On January 23, 2020 Cancer Research Center of Toulouse reported that Immunotherapies are imposing themselves as a revolution in cancer treatment, giving hope to many previously incurable patients (Press release, Cancer Research Center of Toulouse, JAN 23, 2020, View Source [SID1234553456]). They aim to restore the natural defences mounted by the body against cancerous cells, such as lymphocytes, which are often disarmed by the tumour. Despite the promising potential, around 30% of patients do not benefit at all from immunotherapy. Better characterising the inter-cellular interactions in the tumour microenvironment will be key to propose new kinds of immunotherapy.

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LungPredict involves performing a deep molecular characterisation of lung cancer patients at diagnosis, to offer them personalised therapeutic approaches. The pilot phase (2019) consisted in developing logistic, experimental and bioinformatic protocols, assessing the feasibility of the full project.

The plan is to produce transcriptomics, targeted sequencing and high-content imaging on tumour samples for a few hundred patients. Blood is also being collected for future analyses and all data is linked to patients’ clinical records.

As part of this alliance between the company, researchers and clinicians, more similar projects will be launched in the future to exploit an integrative approach to achieve better personalized treatments for other cancers as well.

On January 23, 2020 Certara, the global model-informed drug development and decision support leader, reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or consulting services (Press release, Certara, JAN 23, 2020, View Source [SID1234553472]). This result affirms the pharmaceutical industry’s dedication to employing model-informed drug development approaches for informing key clinical testing decisions, resulting in reduced cost and increased speed in bringing new drugs to patients.

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"We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA," said Certara’s CEO Dr. William Feehery. "Certara’s Simcyp, Phoenix and Global Submit software platforms have been widely used by both the FDA and the biopharmaceutical industry during the past several years for drug development and regulatory review. In addition to the use of our technology, our expert consulting services teams supported the development of therapies for patients with cancer, central nervous system diseases, infectious diseases, and rare diseases in the class of 2019."

During her speech at the Breakthroughs in Medicine conference in Rancho Palos Verdes, CA last September, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of the Agency’s commitment to innovation in drug development. Certara’s mission is closely aligned with that commitment, which was outlined by the Agency in its Congressional testimony on implementing the 21st Century Cures Act:

"As part of FDA’s broader innovation initiative, we are encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations to allow an evaluation of a product’s safety and effectiveness…CDER and FDA’s Center for Biologics Evaluation and Research (CBER) are currently deploying these tools to help predict clinical outcomes, inform trial design, support evidence of effectiveness, and evaluate potential adverse event mechanisms."

Certara’s innovations have had a profound impact on accelerating and improving the efficiency of drug development. During the past six years, Certara’s technology and/or consulting services have been used to inform and expedite the development of about 250 novel therapies. In 2019 alone, Certara provided technology, consulting and/or regulatory writing and submission support for 11 oncology drugs, 12 drugs for orphan diseases, and 16 drugs that received priority or accelerated review. Certara’s quantitative and integrated approach to drug development has enabled sponsors to reduce the size and duration of clinical trials, develop dosing strategies for special populations, such as pediatrics, evaluate alternative formulations, seek expedited regulatory pathways, and leverage in silico models in lieu of conducting clinical trials.

On January 23, 2020 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the pricing of the underwritten public offering previously announced by Chi-Med on January 21, 2020 (Press release, Hutchison China MediTech, JAN 23, 2020, https://www.chi-med.com/chi-med-announces-pricing-of-us110-million-public-offering-of-adss/ [SID1234553438]). Chi-Med will issue and sell 4,400,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, par value US$0.10 each, of Chi-Med at a price of US$25.00 per ADS on the Nasdaq Global Select Market ("Offering"). The gross proceeds to Chi-Med from the Offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$110 million. In addition, Chi-Med has granted the underwriters a 30-day option to purchase up to an additional 660,000 ADSs at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on January 27, 2020, subject to customary closing conditions.

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Chi-Med will receive all of the net proceeds from the sale of ADSs in the Offering, which it intends to use primarily to fund its ongoing research and clinical development efforts and expand its commercialization capabilities.

BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. and Morgan Stanley & Co. LLC (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Deutsche Bank Securities Inc. and HSBC Securities (USA) Inc. are acting as joint bookrunners, and Canaccord Genuity LLC, CLSA Limited and Panmure Gordon (UK) Limited are acting as co-managers.

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.