On July 22, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that Salarius Pharmaceuticals, LLC, has closed its merger with Flex Pharma, Inc.’s wholly owned subsidiary on July 19, 2019 (Press release, Flex Pharma, JUL 22, 2019, View Source [SID1234537640]). Flex Pharma, Inc. has been renamed and will operate as Salarius Pharmaceuticals, Inc. The newly combined company will focus on the continued development of Salarius’ clinical pipeline, which targets rare, orphan cancers for which no approved targeted treatments are currently available and cancers with a high unmet need. The company will be led by Salarius’ current management team under the leadership of President and CEO, David Arthur. Former Flex Pharma President and CEO, William McVicar, Ph.D., will join Salarius’ Board of Directors. The company’s common stock will trade on the Nasdaq Capital Market under the new ticker symbol "SLRX" beginning on July 22, 2019 and will reflect the previously announced 25:1 reverse stock split that occurred effective as of the close of business on July 19, 2019.

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David Arthur, President and CEO of Salarius Pharmaceuticals, stated, "We believe this strategic merger and Nasdaq listing establishes a foundation for future growth. The enhanced visibility and exposure to institutional investors will allow Salarius to showcase the potential of our lead asset, Seclidemstat, and showcase our clinical pipeline. We look forward to sharing important updates with our investors as we advance our clinical programs."

Salarius’ lead compound, Seclidemstat, targets the epigenetic dysregulation underlying Ewing sarcoma, a devastating pediatric, adolescent, and young adult bone and soft-tissue cancer for which no approved targeted therapies are currently available. Seclidemstat is a differentiated, reversible inhibitor of lysine-specific demethylase 1, or LSD1, which is a widely studied epigenetic enzyme and a validated drug target for clinical development. Salarius is currently enrolling refractory and relapsed Ewing sarcoma patients in an open-label Phase 1 dose escalation/dose expansion study, with potential early cohort data readouts in 2020. Salarius is also conducting a Phase 1 clinical study of Seclidemstat in patients with advanced solid tumors including, but not limited to, prostate, breast, and ovarian cancers.

Healthios Capital Markets served as financial advisor in the transaction to Salarius Pharmaceuticals and Flex Pharma’s strategic advisor was Wedbush PacGrow. Pillsbury Winthrop Shaw Pittman LLP is serving as legal counsel to Salarius Pharmaceuticals and Dentons is serving as legal counsel to Flex Pharma.

On July 22, 2019 HAMLET Pharma is reported the successful outcome of the Phase I/II trial, aimed at studying the safety and efficacy of Alpha1H in patients with bladder cancer (Press release, HAMLET Pharma, JUL 22, 2019, View Source [SID1234537656]). The first data analysis has revealed highly significant differences between the Alpha1H treated patients and the placebo group, for several crucial efficacy variables. Treatment was also shown to be safe, as no drug-related side effects were observed.

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Alpha1H triggered significant shedding of cells in all tumor patients, who received the treatment (p< 0.0001).In addition, Alpha1H triggered the excretion of whole tumor fragments into the urine (p<0.0001), illustrating the potent effect compared to the placebo group.

"This is a bench-to-bedside moment and we are grateful to all, who have made this possible. The results inspire us to continue the efforts making Alpha1H available to cancer patients," says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.

"This is a very important milestone for the company. We need more evidence but hopefully this could be the gentle chemotherapy of the future," says Mats Persson, CEO of Hamlet Pharma Ltd.

Alpha1H triggered cell death in the tumor, as shown by cytolysis and apoptosis, a beneficial form of cell death. These findings support the key mechanisms of action of Alpha1H discovered in the laboratory and the successful translation from the laboratory to the clinic.

Carefully selected safety variables were recorded according to safety guidelines. The effects of Alpha1H occurred without drug-related side effects in the patients, consistent with the lack of toxicity observed in animal models of bladder cancer.

The clinical trial of 40 patients (20 placebo and 20 with treatment who received 6 infusions over 22 days) has been a technical success, due to the competence and commitment of the different study teams involved. A team of experts at the Motol University Hospital in Prague handled patient enrolment, clinical care, pathology assessments and treatment. The study was monitored by a highly renowned, clinical trial CRO in Prague. Scientific coordination was from Lund University, where research sample analysis was handled and molecular information obtained. Additional study variables will be communicated as soon as data is available.

Notes to Editors

HAMLET Pharma plans to conduct further studies in bladder cancer and several other cancer indications, such as colon cancer and brain tumors; all hard to cure with current therapies. HAMLET Pharma has 35 patents for the manufacturing and use of HAMLET as well as the second-generation Alpha1H derivative of the HAMLET molecule. HAMLET has been found to kill more than forty types of cancer cells to date in laboratories. The work has been published in leading international journals like The New England Journal of Medicine, GUT commented in Nature Reviews Gastroenterology and PNAS (Proceedings of the National Academy of Science, USA).

On July 22, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported it has enrolled the first patient in a Phase 1 clinical study of the company’s lead compound, Seclidemstat, in patients with advanced solid tumors resistant to standard-of-care therapies. Seclidemstat is a differentiated reversible inhibitor of the widely studied epigenetic enzyme lysine-specific demethylase 1 (LSD1) (Press release, Flex Pharma, JUL 22, 2019, View Source [SID1234537641]). This is Salarius’ second Phase 1 clinical study for Seclidemstat, which is also the subject of an ongoing clinical study focused on Ewing sarcoma, a devastating bone and soft tissue cancer for which Seclidemstat has Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA). Salarius expects to report early cohort data from both Phase 1 clinical studies in 2020.

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David Arthur, President and CEO of Salarius Pharmaceuticals, stated, "We are excited to expand our clinical pipeline for Seclidemstat to include patients with advanced solid tumors and we believe addressing the epigenetic dysregulation underlying certain cancers represents a potentially powerful approach to providing a therapeutic benefit for patients with limited or no other treatment options. With potential data readouts from both clinical programs expected next year, we hope to further establish Salarius in this exciting and growing field."

Seclidemstat is an oral small molecule inhibitor of LSD1, a validated drug target for clinical development. LSD1 is known to associate with more than 60 different gene regulatory proteins to drive a variety of cancer types. High levels of LSD1 expression are often correlated with poor patient prognosis. The open-label, dose escalation/dose expansion Phase 1 clinical study in advanced solid tumor cancers is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of Seclidemstat, as well as establish a recommended dose for Phase 2 studies. The study is enrolling patients with advanced (non-Ewing’s) solid tumors, with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing’s sarcomas and other cancers where Seclidemstat demonstrated single-agent preclinical activity. The study will also use established and exploratory biomarkers to assess sensitivity and early signs of therapeutic activity in these patients.

Michael Gordon, M.D., Medical Director of Oncology Clinical Trials at the HonorHealth Research Institute and principal investigator of the advanced solid tumor Phase 1 study, commented, "Epigenetics is a rapidly growing field within oncology, and selective yet reversible inhibitors such as Seclidemstat represent the cutting-edge progress being made in this space. We know that epigenetic modulation by LSD1 occurs not only through its enzymatic activity as a demethylase, but also via its scaffolding properties. If clinical studies prove Seclidemstat is able to safely and effectively inhibit both mechanisms of gene regulation by LSD1, which is supported by substantial preclinical work, Seclidemstat will have a highly differentiated profile that could translate into improved outcomes for patients."

On July 22, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the Company will release its second quarter 2019 financial results on Monday, August 5, 2019 before the U.S. financial markets open (Press release, Compugen, JUL 22, 2019, View Source [SID1234537657]). Management will host a corresponding conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On July 22, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated a radiation sub-study of its ADP-A2M4 trial in collaboration with the University of Texas MD Anderson Cancer Center in Houston, TX (Press release, Adaptimmune, JUL 22, 2019, View Source [SID1234537643]). Published data indicate that low-dose radiation has the potential to enhance T-cell responses in the context of solid tumors.(1)

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"We have seen compelling data in sarcoma with ADP-A2M4 SPEAR T-cells and will initiate our SPEARHEAD-1 trial for sarcoma patients later this year. In addition, we are eager to increase the depth and durability of the antitumor activity that we have observed in other solid tumors with ADP-A2M4," said Rafael Amado, Adaptimmune’s President of R&D. "There is emerging data showing that low-dose radiation could enhance T-cell tumor trafficking and responses. We are looking forward to the results of this radiation sub-study with ADP-A2M4."

The radiation sub-study is planned to enroll 10 patients across multiple solid tumor indications. Patients will receive low-dose radiation in up to 5 lesions prior to treatment with ADP-A2M4, at target doses of 1 to 10 billion SPEAR T-cells. The lymphodepletion regimen will be fludarabine (30 mg/m2/day) for 4 days and cyclophosphamide (600 mg/m2/day) for 3 days.

Adaptimmune and the MD Anderson Cancer Center have a multi-year strategic alliance designed to expedite the development of novel adoptive T-cell therapies for multiple types of cancer.