On November 5, 2019 CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, reported that it received market approval from the Department of Health in Hong Kong for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago (Press release, CANbridge Life Sciences, NOV 5, 2019, View Source [SID1234550317]). This is the first targeted therapy approved in the CANbridge oncology platform and the first NERLYNX approval in greater China. CANbridge acquired the exclusive NERLYNX development and commercial rights for China, Taiwan, Hong Kong and Macao in 2018, and submitted the NDA for NERLYNX to the National Medical Products Administration (NMPA) in China for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, last year.

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"The rapid and smooth advancement of NERLYNX through the Hong Kong regulatory process to market approval is a testament to the quality of our regulatory expertise, and the CANbridge commitment to bring new treatments to underserved patient populations in greater China," said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. "With this first targeted therapy approved in our oncology platform, CANbridge is able to provide women in Hong Kong, with HER2-positive breast cancer at risk of recurrence, a new and vital treatment option shortly after it was approved in the West."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Research has shown that trastuzumab treatment can reduce the risk of early-stage HER2-positive breast cancer returning after surgery. However, up to 25% of patients treated with trastuzumab experience recurrence. There were 4,391 reported new cases of all types of breast cancer in Hong Kong in 2017, according to a report released by the Hong Kong Registry, Hospital Authority. Of these, it is reasonable to assume that 20-25% could be HER2-positive.

About Neratinib

Neratinib is a potent irreversible tyrosine kinase inhibitor that inhibits tumor growth and metastasis through the blocking of the pan-HER family (HER1, HER2 and HER4) and downstream signal transduction. Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. Neratinib was also approved by the European Medical Agency (EMA) in September, 2018.

On November 5, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the quarter and nine months ended September 30, 2019 (Press release, Conatus Pharmaceuticals, NOV 5, 2019, View Source [SID1234550316]).

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Recent Developments

In June 2019, Conatus announced that top-line results from its ENCORE-LF clinical trial of emricasan did not meet its primary endpoint, and, Conatus and its partner, Novartis, had no further development plans for emricasan. In September 2019, Conatus and Novartis mutually agreed to terminate the collaboration agreement between the parties for the global development and commercialization of emricasan.

As previously announced, Conatus has engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the exploration and evaluation of strategic alternatives to enhance shareholder value. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome.

In connection with the discontinuation of emricasan and Conatus’ efforts to explore and evaluate strategic alternatives, Conatus announced in June 2019 that it was implementing a restructuring plan in order to extend its resources, which included reducing staff and suspending development of its inflammasome disease candidate, CTS-2090, and in September 2019 it implemented another restructuring plan in order to extend its resources, which included further reducing staff.

Financial Results
The net loss for the third quarter of 2019 was $3.3 million compared with $4.6 million for the third quarter of 2018. The net loss for the first nine months of 2019 was $8.7 million compared with $14.1 million for the first nine months of 2018.

All revenues were related to the company’s collaboration with Novartis. Total revenues were $3.4 million for the third quarter of 2019 compared with $7.7 million for the third quarter of 2018. Total revenues were $21.2 million for the first nine months of 2019 compared with $26.2 million for the first nine months of 2018. The decreases in revenues for both periods were primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues from Novartis.

Research and development expenses were $4.7 million for the third quarter of 2019 compared with $9.7 million for the third quarter of 2018. The decrease in research and development expenses was primarily due to lower spending related to emricasan-related activities. Research and development expenses were $22.7 million for the first nine months of 2019 compared with $32.5 million for the first nine months of 2018. These decreases were primarily due to lower emricasan-related research and development expenses.

General and administrative expenses were $2.0 million for the third quarter of 2019 compared with $2.7 million for the third quarter of 2018. General and administrative expenses were $7.7 million for the first nine months of 2019 compared with $8.0 million for the first nine months of 2018. These decreases were primarily due to lower personnel costs resulting from the restructuring plan announced in June 2019.

Cash, cash equivalents and marketable securities were $22.7 million at September 30, 2019, compared with $40.7 million at December 31, 2018. The company is projecting a year-end 2019 net balance of cash, cash equivalents and marketable securities of between $10 million and $15 million.

On November 5, 2019 Genecast (Beijing) Technology reported that it closed a $43 million Series D financing to expand its non-invasive cancer diagnostic business (Press release, ChinaBio, NOV 5, 2019, View Source [SID1234550315]). Founded in 2014, Genecast has developed a circulating tumor DNA detection technology that provides individualized cancer diagnoses. The company offers oncology diagnostic products and services to China biopharmas, collaborating with more than 20 biopharmas and providing comprehensive pre-clinical and clinical testing services. The D round, which brings Genecast’s total VC backing to $93.5 million, was led by CICC Capital.

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On November 5, 2019 The University of Texas MD Anderson Cancer Center and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported an exclusive license agreement and research agreement to develop cord blood-derived chimeric antigen receptor-directed natural killer (CAR NK)-cell therapies, ‘armored’ with IL-15, for the treatment of B-cell malignancies and other cancers (Press release, Takeda, NOV 5, 2019, View Source [SID1234550313]).

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Under the agreement, Takeda will receive access to MD Anderson’s CAR NK platform and the exclusive rights to develop and commercialize up to four programs, including a CD19-targeted CAR NK-cell therapy and a B-cell maturation antigen (BCMA)-targeted CAR NK-cell therapy. Takeda and MD Anderson will also conduct a research collaboration to further develop these CAR NK programs.

"Our vision is to improve upon existing treatments by developing armored CAR NKs that could be administered off-the-shelf in an outpatient setting—enabling more patients to be treated effectively, quickly and with minimal toxicities," said Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. "With their expertise in hematologic malignancies and commitment to developing next-generation cell therapies, Takeda is the ideal collaborator to help our team advance CAR NK-cell therapies to patients in need of treatments."

A Novel Approach to Delivering Off-the-Shelf CARs in an Outpatient Setting
MD Anderson’s allogeneic CAR NK platform isolates NK cells from umbilical cord blood and engineers them to express CARs against specified cancer targets. CAR NK cells are modified with a retroviral vector to deliver genes and enhance their effectiveness to attack specific tumors. A CD19 CAR increases the cells’ specificity for B-cell malignancies while the immunocytokine IL-15 enhances the proliferation and survival of the CAR NK cells in the body.

In contrast to current CAR T-cell therapies that utilize a patient’s own genetically modified T-cells and require a multi-week manufacturing process, CAR NK cells are intended to be manufactured from a non-related donor source and stored for off-the-shelf use, allowing treatment to be delivered more rapidly.

It is anticipated that the CD19 CAR NK-cell therapy could be administered in an outpatient setting. In an ongoing phase 1/2a clinical study treating patients with relapsed and refractory B-cell malignances, the CD19 CAR NK-cell therapy has not been associated with the severe cytokine release syndrome (CRS) or neurotoxicity observed with existing CAR-T therapies.

The development of MD Anderson’s CAR NK platform is led by Dr. Rezvani and is further supported by the adoptive cell therapy platform, Chronic Lymphocytic Leukemia Moon Shot and B-Cell Lymphoma Moon Shot, all part of the institution’s Moon Shots Program, a collaborative effort to rapidly develop scientific discoveries into meaningful clinical advances that save patients’ lives.

Takeda: Accelerating the Development of Multiple Next-Generation CAR Platforms
"MD Anderson’s CAR NK platform represents the curative potential of cell therapies, which is why we are establishing the CD19 CAR NK as our lead cell therapy candidate in oncology," said Andy Plump, M.D., Ph.D., President of Research and Development at Takeda. "We need to work swiftly and with purpose, and as such, we intend to initiate a pivotal study of the CD19 CAR NK in 2021."

In addition to CAR NK-cell therapies, Takeda and its partners are investigating multiple approaches to improving the safety, efficacy and accessibility of first-generation CAR T-cell therapies including gamma delta CAR Ts, induced pluripotent stem cell-derived CAR Ts, CAR Ts targeting solid tumors, and other next-generation approaches. Takeda plans to advance five oncology cell therapies to the clinic by the end of FY20.1 These platforms are being developed both with partners and by applying the expertise of Takeda’s translational cell therapy engine which provides bioengineering, chemistry, manufacturing and control (CMC), clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

Takeda is responsible for the development, manufacturing and commercialization of CAR NK products resulting under the agreement. MD Anderson will receive an upfront payment and is eligible to receive development and commercial milestones for each target as well as tiered royalties on net sales of any such CAR NK product.

MD Anderson and Takeda will continue research for the additional targets and CAR NK platform under the direction of a joint research committee. MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan for this research.

On November 5, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160) reported that the companies have entered into a license agreement for an advanced preclinical product candidate for treating cancer (Press release, BeiGene, NOV 5, 2019, View Source [SID1234550312]). The agent utilizes a proprietary Seattle Genetics antibody-based technology and is expected to advance into clinical trials in the first half of 2020.

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Under the terms of the agreement, Seattle Genetics has retained rights to the product candidate in the Americas (United States, Canada and Latin American countries), Europe and Japan. BeiGene has been granted exclusive rights to develop and commercialize the product candidate in Asia (except Japan) and the rest of the world. Seattle Genetics will lead global development and BeiGene will fund and operationalize the portion of global clinical trials attributable to its territories. BeiGene will also be responsible for all clinical development and regulatory submissions specific to its territories. Seattle Genetics will receive an upfront payment and is eligible to receive progress-dependent milestones for a total deal value of up to $160 million and tiered royalties on any product sales.

"Collaborating with BeiGene on this product candidate has the potential to accelerate its availability both globally and in several key geographic regions, notably China where there is an unmet medical need for anti-cancer therapies," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "BeiGene brings to this collaboration strong clinical and commercial capabilities and a focus on innovative, targeted oncology drugs. We look forward to working together to develop this therapy for patients worldwide."

"Seattle Genetics is recognized for its transformative oncology discoveries and we are excited to collaborate on the global development of this new drug candidate. This collaboration ties closely to our mission, to bring meaningful and innovative new medicines to patients around the world, though our commitment to world-class clinical development and commercialization," said Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operation & Biometrics and APAC Clinical Development at BeiGene. "The pending start of this new global trial adds a complementary molecule to our broad oncology development program, which now includes more than 60 clinical trials around the world."