On July 25, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee consisting of clinical and drug safety experts evaluated the safety data from the first dose cohort and recommended continuation with the second dose cohort in the ongoing Phase Ib/II EMERGE study (ClinicalTrials.gov identifier: NCT03812796) (Press release, 4SC, JUL 25, 2019, View Source [SID1234537749]). Patient recruitment for the second dose cohort has been initiated. The study is being conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

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The multi-center, single-arm, open-label study initiated in January 2019, is a dose escalation study, conducted initially in up to 15 patients with microsatellite-stable gastrointestinal cancer. The study evaluates domatinostat in combination with the checkpoint inhibitor avelumab. The study is conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with a checkpoint inhibitor and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose.

Prof. Cunningham said: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review and are looking forward to enrolling patients into the second dose cohort, especially as checkpoint inhibitors alone so far have not shown clinical activity in patients with microsatellite-stable gastrointestinal cancer."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies, such as the SENSITIZE trial of domatinostat in combination with pembrolizumab, another checkpoint inhibitor, in patients with advanced-stage melanoma.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."

On July 25, 2019 Neuralstem, Inc. (Nasdaq: CUR) ("Neuralstem" or the "Company") reported the pricing of its underwritten public offering of an aggregate of 2,777,777 units at a public offering price of $2.70 per unit for gross proceeds of approximately $7,500,000, before deducting discount and commissions and estimated offering expenses (Press release, Neuralstem, JUL 25, 2019, View Source [SID1234537765]). Each unit is comprised of one share of common stock (or common stock equivalent), one short-term warrant to purchase one share of common stock and one long-term warrant to purchase one share of common stock (collectively, a "warrant combination"). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 416,666 shares of common stock and/or additional 416,666 warrant combinations at the public offering price per share and per warrant combination, before deducting underwriting discounts and commissions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Each short-term warrant has an exercise price of $2.70 per share, is exercisable immediately and terminates on December 31, 2020. Each long-term warrant has an exercise price of $2.70 per share and is exercisable immediately for five years from the issuance date. The shares of common stock (or common stock equivalents), the short-term warrants and long-term warrants comprising the units will be immediately separable upon issuance and will be issued separately. This offering is expected to close on or about July 30, 2019, subject to customary closing conditions.

The net proceeds of the offering are expected to be approximately $6.6 million, after deducting underwriting discounts and commissions and estimated offering expenses. The Company intends to use the net proceeds of the offering for the further development of our stem cell and small molecule assets, advancement of the Company’s acquisition and in-licensing strategy and general corporate purposes.

The securities described above are being offered by the Company pursuant to a registration statement (file no. 333-232273) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 25, 2019. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the securities being offered has been filed with the SEC and is available on the SEC’s website at www.sec.gov and a final prospectus will be filed with the SEC. Electronic copies of the final prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected], or at the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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 July 25, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has started its SPEARHEAD-1 trial with ADP-A2M4 SPEAR T-cells for patients with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) (Press release, Adaptimmune, JUL 25, 2019, View Source [SID1234537734]). Earlier this year, Adaptimmune presented compelling data with responses observed in synovial sarcoma patients treated in the ADP-A2M4 pilot study.

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"This is a pivotal moment for Adaptimmune as we move into the next phase of clinical development with our ADP-A2M4 SPEAR T-cells. We started SPEARHEAD-1 based on the compelling data we recently reported in synovial sarcoma patients. Since our update in May, we have started the three new clinical trials we had committed to: SPEARHEAD-1, SURPASS, and the low-dose radiation sub-study with ADP-A2M4," said Rafael Amado, Adaptimmune’s President of Research & Development. "We are collaborating with excellent centers in this sarcoma trial. We look forward to reporting data from this trial and our other ongoing trials in due course."

The SPEARHEAD-1 trial will treat up to 60 patients with inoperable or metastatic synovial sarcoma or MRCLS who have received prior chemotherapy. Patients will receive doses of up to 10 billion ADP-A2M4 SPEAR T-cells and the lymphodepletion regimen of fludarabine (30 mg/m2/day for 4 days) and cyclophosphamide (600 mg/m2/day for 3 days). The primary endpoint is overall response rate by RECIST v1.1 by independent review. Safety endpoints will be reviewed by an Independent Data Safety Monitoring Board.

"As we make continued progress on the development of our proprietary SPEAR T-cells in solid tumors, we have started preparing for the time when we make our first product commercially available to cancer patients," said Helen Tayton-Martin, Chief Business Officer at Adaptimmune. "We are focused on how to optimally deliver our products through clinical trials and into scaled-up production post-approval. As part of these efforts, we are working with Vineti, the first cloud-based software platform to efficiently take T-cell therapies through clinical trials and into mainstream medicine at commercial scale."

On July 25, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019 (Press release, Verastem, JUL 25, 2019, View Source [SID1234537750]).

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The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 6256817. The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

On July 25, 2019 DURECT Corporation (Nasdaq: DRRX) reported that it will report second quarter and six months ended June 30, 2019 financial results and host a conference call after the market close on Thursday, August 1, 2019 (Press release, DURECT, JUL 25, 2019, https://www.prnewswire.com/news-releases/durect-corporation-to-announce-second-quarter-2019-financial-results-on-august-1-300891306.html [SID1234537766]).

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Thursday, August 1 at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13692344
Webcast: View Source

A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Event Calendar in the "Investors" section.