On December 5, 2018 Apexian Pharmaceuticals reported that Chemotherapy causes chemotherapy-induced peripheral neuropathy (CIPN) in a significant number of patients, yet the pharmaceutical landscape is completely devoid of treatments to prevent CIPN (Press release, Apexian Pharmaceuticals, DEC 5, 2018, View Source [SID1234532133]). The tingling, burning, pain or numbness in the extremities can limit or stop cancer treatment. And, in half the patients affected, CIPN’s symptoms persist five years or more after treatment ends. Apexian Pharmaceuticals aims to change that with their lead compound, APX3330.

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Data presented at the meeting showed continued preclinical support for APX3330 as a potential anti-CIPN treatment, particularly for patients treated with cisplatin or oxaliplatin. Preclinical results presented show APX3330 can block tumor growth while protecting nerve cells.

APX3330, an oral treatment, is currently in a Phase I oncology trial for safety. A Phase II trial is planned in 2019 for anti-tumor and anti-CIPN.

Apexian’s founder and Chief Science Officer, Mark Kelley, PhD, presented the trial’s results in ASCO (Free ASCO Whitepaper)’s Symptom Management Meeting in San Diego, November 16-18, 2018.

Currently ASCO (Free ASCO Whitepaper) does not recommend any drug for preventing or treating CIPN.

"CIPN is a disease with high unmet need and it is exciting to see that APX3330 may have a role to play in addressing the need", says Steve Carchedi, President & CEO of Apexian. "We are committed to developing a portfolio of novel APE1/Ref-1 compound’s that will enhance the lives of patients."

The success of APX3330 builds upon three decades of research by Kelley and his colleagues in modulating a key DNA repair protein, APE1/Ref-1. APX3330 tweaks the protein’s activity to prevent or repair neuronal damage without stimulating cancerous tumors.

APX3330 is Apexian’s lead compound in its growing drug development pipeline.

On December 5, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC) (Press release, AbbVie, DEC 5, 2018, View Source [SID1234531917]). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.

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"Patients are our first priority and we are deeply grateful to the patients and physicians who participated in this trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We remain committed to discovering and developing transformative therapies for people living with cancer."

About the TAHOE Trial
The TAHOE trial is a randomized, open-label, two-arm, Phase 3 trial assessing the efficacy, safety and tolerability of Rova-T versus topotecan in participants with advanced or metastatic small-cell lung cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)1, which is expressed in more than 80 percent of small-cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.2 Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.2 The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.2

Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

On December 4, 2018 AUM Biosciences (AUM), a Singapore headquartered oncology-focused biotechnology company, reported that it has licensed its first novel, highly selective anti-cancer drug, ETC-206, from A*STAR’s Experimental Therapeutics Centre (ETC) (Press release, AUM BioSciences, DEC 4, 2018, View Source [SID1234533612]). The Agency for Science, Technology and Research (A*STAR) is Singapore’s lead public sector agency that spearheads economic oriented research to advance scientific discovery and develop innovative technology.

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AUM has licensed the global rights to develop, commercialize and manufacture ETC-206 in all indications. ETC-206 was discovered and developed through a collaboration between A*STAR’s Experimental Therapeutics Centre (ETC) and Duke-NUS Medical School (a partnership between Duke University School of Medicine and the National University of Singapore). It advanced into first-in-man trials in December 2016. Initial clinical studies suggest that ETC-206 is very well tolerated and could be used as a thera∂ßpy across a range of liquid and solid tumor types.

The drug promises a more targeted approach by inhibiting the Mnk enzyme in cancer cells, which is a key player in promoting cancer growth when activated. This could lower mortality rates for cancer and improve quality of life for cancer patients compared to traditional chemotherapy, which kills cells in a less specific fashion and affects more than just the cancer cells.

"Due to low efficacy and steep costs associated with many cancer treatments, the demand for more precise anti-cancer treatments has become imperative. AUM’s small molecule and biomarker driven approach allows us to implement innovative trial designs enabling "multiple shots on goal", in cancer treatment," AUM’s Chief Executive Officer, Mr. Vishal Doshi said.

ETC-206 is the first in AUM’s pipeline of novel targeted therapies with the potential to be developed both independently and in combination with other therapies. The drug’s ability to isolate and target only cancerous cells promises a breakthrough opportunity globally.

"ETC-206 is a prime example of how A*STAR has been able to translate R&D into positive outcomes to create economic growth and enhance lives for Singaporeans. We look forward to working closely with more Singapore based enterprises such as AUM Biosciences as we continue to leverage our drug discovery and development capabilities to support the growth of the local biotech ecosystem in Singapore." Said Dr Damian O’Connell, Chief Executive Officer of A*STAR’s Experimental Therapeutics Centre.

"Duke-NUS scientists and researchers have led many discoveries with great potential for the welfare of people in Singapore and beyond," stated Dr. David Epstein, Director of Duke-NUS’ Centre for Technology and Development (CTeD), and the School’s Vice Dean for Innovation and Entrepreneurship, who is also an associate professor of the Cancer and Stem Cell Biology Programme. "ETC-206 is an important accomplishment exemplifying Duke-NUS’s mission of facilitating the translation of basic research into commercial entities and products. We are proud to partner with A*STAR in realizing this enterprising venture that was ‘Made in Singapore’ and is being taken forward by AUM, a Singapore-based startup. We look forward to more startups creating entrepreneurship opportunities in the sector."

ETC-206’s licensing by AUM not only puts Singapore on the map, but also enables the company to be at the forefront of emerging oncology trends. This is a significant step towards its vision of "Asia to global" by accelerating the development of innovative and affordable medicines.

"We are now speaking with investors to accelerate ETC-206’s development and our broader molecule acquisition roadmap. AUM will fund further clinical development and will be responsible for regulatory filings, and for clinical studies for this and future drugs," Mr. Doshi commented.

As a future roadmap, AUM has a strategic focus of acquiring and developing promising small molecules targeted oncology assets to unlock their potential, including those that are de-prioritized or not progressed by their originators due to strategic and financial limitations in the healthcare industry. Its mandate of "No biomarker, No drug" serves to increase the probability of success.

Cancer prevalence in Asia is estimated at 17.4 million in 2018, with about 8.8 million new cases every year, accounting for about half of the new global cancer cases. The number of new cases in Asia is expected to increase from 8.8 million in 2018 to 11.8 million by 2030 creating a huge unmet medical need in Asia.

On December 4, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that Dr. Gerrit Dispersyn, President and Chief Operating Officer, will give a presentation at the Tumor Targeted Lymphocytes Summit being held at the Hilton Boston Back Bay in Boston on December 11-13 (Press release, Phio Pharmaceuticals, DEC 4, 2018, View Source [SID1234531867]).

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Dr. Dispersyn’s presentation, titled "Therapeutic Enhancement of TILs with Self-Delivering RNAi through Targeted Gene Silencing," will take place at 12:10 p.m. ET on Thursday, December 13. He will present an overview on the use of RNAi to improve the immunobiology of tumor infiltrating lymphocytes (TILs) and other immune effector cells, how its use compares to other approaches in Adoptive Cell Therapies (ACT), and considerations for clinical and commercial applicability.

Dr. Dispersyn’s presentation will be available under the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com, approximately one hour following the presentation.

The Tumor Targeted Lymphocytes Summit is focused on the topic of optimizing the clinical translation of TILs and endogenous T cells to improve the efficacy of ACT

On December 4, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has engaged cGMP Validation L.L.C. (cGMP Validation) to assist in the preparation of the Investigational New Drug application (IND) that must be submitted to and approved by the U.S. Food and Drug Administration (FDA) before PharmaCyte can begin its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, DEC 4, 2018, View Source [SID1234531883]).

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cGMP Validation is playing a pivotal role for PharmaCyte and will continue to do so as it moves forward with the preparation of its IND. The role of cGMP Validation and its President and Chief Executive Officer, Jesse Gillikin, in particular, is to ensure that each and every step of the manufacturing process of PharmaCyte’s encapsulated cells completely complies with the FDA’s cGMP regulations and all other FDA requirements requested by the U.S. drug regulatory agency. In addition to ensuring that PharmaCyte’s clinical trial product meets regulatory compliance throughout the production process, cGMP Validation will also serve as a resource to Austrianova in its manufacturing process related to cGMP requirements with which it must adhere. For example, cGMP Validation will examine cGMP required documents prepared by Austrianova that concern all "production runs" of the manufacturing process and work with Austrianova to ensure compliance in every respect.

cGMP Validation will also serve, on behalf of PharmaCyte, as the agent for the "release" of the final product that will be implanted into patients before the chemotherapy prodrug ifosfamide is given during the planned clinical trial in LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are extremely fortunate to have been able to retain cGMP Validation as our outside cGMP compliance/validation expert and to have Mr. Gillikin work directly with us and the principals at Austrianova to make certain that the very important manufacturing portion of our IND is complete and compliant with the FDA’s stringent cGMP regulations.

As I mentioned in an interview last summer, we’re almost there. Our checklist of items to be completed has been whittled down to just a few remaining items, and cGMP Validation provides us with the confidence moving forward to get across the finish line. It is imperative that our submission of the IND to the FDA is done flawlessly; therefore, cGMP Validation’s efforts will play a major role in ensuring that the IND we plan to submit to the FDA is as complete and accurate as possible."

cGMP Validation was established in 1997 as a full-service validation/compliance firm offering services for the pharmaceutical, biotechnology, biologics, medical device and medical diagnostic sectors. It has served new and repeat clients across the U.S., Puerto Rico and Canada and has international experience in Europe, Egypt, Korea, Indonesia and Vietnam. cGMP is headquartered in North Carolina, and it has an operational office in Missouri.

Mr. Gillikin is a co-founder of cGMP Validation and serves as its President and Chief Executive Officer. He has been in the pharmaceutical industry since 1978 and has experience in validation, managing QC laboratories, field auditing, and compliance, including interactions with the FDA and international regulatory agencies. His experience has included working with numerous companies in establishing validation and compliance practices. Mr. Gillikin’s experience enables him to provide clients with a wide array of validation resources, such as manufacturing equipment validation, process validation, cleaning validation and computer validation. His extensive work with other companies, as well as his long-standing relationship and experience with the FDA, also enables him to provide auditing, compliance/validation program building and the writing/execution of validation protocols.

Because of the intense efforts that PharmaCyte, cGMP Validation, and PharmaCyte’s clinical team of consultants are currently engaged in with respect to the preparation of the IND, as well as difficulty in coordinating and scheduling travel with everyone involved during the holiday season, PharmaCyte has decided to postpone its planned shareholder meeting until the first quarter of 2019.