patients who did not receive FT but instead received crossover conventional approved BPH treatments. The recent results of Phase 3 studies of Fexapotide for BPH were published earlier this year in the World Journal of Urology (May, 2018, Volume 36, Issue 5, pages 801-809) and communicated in numerous podium and symposium presentations to the American Urological Association, most recently at the Annual Meeting of the AUA in San Francisco on May 20, 2018.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk. One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, brachytherapy) is the relatively high incidence of serious sexual and other problems post-treatment. In 9 studies, Fexapotide treatment has been shown to have a negligible significant adverse effect profile post-treatment and no significant adverse effects on sexual or other functions or testosterone levels.