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 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its second-quarter 2018 financial results on Friday, July 27, 2018, before the market opens (Press release, AbbVie, JUL 10, 2018, View Source [SID1234527630]).

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AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

On July 9, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer and Gregory Chow, Senior Vice President and Chief Financial Officer, will participate at the upcoming Oppenheimer & Co. Inc. Boston Oncology Insight Summit to be held at the Whitehead Institute on July 10, 2018 and 1×1 Day to be held at the Four Seasons Hotel on July 11, 2018 in Boston, MA (Press release, Aptose Biosciences, JUL 9, 2018, View Source;p=RssLanding&cat=news&id=2357337 [SID1234527611]).

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On July 9, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1) (Press release, Astellas, JUL 9, 2018, View Source [SID1234527612]). Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4.

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The companies expect to report topline efficacy and safety results from this first cohort of the EV-201 trial, which is intended to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway, in the first half of 2019.

The companies also reported dosing of the first patient in EV-301, a global, randomized phase 3 clinical trial evaluating enfortumab vedotin in patients with previously treated locally advanced or metastatic urothelial cancer. The EV-301 trial is intended to support a broader global registration strategy and to serve as the confirmatory randomized trial in the U.S. for EV-201. Enfortumab vedotin has been granted Breakthrough Therapy Designation by the FDA for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.

"With enfortumab vedotin, we have the opportunity to address some of the unmet need in advanced urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "With our partners Astellas, we are pleased to advance the enfortumab vedotin clinical trial program with the vision of bringing a new treatment option to patients with advanced urothelial cancer worldwide."

"Despite recent treatment advances, the unfortunate reality is that many patients with metastatic urothelial cancer currently find that their disease will progress after anti-PD-1 or PD-L1 therapy, highlighting the need to identify additional therapeutic options," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "Following encouraging results from our ongoing phase 1 study, we and our partners at Seattle Genetics decided to proceed with these registrational trials. We look forward to future clinical development milestones for enfortumab vedotin."

In addition to EV-201 and EV-301, enfortumab vedotin is also under evaluation in a phase 1 clinical trial (EV-103) in combination with pembrolizumab (Keytruda) in cisplatin-ineligible first-line patients with locally advanced or metastatic urothelial cancer.

About EV-201 Trial
EV-201 is an ongoing single-arm, single-agent pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a checkpoint inhibitor, including those who had also been treated with a platinum chemotherapy (first cohort) and those who were cisplatin ineligible / platinum naïve (second cohort). Approximately 120 patients were enrolled in the first cohort at multiple centers. The primary endpoint is confirmed objective response rate, per independent review. Secondary endpoints include assessments of response duration, disease control, overall survival, progression-free survival, safety and tolerability. The second cohort continues to enroll cisplatin-ineligible, platinum naïve patients with urothelial cancer who have received a PD-1/PD-L1 inhibitor but not a platinum agent.

About EV-301 Trial
EV-301 trial is a global, open label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician’s choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 550 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/PD-L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, overall response rate, disease control rate, duration of response and quality of life.

More information about the enfortumab vedotin clinical trials can be found at View Source

About Urothelial Cancer
According to the American Cancer Society, urothelial cancer, also known as transitional cell carcinoma (TCC), is the most common type of bladder cancer1 (90 percent of cases). Approximately 81,000 people in the U.S. are anticipated to be diagnosed with bladder cancer during 2018. Bladder cancer is the fourth most common cancer in men, but is less common in women. Outcomes are poor for people diagnosed with metastatic disease, with a five-year survival rate of 4.8 percent.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 identified as an ADC target by Astellas, which is expressed on many solid tumors.

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

On July 9, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company and Boehringer Ingelheim reported they have signed an asset acquisition and related agreements centered on MabVax’s program targeting a glycan commonly overexpressed on multiple solid tumor cancers (Press release, MabVax, JUL 9, 2018, View Source [SID1234527613]). Boehringer Ingelheim has acquired all rights in and to the program.

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MabVax will receive a total of US $11 million in upfront and near-term milestones as well as downstream regulatory milestone payments plus further earn-out payments. The asset acquisition is separate and distinct from other programs under development at MabVax, enabling MabVax to retain all rights to its lead HuMab-5B1antibody program which is in Phase 1 clinical trials as a therapeutic product and as a diagnostic product, as well as other antibody discovery programs from the Company’s rich antibody discovery portfolio targeting other cancer antigens.

MabVax discovered the antibody series at the center of this transaction from biological samples, originally from patients who were vaccinated against their solid tumors with a glycan antigen-containing vaccine. The discovery of fully human antibodies directly from vaccinated cancer patients has potential advantages which include greater specificity and reduced toxicities. MabVax completed and has reported on early preclinical development activities to establish the utility of the program.

"We are very pleased to have Boehringer Ingelheim as a major industry partner to further develop one of our preclinical antibody assets based on our proprietary HuMab technology," said David Hansen, President and CEO of MabVax Therapeutics. "This agreement with Boehringer Ingelheim recognizes the value of our innovative approach to discovering novel antibodies to diagnose and treat cancer. We have been committed since the founding of the Company to discovering and developing unique fully human antibodies to diagnose and treat patients with cancers where there remain significant unmet medical needs."