On January 23, 2020 UT Southwestern Simmons Cancer Center reported have discovered a two-drug combo that halts the growth of cancer cells that carry HER2 mutations (Press release, The University of Texas Southwestern Medical Center, JAN 23, 2020, View Source [SID1234553457]).

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The findings, published today in the journal Cancer Cell, were prompted by the observation that, after an initial response, patients with cancers harboring HER2 mutations eventually develop resistance to a promising new cancer drug currently in clinical trials.

The scientists found that another drug, already on the market, counters that resistance and blocks the cancer, thereby providing the basis for a novel drug combination against cancers with mutations in the HER2 gene.

Dhivya Sudhan, Ph.D., a postdoctoral research fellow in the Harold C. Simmons Comprehensive Cancer Center, and collaborators evaluated data from a molecularly guided trial where patients with tumors with HER2 mutations were treated with the HER2 inhibitor neratinib. In this study, patients’ cancers were sequenced as the disease progressed during treatment. Based on this analysis, Sudhan discovered in the laboratory that an effective way to offset eventual resistance to neratinib is with everolimus, a TORC1 inhibitor commonly used to treat other types of breast cancer.

"This finding may give clinicians an effective response to neratinib resistance. That could make a real difference for patients with breast, ovarian, lung, and other cancers harboring HER2 mutations," says Carlos L. Arteaga, M.D., Director of the Simmons Cancer Center at UT Southwestern and corresponding author of the study.

HER2 mutations have long been identified as a key driver in breast and other cancers. The authors of this study zeroed in on a signaling network driven by TORC1, which they showed is the pathway through which HER2-mutant cancers become neratinib-resistant.

"We consistently noted activation of TORC1 signaling as a mechanism of resistance to neratinib across different types of HER2-mutant cancers. Different cancer types used different strategies to escape neratinib, but they all converged on TORC1 signaling," Sudhan says.

In addition to studying tumor sequencing data from HER2-mutant cancer patients across the country who are in clinical trials for neratinib, Sudhan also studied neratinib-resistant cells and tumors that continue to live and grow in the laboratory.

The sequencing of the patients’ cancer before and during the clinical trial showed that some patients already had a mutation that could activate the TORC1 pathway. Others would develop it eventually, but they could benefit from everolimus which is currently used as a TORC1 inhibitor to address the other roles TORC1 plays in cancer. Everolimus would allow the patient to continue benefiting from neratinib’s inhibition of HER2.

Sudhan says the combination of neratinib and everolimus worked in cell lines, organoids established from patient-derived tumors, and in mice harboring HER2 mutant tumors. The next step will be testing this two-drug combo in humans.

Other authors were Angel Guerrero-Zotano, M.D., of the Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Helen Won, M.S., of Memorial Sloan Kettering Cancer Center, New York; Paula González Ericsson, M.D., of the Comprehensive Cancer Center, University of New Mexico, Albuquerque, New Mexico; Alberto Servetto, M.D., of the Simmons Cancer Center at UT Southwestern; Mariela H. Rosario, M.D., of the Simmons Cancer Center at UT Southwestern; Dan Ye, M.D., of the Simmons Cancer Center at UT Southwestern; Kyung-min Lee, Ph.D., of the Simmons Cancer Center at UT Southwestern; Luigi Formisano, M.D., Ph.D., of the Department of Medicine, Vanderbilt University Medical Center; Yan Guo, Ph.D., of the Comprehensive Cancer Center, University of New Mexico; Qi Liu, Ph.D., of the Center for Quantitative Sciences, Vanderbilt University Medical Center; Lisa N. Kinch, Ph.D., of UT Southwestern; Monica R. Brewer, Ph.D., of the Department of Medicine, Vanderbilt University Medical Center; Teresa Dugger of the Department of Medicine, Vanderbilt University Medical Center; James Koch, M.S., of the Department of Medicine, Vanderbilt University Medical Center; Michael J. Wick, Ph.D., of the START Center for Cancer Care, San Antonio; Richard E. Cutler Jr., Ph.D., of Puma Biotechnology Inc., Los Angeles; Alshad S. Lalani of Puma Biotechnology Inc.; Richard Bryce of Puma Biotechnology Inc.; Alan Auerbach, M.S., of Puma Biotechnology Inc.; and Ariella B. Hanker, Ph.D., of UT Southwestern.

Cutler, Lalani, and Auerbach are employees of and hold ownership interest (including patents) in Puma Biotechnology Inc. Guerrero-Zotano has received research and travel grants from Pfizer. Hanker receives research grant support from Takeda. Arteaga is a consultant to Puma Biotechnology. He receives or has received research grants from Puma Biotechnology, Pfizer, Lilly, Bayer, Takeda, and Radius; holds stock options in Provista and Y-TRAP; serves or has served in an advisory role to Novartis, Merck, Lilly, Symphogen, Daiichi Sankyo, Radius, Taiho Oncology, H3 Biomedicine, OrigiMed, Puma Biotechnology, and Sanofi; and reports Scientific Advisory Board remuneration from the Komen Foundation.

The study was funded by the Simmons Cancer Center (P30 CA142543, 440), the Cancer Prevention & Research Institute of Texas (RR170061), the National Cancer Institute Breast SPORE (P50 CA098131), the Vanderbilt-Ingram Cancer Center (P30 CA68485), Susan G. Komen Breast Cancer Foundation (SAC100013), the Breast Cancer Research Foundation (R01CA224899), and the Susan G. Komen Postdoctoral Fellowship (PDF17487926). The authors acknowledge the assistance of the UT Southwestern Tissue Resource supported by the National Cancer Institute (5P30CA142543).

On January 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange in the United States, reported preliminary, unaudited financial results and select operating metrics for the fourth quarter and fiscal year ended December 31, 2019 (Press release, eHealthInsurance, JAN 23, 2020, View Source [SID1234553473]).

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"I am proud of our achievements in 2019. After raising our guidance twice in the past year, we significantly exceeded our financial and operating targets driven by consistently strong execution throughout the year. 2019 culminated with an exceptional performance by our team during the fourth quarter Medicare annual enrollment period. Our marketing and business development organizations drove record consumer demand to the eHealth platform allowing us to grow fourth quarter approved Medicare members in excess of 85%," commented Scott Flanders, chief executive officer of eHealth. "We remain excited about the Medicare market opportunity and significant growth potential ahead of us and are looking forward to sharing our outlook for 2020 as part of our fourth quarter earnings release next month."

The preliminary, unaudited financial results and selected operating metrics included in this press release are based on information available as of January 23, 2020 and management’s initial review of operations for the fourth quarter and year ended December 31, 2019. They remain subject to change based on management’s ongoing review of the company’s fourth-quarter and full year results and are forward-looking statements. eHealth assumes no obligation to update these statements. The actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

As part of the year-end closing process, the company is enhancing the manner in which it estimates residual or "tail" revenue from the company’s Medicare Advantage members approved in prior periods. Since the adoption of Accounting Standards Codification (ASC) 606, the company’s cash collections for Medicare Advantage policies have in general exceeded initial lifetime value estimates. This dynamic has contributed in past quarters to the recognition of increasing amounts of residual or "tail" revenue from Medicare members approved in prior periods. Our preliminary results exclude the positive impact of changes in estimates for expected collections for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019. The company plans to include the results of any such changes in estimates as well as full financial and operating results as part of its fourth quarter and full year 2019 earnings release.

Fourth Quarter and Fiscal Year 2019 Preliminary Results

Excluding any positive impact from the changes in estimates to residual revenue for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019, we expect the following fourth quarter and fiscal year 2019 results:

Revenue for the fourth quarter of 2019 is expected to be in the range of $257.5 to $259.5 million with expected fourth quarter revenue from the Medicare segment in the range of $239.0 to $240.5 million.
GAAP net income for the fourth quarter of 2019 is expected to be in the range of $53.0 to $55.0 million. Adjusted EBITDA(a) for the fourth quarter of 2019 is expected to be in the range of $98.5 to $100.5 million.
Revenue for the year ended December 31, 2019 is expected to be in the range of $462.0 to $464.0 million as compared to the company’s guidance of $365.0 to $385.0 million. Revenue from the Medicare segment for the full year 2019 is expected to be in the range of $403.5 to $405.0 million as compared to the company’s guidance of $318.0 to $333.0 million.
GAAP net income for the year ended December 31, 2019 is expected to be in the range of $31.0 to $33.0 million as compared to the company’s guidance of $20.9 to $25.9 million.
Adjusted EBITDA(a) for the year ended December 31, 2019 is expected to be in the range of $89.0 to $91.0 million as compared to the company’s guidance of $65.0 to $70.0 million.

Adjusted EBITDA is calculated by adding stock-based compensation expense, depreciation and amortization expense, change in fair value of earnout liability, amortization of intangible assets, other income, net of expenses and provision for income taxes to GAAP net income. See "Non-GAAP Financial Information Reconciliations."

Approved Members

The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, grew 88% during the fourth quarter of 2019 compared to the fourth quarter of 2018. The number of approved members for Medicare Advantage products grew 100% over the same time period. For the full year 2019, the number of approved members for all Medicare products grew 81% compared to the full year 2018 with approved members for Medicare Advantage products growing 88% over the same time period.

The number of approved members for major medical individual and family plan (IFP) products grew 1% during the fourth quarter of 2019 compared to the fourth quarter a year ago. For the full year 2019, the number of approved members for IFP products declined 25% compared to 2018. The decline in approved IFP members reflects weaker than expected enrollment activity in the overall individual and family health insurance market as well as our continuing emphasis on the Medicare business in allocating our marketing resources.

On January 23, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has regained the rights to rigosertib in Greater China (Press release, Onconova, JAN 23, 2020, View Source [SID1234553440]). Onconova regained the rights from HanX Biopharmaceuticals (HanX) as a result of the termination of the Onconova-HanX License Agreement pursuant to its terms due to HanX failing to make required payments under the agreement. In exchange for transition assistance and upon further regulatory, development and commercial progress in Greater China, HanX may be eligible to receive from Onconova incentive milestones and royalty payments. The Greater China territory, including mainland China, Hong Kong, Macau and Taiwan, represents one of the key world pharmaceutical markets.

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"We are pleased to regain rigosertib rights for Greater China, and we are encouraged by the opportunity to partner rigosertib in select territories including Greater China as we approach the potential corporate catalyst of topline data for the registrational INSPIRE Trial in 1H 2020," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We thank HanX for their collaborative efforts to advance rigosertib in this key market including the filing of the rigosertib IND in China." Dr. Fruchtman continued, "In 2019, we added partners Knight Therapeutics for Canada, Specialised Therapeutics for Australia & New Zealand, and Inceptua Medicines Access in select countries for pre-approval access to our roster of global corporate partners, joining Pint Pharma for Latin America and SymBio Pharmaceuticals for Japan & Korea. The United States, Europe, and Greater China represent the major pharmaceutical markets Onconova directly controls heading into INSPIRE data read out."

On January 23, 2020 iOnctura B.V., a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, reported the closing of a EUR 15 million Series A financing (Press release, iOnctura, JAN 23, 2020, View Source [SID1234553458]). The financing was led by INKEF Capital and co-led by VI Partners with participation by new investor Schroder Adveq. iOnctura’s founding investor, M Ventures, also participated in the fundraise. iOnctura was founded in 2017 as a spin-out from Merck, with Merck and Cancer Research UK providing a best-in-class pipeline of molecules that harness both direct and immune-mediated anti-cancer activities in solid cancers and cancer fibrosis.

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iOnctura will use the proceeds of the Series A to move its lead molecule IOA-244, a highly selective PI3Kδ-inhibitor, into a Phase I trial in solid tumours and its second program, IOA-289, an ATX-inhibitor, through IND enabling studies. The superior properties of IOA-244 are expected to enable iOnctura to be the first company to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications.

The board of directors of iOnctura BV welcomes Fiona MacLaughlin, of INKEF Capital and Diego Braguglia of VI Partners.

Catherine Pickering, Chief Executive Officer of iOnctura, commented: "iOnctura has made significant progress with its two lead molecules which are being developed as next generation dual immune and tumour targeting therapies. We are very excited to move our first molecule into human clinical testing and accelerate our second molecule towards clinical trials.

We welcome new investors INKEF Capital, VI Partners and Schroder Adveq to iOnctura and with the continued support from our founding investor M Ventures, we look forward to taking iOnctura into the next stage of development."

Fiona MacLaughlin, Director of INKEF Capital, said: "INKEF’s strategy is to support talented management teams developing novel treatments that address high unmet medical needs via novel scientific insights and understanding. The highly experienced executive management team led by Catherine at iOnctura have a solid track record in drug development and commercialisation. Together with the scientific contribution of its world class scientific advisory board and its research partner Cancer Research UK, iOnctura has consolidated a scientific understanding we consider to be a true and valuable differentiator."

Hakan Goker, Chairman of iOnctura board and Executive Investment Director, M Ventures, added: "We helped found iOnctura to deliver clinical validation of emerging new biology around direct and immune mediated effects of key targets in cancer and fibrosis. The differentiated and targeted clinical approach iOnctura is using offers significant potential to treat patients with life-threatening diseases. We are excited to provide continued support to iOnctura as it advances its pipeline into the clinic."

iOnctura’s most advanced program, IOA-244, is a clinical phase, next generation PI3Kδ inhibitor with a unique chemical structure, exquisite selectivity, excellent drug-like properties and an expected best-inclass safety profile. Its second program, IOA-289, is a novel autotaxin (ATX) inhibitor with superior potency compared to clinical-stage ATX inhibitors. IOA-289 is being developed as a first-in-class therapy for solid tumour indications that over express ATX and are burdened with cancer-associated fibrosis. IOA-289 has demonstrated anti-tumour and anti-fibrotic efficacy in preclinical models and is in advanced in vivo safety studies.

On January 23, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that it successfully hosted its 2020 U.S. R&D Day in New York on January 21 (Press release, CStone Pharmaceauticals, JAN 23, 2020, View Source [SID1234553474]). CStone’s management team highlighted major milestones the Company had achieved in research, clinical development, business development and commercialization strategies since its establishment. The management team also provided updates on the progress of the Company’s pipeline. Leading academics and key opinion leaders from China and the United States provided insights on the latest trends in the transformation of cancer treatments in China.

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Targeting five indications, CStone plans to submit five NDAs in 2020 for CS1001, an anti-PD-L1 monoclonal antibody; pralsetinib, a RET inhibitor; and AYVAKITTM (avapritinib), a KIT and PDGFRA inhibitor, in Mainland China and Taiwan. The Company plans to release the top-line data from seven ongoing clinical trials of these three drug candidates. CStone will focus on developing and commercializing innovative immuno-oncology therapies and precision medicines to address the unmet needs in cancer treatment in China and globally, and drive its Pipeline 2.0 strategy to accelerate its transition toward a commercial-stage biopharmaceutical company with a unique and efficient R&D platform. Moreover, the Company plans to submit NDAs for around 10 indications for four products in the next two to three years.

"China’s biopharmaceutical industry is undergoing significant transformation, and CStone is at the forefront of this paradigm shift. With a strategy focused on large cancer indications in China, unmet patient needs, and combination therapies, we are currently conducting over 30 clinical trials, including 13 registrational studies, and 14 combination trials," said Dr. Frank Jiang, Chairman and CEO of CStone. "We are very pleased that Shirley Zhao has joined us as General Manager for Greater China and Head of Commercial Operations, at this inflection point in CStone’s transition from clinical-stage to commercial-stage. In the next two to three years, Shirley will lead the establishment of CStone’s commercialization capabilities and the launch of multiple innovative products in the Greater China region. Leveraging our unique and highly efficient early-stage clinical development platform, we will continue to strengthen our pipeline and drive biopharmaceutical innovations in China."

Event highlights:

CStone’s achievements

CStone has established a clinical development-driven business model and built a world-class clinical team with significant experience in translational medicine and clinical development. In addition, the Scientific Advisory Board comprised of four internationally renowned immuno-oncologists has substantially strengthened the Company’s R&D capabilities in immunotherapies and precision medicines, further enhancing and optimizing CStone’s R&D strategies and product pipeline.
CStone has built a risk-balanced and highly competitive immunotherapy-focused pipeline. Among the Company’s 15 cancer drug candidates, five are in pivotal late-stage clinical development. AYVAKITTM (avapritinib), developed by Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals have received NDA approvals from the U.S. FDA.
Among these trials, the clinical studies of CS1001, an anti-PD-L1 monoclonal antibody, have achieved promising clinical results with patients treated with CS1001 exceeding one thousand. In 2019, CStone released encouraging data from the trials of CS1001 in esophageal carcinoma and a number of other large cancer indications in China at major medical conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Chinese Society of Clinical Oncology (CSCO), and the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings.
The two in-licensed products of CStone’s pipeline candidates that have received NDA approvals from the U.S. FDA are AYVAKITTM (avapritinib), developed by the partner company, Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals. Moreover, Blueprint Medicine has initiated a rolling NDA submission to the U.S. FDA for pralsetinib. All three candidate drugs are being investigated in multiple registrational trials in China.
In December, 2019, the global Phase III VOYAGER trial of avapritinib in third-line gastrointestinal stromal tumors (GIST), and the global Phase I/II ARROW study of pralsetinib in second- and later-line non-small cell lung cancer (NSCLC) have both completed their targeted enrollments of Chinese patients ahead of schedule.
CStone developed comprehensive early-stage programs and is scaling up its combination therapy-focused pipeline. The Company has made significant progress with two of its backbone immunotherapy assets, CS1002, an anti-CTLA-4 monoclonal antibody; and CS1003, an anti-PD-1 monoclonal antibody. Both assets generated promising results as monotherapies in Phase I studies, and CS1003 has already entered a global Phase III registrational trial. In the development of combination therapies, CStone recently initiated multiple combination trials and will continue to advance these combination studies in 2020.
Leveraging a unique and highly efficient R&D platform and an innovation ecosystem, CStone has further strengthened its Pipeline 2.0. The Company will continue to develop first-in-class and best-in-class drugs and therapies to maintain its lead in innovations.
In 2019, CStone advanced two drug candidates in its pipeline into clinical development, and commenced a dozen preclinical research initiatives.
Major milestones expected in 2020 include:

One New Drug Application approval
TIBSOVO, for the treatment of R/R AML, is expected to receive an NDA approval in Taiwan and become CStone’s first commercialized product in the Greater China region.
5 NDA submissions
CStone plans to submit five new drug applications in Mainland China and Taiwan, for CS1001, pralsetinib, and avapritinib.
Seven clinical trial data releases
CStone plans to release top-line data from seven clinical trials of CS1001 (an anti-PD-L1 monoclonal antibody), pralsetinib, and avapritinib, and six of these trials are registrational studies.
Development strategies for 2020

To consolidate resources to focus on the delivery of the 13 milestones.
CStone will build a commercial organization for Greater China equipped with core commercialization capabilities to enable the Company’s successful transition to the commercial-stage.
CStone will continue to seek strategic collaborations with key players, to drive the future growth of the company.
Leveraging its internal R&D, CStone will transition into its Pipeline 2.0 and drive the sustained growth of the Company. In the next three to five years, CStone will add first-in-class and best-in-class multi-specific monoclonal antibodies and molecular backbone assets to its pipeline. The Company plans to further explore tumor microenvironment modulators, cancer vaccines, new pathway inhibitors, and innovative combination approaches that could potentially bolster the effect of anti-PD-(L)1 antibodies.
New product launches

In the next two to three years, CStone plans to launch four of its drug candidates, including avapritinib, pralsetinib, ivosidenib and the anti-PD-L1 monoclonal antibody CS1001, in the Greater China region, targeting a total of 10 cancer indications.
Key messages from KOL speakers

Dr. Paul Bunn, MD, former President of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Distinguished Professor at University of Colorado Cancer Center, commented that latest clinical data of the RET inhibitor pralsetinib were very encouraging. The trial has already completed the patient target enrollment, which included naïve patients and patients who have received platinum-based chemotherapy. He expects this precision medicine will benefit cancer patients in the future.
Dr. Eytan Stein, MD, Professor at the Memorial Sloan Kettering Cancer Center, commented that compared to current standard chemotherapies, ivosidenib could bring significant clinical benefits to AML patients and its high-selectivity could broaden clinical benefits to cancer patients with an IDH1-mutation.
Dr. Yilong Wu, MD, President of the Chinese Thoracic Oncology Group (C-TONG), past president of Chinese Society of Clinical Oncology (CSCO), tenured professor of Guangdong Provincial People’s Hospital and Guangdong Lung Cancer Research Institute, emphasized that CStone has initiated three registrational lung cancer trials and the Company will play an important role in the lung cancer field in China.
– CS1001 is currently being investigated in the Phase III GEMSTONE-301 study in patients with locally advanced or unresectable NSCLC, and it could potentially benefit a wide range of patients. Considering the clinical practices in China, the trial also included patients who had received either concomitant or sequential radiochemotherapy. In addition, CS1001 is also being investigated in a Phase III trial in first-line Stage IV NSCLC.
– The study of pralsetinib in RET-fusion NSCLC has demonstrated promising clinical utility. Due to the persistent high incident rate of lung cancers and the lack of any effective treatment for RET-mutant cancers, pralsetinib has the potential of effectively addressing the current treatment gap in RET-fusion NSCLC in China.
Dr. Jian Li, MD, Professor at Beijing Cancer Hospital and Chairman-elect of the Chinese Society of Clinical Oncology’s (CSCO) Committee on GIST, acknowledged avapritinib’s therapeutic promise in the treatment of GIST in China. Avapritinib is a first-in-class precision medicine approved by the U.S. FDA for the treatment of GIST, and there is currently no effective treatment for PDGFRA D842V mutant GIST in China. Available clinical data of avapritinib in PDGFRA exon 18 mutant GIST (including PDGFRA D842V mutations) have demonstrated compelling antitumor activity and a more tolerable safety profile. The drug could significantly benefit GIST patients who are in need of effective treatment options.
Dr. Weiping Zou, MD, PhD, Professor at University of Michigan, Director of the Center of Excellence for Cancer Immunology and Immunotherapy, and Chair of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) Cancer Immunology Working Group (CIMM), commented that CStone has made significant progress in the past three years, and he will likely to further collaborate with the Company in selecting Class I drug targets for future development and he looks forward to facilitating CStone’s transition to Pipeline 2.0.