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Applied BioMath, LLC Announces Collaboration with Revitope for Mechanistic PK/PD Modeling in Solid Tumors

On July 10, 2018 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying mechanistic modeling, simulation, and analysis to de-risk and accelerate drug research and development, reported a collaboration with Revitope for an in-vitro and human mechanistic PK/PD modeling of Revitope’s bispecific T Cell Engaging Antibody Circuits (TEAC) targeting solid tumors (Press release, Applied BioMath, JUL 10, 2018, View Source [SID1234633659]). "TEAC are designed to increase tumor specificity and launch an immune activation only when bound to the cancer cell surface. This innovative engineering approach has the potential to unleash potent immune responses that are focused entirely on the tumor," said Werner Meier, CSO and acting CEO of Revitope Oncology. "Our goal in this collaboration is to leverage Applied BioMath’s modeling and analyses capabilities to identify TEAC drug properties that drive the potential for a better therapeutic index and ideally more efficacy in immuno-oncology."

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Applied BioMath employs a rigorous fit-for-purpose model development process, referred to as Model-Aided Drug Invention (MADI), which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their MADI approach employs proprietary algorithms and software that were designed specifically for mechanistic PK/PD modeling. "Our mechanistic modeling approach allows our collaborators to assess the feasibility of their therapeutic much more quickly than if they were to rely on experiments alone," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "They’ll be able to quickly answer strategic questions about the ideal properties for their therapeutic concept and help accelerate development in Lead Generation and by prioritizing experiments, thus helping them get into the clinical faster and for less money with potentially a BIC therapeutic, giving themselves a much higher chance of clinical success and maximizing R&D ROI."

Adlai Nortye Announce Global License Agreement for Buparlisib (BKM120)

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.

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."

ArQule Announces Commencement of Proposed Public Offering of Common Stock

On July 10, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock (Press release, ArQule, JUL 10, 2018, View Source [SID1234532697]). In connection with the offering, ArQule expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the offering are to be sold by ArQule.

The Company intends to use the net proceeds of the offering to fund its core clinical programs and for general corporate purposes.

Leerink Partners is acting as sole book-running manager for the offering. Needham & Company is acting as lead manager, and Roth Capital Partners, B. Riley FBR, Inc. and JonesTrading Institutional Services LLC are acting as co-managers for the offering.

The securities described above are being offered by ArQule pursuant to a shelf registration statement on Form S-3 (File. No. 333-213456), including a base prospectus, that was previously filed by ArQule with the Securities and Exchange Commission ("SEC") and declared effective on October 5, 2016. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, also may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

VOLUNTARY ANNOUNCEMENT PRODUCT CO-DEVELOPMENT AND STRATEGIC COLLABORATION AGREEMENT

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]).

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.

Aravive Biologics Completes Phase 1 Trial of Novel GAS6-AXL Pathway Inhibitor, AVB-S6-500

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]).

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."