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 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."

On July 9, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride (Press release, Eagle Pharmaceuticals, JUL 9, 2018, View Source [SID1234527608]).

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As a result, and consistent with the order issued by the U.S. District Court for the District of Columbia (the Court) on June 8, 2018, the FDA will not approve any drug applications referencing BENDEKA until the ODE expires in December 2022. Additionally, on July 7, 2018, the FDA filed a motion with the Court asking it to clarify that the order was not intended to affect applications referencing TREANDA. Eagle continues to believe that an appropriate application of ODE would first allow generic TREANDA entrants in December 2022, rather than November 2019, and expects to vigorously defend the scope of its exclusivity grant.

On July 9, 2018 CTI BioPharma Corp. and Servier reported that the pivotal Phase III study (PIX306) evaluating PIXUVRI (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS) (Press release, CTI BioPharma, JUL 9, 2018, View Source [SID1234527625]).

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"We are disappointed with the outcome of the PIX306 study and will proceed to conduct a thorough review of the clinical data to assess the next steps for the PIXUVRI program," commented Adam Craig, MD, PhD, CEO of CTI BioPharma. "We would like to express our appreciation to the patients, families and investigators who participated in the study."

Results will be submitted for presentation at a major scientific meeting by the end of the year and for publication in a peer-reviewed journal.

About PIX306

The PIX306 study is a randomized, multicenter study comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL).

The PIX306 study enrolled 312 patients who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint was progression-free survival (PFS) while overall survival (OS), complete response rate (CR), overall response rate (ORR) and safety were secondary endpoints.

For more information about the PIX306 study, please visit
View Source

The ClinicalTrials.gov identifier is NCT01321541.

About Non-Hodgkin Lymphoma (NHL)
NHL is a blood cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.1 The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.2

NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.3 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.

About PIXUVRI (pixantrone)
PIXUVRI is the only treatment in the European Union indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).4 PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.5

PIXUVRI has not been approved by the U.S. Food and Drug Administration in the United States (US).

PIXUVRI has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.6 Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product’s immediate availability on the market outweighs the risks due to need for further data.7 The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.

PIXUVRI is mentioned in the ESMO (Free ESMO Whitepaper) guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.8

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.ema.europa.eu

CTI granted Servier rights to commercialize the drug globally in all markets except the US. The two companies continue to work closely to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.

On July 9, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) reported that plans to report second quarter 2018 financial results on August 6, 2018 (Press release, Ligand, JUL 9, 2018, View Source [SID1234527609]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Second Quarter 2018 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates

When: Monday, August 6, 2018

Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)

Conference Call: (833) 591-4752 within the U.S.
(720) 405-1612 outside the U.S.
Conference ID – 9585138

Webcast: Live conference call webcast and replay accessible at www.ligand.com