On February 12, 2020 The Neuroendocrine Tumor Research Foundation (NETRF), Boston, MA, reported $3.5 million in neuroendocrine tumor (NET) research grants to fund 12 projects around the world in pursuit of more precise treatments for this uncommon cancer affecting an estimated 171,000 Americans (Press release, NETRF, FEB 12, 2020, View Source [SID1234554385]).

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After investing $26 million in research during the past 15 years, NETRF has helped to establish the NET knowledge base needed to expand the exploration of improved treatments, according to Elyse Gellerman, NETRF chief executive officer. "We can see real momentum in this new round of grants. We hope the discoveries from these projects will lead to improved treatment options for patients."

NETRF is supporting a new pioneering approach to NET immunotherapy with a Petersen Accelerator Award to Steven Libutti, MD, Rutgers Cancer Institute of New Jersey, to characterize a novel immune regulator called B7x to determine whether it has a role in shutting off the body’s immune response to fight against pancreatic NETs.

This round of funding features multiple new fronts for NETRF. To help grow the NET scientific workforce, the Foundation granted two inaugural Mentored Awards for early career researchers, one of which was funded by an educational grant from Ipsen. There were also new areas of NET inquiry. For the first time, NETRF is funding pheochromocytoma and paraganglioma research, including an evaluation of a novel radiotracer for imaging adrenal NETs.

NETRF also funded four research projects in lung NETs, an area that has not previously received the attention of other NET sites. These lung studies include:

Conducting single-cell genomic analyses to understand how lung NETs form, grow, and spread.
Mapping the cellular networks of typical and atypical lung NETs to find biomarkers that help predict a tumor’s aggressiveness.
Characterizing the molecular makeup of a newly identified, aggressive lung NET called "supra-carcinoid."
Determining the sociodemographic and geographic patterns of lung NETs in California.
"Advances in NET research have been hampered by the lack of effective laboratory disease models, and a limited understanding of the molecular and genetic profiles of NETs," said John Kanki, PhD, NETRF director of research. "Now that we are making strong headway along these lines, we can finally begin to drill deeper with greater specificity, to identify and explore new strategies for treating NETs."

NET tumors require the expansion of new blood vessels in order to grow and spread and two new grants explore new therapies that target developing tumor blood vessels. Researchers at Vanderbilt University will explore the potential efficacy of a combination therapy testing a drug known to affect the formation of new blood vessels (cabozantinib) together with an experimental drug called CB-839. At Columbia University Medical School, scientists will conduct preclinical laboratory experiments to test whether turning off two complementary blood vessel-forming processes together can improve therapeutic efficacy in pancreatic NETs.

NETRF also approved grants to study a potential cause of small intestinal multifocal tumors and to evaluate the role of the gut microbiome in carcinoid syndrome.

Seventy-five percent of the grants were awarded to research institutions that are new to NETRF including five grants funding international research at Erasmus MC, University Medical Center Rotterdam, Netherlands; Hebrew University of Jerusalem, Israel; International Agency for Research on Cancer (IARC-WHO), Lyon, France; Istituto Auxologico Italiano – Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; and Weizmann Institute of Science, Rehovot, Israel.

Seven of the 12 grants fund innovative NET research at American academic institutions, including Columbia University Medical Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; University of California, San Francisco, CA; Tufts Medical Center, Boston, MA; University of Michigan, Ann Arbor, MI; and Vanderbilt University Medical Center, Nashville, TN.

The NETRF grant process is a competitive and structured peer-reviewed process. The Foundation is currently accepting applications for its next grant cycle. Applications must be received by March 9, 2020. View Source

Gellerman thanked the many individuals and foundations whose gifts to the 501(c)(3) nonprofit organization support NETRF’s research and educational activities. A generous gift from the Margie and Robert E. Petersen Foundation will fund several of the new projects. Additional support has been provided by the Goldhirsh-Yellin Foundation of Los Angeles and Advanced Accelerator Applications.

On February 12, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that its "Annual Report 2018" published in March 2019 has won Second Prize for the second consecutive year in the 22nd NIKKEI Annual Report Awards (Press release, Chugai, FEB 12, 2020, View Source [SID1234554194]).

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Started by Nikkei Inc. in 1998, the NIKKEI Annual Report Awards are presented with the aim to further enhance and promote annual reports published by Japanese companies. This year, 133 companies participated, significantly exceeding the number in the previous year, and a Grand Prize, three Second Prizes, two Special Prizes, and 14 Honors were awarded.

Chugai began integrated reporting from Annual Report 2012 and has made various efforts to promote a better understanding of its unique strengths and corporate value among a wide range of stakeholders. As a result, our report has continually earned high acclaim, receiving an award every year since 2012, and winning the Grand Prize for two consecutive years in 2014 and 2015.

Chugai’s Annual Report 2018 was highly evaluated for "containing a very high quality description of the core components of integrated reporting such as vision, business model, strategy, risk and opportunity, performance, governance, sustainability, and the reason for creating the new mid-term business plan. The report also explained the company’s relationship with the majority shareholder and how it ensures the rights and equality of shareholders."

In addition, Chugai’s Annual Report has been awarded a Prize for Excellence in Integrated Reporting in the 7th WICI Japan Award for Excellence in Integrated Reporting, marking the first time Chugai has been a double award winner.

Chugai will continue striving to disclose information in an easy-to-understand manner in order to help satisfy the needs of its many stakeholders.

On February 12, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that the research team lead by Dr. Jose Conejo-Garcia, Chair of the Department of Immunology at Moffitt Cancer Center, Anixa’s development partner, has completed and validated the reformulation of the viral vector necessary for its CAR-T program (Press release, Anixa Biosciences, FEB 12, 2020, View Source [SID1234554216]).

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Last year, Anixa announced, that in order to improve the potential efficacy of its CAR-T therapy, it would reformulate the viral vector used to infect and engineer each individual patient’s T-cells. The purpose was to increase the expression level of the Follicle Stimulating Hormone (FSH) on the engineered, autologous T-cells. With the successful viral vector reformulation, verification and validation, the new viral formulation is now being manufactured under Good Manufacturing Practice (GMP) conditions. This manufacturing process is expected to take approximately three months and Anixa and Moffitt remain on track to file the Investigational New Drug (IND) application in 2020.

CAR-T therapy requires the extraction and isolation of an individual’s T-cells, followed by engineering these cells to enable them to more effectively kill cancer. These cells are then expanded and reinfused into the patient. Engineering these cells is performed by using a virus that itself has been engineered. The engineered virus initially infects the T-cells. Successive to infection, the virus induces the cellular machinery of the patient’s T-cell to create on its surface, the "homing missiles" which in the case of Anixa’s therapy are FSH molecules. It is expected that a T-cell with more FSH on the surface will be more effective at targeting ovarian cancer.

Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased to have completed this first milestone in our development program and remain confident in our previously stated development timeline."

"Our laboratory completed the reformulation of the viral vector, and we have demonstrated its ability to increase the concentration of FSH on the surface of transformed human T-cells. We expect the increased expression of FSH to provide better efficacy of our drug for ovarian cancer patients. We are looking forward to taking this therapy into the clinic as soon as possible," stated Dr. Conejo-Garcia.

On February 12, 2020 AVEO Oncology (NASDAQ: AVEO) reported the publication of results from a monotherapy trial of tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), in patients with advanced, inoperable hepatocellular carcinoma (HCC) in the British Journal of Cancer (Press release, AVEO, FEB 12, 2020, View Source [SID1234554234]). The article, titled "A multicentre phase 1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma," is available online first via this link.

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For the Phase 1b/2 tivozanib study, a total of 27 patients were enrolled. The study sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC. The recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once daily for 21 days followed by 7 days off treatment on a 28-day cycle. Median progression free and overall survival were 24 weeks and 9 months, respectively, for patients treated at the RP2D, with an overall response rate of 21%. A significant decrease in soluble plasma VEGFR-2 was also observed, suggesting adequate target engagement.

"HCC represents the fastest rising cause of cancer-related death in the U.S., with five-year survival at approximately 26%," said Michael Bailey, president and chief executive officer. "This study is an important steppingstone in understanding tivozanib’s safety and efficacy in HCC, and was the foundation for our ongoing Phase 1b/2 DEDUCTIVE study of tivozanib in combination with IMFINZI (durvalumab). As we work toward our expected filing of a New Drug Application with the FDA this quarter for tivozanib in kidney cancer, we look forward to expanding our tivozanib-immunotherapy clinical strategy as part of our effort to maximize its long-term potential."

Enrollment is currently underway in a Phase 1b/2 DEDUCTIVE study of tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with HCC who have not received prior systemic therapy. The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca.

"In a number of solid tumor indications, including metastatic liver cancer, VEGF-TKI/immunotherapy combinations are playing an increasingly important role in initial treatment selection," said Renuka Iyer, M.D., senior author of the publication and Professor of Oncology and Co-Director, Liver and Pancreas Tumor Center, Roswell Park Comprehensive Cancer Center. "Central to these combinations is the tolerability of the VEGF-TKI backbone. With an early efficacy signal and favorable tolerability profile demonstrated in this study, tivozanib shows great potential as a VEGF-TKI for such combinations. I look forward to seeing this potential elucidated in the ongoing DEDUCTIVE study of tivozanib and durvalumab in HCC."

About Tivozanib

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is intended to support a regulatory submission of tivozanib in the U.S. as a treatment for relapsed/refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

On February 12, 2020 Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues increased 66% and gross profit rose 57% for its fiscal 2020 first quarter ended December 31, 2019 (Press release, Veru, FEB 12, 2020, View Source [SID1234554217]).

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First-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 66% to $10.6 million from $6.4 million;

Gross profit increased 57% to $7.3 million from $4.6 million;

FC2 US prescription net revenues increased 148% to $6.1 million from $2.4 million;

Operating loss was $1.8 million; and

Net loss was $3.3 million, or $0.05 per share.

"Our robust fiscal 2020 first quarter net revenues and gross profit were driven primarily by the 148% growth in prescription sales of FC2," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Both our top line and gross profit for the period exceeded last year’s first quarter, as well as the preceding quarter. Increased public sector sales of FC2 and growing demand for our PREBOOST/Roman Swipes product were also key contributors to our positive momentum. We continue to generate significant cash to invest in the clinical development of our prostate and oncology drug pipeline. We are off to a great start for fiscal 2020.

"On the clinical development front, we are on target to complete before the end of our current quarter, the Phase 1b portion and to initiate the Phase 2 portion of the clinical trial for VERU-111, our proprietary prostate cancer product. VERU-111, an oral, next generation, first-in-class, selective antitubulin, has demonstrated preliminary antitumor activity in men with metastatic castration resistant prostate cancer and appears to be well tolerated with no evidence of treatment induced neutropenia, neurotoxicity or allergic (hypersensitivity) reactions that typically occur with IV taxane chemotherapy. To date, our Phase 1b/2 clinical study has enrolled and dosed 39 patients from 4.5 mg per day up to 81

mg per day. The study protocol called for continuing to enroll patients until a maximum tolerated dose was reached, or some safety side effect that indicates that higher doses may not be well tolerated, was observed. There have been reported side effects consistent with VERU-111’s and other antitubulins’ cytotoxic effects, such as mostly mild to moderate diarrhea, nausea, and vomiting, which appear to be dose dependent.

"Although this study was designed for determination of safety, we do see evidence of preliminary antitumor activity. Historical controls from the literature report that the time to imaging based tumor progression in men like those enrolled in our study averages about 3.7 months. In our Phase 1b/2 trial, we have 20 men in the study that had the potential to be treated for 4.5 months. Even without having an optimal dose or dose schedule yet determined, there are 4 men who are still ongoing in the trial with no progression at 11.75, 10.4, 10.4 and 7.6 months. All these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 11.75 months had a PSA reduction of -63% and has had cancerous lymph nodes shrink as measured by CT scan and confirmed by a second CT scan. We also have another patient who at the time of enrollment had progressing prostate cancer bone metastases, show improvements of these bone metastases based on a bone scan following treatment with VERU-111. There is also evidence that these anticancer effects appear to have a dose response—meaning higher doses at 3-week cycles have more activity.

"Last month, we announced positive top line data from our Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy (ADT) induced hot flashes in men who have advanced prostate cancer. The interim results at Day 42 indicate that Zuclomiphene has clinically meaningful activity against moderate to severe hot flashes and appears to be well tolerated with no reports of estrogen related side effects like breast tenderness or enlargement or venothromboembolic events. We plan to meet with the FDA to review the development plan and based on that discussion, we anticipate initiation of the pivotal Phase 3 clinical trial to evaluate Zuclomiphene for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer by early summer.

"Our plan is also to submit by the end of next quarter an Investigational New Drug (IND) application for VERU-100, our long-acting 3-month, small volume, subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer.

"TADFIN (Tadalafil and Finasteride Combination Capsule), which is being developed for benign prostatic hyperplasia (BPH) and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor, is collecting 12-month stability data on manufacturing batches. The Company will submit an NDA for TADFIN which is expected in the second half of 2020. Our plan is to launch this product in the U.S. via telemedicine.

"Finally, two of our scientific abstracts have been accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium and are to be presented this weekend. The first presentation will provide proof of concept preclinical data on VERU-100 as a long acting GnRH antagonist subcutaneous depot. The second presentation is a survey of the impact of hot flashes on a contemporary cohort of men with advanced prostate cancer on ADT. This is the patient population that Zuclomiphene is being developed for to address this unmet medical need."

Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register,

download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10138979, for one week.