On October 22, 2018 Taiho Pharmaceutical Co., Ltd. and Servier reported that the clinical data from the pivotal Phase III (TAGS) trial were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress held in Munich, Germany, from October 19 to 23 (Press release, Taiho, OCT 22, 2018, View Source [SID1234530335]). The study results were simultaneously published in The Lancet Oncology. Based on the results, Servier filed a new application for an additional indication for gastric cancer to the European Medicines Agency (EMA) for LONSURF.

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The TAGS trial evaluates LONSURF (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) cancers who have progressed or are intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. TAGS, a phase 3, randomised, double-blind study of trifluridine/tipiracil (TAS-102) versus placebo in patients with refractory metastatic gastric cancer (Abstract #LBA25), data were presented by Hendrik-Tobias Arkenau, MD, PhD, from the Sarah Cannon Research Institute UK at the ESMO (Free ESMO Whitepaper) 2018 Congress during an oral session on Sunday, October 21 at 11:10 AM CEST.

In the TAGS trial, patients treated with LONSURF showed a clinically meaningful and statistically significant improvement in OS compared with placebo, a 31 percent risk reduction of death (HR 0.69), which translated into a prolongation of median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo). In addition, LONSURF demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo, as well as a predictable and manageable safety profile consistent with that previously reported in patients with metastatic colorectal cancer (mCRC). Taiho Pharmaceutical and Servier remain committed to making further contributions to patients and to medical practitioners engaged in the treatment of cancer.

About TAGS
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine/tipiracil), also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial is overall survival (OS), and the main secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

The TAGS trial aimed to enroll 500 adults 18 years and older, with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The trial enrolled 507 subjects and was conducted in Japan, the United States, the European Union, Russia, Belarus, Israel, and Turkey.

For more information on the TAGS trial, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About Gastric Cancer
Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually1 . In Japan, gastric cancer is
the most common cancer and the third most common cause of cancer-related death (after lung and colorectal cancer), causing around 45,000 deaths annually2
.
In recent years, the outcome for gastric cancer has improved remarkably, and survival has increased dramatically over the past 10 years. As cancer progresses, however, numerous complications can limit the usable drugs and preclude intensive chemotherapy. Prolonging survival and relieving symptoms in late-stage treatment for metastatic gastric cancer are issues for which it is thought important to increase the options for new therapeutic drugs. At present, nivolumab and irinotecan are recommended in Japan as the standard third line treatment for metastatic
gastric cancer.

About LONSURF
LONSURF (trifluridine/tipiracil) is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S.
subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

In 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TYY Biopharm launched LONSURF in
Taiwan in July 2018, and Jeil Pharmaceutical is preparing to bring the drug to market in South Korea.

As of October 2018, LONSURF has been approved as a treatment for mCRC in 61 countries and regions worldwide.

On October 22, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that its third quarter 2018 financial results will be released after market close on Thursday, November 8, 2018 (Press release, Coherus Biosciences, OCT 22, 2018, View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" rel="nofollow">View Source [SID1234531696]). Starting at 4:30 p.m. ET, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing third quarter 2018 financial results, we will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, November 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7181479
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On October 22, 2018 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, presented clinical trial data from its lead oncology drug candidate, AMC303, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich (Press release, amcure, OCT 22, 2018, View Source [SID1234530042]). The data presented on Sunday, 21 October in a proffered oral presentation demonstrated the favorable safety profile of AMC303. The company is currently conducting a Phase 1b expansion cohort and expects to publish updates from the study in 2019.

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AMC303 is a cyclic peptide targeting CD44v6, a key cell membrane protein in pathways of several receptor-tyrosine kinases, such as c-MET, VEGFR-2 and RON. This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body. Trial results presented at ESMO (Free ESMO Whitepaper) 2018 have shown the compound to be well-tolerated in 27 patients with a total of 11 different cancer types, with a favorable PK profile. No related serious adverse events (SAEs) were reported, and most frequently reported related events were infusion related reactions and hypersensitivity (grade 1-2, in 22% of patients), followed by nausea, diarrhea and fatigue.

"AMC303 was well tolerated in a heavily pretreated and diverse cancer patient population. The most related adverse events were transient and manageable. AMC303 has thus the potential of being a safe therapeutic option with a unique and additive mechanism of action," said Dr. Emiliano Calvo, MD, Lead Investigator of the trial at the Hospital Madrid Norte Sanchinarro and Director at the START Madrid-CIOCC Early Phase Clinical Drug Development program.

"These encouraging data support the continuation of the trial into its second part, targeting patients with a moderate to high expression of the target molecule CD44v6 and selected cancer types with a confirmed squamous cell histology. We look forward to updating the community on the progress of this trial and publish additional data sets as they emerge," added Klaus Dembowsky, CEO of amcure GmbH.

The trial, conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. In addition, the study includes a comprehensive biomarker program. The study was designed to include a broad variety of tumor types in the first part of the study irrespective of the target expression and a tumor type-specific expansion cohort at the recommended dose for a subsequent Phase 2 study. With the expansion cohort, amcure focuses its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

For more information on the trial please visit View Source

About AMC303
amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

On October 22, 2018 Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet patient needs in aesthetic and medical dermatology and immunology, reported the closing of its underwritten public offering of 9,941,750 shares of its common stock at a price to the public of $10.75 per share, which includes the full exercise of the underwriters’ option to purchase 1,296,750 additional shares, for total gross proceeds of approximately $106.9 million, before deducting underwriting discounts and commissions and offering expenses (Press release, Aclaris Therapeutics, OCT 22, 2018, View Source [SID1234530061]). All of the common stock in the offering was sold by Aclaris.

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Leerink Partners and Evercore ISI acted as joint book-running managers for the offering. Cantor acted as lead manager for the offering. Guggenheim Securities acted as co-manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on November 2, 2016 and declared effective by the SEC on November 14, 2016. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other 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 other jurisdiction.

On October 22, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported positive interim data from the fully enrolled epithelioid sarcoma cohort of its ongoing Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor (Press release, Epizyme, OCT 22, 2018, View Source [SID1234530043]). The data were presented by the study’s lead investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Services, Memorial Sloan Kettering Cancer Center, during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany.

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Interim data as of August 21, 2018 from the 62 patients enrolled show that tazemetostat treatment demonstrated clinically meaningful activity for patients with epithelioid sarcoma (ES). Oral, twice daily administration of tazemetostat resulted in durable objective responses and encouraging overall survival in both treatment-naive patients and patients who had been previously treated with an anticancer therapy. In addition, tazemetostat was generally well-tolerated.

"Epithelioid sarcoma is a rare and aggressive form of soft tissue sarcoma, with limited effective treatment options available. We often see patients diagnosed with advanced disease who have a very poor prognosis," said Dr. Gounder. "It is highly encouraging to see these updated efficacy and tolerability data with tazemetostat, and I believe this agent has the potential to be an important treatment option for patients with epithelioid sarcoma and their treating physicians."

"We are very pleased with the interim data from this cohort, which represents the largest prospective study of epithelioid sarcoma with any approved or investigational anticancer treatment to date. The data presented today further demonstrate the potential treatment opportunity we see with tazemetostat," said Rob Bazemore, president and chief executive officer of Epizyme. "We are one step closer to achieving our mission of bringing epigenetic treatments to people with cancer and other serious diseases. We look forward to working with investigators and regulators in an effort to bring to market the potential first therapy indicated for patients with epithelioid sarcoma."

Epithelioid Sarcoma Interim Efficacy Data
Epithelioid sarcoma is an ultra-rare and aggressive soft tissue sarcoma, characterized by a loss of the INI1 protein. It is most commonly diagnosed in young adults (18-40 years old) and is often fatal, with a median survival of less than one year in treatment-naive patients. Today, there is no treatment indicated specifically for epithelioid sarcoma.

The ES cohort completed enrollment in July of 2017 with 24 treatment-naive patients and 38 relapsed and/or refractory patients for a total of 62 epithelioid sarcoma patients. The primary endpoint of the study is objective response rate (ORR), comprised of complete and partial responses as measured by RECIST 1.1. Key secondary endpoints include duration of response, overall survival, disease control rate (DCR; comprised of confirmed objective responses for any duration or disease stabilization of 32 weeks or more) and safety.

Interim findings are summarized below, based on an August 21, 2018 data cut-off date.

Notably, since the data cut-off, one patient in the treatment-naive group who had stable disease subsequently achieved an objective response. This additional patient brings the total to six responders (~25%) in this treatment-naive group and nine responders (15%) in the overall population, to date, with several patients with stable disease remaining on treatment.

Tazemetostat Interim Safety Data
Tazemetostat has been generally well-tolerated and continues to demonstrate favorable safety in the Phase 2 study, with no discontinuations or deaths due to treatment-related adverse events (AEs) observed. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2. Only 13 percent of patients experienced a grade 3 or higher treatment-related AE. Treatment-related AEs with an incidence of 10 percent or greater were fatigue (26%), nausea (26%), decreased appetite (16%), vomiting (16%), diarrhea and weight decrease (13%) and anemia (10%).

"We are pleased with the clinically meaningful and durable objective responses observed in this study, with a number of stable disease patients who are still on treatment and have the potential to achieve an objective response in the future," stated Dr. Shefali Agarwal, medical oncologist and chief medical officer of Epizyme. "These updated efficacy and safety data from the completed ES cohort suggest that tazemetostat may play an important role for patients in the future, particularly when considering the known limitations and challenges with current treatment options, and further bolster our confidence in our first planned NDA submission for tazemetostat. I’d like to thank the study investigators, medical staffs, and most importantly, the patients and caregivers, who have participated in this trial and supported the ongoing development of tazemetostat."

Conference Call Information
Epizyme management will host a conference call today at 8:30 am E.T. To participate in the conference call, please dial 877-844-6886 (domestic) or 970-315-0315 (international) and refer to conference ID 8780088. The webcast can be accessed in the Investor Relations section of the company’s website at www.epizyme.com. The replay of the webcast will be available in the investor section of the company’s website for 60 days.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).