On September 20, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported the appointment of industry veteran Scott Garland as president and chief executive officer, effective October 8, 2018 (Press release, Portola Pharmaceuticals, SEP 20, 2018, View Source;p=irol-newsroomArticle&ID=2368241 [SID1234529523]). Mr. Garland brings to his new role more than two decades of broad executive leadership experience, including a strong track record driving multiple billion dollar product launches. He will also serve on the Company’s Board of Directors.

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Mr. Garland joins Portola from Relypsa, Inc., where he was president and previously chief commercial officer. During his tenure, Mr. Garland was responsible for the integration and growth of the U.S. operations after Relypsa was acquired by Vifor Pharma Group in 2016.

Prior to Relypsa, Mr. Garland was executive vice president and chief commercial officer of Exelixis, Inc., where he led global commercial operations and directed sales, marketing and market access in the United States. Previously, Mr. Garland spent close to a decade at Genentech leading full scale commercial franchises for two multi-billion dollar therapies – Avastin (bevacizumab) and Rituxan (rituximab). He started his career at Merck as a sales representative and then went on to serve at Amgen in various sales and marketing roles, including market development, to support the launch of Aranesp (darbepoetin alfa).

Hollings C. Renton, Chairman of the Board, said: "Scott is an exceptional choice to lead Portola through this exciting period of commercial evolution. His leadership and operational experience in hematology, oncology and hospital-based products aligns with our portfolio, and I am confident he will help realize the full potential of the Company’s life-changing medicines, drive long-term growth to maximize shareholder value and develop a best-in-class culture that will allow us to continue to attract and retain top industry talent. We look forward to introducing Scott during our third quarter conference call in early November."

Mr. Garland said: "This is a rare opportunity to join a company with two FDA-approved medicines, a promising compound in development and a financial position to support long-term growth. I am excited to partner with such a committed Board and leadership team to build on the Company’s current pace of innovation and focus on execution to deliver potentially life-saving therapies to patients."

Mr. Garland holds an M.B.A. from the Fuqua School of Business at Duke University and a Bachelor of Science degree in biological sciences from California Polytechnic State University, San Luis Obispo. He has been a member of the Board of Directors of Karyopharm Therapeutics since 2014.

On September 26, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported it will present an update on and data from its NBTXR3 development program at the International Conference on Immunotherapy Radiotherapy Combinations that will take place from September 20 to 22, 2018 in Paris, France (Press release, Nanobiotix, SEP 20, 2018, View Source [SID1234529669]).

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Follow-up of Phase I/II in advanced Head and Neck cancers in elderly and frail patients ineligible for cisplatin or
intolerant to cetuximab In the Phase I part of this trial, which is conducted to determinate the recommended dose, 18 patients have been injected with NBTXR3. Follow-up of patients that received highest doses of NBTXR3 (15% and 22% dose levels) shows that every patient alive at the 12-month cut-off date was still alive after 23 months or more. At 26 months, one of the patients treated at the 15% dose level had died.

These data suggest the potential of NBTXR3 to impact survival for this advanced cancer patient population.
Immuno biomarker study in randomized phase II/III soft tissue sarcoma clinical trial Immunohistochemistry analyses revealed that, compared to radiation therapy alone (29 patients), NBTXR3 activated by radiation therapy (23 patients) increased the density of CD8+ T cell lymphocyte, and decreased FOXP3+ (Treg) into the tumors, while macrophage number remained relatively constant. These data indicate that NBTXR3 activated by radiation therapy could modulate the antitumor immune response.

In vivo investigation of NBTXR3 mode of action inducing distant immune response on CT26 tumoral model
Depletion experiment of CD8+ T cells (NBTXR3+3x4Gy+anti-CD8) induces a partial loss of tumor growth control of
treated tumors, and a complete abolition of the abscopal effect (distal tumors). This result indicates that the abscopal effect was driven by CD8+ T cells. Interestingly, depletion of CD4+ T cells (NBTXR3+3x4Gy+anti-CD4) increases the efficacy of NBTXR3 + radiation therapy at both sites (treated and distal tumors). As anti-CD4 treatment lead to Treg depletion (known to have a protumoral role), Treg depletion might have improved NBTXR3 radiation therapy treatment. These observations continue to support the rationale for the use of NBTXR3 activated by radiation therapy to seek to transform tumors

On September 20, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings, at the 2018 Cantor Fitzgerald Global Healthcare Conference (Press release, Supernus, SEP 20, 2018, View Source [SID1234529925]).

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Date: Wednesday, October 3, 2018

Time: 8:35 a.m. ET
Place: InterContinental New York Barclays Hotel, New York City

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.

On September 20, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 1:10 p.m. EDT on Monday, October 1, at the Cantor Global Healthcare Conference (Press release, Puma Biotechnology, SEP 20, 2018, View Source [SID1234529505]). The conference will be held at the InterContinental New York Barclay Hotel.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On September 20, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing fusion protein therapies for the treatment of cancer, reported that the company will present its three-month Phase 3 VISTA Trial data during a poster session at the Global Congress on Bladder Cancer 2018 (Press release, Sesen Bio, SEP 20, 2018, View Source [SID1234529506]). The congress is being held Sept. 20-21, 2018 in Madrid. The ongoing VISTA registration trial is evaluating Vicinium, Sesen Bio’s lead product candidate, for the treatment of people with high-grade non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG).

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The data, which were presented during a plenary session at the American Urological Association Annual Meeting in May 2018, include a biomarker update showing that nearly all screened patient samples expressed EpCAM, the molecular target of Vicinium.

"We are delighted to present the three-month VISTA Trial data at the Global Congress on Bladder Cancer and further showcase the promise of Vicinium in treating people with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Today, patients who are unresponsive or become refractory to BCG therapy have virtually one option: complete removal of their bladder. This is a long, challenging and life-altering procedure with a high rate of mortality that nearly half of people who face it choose not to undergo. It is critically important that such people are provided an effective and tolerable option that spares them from having to make such a difficult decision and saves their bladder. We believe that Vicinium holds significant potential as a targeted treatment that could renew the lives of these underserved patients."

As announced in May, the three-month data are from 111 patients in the VISTA Trial with high-grade NMIBC that is either carcinoma in situ (CIS), which is cancer found on the inner lining of the bladder that has not spread into muscle or other tissue, with or without papillary disease, or from patients with papillary disease without CIS, which is cancer that has grown from the bladder lining out into the bladder, but has not spread into muscle or other tissue. In an analysis assessing pooled CIS patients (n=77), based on final U.S. Food and Drug Administration guidance on treatment of BCG-unresponsive CIS NMIBC patients (defined as patients with recurrent CIS within 12 months of adequate BCG therapy)1, Vicinium treatment resulted in a complete response rate of 42 percent at three months. In patients with papillary disease without CIS, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.

In addition, Vicinium has been well-tolerated in the VISTA Trial. Of the treatment-related adverse events in the three-month analysis, four percent were Grade 3 or 4, with no Grade 5 treatment-related adverse events. Four treatment-related serious adverse events were reported, including acute kidney injury or renal failure and cholestatic hepatitis.

About Vicinium
Vicinium (also known as VB4-845), Sesen Bio’s lead product candidate, is a fusion protein being developed for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.