On April 26, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported that the Company intends to release its operational highlights and financial results for the quarter ended March 31, 2018 on Tuesday, May 8, 2018, and to host a conference call the same day at 4:30 p.m. EDT (Press release, Synthetic Biologics, APR 26, 2018, View Source [SID1234525768]). The dial-in information for the call is as follows:

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U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

On April 26, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the FORWARD I Phase 3 registration trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer will continue as planned without modification (Press release, ImmunoGen, APR 26, 2018, View Source [SID1234525743]). The decision follows a recommendation by the Independent Data Monitoring Committee (IDMC) based upon successful completion of a pre-specified interim futility analysis after 80 progression-free survival (PFS) events as determined by blinded, independent central review. ImmunoGen has also completed full enrollment of the trial two months ahead of schedule and expects top-line results from FORWARD I during the first half of 2019.

"Ovarian cancer is the leading cause of death from gynecological cancers, and patients diagnosed with this life-threatening disease have limited treatment options, especially once they develop platinum-resistant disease," said Anna Berkenblit, M.D., vice president and chief medical officer of ImmunoGen. "We are encouraged that the IDMC recommended FORWARD I proceed as planned and are pleased that the trial has reached full enrollment earlier than expected. We look forward to assessing top-line data in the first half of 2019."

FORWARD I is an ongoing Phase 3 trial designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of folate receptor alpha (FRα) who have been treated with up to three prior regimens. The primary endpoint of this study is PFS, which is being assessed in the entire study population and in the subset of patients with high FRα expression. Enrollment was initially planned to be completed by the end of June.

ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe. This trial is intended to support full marketing approval of mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill these targeted cancer cells.

Mirvetuximab is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in the Phase 1b/2 FORWARD II trial.

About Ovarian Cancer and FRα
It is estimated that 22,000 women are diagnosed annually with ovarian cancer in the US. With more than 14,000 deaths each year, ovarian cancer accounts for more deaths than any other cancer of the female reproductive system.1

Standard first-line therapy for ovarian cancer is a platinum-based combination regimen. Once the cancer becomes platinum-resistant, treatment options include single-agent cytotoxic therapies such as pegylated liposomal doxorubicin, paclitaxel, or topotecan, and combination therapies that include Avastin.

There is a significant need for more effective, better-tolerated therapies for recurrent ovarian cancer. It is estimated that approximately 19,000 women in the US and approximately 24,000 women in the EU have platinum-resistant ovarian cancer requiring second-line or later treatment.2 ImmunoGen estimates that 60% of ovarian cancer cases have medium or high FRα expression.

On April 26, 2018 The PharmaMar Group (MSE: PHM) reported €44.7 million in total revenues in the first quarter of 2018, compared with €45.5 million in the same period of 2017 (Press release, PharmaMar, APR 26, 2018, View Source [SID1234526548]). Of that figure, €18.4 million were related to sales of
Yondelis, compared to €22.5 million in the same period of the previous year. The difference was mainly due to the fact that a major order from the Scandinavian distributor was shifted to the second quarter. Consequently, that volume will be recovered in the following months. Other factors that contributed to this difference in quarterly revenues were the fact that there were no sales of raw material to partners Janssen and Taiho in 1Q18, contrasting with €1.4 million in the same period of the previous year, and also price erosion in some European countries.

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Revenues in the Consumer Chemicals division totaled €16.8 million in the first quarter of 2018, compared with €17.4 million in the same period last year. This slight difference was mainly due to the fact that the distributors delayed their summer insecticide sale campaign due to adverse weather in the last few months.

Revenues from royalties, licensing and other agreements amounted to €8 million in the first quarter of 2018, compared with €3.8 million in the first quarter last year. This item included €4 million collected under the agreement signed with Seattle Genetics in February.
As a result, group EBITDA amounted to €-0.9 million in the first quarter of 2018.

The group reported a net attributable loss of €-1.3 million in the first quarter of 2018, which represents a 45% improvement on the €-2.4 million recorded in the first quarter of 2017.

On April 26, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that it will report its first quarter financial results before the open of the U.S. markets on Thursday, May 3, 2018 (Press release, Pacira Pharmaceuticals, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344859 [SID1234525722]). The announcement will be followed by a conference call at 8:30 a.m. ET. Participating in the call from Pacira will be Dave Stack, chairman and chief executive officer, and other members of the company’s senior management team.

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The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 6585169. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 6585169. The replay of the call will be available for one week from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

On April 26, 2018 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, reported the start of a Phase II combination trial of its lead compound ISA101b and Pfizer´s 4-1BB agonist Utomilumab, which will be sponsored and conducted by The University of Texas MD Anderson Cancer Center (Houston, TX) (Press release, ISA Pharmaceuticals, APR 26, 2018, View Source [SID1234525744]).

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The goal of the open-label Phase II study in patients with HPV16-positive, incurable oropharyngeal cancer is to investigate whether a combination of ISA101b with Utolimumab is able to shrink or slow the growth of tumors. The safety of the study drugs will also be evaluated. The study will enroll up to 27 patients, who will receive three subcutaneous administrations of ISA101b at four-week intervals and Utolimumab intravenously every 4 weeks for up to 12 doses. Primary endpoint of the study will be Overall Response Rate (ORR) assessed by RECIST 1.1 criteria. Secondary endpoints include adverse events, response rates monitored by radiographic assessment and immune-related progression-free survival monitored by radiographic assessment.

ISA Pharmaceuticals´ lead compound ISA101 is a clinical-stage SLP immunotherapy targeting HPV16-induced diseases such as cervical cancer and head and neck cancer. Utolimumab, a 4-1BB agonist, is under investigation by Pfizer for the treatment of various cancers

"We are very excited to launch this second trial in our collaboration with ISA and Dr. Melief. The study has the potential to demonstrate Utomilumab’s specific effect on vaccine-induced T cells with enhanced tumoricidal activity," said Bonnie Glisson, MD, Professor in the Department of Thoracic/Head and Neck Medical Oncology at MD Anderson and principle investigator of the study. "The ISA101b plus Utomilumab trial represents the clinical translation of research at MD Anderson by Drs. Curran and Sastry which showed that an HPV peptide vaccine and 4-1BB agonist antibody was the most effective vaccine I/O combination in mouse models of HPV-driven cancer."

"We are delighted to expand our collaboration with MD Anderson by this second Phase II trial," said Prof. Cornelis Melief, CSO of ISA Pharmaceuticals. "ISA101 has so far demonstrated great potential for the treatment of patients with HPV16-positive solid tumors and our goal is to provide novel, advanced therapeutic options for these patients. Combining our vaccine with Utolimumab is an exquisite opportunity to explore a promising new option, because Utolimumab is likely to expand vaccine-induced tumor-specific T cells."

Oropharyngeal cancer, a subtype of head and neck cancer, affects tissues of the throat (oropharynx), e.g. the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx. Oropharyngeal cancers can be divided into two types: HPV-positive, which are related to human papillomavirus infection, and HPV-negative cancers, which are usually linked to alcohol or tobacco use.