On July 30, 2018 Surface Oncology (NASDAQ: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s lead investigational candidate SRF231 for the treatment of patients with multiple myeloma (Press release, Surface Oncology, JUL 30, 2018, View Source [SID1234527965]). SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells which prevents them from being engulfed and eliminated by macrophages.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While the potential applications for SRF231 in oncology are quite broad, we are particularly excited about the opportunity to provide benefit to patients with multiple myeloma. We have already demonstrated the ability of our antibody to increase phagocytosis of myeloma cells and to shrink tumors in preclinical models," said Rob Ross, M.D., chief medical officer of Surface Oncology. "Receiving orphan designation for SRF231 represents an important milestone as we continue to progress the program in the clinic in multiple myeloma and other cancer types."

The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation provides certain benefits to the drug developer including the potential for seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.

SRF231 is currently being evaluated in a multi-center, open-label Phase I trial to assess safety and tolerability in multiple ascending doses with the goal of establishing a recommended dose for further study. Following the dose escalation phase, the company intends to evaluate the safety and efficacy of SRF231 in a targeted set of solid and hematologic malignancies.

ABOUT SRF231

SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis. SRF231 preclinical results presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper) meetings demonstrated that SRF231 has potent anti-tumor activity preclinically in several different tumor models and in combination with existing cancer modalities. Importantly, preclinical studies also showed that SRF231 does not induce hemagglutination, an important potential safety advantage.

On July 30, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the Canaccord Genuity 38th Annual Growth Conference on Thursday, August 9, 2018 at 11:30 a.m. Eastern Time in Boston (Press release, Veracyte, JUL 30, 2018, View Source [SID1234527966]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The live webcast of the presentation and a subsequent replay may be accessed by visiting Veracyte’s website at View Source The replay of the webcast will be available shortly after the conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

Champions Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On July 30, 2018 Eli Lilly and Company (NYSE: LLY) reported a three-year extension of its cancer research collaboration with Dana-Farber Cancer Institute (Press release, Eli Lilly, JUL 30, 2018, View Source [SID1234529756]). Since 2015, scientists from Lilly and Dana-Farber have been working together on pre-clinical and clinical studies, molecular analyses of patient samples and the design and conduct of clinical trials to help advance cancer care.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to announce the extension of our collaboration with Dana-Farber Cancer Institute. This collaboration provides an opportunity for scientists and clinicians at a premier cancer center to bring creative new ideas about the underlying science and how this might drive future clinical opportunities for multiple Lilly therapeutic candidates," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "The extension will provide continued funding for initial testing of several such ideas in the lab and in the clinic, which could eventually inform new treatment avenues for cancer patients."

During the first three years of the collaboration, Lilly has been allowed access to expertise within Dana-Farber to further develop multiple pre-clinical and clinical compounds in Lilly’s pipeline, including new indications, novel combinations, and biomarker strategies. This collaboration has fostered fresh ideas, strong communication and important feedback in pre-clinical and clinical study design, process and execution.

"Our collaboration with Lilly has provided the opportunity to bridge academia and industry at the early stages of cancer research," said Barrett Rollins, M.D., Ph.D., chief scientific officer of Dana-Farber. "Our shared approach has helped speed learning across labs and disease groups, and serves to enable and accelerate the testing of new hypotheses. This collaboration is important as we consider the potential impact the research may have on cancer care."

Under the agreement, Dana-Farber researchers were, and will continue to be, granted permission to conduct independent pre-clinical and clinical studies on select Lilly compounds. All compounds evaluated through this collaboration will continue to be fully owned by Lilly. Financial terms of the agreement were not disclosed.

On July 30, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Food and Drug Administration (FDA) has allowed the Company’s IND application for its ADXS-HOT drug candidate for non-small cell lung cancer (NSCLC) (Press release, Advaxis, JUL 30, 2018, View Source [SID1234527949]). Advaxis anticipates that because of this timely allowance, the first patient in the Phase 1/2 trial for this NSCLC drug candidate will be dosed by the end of 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ADXS-HOT is a cancer-type specific immunotherapy approach that leverages the Company’s proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary tumor-associated antigens. To date, more than 10 drug candidates have been designed for different tumor types in the ADXS-HOT program.

"This is an exciting time for Advaxis as we prepare to initiate the first clinical trial with a drug candidate from our ADXS-HOT program. This drug candidate, ADXS-503, has been designed for the treatment of patients with NSCLC," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With our increased strategic focus on neoantigen-based therapeutics, including the personalized, patient-specific approach of our ADXS-NEO program, already in a clinical trial, we anticipate having five neoantigen-based drug candidates in clinical evaluation by the end of 2019. Our next two ADXS-HOT drug candidates will focus on prostate and bladder cancers. These two tumor types, along with NSCLC, were prioritized based on our evaluation of a number of factors relating to each, including the unmet medical need, time and investment required to demonstrate meaningful clinical activity and immunological sensitivity," concluded Mr. Berlin.

The Company plans to initiate a Phase 1/2 clinical trial that will seek to establish the safety, tolerability and effectiveness of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with metastatic NSCLC in different lines of therapy, at up to 20 centers across the U.S.

"I am pleased we can move forward to advance our first trial with ADXS-503, the first drug candidate in our ADXS-HOT program. This is an important clinical milestone as we seek to demonstrate proof-of-concept for ADXS-HOT immunotherapy in NSCLC, where there remains significant unmet need despite the introduction of checkpoint inhibitors and targeted therapies," said Andres Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Advaxis. "Earlier drug candidates from our Lm platform expressing a single antigen have shown a favorable safety profile and preliminary clinical activity in more than 500 subjects treated to date across different tumor types. This clinical experience with prior Lm drug candidates, combined with our ability to leverage the large capacity of our Lm vector to express multiple neoantigens and other tumor-associated antigens, provides the foundation for our belief that ADXS-HOT drug candidates such as ADXS-503 for NSCLC can provide a new standard for off-the-shelf neoantigen vaccines."

Advaxis affirms plans to submit a total of four INDs for drug candidates from its ADXS-HOT program by the fourth quarter of 2019. Beyond NSCLC, prostate cancer and bladder cancer, the fourth ADXS-HOT drug candidate will be selected from breast, colorectal, ovarian or 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, they are an off-the-shelf treatment approach been designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

About ADXS-NEO

ADXS-NEO is an investigational personalized Lm-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens identified through DNA sequencing of a patient’s own tumors. The program focuses on creating a customized treatment for each patient targeting multiple neoantigens found in a biopsy of the patient’s tumor. ADXS-NEO is being developed in partnership with Amgen.