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First domatinostat combination data from Phase Ib/II SENSITIZE study presented at ESMO

On September 30, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the publication of data from the first part of the Phase Ib/II SENSITIZE Study at the European Society for Medical Oncology Congress 2019 in Barcelona (Press release, 4SC, SEP 30, 2019, https://www.4sc.com/news/first-domatinostat-combination-data-from-phase-ib-ii-sensitize-study-presented-at-esmo/ [SID1234539936]).

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The SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitor).

In the first part of the study, three patient cohorts were treated at three different dose levels of domatinostat in combination with pembrolizumab. At the time of data cut-off (July 15th, 2019, study still ongoing) a total of 23 patients were enrolled into the study:

Domatinostat in combination with pembrolizumab was safe and well tolerated
No increase in frequency or intensity of immune-related AEs observed
Signs of efficacy were observed, including one patient with a confirmed partial response and 7 patients with stable disease (4 confirmed)
Indication of dose-dependency for domatinostat, with best results at the highest dose
Preliminary biomarker analyses indicate a domatinostat-induced change in immunological tumor patterns
Jason Loveridge, Ph.D., CEO of 4SC: "Taking note of the favorable safety profile and first signs of clinical efficacy from the combination of domatinostat and pembrolizumab in this very hard to treat, anti-PD-1-refractory patient population is exciting and hugely encouraging. Especially since the preliminary tumor analyses indicates a confirmation of the proposed domatinostat-induced immunological effect. As such, we believe that the combination of domatinostat with anti-PD-(L)1 will provide a valuable therapeutic option for patients that do not respond to checkpoint blockade alone and we now look forward to starting our MERKLIN study in a comparable group of patients with Merkel-cell carcinoma within the coming months."

Phase II Study results of trabectedin combined with low-dose radiation therapy for Soft Tissue Sarcoma are presented at ESMO

On September 30, 2019 Sarcoma Research Groups in Spain, France and Italy, in collaboration with PharmaMar (MSE:PHM), reported that have presented the results of the metastatic patient group cohort from the single-arm, phase II multicenter study of trabectedin in combination with low-dose radiation therapy for the treatment of Soft Tissue Sarcoma (STS) (Press release, PharmaMar, SEP 30, 2019, View Source [SID1234539935]). The results were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which is being held from September 27th to October 1st in Barcelona.

The study, led by Dr. Martín Broto, oncologist at the Virgen del Rocío University Hospital in Seville (Spain), has reached its primary endpoint of Overall Response Rate (ORR), with 55.6% of responses to the treatment.

Trabectedin in combination with a low-dose of radiotherapy has shown relevant activity in a wide range of soft tissue sarcoma types in patients with advanced metastatic disease, giving other therapeutic options for tumor reduction beyond the first line of treatment.

In addition, this combination has shown a significant impact on Progression Free Survival (PFS) and Overall Survival (OS) in patients with advanced disease who have received a median of two previous lines of treatment. The six-month median for PFS was 75%, while the six-month median for OS was reached by 86% of patients.

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Five Prime Therapeutics Presents Updated Data From the Phase 1a/1b Trial of FPA150 at the European Society for Medical Oncology 2019 Congress

On September 30, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, reported updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain (Press release, Five Prime Therapeutics, SEP 30, 2019, View Source [SID1234539934]). The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.

The FPA150 data presented at ESMO (Free ESMO Whitepaper) included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer.

"B7-H4 is a novel T cell immune checkpoint and the early results from the phase 1b monotherapy portion of our FPA150 study provide the first clinical demonstration of B7-H4 as a potential therapeutic target," said Helen Collins, Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Based on the study results to-date, we continue to believe that the most promising opportunity for FPA150 is in combination with other therapeutic agents."

Key highlights from the presentation include:

Phase 1 FPA150 Monotherapy:

Two patients with B7-H4 positive ovarian cancer experienced a confirmed partial response (one in the dose escalation and one at the recommended dose of 20mg/kg)

10 patients with stable disease remain on therapy as of August 9, 2019

Increased tumor infiltration of T cells and NK cells observed in patients with a partial response or stable disease

Recommended dose of 20 mg/kg was well tolerated in all patients

Phase 1 Safety Lead-in Combination of FPA150 + Pembrolizumab :

Combination was well tolerated in the first four patients treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)

Expansion initiated in August 2019 in a cohort of ovarian cancer patients with B7-H4 overexpression

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 overexpression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as promoting enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4.

Entry into a Material Definitive Agreement

On September 26, 2019, vTv Therapeutics Inc. (the "Company"), reported that it has entered into a letter agreement (the "September 2019 Letter Agreement"), with MacAndrews & Forbes Group LLC (the "Investor"), for the Investor’s commitment to purchase, at the Company’s option, exercisable on demand during a one-year period after the date of the Letter Agreement (the "Investment Period"), the Company’s Class A common stock, par value $0.01 per share ("Common Stock") at a per share price of $1.46, which is equal to the closing price of the Common Stock for the trading day prior to the date of the September 2019 Letter Agreement (Filing, 8-K, vTv Therapeutics, SEP 30, 2019, View Source [SID1234539933]). The September 2019 Letter Agreement also permits the Investor to exercise an option to purchase Common Stock at the same price up to three times during the Investment Period. The aggregate amount of Common Stock that may be purchased by the Investor (whether at its or the Company’s option) pursuant to the September 2019 Letter Agreement is limited to $10.0 million.

In consideration for the commitment of the Investor under the September 2019 Letter Agreement, the Investor will receive warrants (the "Warrants") to purchase 400,990 shares of the Company’s Common Stock, exercisable at a price of $1.68, which is 115% of the option price under the September 2019 Letter Agreement. The Warrants will be exercisable until September 26, 2026.

The obligation of the Investor to fund and the obligation of the Company to issue shares under the September 2019 Letter Agreement is subject to the execution of mutually acceptable definitive documentation at the time of a request for funding.

As of September 26, 2019, subsidiaries and affiliates of the Investor held 23,084,267 shares of the Company’s Class B Common Stock and 23,506,897 shares of the Company’s Class A Common Stock. As a result, the Investor’s holdings represent approximately 81.5% of the combined voting power of the Company’s outstanding common stock. One of the Company’s directors, Paul G. Savas, is also an employee of the Investor. The transactions described above were approved in accordance with the Company’s Related Person Transactions Policy.

The descriptions of the September 2019 Letter Agreement and the Warrants contained herein do not purport to be complete and are qualified in their entirety by reference to the September 2019 Letter Agreement and the Warrants, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2019.

Synlogic to Present at the Chardan 3rd Annual Genetic Medicines Conference

On September 30, 2019 Synlogic, Inc. (NASDAQ: SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will provide a corporate update at the Chardan 3rd Annual Genetic Medicines Conference on Monday, October 7 at 4:15 pm ET, in New York City (Press release, Synlogic, SEP 30, 2019, View Source [SID1234539932]).

A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.