On July 10, 2018 Adlai Nortye Biopharma Co., Ltd. ("Adlai Nortye" or "the Company"), a biopharmaceutical company dedicated to discovering and commercializing new drugs in the field of oncology/immuno-oncology, announced today that it has entered into a Global License Agreement ("the Agreement") with Novartis Pharma AG, a global pharmaceutical company (Press release, Adlai Nortye Biopharma, JUL 10, 2018, View Source [SID1234556283]). Under the terms of the Agreement, except for certain rights maintained by Novartis Pharma AG, Adlai Nortye will have exclusive development and commercialization rights to buparlisib worldwide for all the therapeutic, prophylactic and/or diagnostic uses in humans.

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Buparlisib (BKM120) is an oral pan-PI3K inhibitor that targets all class 1 PI3K isoforms and is active in both hematologic malignancies and solid tumors. It has shown promising efficacy in combination with paclitaxel in head and neck squamous cell carcinoma (HNSCC) and has received a Fast-Track designation from the FDA.

"Combination of buparlisib and paclitaxel demonstrated improved clinical efficacy with a manageable safety profile in patients with HNSCC compared to paclitaxel alone," said Dr. Lars Birgerson, Chief Development Officer of Adlai Nortye and President & CEO of Adlai Nortye USA Inc. "We believe that buparlisib will be another key component in furthering development of our oncology pipeline, and it has great potential for future application in cancer treatment."

"Buparlisib has been extensively profiled in breast cancer and other tumor types. Buparlisib when combined with other therapies has shown impressive anti-cancer efficacy in HNSCC," said Carsten Lu, CEO of Adlai Nortye, "It has very good market prospects when combined with paclitaxel, and we are planning to carry out clinical trials of combination of buparlisib and immune check point inhibitor treatment."

On July 10, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), reported that the Japan Patent Office has issued Japanese Patent No. 6325573 for CG-806 (Press release, Aptose Biosciences, JUL 10, 2018, View Source;p=RssLanding&cat=news&id=2357553 [SID1234527629]). The granted patent claims various compounds, including the CG-806 compound, pharmaceutical compositions comprising the CG-806 compound, and uses for the treatment of various diseases, such as cancer. The patent is expected to provide protection until the end of 2033.

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"This newly issued patent extends the CG-806 patent protection into an important market and is a welcome addition to the US patent that was issued last year," stated Dr. William G. Rice, Chairman, President and Chief Executive Officer of Aptose. "As noted previously, we plan to continue expansion of the patent portfolio through additional findings and applications."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On July 9, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp., a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported the closing of an agreement providing ApolloBio with the exclusive right to develop and commercialize Toca 511 & Toca FC within the greater China region (Press release, Tocagen, JUL 9, 2018, View Source;p=RssLanding&cat=news&id=2357366 [SID1234527620]). ApolloBio has garnered all regulatory approvals for the agreement and paid Tocagen the upfront payment of $16 million.

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Under the terms of the agreement signed with ApolloBio in April 2018, Tocagen is also eligible to receive potential payments of $4 million in near-term development milestones, including a milestone for the completion of enrollment in the ongoing Phase 3 Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, the agreement provides for low double-digit tiered royalty payments based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"We’re pleased to have completed our strategic partnership agreement with ApolloBio, allowing us to expand the global commercial opportunity for Toca 511 & Toca FC amidst important recent developments in China to facilitate patient access to medical innovations," said Marty Duvall, chief executive officer of Tocagen. "This partnership also strengthens Tocagen’s cash position to fuel our pivotal Phase 3 Toca 5 trial and our pipeline-expanding R&D efforts."

"We are eager to collaborate closely with Tocagen and advance the development of Toca 511 & Toca FC in greater China," said Dr. Weiping Yang, chief executive officer of ApolloBio. "This partnership is an example of our commitment to bringing novel immuno-oncology treatments to the large patient population in China as soon as possible."

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

On July 9, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the company will participate in the Oppenheimer Boston Oncology Insight Summit July 10 – 11, 2018 (Press release, VBI Vaccines, JUL 9, 2018, View Source [SID1234527621]). The two-day summit will feature a series of discussions with primary investigators at the Whitehead Institute in Cambridge, Massachusetts, followed by one-on-one meetings with institutional investors at the Four Seasons Hotel in Boston, MA.

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Event Details
Event: Oppenheimer Boston Oncology Insight Summit
Dates: July 10 – 11, 2018
Location: Boston, MA
Event Website: View Source

On July 9, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported that ClinicalTrials.gov has updated its website to now include OncBioMune’s Phase 2 clinical trial evaluating ProscaVax as the first ever therapeutic vaccine for prostate cancer patients in the active surveillance group (Press release, Oncbiomune, JUL 9, 2018, View Source [SID1234527803]). The trial is being hosted at Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA, and includes the Dana-Farber Cancer Institute.

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study will evaluate the safety and efficacy of ProscaVax in patients with localized prostate cancer. The goal of the study is to determine if ProscaVax administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy.

Details on the trials can be viewed at: View Source

"The initiation of this study represents a milestone moment for our company, shareholders and the more than 160,000 men that will learn they have prostate cancer this year," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "For the first time ever, prostate cancer patients in the trial will have a therapeutic vaccine as an option rather than waiting for disease progression or jumping into more invasive treatments options that frequently are accompanied by very unpleasant side effects, such as urinary incontinence and impotence. We look forward to the commencement of enrollment and to the future where we will learn more about the efficacy of ProscaVax as a front-line treatment for prostate cancer."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.