On December 2, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that data from its ongoing studies utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology will be presented during a poster session at the San Antonio Breast Cancer Symposium (SABCS) (Press release, Anixa Biosciences, DEC 2, 2019, View Source [SID1234551824]).

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The symposium takes place December 10 – 14, 2019 in San Antonio, TX, and is designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease. The meeting will be attended by both U.S. and international researchers and healthcare professionals who are involved in breast cancer research and clinical care.

Poster presentation details are as follows:

Title: Combining HyperVOX with pattern recognition neural networks: A new method for analyzing flow cytometry-based immunophenotyping data for increased early detection of stage I/II breast cancer (BCa)

Authors: George A. Dominguez, Ph.D.; John Roop; Alex Polo; Anthony J. Campisi; Dmitry I. Gabrilovich, MD, Ph.D.; Amit Kumar, Ph.D.

Poster Session and Number: Session 5, P5-01-16

Location: Henry B. Gonzalez Convention Center, Hall 1

Date and Time: Friday, December 13, 2019 (5:00 PM – 7:00 PM CT)

To receive a copy of the presentation, please email your request to [email protected] starting December 14, 2019 and include your name, title, and contact information.

About Cchek
Cchek is an early cancer detection technology, that measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method that offers improved affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

On December 2, 2019 NantKwest, Inc. (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, reported promising safety data generated from the first six patients in its QUILT-3.064 trial (Press release, NantKwest, DEC 2, 2019, View Source [SID1234551840]). The first-in-human study evaluated the safety and preliminary efficacy of the Company’s first-in-class, tumor-targeted PD-L1.t-haNK cell therapy in patients with locally advanced or metastatic solid tumors.

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"The unique dual-targeting of PD-L1.t-haNK to both PD-L1 expressing tumors and therapeutic monoclonal antibodies has the potential to be transformative to the treatment of advanced solid tumors with cell-based therapies," said Dr. Patrick Soon-Shiong, the Chairman and CEO of NantKwest. "PD-L1.t-haNK is a cryopreserved, off-the-shelf product that can rapidly deliver treatment to patients in an outpatient setting while avoiding the extensive manufacturing delays associated with autologous CAR-T therapies. We look forward to reporting full study results from the phase 1 cohort and moving toward a recommended phase 2 dose. We continue to advance our innovative cell therapies such as PD-L1.t-haNK in combination with ImmunityBio’s N-803, an IL-15 superagonist that is designed to stimulate the activation and proliferation of the patient’s own NK cells to maximize the potential of immunogenic cell death to treat cancer," continued Soon-Shiong. NantKwest and a wholly owned subsidiary of ImmunityBio have entered into an exclusive collaboration agreement to co-develop NantKwest’s proprietary off-the-shelf NK platforms in combination with N-803.

On December 2, 2019 at the NantKwest Key Opinion Leader and Investors conference, Dr. Soon-Shiong described the clinical development plans for two of NantKwest’s first-in-class NK products: haNK, which was developed to target binding to approved monoclonal therapies such as Trastuzumab, Rituximab and Cetuximab; and PD-L1.t-haNK, which was also designed to target these approved therapies plus directly target PD-L1-expressing tumor cells.

PD-L1.t-haNK cells are a human-derived, allogeneic, natural killer cell line engineered to express a chimeric antigen receptor (CAR) targeting PD-L1, whose origins arise from NantKwest’s proprietary NK-92 (aNK) master cell bank. In addition to targeting PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for enhanced CD16-targeted antibody-dependent cellular cytotoxicity capabilities.

John Lee, M.D., Clinical Senior Vice President at NantKwest, said, "We are highly encouraged by the early safety results with PD-L1.t-haNK in a patient population with advanced, difficult to treat solid tumors. All patients were able to be infused in the outpatient setting without any reported cytokine toxicities or immune related adverse events. NantKwest’s approach has been designed to overcome the challenges and limitations typically seen when treating solid tumors with CAR-T and other immunotherapy approaches and I look forward to progressing our studies to advance this innovative new approach to cancer therapy."

Study Design

The QUILT-3.064 study is an open-label, Phase 1 study of PD-L1.t-haNK in subjects with locally advanced or metastatic solid cancers to evaluate safety, preliminary efficacy, determine maximum tolerated dose (MTD) or highest tolerated dose (HTD) and designate the recommended Phase 2 dose (RP2D). The study is being conducted in two parts: the first is evaluating dose escalation using a 3 + 3 design and the second part will evaluate the expansion of the recommended Phase 2 dose (RP2D) to further assess the safety and efficacy of PD-L1.t-haNK therapy. In part one, six subjects were sequentially enrolled, starting at dose level 1 and assessed for dose-limiting toxicities. The primary study objectives are to determine the MTD or HTD, RP2D (recommended phase 2 dose), and safety. The secondary endpoints include objective response rate (ORR), progression free survival (PFS) and overall survival (OS). More information can be found at ClinicalTrials.gov, Identifier: NCT04050709.

On December 2, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), reported a clinical collaboration agreement with Merck, known as MSD outside the United States and Canada through a subsidiary, to evaluate the combination of Seattle Genetics’ and Astellas’ antibody-drug conjugate (ADC) enfortumab vedotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer (Press release, Astellas, DEC 2, 2019, View Source [SID1234551809]).

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Under the terms of the agreement, the three companies will conduct and fund a global, registrational phase 3 clinical trial to be led by Seattle Genetics. The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer. The companies are working in consultation with regulatory authorities to finalize the trial design and currently plan to initiate the trial in the first half of 2020.

"We look forward to initiating a randomized phase 3 trial in patients with previously untreated locally advanced or metastatic urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Recent data from a phase 1b trial of enfortumab vedotin in combination with pembrolizumab showed evidence of clinical activity leading to the development of this phase 3 trial."

"An unmet medical need exists for previously untreated patients with metastatic urothelial cancer, and we are committed to studying enfortumab vedotin in combination with other agents in different stages of urothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas. "We look forward to further evaluating enfortumab vedotin and pembrolizumab in this high unmet need patient population."

Enfortumab vedotin is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The PDUFA action date is March 15, 2020.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2019, more than 80,000 people will be diagnosed with bladder cancer in the United States. Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.2

About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.

On December 2, 2019 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported that it will present at the Piper Jaffray 31st Annual Healthcare Conference in New York, NY (Press release, Boundless Bio, DEC 2, 2019, View Source [SID1234551841]).

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Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will give a company overview on Thursday, Dec. 5, 2019 from 2:50 – 3:10 p.m. EST.

About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes

On December 2, 2019 RhoVac AB ("RhoVac") reported that the collaboration agreement with Colpman Consulting Ltd ("Colpman Ltd") has been terminated by mutual agreement, in the light of RhoVac’s aim to secure an agreement with a partner after completion of the current clinical phase IIb study (Press release, RhoVac, DEC 2, 2019, View Source [SID1234555926]).

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The agreement that RhoVac signed with Colpman Ltd in March 2018 to find a development partner for RV001 has been formally terminated by mutual agreement. In the future, RhoVac’s CEO, Anders Månsson, will lead the company’s business development efforts, which aim to secure an agreement with a partner that can further develop the RV001 project in clinical phase III in prostate cancer, and also in other potential metastatic cancer indications, and subsequently launch the product.

CEO Anders Månsson comments:

"Since I started at RhoVac, I have been involved in the work and the dialogues that Colpman Ltd has initiated on RhoVac’s behalf. Colpman Ltd has done a good job, but as Rhovac chose to proceed with the value-adding clinical phase IIb study in-house, both the time perspective and the offer to our potential partners have changed. RV001 is now a project that, after completion of the current clinical phase IIb study in prostate cancer, can be taken directly into phase III, the last stage of development before market approval. With the great potential that RV001 can have for treating metastatic prostate cancer specifically – and metastatic cancer in general – I look forward to further intensifying our own business development efforts as we approach the end of the ongoing clinical phase IIb study."