On August 20, 2018 Aravive Biologics, Inc. reported that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer (Press release, Aravive Biologics, AUG 20, 2018, View Source [SID1234529000]).

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"Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer," said Ray Tabibiazar, M.D., Executive Chairman of Aravive Biologics. "We look forward to initiating the Phase 1b portion of our planned Phase 1b/2 study combining AVB-S6-500 with standard-of care therapies in patients with platinum-resistant ovarian cancer before the end of the year."

The FDA’s Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

"We are very pleased that the FDA has granted Fast Track status to AVB-S6-500," said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D at Aravive. "This important designation is based on the promising safety and activity observed to-date with AVB-S6-500, and we look forward to working closely with the FDA as we advance its development in ovarian cancer."

About AVB-S6-500

AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. Research has shown GAS6-AXL signaling to be a key molecular pathway that promotes tumor growth and metastases, as well as immune evasion and resistance to other anticancer agents. AXL and GAS6 expression correlate with poor prognosis in cancer. Results of a Phase 1 study of AVB-S6-500 in healthy volunteers showed a favorable safety profile, with no reported serious or dose-limiting adverse events. Moreover, results of that trial showed a dose-related reduction of circulating free GAS6, a measurement that Aravive anticipates will be highly useful as a biomarker to better monitor the therapeutic responses and potentially to better select responder patient populations. A reduction in this biomarker has correlated to anti-tumor activity in preclinical animal studies. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. GAS6/AXL inhibition has also shown potential as a strategy for the treatment of certain fibrotic diseases.

On August 19, 2018 Harbour BioMed reported it has entered into an exclusive strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) to develop and commercialize A167, an anti-PD-L1 antibody in Phase 2 clinical development, worldwide outside of the Greater China region (Press release, Harbour BioMed, AUG 19, 2018, View Source [SID1234528980]). The companies will also collaborate in developing combination therapies of A167 with other agents for commercialization in their respective territories. The potential value of the partnership exceeds $350 million in addition to royalties.

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"Anti-PD-L1 therapy has been validated in many clinical trials in the Immuno-Oncology area. A167 has significant potential as a single agent and as the foundation for combination therapy with other innovative drugs. We are delighted to advance A167 globally and work closely with Kelun-Biotech to achieve its therapeutic potential," said Dr. Jingsong Wang, Harbour BioMed’s founder, Chairman and Chief Executive Officer. "We plan to conduct A167-based combination trials globally by ourselves, including with innovative compounds we are developing, or in collaboration with our partners, to find better therapeutic options against a wide range of tumor types." Dr. Wang noted that the partnership with Kelun-Biotech, Harbour’s first global development alliance, is an important step that accelerates our plan to build a highly innovative, clinical-stage portfolio for worldwide markets.

"A167 is one of the important compounds in our portfolio," said Dr. Tongtong Xue, Chief Executive Officer of Kelun-Biotech. "We are glad to enter this collaboration with Harbour BioMed which is based on trust in our partner’s capabilities and expertise. The Harbour team brings extensive global clinical development experience that will accelerate clinical trials with A167, especially in the area of combinational therapies." Dr. Xue noted that the collaboration is the second alliance Kelun-Biotech entered with Harbour this year. "We entered a strategic partnership with Harbour to co-discover, co-develop and commercialize antibodies against innovative targets, based on Harbour’s leading fully human antibody discovery platforms. We have made significant progress in our joint discovery programs against multiple targets in oncology and immunological diseases."

A167 is an immune-oncology investigational antibody developed by Kelun-Biotech. It binds to immune checkpoint protein PD-L1 and reactivate T cells in the body against cancer cells. The antibody has potential usage in a broad range of solid tumor and hematological malignancies in monotherapy and in combination with other agents. A167 is currently in multiple Phase 1 and Phase 2 clinical trials in China targeting lymphoma and solid tumors.

Under the agreement, Kelun-Biotech will receive upfront, development and regulatory milestones, and commercial milestones based on preset goals, with a potential value of more than $350 million, in addition to royalties based on annual net sales. Harbour will have exclusive rights to develop, manufacture and commercialize A167 in regions outside of Greater China. Both companies will share data generated from their own research and clinical trials to support mono and combination therapies of A167 with other agents for both parties’ development and registration.

On August 19, 2018 Lion TCR Pte. Ltd., a Singapore-based Biotech company reported that it has receives approval from Health Sciences Authority (HSA), Singapore, for its Phase I/II multicentre clinical study of its product candidate (LioCyx) for treatment of relapsed liver cancer post-liver transplantation (Press release, Lion TCR, AUG 19, 2018, View Source [SID1234528981]). The first such trial in Singapore and for the region that uses precision T cell receptor (TCR) immune cell therapy to target Hepatitis B virus (HBV)-related liver cancer, which forms at least 80% of liver cancers in Asia. 80% of the 800,000 new liver cancer cases in the world yearly are diagnosed in Asia Pacific, including China, Vietnam, Thailand, Indonesia, South Korea and Singapore. Liver cancer is the world’s third most deadly cancer with very limited treatment options and poor treatment outcome. There is currently no effective treatment available for liver cancer relapsed patients post-liver transplantation.

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LioCyx is developed by Lion TCR’s scientific founder, Prof. Antonio Bertoletti, a world-renowned HBV-liver cancer clinician scientist. Several Investigator-sponsored trials of LioCyx in Singapore and China have showed results of good safety profile and encouraging signs of efficacy. "We are very delighted with the approval of Phase I/II clinical trial of our LioCyx, the first engineered TCR-T cell therapy for treatment of liver cancer in Singapore. It is an utmost encouragement on the recognition of innovative therapy for patients in need. Singapore HSA has been very efficient, transparent and professional in reviewing our application for the clinical trial of this innovative immunotherapy", said Dr. Victor Li Lietao, founder and CEO of Lion TCR.

Patients recruitment for the Phase I/II clinical trial will begin with National University Hospital (NUH), Singapore. Lion TCR is in the midst of including more medical centres in Singapore and China into the trial.

On August 17, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that two posters will be presented by Endocyte scientists at the ACS National Meeting & Exposition being held in Boston, MA from Aug. 19 – 23, 2018 (Press release, Endocyte, AUG 17, 2018, View Source [SID1234528962]).

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Presentations are as follows:

Abstract # MEDI 425
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 3: Design and synthesis of pro-PBD conjugates containing a self-immolative substituted disulfide linkers
When: August 22, 2018, from 7:00 pm to 9:00 pm
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Abstract # MEDI 426
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 4: Design of novel oxime-based pro-PBD conjugates that release active drug via intramolecular diazepine-ring-closure
When: August 22, 2018, from 7:00 pm to 9:00 pm.
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On August 17, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018 (Press release, Mateon Therapeutics, AUG 17, 2018, View Source [SID1234528963]). OX1222 is the Company’s clinical trial of OXi4503 in combination with cytarabine for the treatment of relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503. The FDA is allowing the study to continue to treat and enroll patients using a dose of 9.76 mg/m2 of OXi4503, which the Company previously tested in cohort 5 of Study OX1222.

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The partial clinical hold follows two potential dose-limiting toxicities (DLTs) observed at the 12.2 mg/m2 dose level that was being evaluated in cohort 6 of Study OX1222. These DLTs consist of one patient experiencing hypotension shortly following initial treatment with OXi4503, and another patient experiencing acute hypoxic respiratory failure approximately two weeks after receiving OXi4503 and cytarabine. Both events were deemed "possibly-related" to OXi4503, and both patients recovered following treatment. The protocol for Study OX1222 generally defines a DLT as any grade 3 serious adverse event (SAE) where a relationship to OXi4503 cannot be ruled out. The FDA has indicated that additional data on patients receiving 9.76 mg/m2 of OXi4503 must be evaluated before the Company resumes dosing at 12.2 mg/m2.

"Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed two complete remissions in the four patients that we treated," said William D. Schwieterman, M.D., Chief Executive Officer of Mateon.