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 10, 2018 CSPC Pharmaceutical Group Limited (the "Company") is reported that the Company has entered into a product co-development and strategic collaboration agreement (the "Agreement") with Shanghai Junshi Biosciences Co., Ltd. ("Junshi") in relation to the clinical development, registration and commercialization of PD-1 (the anti-PD-1 monoclonal antibody exclusively supplied by Junshi) in combination with albumin-bound paclitaxel for the treatment of breast cancer (the "Product") (Press release, CSPC Pharmaceutical, JUL 10, 2018, View Source [SID1234532266]).

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Pursuant to the Agreement, the Company and Junshi shall form a joint research committee to (1) formulate clinical strategy for the development of the Product; (2) establish and monitor the clinical trials timeline and progress; (3) ensure the full access of clinical data by both parties; (4) discuss and make decision on combination studies of PD-1 with albumin-bound paclitaxel and other chemotherapeutic agents; and (5) resolve any issues that arise during the process of the development and registration of the Product.

The Company shall be responsible for (1) designing and executing clinical trials for the Product; (2) supplying albumin-bound paclitaxel to conduct clinical trials of the Product in the People’s Republic of China (including Hong Kong, Taiwan and Macau) (the "Territory"); (3) applying and securing approval of the Product in the Territory; and (4) commercialization of the Product in the Territory.

Junshi shall be responsible for (1) securing approval of PD-1 single entity in the Territory; (2) supplying PD-1 for the Company to conduct clinical trials for the Product in the Territory; (3) supplying PD-1 to the Company for sales of the Product in the Territory according to a supply agreement to be mutually agreed between the parties.

Junshi grants to the Company a royalty-bearing exclusive license to commercialize the Product in the Territory for a term commencing from the date of the Agreement until 20 years from the receipt of the relevant regulatory approval in the Territory (the "Term"), which allows the Company during the Term to (1) perform clinical and non-clinical studies of the Product; (2) apply for and obtain approvals of the Products in the Territory; and (3) market and sell the Product in the Territory.

Junshi and its affiliates shall not grant any right or license of its PD-1 to any third party for the purpose of development and commercialization of the Product in the Territory. The Company and its affiliates shall only collaborate with Junshi to develop and commercialize the Product.

The Company agrees to pay to Junshi a milestone payment of RMB30,000,000 at each of the five milestone events (i.e. up to an aggregate of RMB150,000,000) leading to the product approval and issuance of product licence by the China Drug Administration for the Product.

All intellectual property rights related to the Product, to the extent solely discovered, invented or developed under the Agreement, shall be jointly owned by the Company and Junshi.

On July 10, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a clinical update, as follows (Press release, Advaxis, JUL 10, 2018, View Source [SID1234527648]):

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Plans to withdraw its Conditional Marketing Authorization Application (MAA) in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy

Submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to study its first ADXS-HOT drug candidate for the treatment of non-small cell lung cancer (NSCLC)

Selection of prostate cancer as the second cancer type within its ADXS-HOT program to move towards the clinic, with an IND filing anticipated within the next six months

Advaxis’ regulatory action in Europe is based on European Medicines Agency (EMA) feedback following its initial review indicating the application will likely need additional data to support a conditional approval. The February 2018 submission included data from the Phase 2 GOG-0265 study in 50 patients, which showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with persistent, recurrent or metastatic carcinoma of the cervix, representing a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate was unprecedented when compared against historical data.

The Company continues to believe that the results from the GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac. As previously communicated, Advaxis is actively seeking a partner to support the late-stage cervical cancer program.

The Company also announced that it has submitted an IND with the FDA to study its first product candidate from the ADXS-HOT program, ADXS-503, for the treatment of NSCLC. Upon allowance of the IND for ADXS-503, the Company plans to initiate an open-label, Phase 1/2 clinical trial. Further details of the study design will be provided after the IND is allowed. Advaxis expects the first patient will be dosed by the end of 2018. Additionally, Advaxis anticipates submitting a second IND from the ADXS-HOT program within the next six months, for its drug candidate referred to as ADXS-504, for the treatment of prostate cancer.

"We are pleased to submit the ADXS-503 IND and look forward to advancing our ADXS-HOT NSCLC drug candidate into the clinic. Our ADXS-HOT program leverages both the benefits of our Lm technology platform, which has shown clinical activity in earlier generation drug candidates, and the use of neoantigen targets. We believe that neoantigen-based treatments have the potential to transform cancer care, and the ADXS-HOT program allows us to develop cancer-type specific therapies across a broad range of tumor types," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With our announcement today of plans for a second IND submission for an ADXS-HOT construct in prostate cancer, we feel confident we can reach proof-of-concept for these off-the-shelf therapeutics in a relatively rapid and cost-effective manner."

Advaxis affirms plans to submit a total of four INDs for drug candidates from its ADXS-HOT program by the end of calendar year 2019, resulting in Phase 1/2 studies evaluating safety, immune responses and preliminary clinical activity of four different constructs addressing four different tumor types. Beyond NSCLC and prostate cancer, the next two ADXS-HOT product candidates will be selected from breast, colorectal, bladder, ovarian and head and neck cancers.

About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. Although ADXS-HOT drug candidates have not yet been tested in patients, each product candidate has been designed to potentially treat all patients with a specific cancer type, without the need for pre-treatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

On July 10, 2018 Aravive Biologics, Inc. reported that the company has completed both the single ascending dose and repeat dose portions of its Phase 1 study of AVB-S6-500 in healthy volunteers (Press release, Aravive Biologics, JUL 10, 2018, View Source [SID1234528276]).

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The study met the safety and tolerability endpoints for the trial. As previously announced, the study also demonstrated clinical proof-of-mechanism for AVB-S6-500 in neutralizing GAS6, based on analysis of the single ascending dose portion of the study which demonstrated a dose-dependent decrease in measurable, circulating free GAS6 in serum. Aravive plans to submit full results of the study for potential presentation at a major medical meeting later in 2018. Also during the second half of 2018, the company expects to initiate the Phase 1b portion of a Phase 1b/Phase 2 trial combining AVB-S6-500 with standard-of care-therapies in patients with platinum-resistant ovarian cancer.

Elevated GAS6 levels have been associated with poor prognosis in cancer. As a decoy molecule, AVB-S6-500 has been shown to neutralize GAS6 activity by binding to that molecule with very high affinity. In doing so, AVB-S6-500 selectively inhibits triggering of the GAS6-AXL signaling pathway. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. Inhibition of the GAS6-AXL pathway has also shown potential as a strategy for the treatment of certain fibrotic diseases.

"We are pleased with the positive outcome of this first study of AVB-S6-500 in humans. The results not only demonstrated initial safety and tolerability for this therapeutic candidate but clearly showed a dose-related reduction of circulating free GAS6, a measurement that we anticipate will be highly useful as a biomarker of drug activity in future clinical studies," said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D at Aravive. "We look forward to our anticipated initiation of the Phase 1b portion of our planned Phase 1b/Phase 2 studies in ovarian cancer during the second half of this year, which are designed to evaluate the anti-cancer effects of lowering of GAS6 in patients with ovarian cancer."

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."