On July 10, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a clinical update, as follows (Press release, Advaxis, JUL 10, 2018, View Source [SID1234527648]):

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Plans to withdraw its Conditional Marketing Authorization Application (MAA) in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy

Submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to study its first ADXS-HOT drug candidate for the treatment of non-small cell lung cancer (NSCLC)

Selection of prostate cancer as the second cancer type within its ADXS-HOT program to move towards the clinic, with an IND filing anticipated within the next six months

Advaxis’ regulatory action in Europe is based on European Medicines Agency (EMA) feedback following its initial review indicating the application will likely need additional data to support a conditional approval. The February 2018 submission included data from the Phase 2 GOG-0265 study in 50 patients, which showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with persistent, recurrent or metastatic carcinoma of the cervix, representing a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate was unprecedented when compared against historical data.

The Company continues to believe that the results from the GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac. As previously communicated, Advaxis is actively seeking a partner to support the late-stage cervical cancer program.

The Company also announced that it has submitted an IND with the FDA to study its first product candidate from the ADXS-HOT program, ADXS-503, for the treatment of NSCLC. Upon allowance of the IND for ADXS-503, the Company plans to initiate an open-label, Phase 1/2 clinical trial. Further details of the study design will be provided after the IND is allowed. Advaxis expects the first patient will be dosed by the end of 2018. Additionally, Advaxis anticipates submitting a second IND from the ADXS-HOT program within the next six months, for its drug candidate referred to as ADXS-504, for the treatment of prostate cancer.

"We are pleased to submit the ADXS-503 IND and look forward to advancing our ADXS-HOT NSCLC drug candidate into the clinic. Our ADXS-HOT program leverages both the benefits of our Lm technology platform, which has shown clinical activity in earlier generation drug candidates, and the use of neoantigen targets. We believe that neoantigen-based treatments have the potential to transform cancer care, and the ADXS-HOT program allows us to develop cancer-type specific therapies across a broad range of tumor types," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With our announcement today of plans for a second IND submission for an ADXS-HOT construct in prostate cancer, we feel confident we can reach proof-of-concept for these off-the-shelf therapeutics in a relatively rapid and cost-effective manner."

Advaxis affirms plans to submit a total of four INDs for drug candidates from its ADXS-HOT program by the end of calendar year 2019, resulting in Phase 1/2 studies evaluating safety, immune responses and preliminary clinical activity of four different constructs addressing four different tumor types. Beyond NSCLC and prostate cancer, the next two ADXS-HOT product candidates will be selected from breast, colorectal, bladder, ovarian and head and neck cancers.

About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. Although ADXS-HOT drug candidates have not yet been tested in patients, each product candidate has been designed to potentially treat all patients with a specific cancer type, without the need for pre-treatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

On July 10, 2018 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for second quarter 2018 following the close of market on Monday, July 30, 2018 (Press release, Illumina, JUL 10, 2018, View Source [SID1234527637]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 30, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 800-708-4539, or 1-847-619-6396 outside North America, both with passcode 47172781.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on July 30, 2018 through August 6, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 47172781.

On July 10, 2018 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported the appointment of Christina Coughlin, MD, PhD, as Chief Medical Officer and Executive Vice President (Press release, Tmunity Therapeutics, JUL 10, 2018, View Source [SID1234527636]). Dr. Coughlin formerly served as Chief Medical Officer at Immunocore Ltd., a British biotechnology company, where she was responsible for leading the effort to develop novel bispecific T cell receptor-based biologics for cancer immunotherapy.

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"Chris’ depth and breadth of experience in immunotherapeutic clinical development will be tremendously valuable to Tmunity," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "We are fortunate to have her clinical and scientific leadership as we advance our portfolio of next-generation T cell immunotherapies, targeting liquid and solid tumor cancers, through pre-clinical and Phase 1 studies."

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In her role at Tmunity, Dr. Coughlin will be responsible for clinical development, program leadership and regulatory affairs.

"In addition to her great immunotherapeutic industry knowledge, Chris will also fuse the research and translational capabilities that she developed when she was part of our team at UPenn," said Carl H. June, MD, Director of the Center for Cellular Immunotherapies at the Perleman School of Medicine, and Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania.

During her tenure at Immunocore, Dr. Coughlin led the Company’s clinical efforts and developed a pivotal program around the gp100-specific TCR bispecific in uveal melanoma. She previously led early development programs at Novartis, including programs focused on the investigation of checkpoint inhibition and PI3’ kinase inhibition. Dr. Coughlin has both biotechnology and large pharmaceutical industry experience, having held senior medical positions at Morphotek (Eisai), Pfizer and Wyeth.

Earlier in her career, Dr. Coughlin was a physician-scientist at the University of Pennsylvania and the Children’s Hospital of Philadelphia where she studied patient responses to tumor antigens with Dr. Robert Vonderheide in the division of Translational Research under the direction of Dr. June.

Dr. Coughlin holds a Bachelor of Science degree from Temple University and an MD and PhD from the University of Pennsylvania. She completed her residency and a hematology/oncology fellowship at Children’s Hospital of Philadelphia, as well as a research post-doctoral fellowship at the University of Pennsylvania. Dr. Coughlin was also elected a Fellow of the Royal Society of Medicine (London, UK).

On July 10, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Tuesday, July 31, 2018 (Press release, Neurocrine Biosciences, JUL 10, 2018, View Source [SID1234527635]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9177 (US) or 785-424-1669 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at View Source A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On July 10, 2018 VBL Therapeutics (NASDAQ:VBLT) reported the publication of data on the potential role of MOSPD2 in metastatic breast cancer in the International Journal of Cancer (Press release, VBL Therapeutics, JUL 10, 2018, View Source [SID1234527633]).

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VBL’s data demonstrate for the first time that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be employed to prevent the spreading of breast cancer cells. Histological analysis of specimens shows that MOSPD2 levels were correlated with the stage of tumor invasiveness, and were profoundly elevated in invasive and metastatic breast cancer, making it an attractive target for potential treatment of late-stage breast cancer.

"Our research has previously shown that MOSPD2 plays a key role in the regulation of cell motility in the immune system. The current publication further demonstrates that it also plays an important role in cancer cell metastasis, and that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95% in certain models," said Itzhak Mendel, Ph.D., Immunology Director of VBL Therapeutics and co-author of the paper. "We continue to advance our exciting VB-600 series of antibodies targeting MOSPD2 for oncology and inflammatory indications."

At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) conference in April this year, VBL presented a late-breaking proof-of-concept study demonstrating antibody-mediated killing of MOSPD2-expressing cancer cells. VBL research has also shown that knocking-out the MOSPD2 gene in mice could protect the animals from developing some inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.

VBL is developing the VB-600 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file an IND in this program by year-end 2019.