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 20, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the pricing of its initial public offering of 6,000,000 shares of common stock at a public offering price of $16.00 per share, for gross proceeds of $96 million, before underwriting discounts and commissions and estimated offering expenses payable by the Company (Press release, Y-mAbs Therapeutics, SEP 20, 2018, View Source [SID1234529522]). All shares are being offered by the Company.

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In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock from the Company at the initial public offering price, less underwriting discounts and commissions.

The Company’s common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "YMAB" on Friday, September 21, 2018. The offering is expected to close on Tuesday, September 25, 2018, subject to customary closing conditions.

BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager for the offering and BTIG is acting as co-manager for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission (the "SEC") on September 20, 2018. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by phone at (631) 274-2806.

Additionally, when available, copies of these documents may be obtained for free by accessing the EDGAR database on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 20, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the United States and Canada, to evaluate the combination of Daiichi Sankyo’s investigational HER2 targeting antibody drug conjugate DS-8201 and KEYTRUDA (pembrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC) (Press release, Daiichi Sankyo, SEP 20, 2018, View Source [SID1234529511]).

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"We are excited to pursue this opportunity to evaluate the safety, tolerability and activity of DS-8201 in combination with KEYTRUDA and whether this combination may provide a potential new treatment approach for patients with HER2 expressing advanced breast and non-small cell lung cancer," said Tom Held, Vice President, Head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo. "Strategic collaborations like this support our goal to pursue, investigate and maximize the application of DS-8201 in combination with other compounds that target different pathways to address unmet needs of patients with cancer."

About the Study

Under the terms of the agreement, Daiichi Sankyo will conduct a two-part phase 1b multicenter, open-label study to:

・ Determine the safety, tolerability and dose of DS-8201 in combination with KEYTRUDA and evaluate efficacy of the combination in patients with HER2 expressing advanced/metastatic breast cancer and patients with HER2 expressing or HER2 mutant advanced/metastatic NSCLC.

・ Enroll patients into one of four cohorts: patients with HER2 positive advanced breast cancer who have been previously treated with ado-trastuzumab emtansine (T-DM1) (cohort 1); patients with HER2 low expressing advanced breast cancer (IHC 1+ or IHC 2+/ISH-) who have received available standard of care (cohort 2); patients with HER2 expressing advanced NSCLC (IHC 1+, 2+, or 3+) who have not received prior treatment with anti-PD-1 or anti-PD-L1 agents (cohort 3); and patients with HER2 mutant advanced NSCLC who have not received prior treatment with anti-PD-1 or anti-PD-L1 agents (cohort 4).

The primary endpoints of the study are maximum tolerated dose/recommended expansion dose and overall response rate. Secondary endpoints include duration of response, disease control rate, progression-free survival, overall survival, time to response and safety. The study is expected to enroll approximately 125 patients in the U.S. and Europe. Additional details of the agreement were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About DS-8201

DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

DS-8201 is currently in pivotal phase 2 clinical development for HER2 positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) in North America, Europe and Asia; pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01) in Japan and South Korea; phase 2 development for HER2 expressing advanced colorectal cancer in North America, Europe and Japan; phase 2 development for unresectable and/or metastatic non-squamous HER2 overexpressing or HER2 mutated non-small cell lung cancer (NSCLC) in North America, Europe and Japan; and phase 1 development for other HER2 expressing advanced/unresectable or metastatic solid tumors in the U.S. and Japan.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration. DS-8201 has also been granted SAKIGAKE Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer.

DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On September 20, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported that the first three patients have been enrolled in its pivotal Phase 3 clinical trial, named ‘TRYbeCA1’, evaluating its lead product candidate eryaspase for the treatment of second line metastatic pancreatic cancer (Press release, ERYtech Pharma, SEP 20, 2018, View Source;p=RssLanding&cat=news&id=2368155 [SID1234529509]).

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The TRYbeCa1 (NCT03665441) trial will enroll approximately 500 patients with second line metastatic pancreatic cancer in 120-130 clinical sites in Europe and the US. Patients who meet the eligibility criteria are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/abraxane or irinotecan -based regimen) or chemotherapy alone until disease progression. The primary endpoint is overall survival. An interim analysis is foreseen when approximately two-thirds of events have occurred.

The launch of the TRYbeCA1 Phase 3 trial follows the positive Phase 2b results in the same patient population, that were reported in September 2017. This open-label, multi-center, 2-to-1 randomized study in 141 patients demonstrated significant improvement in both overall survival and progression-free survival. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.

"The results from our landmark Phase 2b study are highly promising and underscore the importance of targeting tumor metabolism pathways in pancreatic cancer. We are hopeful to provide a novel treatment modality for this highly unmet medical need. We are very pleased that eryaspase has now moved into Phase 3 and patient enrollment has started as planned. Our first three enrolled patients mark the initiation of the trial in Europe. Early next year, we expect sites in the United States will begin enrolling as well," commented Iman El-Hariry, Chief Medical Officer.

About pancreatic cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.

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.