On June 3, 2020 Novellus, a precision-oncology drug development company, reported that it has entered into an exclusive worldwide license agreement with Plexxikon, a member of the Daiichi Sankyo Group, for PLX8394, its clinical-stage oncology drug candidate which targets the BRAF protein (Press release, Novellusdx, JUN 3, 2020, View Source [SID1234560782]). PLX8394 is currently completing a Phase 1/2 trial in patients with advanced, unresectable solid tumors.

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"We are excited about executing this agreement with Novellus for PLX8394, as it enables our unique BRAF inhibitor to potentially offer clinical benefit for non-V600 patients as well as V600 patients that lack other treatment options," said Gideon Bollag, PhD, Plexxikon CEO.

"We are very pleased to sign this agreement with Plexxikon, an established drug development company with an impressive track record, including two marketed oncology drugs. We believe that the combination of PLX8394 with our Functional Annotation for Cancer Treatment (FACT) technology will enable rapid and successful development of this novel BRAF inhibitor for patient subpopulations in dire need," said Michael Vidne, PhD, Novellus CEO. "This agreement is the first step in Novellus’ strategy to develop compounds by functionally testing them on hundreds of mutations to identify hyper-specific biomarkers and match them with the right patients."

Under the terms of the agreement, Plexxikon grants Novellus rights to research, develop, manufacture and exclusively commercialize PLX8394 worldwide. Plexxikon will receive an undisclosed upfront payment, additional developmental milestones, and royalty payments.

About PLX8394

PLX8394 is an investigational, oral, small molecule inhibitor of the oncogenic BRAF serine/threonine-protein kinase, which accelerates BRAF mutant cancers by activating the RAS/MAPK pathway. PLX8394 is a next-generation BRAF inhibitor that blocks signaling from both monomeric BRAFV600 and dimeric BRAFnon-V600 mutant proteins, and unlike previous BRAF inhibitors, does not induce paradoxical activation of the MAPK pathway in cells with stimulated RAS signaling. The drug has demonstrated favorable preliminary clinical data in a biomarker-driven Phase 1/2 study in patients with advanced, unresectable solid tumors. The study will now enroll more patients.

On June 3, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the virtual Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 (Press release, AbbVie, JUN 3, 2020, View Source [SID1234560781]). Richard A. Gonzalez, chairman and chief executive officer, AbbVie, will present at 9:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On June 3, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE, a therapy for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, JUN 3, 2020, View Source [SID1234560761]).

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The FDA defines a "rare pediatric disease" (RPD) as a serious or life-threatening disease primarily affecting individuals aged 18 years or younger that impacts fewer than 200,000 people in the United States. The program is intended to facilitate development of new drugs and biologics for the prevention and treatment of RPDs.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.1 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.2

Upon FDA marketing approval of 67Cu-SARTATE for neuroblastoma with RPD designation, Clarity may be eligible to receive a Priority Review Voucher (PRV), which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months. The Voucher may also be sold or transferred and to date PRVs have been sold for between US$67.5 million to US$350 million.

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "The FDA decision to grant RPDD to 67Cu-SARTATE for the treatment of neuroblastoma, following an earlier decision to grant it an Orphan Drug Designation, emphasises the critical need for better treatments for this devastating disease, and is testament to the significant level of work we have completed to date on this therapy.

"The current neuroblastoma treatment strategies are limited, especially in late-stage disease, and the prognosis of high-risk neuroblastoma patients remains unfavourable. Our team at Clarity and our collaborators around the world are committed to improving these outcomes.

"We are very excited about the development of SARTATE in neuroblastoma and are looking forward to the results from our US-based Phase 1/2 trial3. We are hoping that the grant of RPDD will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

On June 2, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported that it has completed a Type B meeting with the United States Food and Drug Administration (FDA) for its drug-device combination product HCC011, slated for the treatment of hepatocellular carcinoma (HCC) (Press release, Tetra Bio Pharma, JUN 2, 2020, View Source [SID1234561076]). This product has received an orphan drug designation for the treatment of HCC.

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The FDA provided guidance on the nonclinical safety and human clinical pharmacology, safety and efficacy requirements to seek marketing approval for HCC011 as an anticancer treatment. The FDA agreed with Tetra’s proposed nonclinical safety program to support the clinical development program and a New Drug Application (NDA).

The FDA also agreed with Tetra that a food effect study is not required for HCC011 as absorption mainly occurs in the lung and is therefore not affected by the liver first pass metabolism effect. This was also confirmed by Health Canada.

Several anticancer drugs have obtained accelerated approval by the FDA based on the outcome of a single arm trial. Tetra requested guidance from the FDA on this potential path, including the development of HCC011 as an adjunct to Sorafenib, as we believe that the drug-drug combination would result in a superior outcome in patients. The FDA provided a response to the proposed trials and options. Tetra must demonstrate the effect of HCC011 on tumor progression as a monotherapy before aiming for developing HCC-011 as an adjunct to Sorafenib. The FDA preferred an efficacy endpoint of Overall Survival for marketing applications seeking regular approval for the treatment of patients with advanced unresectable or metastatic HCC. In addition, they stated that Progression-Free Survival (PFS) may be considered in support of regular or accelerated approval, depending on the magnitude of PFS improvement, provided that it is accompanied by an acceptable risk-benefit profile and no decrement in overall survival.

"We are very pleased with the detailed feedback of Friday’s meeting with the U.S. FDA. Tetra’s clinical research team can now launch the development program." said Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma. "Since the demonstration of the liver toxicity of Epidiolex, we have observed that both the FDA and Health Canada are asking more and more questions on the safety of phytocannabinoid-derived drugs and requiring stricter inclusion-exclusion enrolment criteria and patient monitoring tests and frequency to ensure the safety and well-being of study subjects. On April 2nd 2020, we announced the launch of a clinical study to map out the cannabinoid metabolites in humans following inhalation of QIXLEEFTM and CAUMZTM. The same testing will be extended to HCC011. We hope to demonstrate a safer metabolism profile when CBD and THC are taken by the inhalation route over the oral or sublingual routes. If favorable, this will provide important data to the regulators regarding the safety of inhaled phytocannabinoids."

On June 2, 2020 Genor Biopharma reported that $160 million from the likes of Hillhouse Capital and Temasek Holdings to advance its clinical-stage autoimmune and cancer programs, prepare the launch of its most advanced prospects and support early-stage R&D (Press release, Genor Biopharma, JUN 2, 2020, View Source [SID1234560785]).

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The series B financing will also support potential partnerships both at home and abroad, DealStreetAsia reported Monday. Hillhouse led the round, with Temasek, Shanghai-based Haitong Capital, Cavenham PE and CR-CP Life Science Fund also chipping in.

"We are very honored to receive the recognition and support from existing and new investors in this round of financing," said Genor CEO Feng Guo, Ph.D., as quoted by China Money Network. "2020 is a crucial year for Genor Biopharma. We are working for clinical applications of some products in the final development stage, and accelerate the development of innovative drugs in the field of tumor immunotherapy."