On August 20, 2018 Batu Biologics, a clinical stage immuno-oncology Company, reported the filing of a patent application covering methods of selecting patients likely to respond to ValloVax (Press release, Batu Biologics, AUG 20, 2018, View Source [SID1234529001]).

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ValloVax is a placental endothelial cell based immunotherapy that is designed to stimulate an immune response against several antigens associated with tumor blood vessel formation, or angiogenesis.

"It is well established in the area of organ transplantation that the rate and degree of tissue rejection is largely determined by HLA composition of the donor transplanted organ in relation to the HLA composition of the recipient. Therefore, the relationship between the HLA of the transplant and the patient directly plays a role in determining the immunogenicity of the transplant," stated Samuel Wagner, President and CEO of Batu Biologics. "In the case of cellular therapeutic cancer vaccines, you can think of the cellular product as a transplant that is designed to be rejected. The stronger the degree of tissue rejection, the stronger the immunogenicity of the vaccine. Batu Biologics has developed proprietary methods of personalizing the immunogenicity of our vaccine by predicting clinical response using specific HLA alleles found to be restricted to patients who have historically responded to our therapy."

"The concept of personalizing the immunogenicity of Batu Biologics’ lead program ValloVax, means that the Company is in the process of developing screening methodologies to identify patients who are ideal candidates to receive this immunotherapy," said Dr. Santosh Kesari, consulting Chief Medical Officer of Batu Biologics. "Therapeutic cancer vaccines designed to stimulate immunity to cancer have been well studied with the first FDA approval of a dendritic cell based vaccine for prostate cancer, Provenge, in April 2010. However demonstrating clinical efficacy in a statistically significant manner in the broad population has historically been difficult, and this has been demonstrated by numerous cancer vaccine failures in the Phase 3 setting. Traditionally patient stratification for cancer vaccines has been focused on matching vaccine targets to mutations on the patient’s tumor. However this approach fails to address a critical aspect of vaccine development: the efficacy of vaccines is primarily dependent on the patient’s ability to initiate a T cell response against the antigens of interest. Batu Biologics is taking a new approach to cancer vaccines, by addressing a key issue in vaccine development: the variability of immunogenicity on a patient-to-patient basis."

By preselecting patients who are predisposed to have a stronger T cell mediated and antibody mediated immune response to the vaccine, Batu Biologics may be able to improve outcomes without the need to include toxic adjuvants in the formulation of the therapeutic product. Traditionally, adjuvants are carefully selected to modulate an immune response to vaccine antigens of interest. In Batu Biologics’ case, we are leveraging a natural understanding of transplantation immunology to optimize the immunogenicity of our vaccine.

Batu Biologics anticipates initiating a Phase 1/2 study for patients with metastatic non small cell lung cancer in the United States in late 2018. The phase 1 component of the study will focus on evaluating the safety and immunogenicity of ValloVax at two different dose levels. The Phase 2 component of the trial will focus on demonstrating efficacy of ValloVax directly compared to the standard of care in a defined patient population.

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 20, 2018 Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases, reported that it has dosed the first patient in a Phase I study, part of an ongoing collaboration with GlaxoSmithKline (GSK) (Press release, Immunocore, AUG 20, 2018, View Source [SID1234528999]).

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The study, the first programme under Immunocore’s collaboration with GSK to proceed into clinical development, will assess the safety and tolerability of IMCnyeso, an ImmTAC molecule, in patients with non-small cell lung cancer (NSCLC), bladder cancer, melanoma and synovial sarcoma, positive for NY-ESO-1 and/or LAGE-1A. The start of the study has triggered an undisclosed milestone payment to Immunocore.

Under the terms of the collaboration entered into in 2013, Immunocore is responsible for all pre-clinical development and for the initial clinical trial in patients for each of the first two target programmes. Upon exercise of each programme option, GSK would be responsible for the remaining development and commercialisation activities for that target.

Joseph Dukes, Director and Head of Biology at Immunocore, commented: "We are delighted that our world-leading science has delivered a second ImmTAC into the clinic. This is the first partnered programme to commence dosing in patients, representing a critical milestone in our collaboration. It puts this promising programme onto a clinical development path, which we hope will ultimately result in a new treatment option for patients with some of the most difficult-to-treat tumours."

James Smothers, Vice President and Head of Immuno-Oncology DPU at GSK, said "At GSK we are focussed on delivering transformational medicines for cancer patients and we are excited to investigate the scientific promise of ImmTAC technology. The start of this phase I study is another marker of success in our productive collaboration with Immunocore."

On August 20, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:00 a.m. (Eastern Time) on Thursday, September 13th, to review its Pharmaceutical Business (Press release, Johnson & Johnson, AUG 20, 2018, View Source [SID1234528998]). Joaquin Duato, Vice Chairman of the Executive Committee; Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals; Mathai Mammen, Global Head, Janssen Research & Development and Lesley Fishman, Senior Director Investor Relations will host the call.

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on September 21, 2018. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13681049.

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.