On June 2, 2020 Sanofi Chief Executive Officer Paul Hudson along with R&D and commercial leaders reported that it will provide an overview of Sanofi’s oncology strategy and progress update of its related key products and pipeline programs. Sanofi’s oncology strategy is focused on four core therapeutic areas with four anchor treatments the company believes have the potential to transform patient care (Press release, Sanofi, JUN 2, 2020, View Source [SID1234560787]).

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The four areas of strategic focus within oncology, including multiple myeloma, skin, lung, and breast cancers. Sanofi’s four anchor oncology treatments include Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody and Libtayo (cemiplimab-nwlc), a PD-1 checkpoint inhibitor1 and the pipeline programs – an investigational anti-CEACAM 5 antibody drug conjugate and SERD (‘859), an investigational oral selective estrogen receptor degrader.

"We are rapidly building momentum with the execution of our oncology strategy, with several developments on both our pipeline and marketed treatments. Additionally, we are assembling a world-class development and marketing team to support our growth in this core area," said Hudson. "We believe our efforts and treatments have the potential to make a significant difference in the lives of people living with cancer."

"We’ve developed a focused oncology strategy, and are making significant clinical progress to support our ambitions," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "With a deep toolbox of therapeutic platforms enabling us to discover highly differentiated molecules, Sanofi has a tremendous opportunity to continue our momentum and build a sustainable presence in oncology."

The virtual investor event will be held today from 4:00-5:30 pm CET/10:00-11:30 am EST. Sanofi speakers include:

Paul Hudson, Chief Executive Officer

John Reed, Global Head of Research and Development

Partnered with Regeneron

Dietmar Berger, Chief Medical Officer and Global Head of Development

Peter Adamson, Global Head of Development, Oncology

Alex Zehnder, Global Franchise Head, Oncology

Additional information about today’s oncology presentation can be found at:

View Source

On June 3, 2020 Shorla Pharma reported that picking up $8.3 million to push its programs through regulatory approval and build up its technical and commercial operations ahead of its first drug launch in 2021 (Press release, Shorla Pharma, JUN 3, 2020, View Source [SID1234560786]). The company will hire "key personnel" in Ireland, Cunningham told FierceBiotech. And with the U.S. as its first market, part of the funds will go toward setting up an outpost to take care of business development and regulatory and commercialization activities stateside.

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The Dublin-based company is working on three programs, all of which are improvements on established drugs, which may have a difficult-to-use formulation, not treat certain types of cancer very well or be in limited supply. Cunningham and Ryan didn’t disclose what the drugs are, beyond saying they are all "established active substances" that have been "proven from a safety and efficacy perspective."

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."