On June 15, 2020 Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter "Solasia"), a specialty pharmaceutical company based in Asia, reported the positive results from the pivotal Phase 2 study with SP-02 (a new anti-cancer drug, international generic name: darinaparsin, hereinafter "darinaparsin") for relapsed or refractory peripheral T-cell lymphoma (hereinafter "PTCL") in Asia (Press release, Solasia, JUN 15, 2020, View Source [SID1234561108]).

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The primary endpoint (antitumor effect) was achieved.
No new safety concerns were identified in the safety analysis.
This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL. Solasia begins preparing for the NDA Filing.
Darinaparsin is a novel mitochondrial targeting drug (organic arsenic compound) that has been developed for the treatment of various hematological cancers and solid cancers. This study was conducted as a multinational, multicentre, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in relapsed or refractory patients with PTCL in Japan, South Korea, Taiwan and Hong Kong.

Solasia holds an exclusive worldwide license to develop and commercialize darinaparsin. For Japan market, Solasia has already entered into an exclusive license agreement with Meiji Seika Pharma Co., Ltd., for the commercialization of darinaparsin, and for Latin America, with HB Human BioScience SAS. Based on these positive results, Solasia will actively seek licensing partners for the United States, Europe and other regions.

About darinaparsin (SP-02)

Darinaparsin is a novel mitochondrial-targeted agent (organoarsenic) being developed for the treatment of various hematologic and solid cancers. In a US Phase 2 study, darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular PTCL. Furthermore, the Phase 1 study done in US, and the Pan-Asian Phase 1 study both demonstrated positive efficacy and safety. Darinaparsin has been granted orphan drug designation in US and EU.
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About peripheral T-cell lymphoma (PTCL)

Malignant lymphoma is a general term to describe tumors that have developed from lymphocytes, mainly in the immune tissue (lymph nodes). A variety of clinical pathological characterizations present in malignant lymphoma. Malignant lymphoma is classified as Hodgkin Lymphoma (HL) and Non-Hodgkin’s Lymphoma (NHL). NHL mainly consists of B-cell lymphoma and T-cell lymphoma. It is reported that relatively higher incidence of T-cell lymphoma rather than B-cell lymphoma in Japan and Asia. PTCL is a major subtype of T-cell lymphoma with a high incidence rate. Although there is no standard treatment established to treat PTCL, CHOP therapy is widely used as front line treatment. However, there is a large need for more effective and safer therapies as the clinical efficacy of CHOP to treat PTCL is limited. In addition, there are no standard salvage therapies for PTCL, and new, breakthrough therapies are needed.

On June 15, 2020 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, reported that Lindsay Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a company overview and host one-on-one investor meetings at the Raymond James Human Health Innovation Conference (Press release, Fortress Biotech, JUN 15, 2020, View Source [SID1234561107]). The presentation will take place on Thursday, June 18, 2020, at 11:00 a.m. EDT. The conference will be held in a virtual meeting format.

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On June 15, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will present at the Raymond James 2020 Human Healthcare Innovation Conference on Thursday, June 18 at 10:20 a.m. Eastern Time (Press release, Selecta Biosciences, JUN 15, 2020, View Source [SID1234561106]).

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A live webcast and a copy of the presentation will be available on the Investors & Media section of the Selecta website at www.selectabio.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

On June 15, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603 (Press release, Bellicum Pharmaceuticals, JUN 15, 2020, View Source [SID1234561105]). BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2). BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates both the company’s iMC activation and CaspaCIDe safety switch technologies.

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"The FDA’s clearance of our IND for BPX-603 marks a significant milestone for Bellicum, adding a second clinical program to further evaluate our novel GoCAR-T technology’s ability to enhance CAR-T and host immune cell activity against solid tumors," said Rick Fair, President and Chief Executive Officer of Bellicum. "We look forward to initiating our Phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year."

HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or "iMC". MC signaling is believed to boost effector cell proliferation and survival; enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment; and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.

On June 15, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully accelerated the development of its Container Closure Integrity (CCI) test– an essential component of the Stability Test required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JUN 15, 2020, View Source [SID1234561104]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We are extremely pleased that the company we selected to develop our CCI test was not only successful in the development of the test, but that it was able to complete the development phase of the test much sooner than we anticipated given the test had to be developed from scratch because it is specific to our clinical trial product.

"There were three components to the development of our CCI test, and fortunately, each component was developed without a single setback. Now, we’re in a position to run the CCI test according to the method developed."

The FDA specifically required a CCI test be run on pre-filled syringes containing 300 cellulose sulphate microcapsules in 2mls of freezing medium, and then the data from the CCI test be included in PharmaCyte’s Investigational New Drug application (IND). Initially, PharmaCyte was prepared to submit the IND with the CCI test data following the IND submission. Because we envisioned the CCI test taking much longer to develop, we planned to use the data from the sterility test as a surrogate for the CCI test. However, use of a surrogate may no longer be required.

The first developmental phase of the CCI test was to develop a High Voltage Leak Detection (HVLD) program setup and feasibility study. The objective was to develop a preliminary leak test method with the capability of differentiation of the PharmaCyte syringe system with 5μm defects and those without 5μm defects. These parameters were utilized for performance qualification and functioned to verify the use of the PharmaCyte system with a HVLD instrument.

The second developmental phase of the CCI was to develop the method for such a HVLD system. The method development included using a PTI E-Scan HVLD leak test instrument with a sample set of laser-drilled defects (small manually created holes on the sides of several syringes) and use of syringes with no known defects at all. Certain parameters were used for optimization. The method was developed using PharmaCyte’s filled syringes. A representative placebo was also utilized. The final product was verified in development prior to the validation with the optimized parameters.

The third developmental phase was to validate a leak test method using HVLD technology. All work was completed using a PTI E-Scan HVLD leak test instrument. Validation included three test series across multiple days and operators.

Now all that remains is the development of a protocol by which frozen samples of PharmaCyte’s clinical trial product will be tested employing the validated high voltage method for PharmaCyte’s syringe system for container closure integrity over time. That work is underway.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source