On October 6, 2020, Advaxis, Inc. (the "Company") reported that received a notice (the "Notice") from Aratana Therapeutics, Inc. ("Aratana"), dated September 17, 2020, indicating that Aratana is terminating the Exclusive License Agreement, dated March 19, 2014, by and between Aratana and the Company (the "Agreement") and that such termination of the Agreement will be effective on December 21, 2020 (Filing, 8-K, Advaxis, OCT 6, 2020, View Source [SID1234568218]). Other than in respect of the Agreement, there is no material relationship between the Company and Aratana.

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Under the Agreement, the Company granted Aratana an exclusive, worldwide, royalty-bearing license, with the right to sublicense, certain of the Company’s proprietary technology to enable Aratana to develop and commercialize animal health products targeted for treatment of osteosarcoma and other cancer indications in animals. Aratana paid an upfront payment to the Company in the amount of $1 million upon signing of the Aratana Agreement. The Agreement also required Aratana to pay the Company (a) up to $36.5 million based on the achievement of milestones relating to the advancement of products through the approval process with the United States Department of Agriculture in the United States and the relevant regulatory authorities in the European Union, and up to an additional $15 million in cumulative sales milestones based on achievement of gross sales revenue targets for sales of any and all products for use in non-human animal health applications, or the Aratana Field (regardless of therapeutic area), and (b) tiered royalties starting at 5% and going up to 10%, paid based on net sales of any and all products (regardless of therapeutic area) in the Aratana Field in the United States. The Agreement required royalties for sales of products outside of the United States to be paid at a rate equal to half of the royalty rate payable by Aratana on net sales of products in the United States (starting at 2.5% and going up to 5%). The Agreement also required Aratana to pay the Company 50% of all sublicense royalties received by Aratana and its affiliates. In fiscal year 2019, the Company received approximately $8,000 in royalty revenue from Aratana.

The Notice of termination follows Aratana’s acquisition by Elanco Animal Health Incorporated, effective July 18, 2019.

The Company will not incur any early termination penalties as a result of the termination. Aratana will be required to make all payments to the Company that would have otherwise been payable under the Agreement through the effective date of the termination.

On October 6, 2020 Nanotein Technologies, Inc., an innovative startup biotechnology company in the San Francisco Bay Area, and Polaris Group, a developer of novel treatments for cancer, reported they have entered into a strategic partnership to advance Nanotein’s protein-based solutions for superior cellular therapy manufacturing (Press release, Polaris Pharmaceuticals, OCT 6, 2020, View Source [SID1234568215]). As part of the agreement, Polaris will manufacture research use only and GMP grade material for Nanotein. Polaris will receive equity and royalties for their manufacturing services.

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On October 6, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported its third quarter earnings conference call will be webcast on Friday, November 6, 2020, at 8:30 a.m. ET (Press release, Zimmer Holdings, OCT 6, 2020, View Source [SID1234568177]). A news release detailing the quarterly results will be made available that day at 6:30 a.m. ET.

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The live audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit https://investor.zimmerbiomet.com. A digital recording will be available after the completion of the conference call, from November 6, 2020 to January 10, 2021. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

On October 6, 2020 Medical College of Wisconsin reported that a novel cancer therapy studied with promising clinical outcomes is leading to a larger phase II trial to improve on the current standard of care (Press release, Medical College of Wisconsin, OCT 6, 2020, View Source [SID1234568176]). Results of phase I of the first-in-the-world double targeted chimeric antigen receptor (CAR) T-cell therapy clinical trial were published in Nature Medicine.

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This is a novel, cell-based treatment against cancer targeting two proteins (antigens CD19 and CD20) on the surface of cancer cells. This CAR-T cell therapy trial began in October 2017 and resulted in safe and promising outcomes for patients with relapsed and refractory B cell non-Hodgkin lymphomas which are cancers of the immune system. MCW researchers collected patients’ own immune cells (T-cells) and then used a specially engineered virus to augment their ability to identify and kill cancerous cells and effectively destroy the lymphoma. While phase I focused on safety and feasibility of the treatment, a multi-institutional phase II is being developed to determine the true efficacy and understand how the nuances of the treatment process can result in excellent outcomes for a larger subset of patients.

All patients in the clinical trial had failed prior treatments and their cancer had relapsed. Within 28 days of the CAR-T cell therapy, 82 percent responded positively. Six months later, more than half of the patients’ cancer remained in remission. A higher dose of the treatment correlated with a prolonged remission, a trend the researchers plan to study further in the trial’s second phase.

"Immuno-oncology using T-cell treatments shows incredible promise for cancer patients," said Nirav Shah, MD, MSHP, principal investigator of the trial, associate professor of medicine in the division of Hematology and Oncology at MCW, and lymphoma and stem cell transplant specialist at the Froedtert & the Medical College of Wisconsin Clinical Cancer Center at Froedert Hospital. "This is a giant leap forward in personalized medicine. Very few cancer centers offer these novel combination of resources and high level of personalized medicine expertise. The encouraging results of this trial pave the way for more effective and efficient treatment options."

While CAR-T cell therapy has been under development since 2012, the Froedtert & MCW Clinical Cancer Center treated the first patients using this dual-targeted gene therapy. The new treatment genetically alters a person’s own immune cells to target cancer cells in a unique and personalized fashion, a significant departure from more routine chemotherapy.

The cell product used for treatment was manufactured using the CliniMACS Prodigy device, which is part of an automated CAR-T cell manufacturing platform developed by Miltenyi Biotec, a global company dedicated to enabling cellular and gene therapies. A colloboration of scientists and clinicians recognized the potential of this treatment several years ago and began acquiring necessary equipment to prepare for a clinical trial. Housed at the Froedtert & MCW Clinical Cancer Center, the CliniMACS Prodigy device enabled the research team to conduct the CAR-T cell immunotherapy through a self-contained, desktop system, producing new cells ready to be infused back into a patient’s bloodstream within 14 days. With the device, the entire process was performed locally at Froedtert Hospital, saving precious time for the patients.

The launch of this clinical trial is the result of decades of collaborative cancer and cellular immunotherapy research at the Blood and Marrow Transplant and Cellular Therapy program. Pioneers in the field of immunotherapy, these researchers worked on ideas of harnessing the body’s own immune system to fight cancer cells, leading to innovative alternatives to traditional chemotherapy, radiation and transplants, that are often effective in killing cancer cells but also frequently damage the body’s healthy cells. This knowledge paved the way for the CAR-T cell treatment, which trains the patient’s own immune cells to kill the cancer, rather than relying on foreign, toxic substances.

"We are harnessing knowledge from decades of research to improve outcomes for patients with lymphoma," said Parameswaran Hari, MD, MRCP, MS, senior author and professor and chief of the Division of Hematology and Oncology at MCW, specializing in treating individuals with myeloma, leukemia and lymphoma at the Froedtert & MCW Clinical Cancer Center. "There is amazing potential here for the future of not just lymphoma patients but patients with many other cancers."

This research was made possible through philanthropic dollars raised by the Children’s Wisconsin Foundation and the MACC Fund (Midwest Athletes Against Childhood Cancer, Inc.) and their support of the Cell Therapy Lab at MCW.

"This clinical trial demonstrates the strength of the partnerships across this campus and the power of academic medicine," said David Margolis, MD, program director of the Bone Marrow Transplant (BMT) and Cellular Therapy Program and professor of pediatrics and interim chair of the Department of Pediatrics at MCW. "The expertise of MCW researchers, state-of-the-art facilities of Children’s and Froedtert and generosity of this community made this work possible."

On October 6, 2020 HUYA Bioscience International (HUYABIOTM ), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) (Press release, HUYA Bioscience, OCT 6, 2020, View Source [SID1234568175]).

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "The submission of the regulatory application in Japan for R/R ATL is a significant milestone for HUYABIO. The durability and strong immuno-oncology properties of HBI-8000 sets the stage for improved cancer treatment of both solid and liquid tumors. We look forward to drug approval and a positive impact on the quality of life of these patients."

The new drug application is based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients all had advanced disease either refractory or relapsed after receiving mogamulizumab and had few effective treatment options. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

"Aggressive ATL is primarily a disease of the elderly with a poor three-year survival rate of 25%. There are few effective treatment options. It remains to be an important unmet medical need in Japan and a challenging public health issue. Clinical data from HBI-8000 has shown the promise to fulfill such a need. Orphan Drug Designation has been granted to HBI-8000 for R/R ATL, and peripheral T-cell lymphoma", said Dr. Bob Goodenow, President of HUYABIO.

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.