On January 29, 2019 Genetic Immunity, a clinical stage biotechnology company, is reported that it is expanding its collaboration with JSC Pharmadis by granting licenses to twenty cancer indications of its trans-dermally delivered pDNA-based vaccine technology (Press release, Genetic Immunity, JAN 29, 2019, View Source [SID1234554012]).

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The new indications cover twenty different cancer types including vaccines for the treatment of: prostate cancer, glioblastoma, colon & rectal cancer, Non-Hodgkin lymphoma, endometrial cancer, stomach cancer, bladder cancer, cervical cancer, lung cancer, thyroid cancer, leukemia, breast cancer, kidney cancer, ovarian cancer, liver cancer, myeloma, lip-oral cavity cancer, oesophagus cancer, brain cancer and gallbladder cancer.

"We are gratified to have expanded our collaboration with Pharmadis with the license of a tremendous portfolio of potential cancer immunotherapies. Closely following our HIV vaccine deal, the management of Pharmadis felt it would be a tremendous opportunity for them to have access to a broad range of possible treatment breakthroughs. Once they understood the basis of our platform technology, it was an easy next step for us to expand our collaboration and work with a single pharma player in Russia," stated Viktor Rozsnyay, CEO of Genetic Immunity.

"I think this is a singular collaboration, as to my knowledge, no-one has ever licensed such a broad range of product candidates based on a single product platform. We are excited for this opportunity and bring to market a revolutionary array of cancer treatments that can affect the lives of millions of people," added Rozsnyay.

Under terms of the new agreement, Pharmadis received rights to market all twenty cancer vaccines in Russia and the Commonwealth of Independent States. Genetic Immunity and Pharmadis will jointly develop all vaccines and seek Russian marketing approval. Clinical trials will be conducted beginning with prostate cancer and glioblastoma. Upon approval Genetic Immunity will receive double-digit royalties on sales.

The DermaVir immunotherapy vaccine platform contains a novel plasmid DNA that encodes disease specific antigens. The first product to demonstrate this technology is Genetic Immunity’s HIV vaccine that Pharmadis licensed in 2018. For cancer vaccines based on the technology platform the disease specific pDNA will be used with appropriate antigens coded. The vaccine is topically administered using the DermaPrep medical device.

"Upon completing our HIV vaccine license with Genetic Immunity, we continued discussion to see how we may use other products in Russia. As we became familiar with the Company’s pDNA platform technology we felt it would make sense to propose an extension to our licensing agreement to cover as many cancer types as possible. Genetic Immunity’s management agreed with our proposal and we are happy to further our collaboration. The next two to three years will be of paramount importance as we hope to bring to market a number of revolutionary cancer vaccines to combat the disease," stated Nikolai Kovalev, Managing Director of Pharmadis.

The design of pDNA needed for prostate cancer and glioblastoma is already underway. Once completed, an investigator sponsored trial will be conducted in Moscow, Russia, at the European Medical Center. The first indication will cover glioblastoma, an aggressive brain cancer, with principal investigator Professor Alexey Krivoshapkin, a world-renowned neurosurgeon.

Plasmid DNA based vaccines have been proven safe, but poorly immunogenic in human subjects. Genetic Immunity has developed several technologies to improve the immunogenicity of DNA-encoded antigens, including:

Antigeneering of plasmid DNA to safely and authentically express most of the antigens of HIV or other pathogens, including cancer.
The formulation of plasmid DNA to a pathogen-like nanoparticle called NanoComp. These nanoparticles target professional antigen-presenting cells, such as Langerhans cells and dendritic cells.
A targeted transdermal delivery device called DermaPrep. It has been shown that topical DermaPrep administration results in antigen expression in the lymph nodes by dendritic cells.

On January 29, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported that its fourth-quarter and full-year 2018 financial results will be released on Wednesday, Feb. 27, 2019 (Press release, Horizon Pharma, JAN 29, 2019, View Source [SID1234532932]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

On January 29, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that it will report financial results for the second quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, February 5, 2019 (Press release, Array BioPharma, JAN 29, 2019, View Source [SID1234532950]). Ron Squarer, Chief Executive Officer, will lead the call.

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Date:

Tuesday, February 5, 2019

Time:

9:00 a.m. Eastern Time

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

9778144

Webcast, including Replay and Conference Call Slides:
View Source

On January 29, 2019 Triphase Accelerator, together with its majority shareholder FACIT, reported a new strategic collaboration with Celgene for a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers including leukemia (Press release, Celgene, JAN 29, 2019, View Source [SID1234536469]). Triphase is a drug development company advancing novel compounds through Phase 2 proof-of-concept, including the WDR5 program.

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Under the terms of the agreement, Celgene has the option to acquire TRPH-395 from Triphase Accelerator. Celgene will pay an upfront of US$40M and upon exercise of the option, Celgene will pay up to US$940M in contingent development, regulatory and sales milestones. Additional payments for sales-based royalties are also possible.

"As with our previously announced spin outs, the Drug Discovery team at Ontario Institute for Cancer Research (OICR), led by Dr. Rima Al Awar, has yet again produced a world-class asset for patients with cancer," remarked Dr. David O’Neill, President of FACIT. FACIT seed financed Propellon Therapeutics to commercialize the preclinical asset and ran a competitive global business development process to identify strategic partners. Multiple formal offers were received from the US, Europe and Japan, reflecting the high quality of science in the program.

Dr. O’Neill continued "The quality of the team and commitment by Triphase Accelerator to engage Ontario researchers and clinical sites in its high content studies, combined with its long-standing relationship with Celgene made this partnership the most compelling path to impact patients and the local economy." While additional payments to the program are largely contingent on clinical success, the significant financial commitment will enable re-investable returns by FACIT in the Ontario innovation economy.

The WDR5 protein is critical for the formation and activities of certain protein complexes that are associated with DNA and indirectly modify genes. These processes represent an exciting new therapeutic field, referred to as epigenetics. Blood cancers like leukemia can result when WDR5-associated protein complexes are not appropriately regulated in the body. Drug compounds that can disrupt these cancer-causing cellular activities represent a novel therapeutic approach, which may also improve clinical outcomes in patients with solid tumours.

"This transaction represents a significant milestone for Triphase Accelerator as it brings together our long-standing collaboration with Celgene and a first-in-class asset from Ontario" said Dr. Ilse Treurnicht, Executive Chairperson at Triphase Accelerator. "We are excited that this transaction is another step forward to realizing the vision of the founding partners – OICR, MaRS Innovation and MaRS – and will allow Triphase to apply its unique science based, rapid, and cost-effective approach to advancing this Ontario based program toward clinical proof of concept."

"Our investment in Propellon’s technology reflects our commitment to developing first-in-class epigenetic therapies for patients with hematological cancers," remarked Dr. Jorge DiMartino, Vice President of Translational Development at Celgene. "The teams at OICR Drug Discovery, FACIT and Triphase Accelerator have together created an optimal pathway for oncology innovation and help make Ontario a strong collaborator and destination for our investment."

"This is a great day for cancer research in Ontario. Congratulations to FACIT, OICR and Triphase Accelerator," said Todd Smith, Minister of Economic Development, Job Creation and Trade. "This discovery and investment will benefit Ontario cancer patients and support industry jobs in the province. Ontario is open for business, and we welcome more innovative cancer research and trials."

"This is an exciting development for cancer research and innovation in Ontario, and I congratulate FACIT, OICR and Triphase Accelerator on their important collaboration," said Christine Elliott, Deputy Premier and Minister of Health and Long-Term Care. "It’s partnerships like these that keep Ontario open for business and are invaluable as we work toward developing a long-term transformational health care strategy guided by innovation, integration and the better use of technology."

On January 29, 2019 Perrigo Company plc (NYSE: PRGO; TASE), a leading global provider of "Quality, Affordable Self-care Products", reported that the company expects to receive a milestone payment of $250 million from RPI Finance Trust, an affiliate of Royalty Pharma ("RPI") (Press release, Perrigo Company, JAN 29, 2019, View Source [SID1234532951]). This expected payment is the result of RPI’s contingent payments for Tysabri exceeding $333 million in calendar 2018.

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Perrigo’s President and CEO Murray S. Kessler stated, "Receipt of this milestone payment will enhance our financial flexibility to drive growth organically and through bolt-on acquisitions. We look forward to sharing more details about the company’s transformation plans including our capital allocation strategy during our upcoming Analyst Event, planned for this spring."

Under Perrigo’s agreement with RPI, Perrigo has the right to receive an additional $400 million milestone payment if RPI’s contingent payments for Tysabri sales in 2020 exceed $351 million.