On December 4, 2019 COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, reported is presenting posters at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, ASH (Free ASH Whitepaper) 2019, in Orlando, FL from December 7-10, 2019 (Press release, COTA, DEC 4, 2019, https://www.prnewswire.com/news-releases/cota-presents-posters-at-ash-annual-meeting-reviewing-complexities-of-generating-rwd-and-how-it-complements-traditional-clinical-trial-data-300969065.html [SID1234551947]). Collectively, the posters review existing challenges for generating RWD and the promise of this data to support new research in cancer biology.

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"The genetic environment – whether of individual patients or cancer cells – is playing an increasing role in how patients are being treated. Examining sources of real-world data in depth allows us to quickly, inexpensively test hypotheses related to the treatment of patients with specific biomarkers and their outcomes," said Andrew Norden, MD, Chief Medical Officer at COTA.

The Unforeseen Medical and Business Challenges Found When Integrating Abstracted Data from Disparate EHR Systems While Building the Curecloud Direct-to-Patient Multiple Myeloma Registry

Researchers from COTA and Multiple Myeloma Research Foundation (MMRF) explore challenges associated with existing methods of patient data curation to build the MMRF Registry. Despite a significant investment in electronic health records in the United States, many institutions are unable to provide relevant, research-grade clinical data in a timely, cost-free, and coded manner. A comprehensive, research-focused data abstraction process for coded data exchange is being established to support future RWD projects.

Chromosome 1q Amplification Is Associated with a History of Prior Malignancies Among Patients Newly Diagnosed with Multiple Myeloma

Researchers from COTA and Hackensack University Medical Center studied patients with newly diagnosed multiple myeloma who also had a history of prior malignancy. Using COTA’s RWD, they were able to identify an association with a prior history of cancer, especially prostate cancer, and amp(1q) in multiple myeloma. This relationship is worth further exploration of whether there is a common pathway associated with these characteristics. These findings are significant because patients with prior malignancies are often excluded from enrollment in clinical trials and rarely studied. Overall, the results reported suggest that RWD is an efficient and comparatively inexpensive tool to support research in cancer biology.

Thanks to a growing understanding and acceptance of RWD by regulatory bodies, it has been increasingly incorporated into clinical research, helping to expedite studies compared with traditional clinical trial methods alone. Rather than replacing clinical trials, these two models can complement each other to improve clinical trial design and postmarket research, allowing for a more complete picture of the patient group being studied.

Members of COTA’s Life Sciences team will be at ASH (Free ASH Whitepaper) to discuss their work with the Multiple Myeloma Research Foundation (MMRF) and Hackensack University Medical Center (HUMC). Contact [email protected] to set up a meeting to learn more about how RWD can accelerate clinical research and ultimately reduce the cost of clinical trials.

The two posters will be exhibited in Hall B, Level 2 on Monday, December 9, 2019, 6:00 PM – 8:00 PM and Saturday, December 7, 2019, 5:30 PM-7:30 PM.

On December 3, 2019 Alphamab Oncology is reported to raise about HK$1.7 billion ($221.1 million) in an IPO on the Hong Kong stock exchange next week in an offering that would value the company at HK$8.7 billion if priced at the midpoint of the proposed range (Press release, BioCentury, DEC 3, 2019, View Source [SID1234551856]).

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The pre-profit company proposed to sell 179.4 million shares at HK$9.10-HK$10.20 on the exchange’s biotech chapter.

The announcement came on the heels of an IPO on the exchange by Pharmaron Beijing Co. Ltd. (Shenzhen:300759; HKSE:03759), which began the year by listing on the Shenzhen exchange and closed it out with a raise of HK$4.6 billion in Hong Kong on Nov. 27.

Alphamab Oncology Ltd. spun out of Suzhou Alphamab Co. Ltd. last year to focus on oncology (see "Alphamab’s Cancer Cash").

The company has eight biologics in development, including four in clinical testing.

About 75% of the financing will support clinical development of KN046, a bispecific mAb targeting CTLA-4 and PD-L1 in Phase Ib/II for various solid tumors; KN026, a bispecific mAb targeting two HER2 epitopes, in Phase I to Phase II testing for solid tumors including breast and gastric cancers; and the Nulojix belatacept biosimilar KN019, which the company plans to take into a Phase II trial in August for rheumatoid arthritis.

Alphamab Oncology plans to submit BLAs for KN046 and KN026 in 3Q21 and 4Q22, respectively.

Morgan Stanley, CLSA and Jefferies are underwriters. If priced at the midpoint, cornerstone investors Matthews Funds, OrbiMed, Greenwoods, MSAL, Lake Bleu Capital, Luye Pharma and Taiking Life would be eligible to purchase 60% of the offering.

Entities associated with founder, Chairman and CEO Ting Xu will hold a 37% post-IPO stake in the company. Xu holds a 51% stake in Suzhou Alphamab, of which he is chairman.

Alphamab Oncology expects to announce the IPO price on Dec. 11 and begin trading Dec. 12.

The exchange’s pre-revenue chapter is showing signs of life after a summer lull, with three biotechs going public since September (see "After Lull, Local Demand Boosts Ascentage")

Pharmaron prices

In its first day of trading Nov. 28, Pharmaron’s stock gained HK$2.75 to HK$42.25 in Hong Kong before dipping to a close of HK$40.45 on Monday.

The Beijing-based company sold 117 million shares at HK$39.50 in the deal, which was underwritten by Goldman Sachs, CLSA, Orient Securities and China Renaissance. The dual listing valued the CRO at HK$30.7 billion.

Both of the Hong Kong IPO’s tranches were oversubscribed. The company initially offered to sell 11.6 million shares to Hong Kong investors and 104.9 million shares to the international community. The final IPO comprised 58.3 million shares to local investors and 58.3 million shares to international investors. Pharmaron received local investor applications for 1.3 billion shares, which prompted the international share re-allotment.

Cornerstone investors China Structural Reform Fund, Lake Bleu Prime Healthcare Master Fund, OrbiMed, Worldwide Healthcare Trust, Athos Asia Event Driven Master Fund and Oaktree purchased about 31.7 million shares of the offering

The company, which has operations in China, the U.S. and the U.K., provides laboratory, clinical development and CMC services to biotech start-ups and global pharma.

Pharmaron reported net profits of RMB156.7 million in 1H19, up 30% from RMB120.4 million in the same period last year. In 2018, North American, European and Chinese customers contributed 62%, 22% and 10% of the company’s revenues, respectively.

The company plans to use around 30% of the funding to expand its capabilities in China in response to increasing demand for its laboratory and CMC services. Pharmaron will allocate around 10% of the funds to expand its operations in the U.S and U.K., 20% to establish a biologics R&D platform and another 15% for acquisition of CRO and CMO companies in U.S., Europe, Japan or China.

In May, the company completed a series of equity purchases in Nanjing-based clinical CRO CR Medicon, gaining a 55.6% stake in return for RMB150 million in cash.

Targets: CTLA-4 (CTLA4; CD152) – Cytotoxic T-lymphocyte associated protein 4; HER2 (EGFR2; ErbB2; neu) – Epidermal growth factor receptor 2; PD-1 (PDCD1; CD279) – Programmed cell death 1

On December 3, 2019 Veracyte (Nasdaq: VCYT) reported that it has executed a definitive agreement with NanoString for the exclusive global license to the nCounter platform for diagnostic use (Press release, Veracyte, DEC 3, 2019, View Source [SID1234551878]). The strategic transaction positions Veracyte to expand its genomic diagnostics business globally, with the ability to deliver its advanced genomic tests to physicians and their patients via hospital and clinical laboratories throughout the European Union and other parts of the world.

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Veracyte believes that the transaction will ultimately enable it to access a global market worth more than $40 billion for its current and pipeline products, while expanding its margins through test menu expansion on the nCounter platform. The elegantly designed, FDA-cleared, automated nCounter system is expected to enable broad testing utility through its ability to simultaneously analyze RNA, DNA or protein targets in up to 800 genes.

Veracyte expects to begin offering its Envisia classifier, for use in idiopathic pulmonary fibrosis diagnosis, to international customers in 2021 as a kit-based test that runs on the nCounter system. The company expects its in-development nasal swab classifier, for use in lung cancer diagnosis, to follow on the nCounter system in 2022, after the test becomes available in Veracyte’s CLIA laboratory in the United States in early 2021. The nCounter system can also run additional genomic tests developed by Veracyte, as well as by potential diagnostics or biopharmaceutical partners seeking access to global markets.

As part of the transaction, Veracyte has also acquired the NanoString Prosigna breast cancer prognostic test and in-development LymphMark lymphoma subtyping assay, further expanding the company’s oncology portfolio.

"NanoString has developed a versatile, world-class diagnostics platform, which we believe will enable us to realize our vision of becoming a leading global provider of advanced genomic testing," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We are especially excited about the opportunity to bring our noninvasive nasal swab classifier to a global market, where it can help save more lives in the fight against lung cancer. Ultimately, this transaction will further our ability to inform clinical care decisions throughout the patient journey in cancer and other clinical indications, while allowing us to deliver profitable, long-term growth for our shareholders."

"Veracyte is a world-class diagnostics company with an expanding menu of innovative genomic tests that are well-positioned for successful global commercialization," said Brad Gray, president and chief executive officer of NanoString. "They are the ideal company to help ensure that our nCounter-based diagnostic platform can benefit as many patients around the world as possible."

Veracyte has agreed to pay NanoString$40 million in cash and $10 million in Veracyte common stock, and up to an additional $10 million in cash contingent upon the commercial launch of Veracyte diagnostic tests for use on the platform.

Veracyte expects to realize a modest revenue contribution through the transaction of $6 million to $8 million in 2020, with a neutral impact to cash flow from the current business.

Transaction Details and Rationale

World-Class Technology and Instrumentation Platform – Exclusive worldwide clinical diagnostic rights to the nCounter system technology and instrumentation platform provides Veracyte with pricing, margin and other commercial flexibility for global expansion that would not be possible through third-party distribution partners. The system’s automated and simple-to-use design requires less than two hours of hands-on time, making genomic testing more accessible to patients through laboratories that previously may not have had the resources or expertise to perform such complex testing.

Veracyte expects the expertise of the key technical team that will join the company as part of the transaction to facilitate test integration. Veracyte’s product discovery and certain commercial products will continue to be powered by its RNA whole-transcriptome sequencing platform, enabling continued expansion of its world-class biorepositories of patient samples in key clinical indications.
Global Commercial Infrastructure – Key members of the NanoString global diagnostics sales, marketing, medical affairs and distribution teams will join Veracyte, enabling Veracyte to accelerate its global expansion initiatives.
Expanded Genomic Test Menu – The Prosigna test is available on the nCounter system globally and in the United States to inform risk of recurrence in subgroups of women with breast cancer. Veracyte intends to offer the Prosigna test as a distributed kit within and outside of the United States. It will also add the test to its menu of advanced genomic products offered in the United States through its CLIA-certified laboratory. The LymphMark lymphoma subtyping test is currently in development.
Advisors

Fenwick & West LLP is serving as legal advisor to Veracyte.

Conference Call and Webcast

Veracyte will host a conference call and webcast to discuss the transaction today at 5:30 p.m. Eastern Time. The call will include a slide presentation, which participants may view at View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at the above link.

The conference call can be accessed as follows:

US/Canada Participant Dial-In Number (toll-free):

(855) 541-0980

International Dial-In Number:

(970) 315-0440

Conference I.D.:

5672629

On December 3, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the China National Medical Product Administration (NMPA), has approved the clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd., a biopharmaceutical company focused on cell therapy (Juventas) (Press release, CASI Pharmaceuticals, DEC 3, 2019, View Source [SID1234551894]). CASI previously reported its acquisition of exclusive worldwide commercial rights to CNCT19 from Juventas. Juventas has responsibility for the clinical development of CNCT19.

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Larry Zhang, CASI’s President, commented, "This is a very exciting milestone for CASI. CAR-T therapies were first approved in the United States in 2017; there are currently no CAR-T therapies marketed in China. CNCT19 will be manufactured in China at a cost significantly less than the cost of imported therapies, which ultimately enables us to make it more widely available to the Chinese patient population. We expect to start enrolling patients in early 2020."

About CNCT19
CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. CASI holds the worldwide commercial rights to CNCT19. Juventas is responsible for the development of CNCT19 with CASI’s participation on the program’s steering committee.

About Juventas
Juventas Cell Therapy Ltd. is a China-based domestic biopharmaceutical company established in 2018 focused on R&D, clinical translation and commercialization of innovative immune cell therapy. Juventas’ R&D operations are based in Beijing and its GMP facility is located in Tianjin City. More information on Juventas and its pipeline is available at www.juventas.cn.

On December 3, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, and Hanmi Pharmaceutical Co., LTD reported a license and collaboration agreement for FLX475 in Asia (Press release, RAPT Therapeutics, DEC 3, 2019, View Source [SID1234570684]). FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.

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"We are actively building our immuno-oncology portfolio, and see FLX475 as a potential keystone in our effort to deliver new safe and effective cancer therapeutics to patients who need them," said Hanmi CEO Se-Chang Kwon, Ph.D. "This compound complements our current product portfolio and has the potential to address a large and growing population of patients suffering from cancers that are prevalent in Asian countries. We look forward to partnering with RAPT to advance FLX475 through the clinic efficiently."

Under the terms of the agreement, RAPT will receive $10 million in an upfront payment and near-term milestone payment. Additionally, RAPT will receive up to $48 million in success-based development milestones and up to $60 million in potential sales milestones, as well as double-digit royalties on any future sales of FLX475 in the specified territories. In return, Hanmi will receive an exclusive license to develop, in parallel with RAPT, and commercialize FLX475 for the treatment of cancer in South Korea and China, including Taiwan and Hong Kong. In addition to leveraging its clinical trial infrastructure in Korea and China to augment RAPT’s ongoing Phase 1/2 clinical study of FLX475, Hanmi will also conduct a Phase 2 clinical trial in Korea and China to evaluate FLX475 in patients with gastric cancer.

"FLX475 targets "charged" tumors including virally-associated cancers, gastric cancer, non-small cell lung cancer, triple negative breast cancer and head and neck cancers, which are predicted to have high levels of CCR4 ligands, regulatory T cells and CD8+ effector T cells," said Yung-Jue Bang, M.D., Ph.D., professor of Medical Oncology at Seoul National University Hospital. "I believe FLX475 has the potential to offer patients a new therapeutic option that is desperately needed, particularly in Korea, which has the highest rate of gastric cancer in the world."

"This collaboration with Hanmi can provide us an entry point into the Asian market, allowing us to potentially expand our geographic footprint in a region with high prevalence of patients with "charged" tumors who we believe are most likely to respond to FLX475," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "Hanmi, with its fully integrated R&D infrastructure and nimble execution efficiency, has accumulated clinical development experiences and an extensive network of key opinion leaders. We believe Hanmi is a perfect partner for the development of FLX475."

FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. RAPT is developing FLX475 for the treatment of a broad range of "charged" tumors, which represent cancer types the company believes are most likely to respond to FLX475, where a large quantity of Treg cells are likely to be the cause of immune suppression within the tumor. FLX475 blocks the migration of Treg to the tumor, which may restore naturally occurring antitumor immunity and synergizing with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators and adoptive T cell therapy.

RAPT is currently enrolling patients in a Phase 1/2 study of FLX475 as a monotherapy, and in combination with pembrolizumab, in patients with "charged" tumors and expect results from the Phase 2 portion of the trial in the first half of 2020.