On December 21, 2017 ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), reported that Laurence Cooper, M.D., Ph.D., Chief Executive Officer, will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 11, 2018 at 10 a.m. PST (Press release, Ziopharm, DEC 21, 2017, View Source [SID1234522761]). The presentation will include a detailed update on the Company’s clinical development programs and corporate development efforts.

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To access a live audio webcast of the presentation, please visit the Investor Relations section at www.ziopharm.com. The webcast will be archived for 90 days.

On December 21, 2017 Janssen Biotech, Inc. ("Janssen"), a Janssen Pharmaceutical Company of Johnson & Johnson, reported that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited ("Legend"), subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA) (Press release, Johnson & Johnson, DEC 21, 2017, View Source [SID1234522753]). LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Despite significant advances, multiple myeloma remains an incurable disease for most patients, creating the need for additional, highly active options. LCAR-B38M provides an innovative approach with the potential to transform the treatment of myeloma," said Peter F. Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We look forward to collaborating with the pioneering scientific team at Legend and applying our expertise to the development of this cell therapy, with the goal of building regimens aiming for a cure."

LCAR-B38M is the first CAR-T therapy accepted for review by the CFDA. Under terms of the agreement, Legend will grant Janssen a worldwide license to jointly develop and commercialize LCAR-B38M in

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multiple myeloma with the Legend team of experts. Janssen will record worldwide net trade sales, except for sales made in Greater China. The companies have entered into a 50/50 percent cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30/70 percent cost-sharing/profit-split arrangement. Janssen will make an upfront payment of $350 million that will be recorded in the fourth quarter and additional payments based upon the achievement of certain development, regulatory and sales milestones.

Johnson & Johnson reaffirms its previously announced adjusted earnings guidance for full-year 2017 of $7.25-$7.30 per share.

"We are pleased to enter into a partnership with Legend to gain access to their CAR-T platform, an important future therapeutic modality for Janssen," says Mathai Mammen, M.D., Ph.D., Global Head, Science & Development, Janssen Research & Development, LLC. "Legend is an innovative biotech company that has developed a differentiated CAR-T therapy, which has shown promising results in early-stage multiple myeloma trials conducted in China. We are excited to bring Janssen’s global expertise in drug development to advance this innovation into potential new treatment options for patients around the world."

About CAR-T and BCMA
CAR T-cells are an innovative approach to eradicate cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells. By targeting BCMA via a CAR-T approach, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.1,2 While some patients with myeloma have no symptoms at all, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections.3 Despite significant treatment advances in the past 10 years, many myeloma patients relapse after initial or secondary treatment and/or become resistant to therapies. There is a significant unmet medical need for more efficacious treatments that can overcome resistance associated with standard of care based on an immunomodulatory agent and/or a proteasome inhibitor to induce deeper and durable responses.1,4 Globally, it is estimated that 124,225 people were diagnosed and 87,084 died from multiple myeloma in 2015.5,6

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Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Please visit www.janssen.com/oncology.

On 20 December 2017, Idorsia Ltd reported that it has entered into a research collaboration that provides Roche with an exclusive option right to develop and market first-in-class compounds for a promising new approach in the field of cancer immunotherapy (Press release, Hoffmann-La Roche, DEC 20, 2017, View Source [SID1234584171]).

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Martine Clozel, M.D. and Chief Scientific Officer of Idorsia, commented: "The preclinical data we have generated leads us to believe that our approach can translate into significant therapeutic benefits for patients. By joining forces, we are combining our advanced drug discovery program together with the cancer immunotherapy expertise of Roche. I am looking forward to the collaboration with our partner to leverage our research and bring compounds through clinical development as soon as possible."

About the terms of the agreement

The parties will collaborate on the discovery of products through the formation of a joint committee, chaired by Idorsia.

Roche will pay Idorsia an upfront payment of CHF 15 million and will have the option to exclusively license Idorsia compounds and compounds resulting from the collaboration, for a further payment of 35 million, after a pre-determined period. After the exercise of its option right, Roche would have the exclusive worldwide right to develop and commercialize the Idorsia and collaboration compounds.

Idorsia will be eligible to receive one-time development and regulatory milestones of up to CHF 410 million. Idorsia will also be entitled to one-time milestones based on sales thresholds, as well as tiered royalties on annual net sales of all products resulting from the collaboration.

On December 20, 2017 Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) reported that management will present at the Goldman Sachs Healthcare CEOs Unscripted Conference on Thursday, January 4, 2018 at 1:45 p.m. Eastern Time (Press release, Alexion, DEC 20, 2017, View Source [SID1234522720]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

On December 20, 2017 Bayer reported that its collaboration partner Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company based in Stamford, CT, has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib (Press release, Bayer, DEC 20, 2017, View Source [SID1234522722]). The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo Oncology expects to complete the NDA submission in early 2018.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The initiation of the rolling submission in the U.S. by Loxo Oncology is an important milestone, as it brings us one step closer to potentially being able to offer a much needed new treatment option for patients with TRK fusion cancers in the near future," said Robert LaCaze, Member of the Executive Committee at Bayer AG’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit.

About larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated an 80 percent investigator-assessed overall response rate (ORR) and a 75 percent independently-reviewed confirmed ORR, across many different types of solid tumors. Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Loxo Oncology leads worldwide development and U.S. regulatory activities. Bayer leads ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

About TRK fusion cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.

Cancers harboring genetic alterations
Scientists have long been working to better understand how a normal cell becomes a cancer cell to deliver better therapies with fewer side effects. Some people develop cancers that are caused by a single inappropriate DNA change, known as "oncogenic drivers." When a genetic test identifies a patient with an oncogenic driver, there is the potential for use of highly selective drugs that inhibit oncogenic drivers in cancer. While there has been made notable progress in improving outcomes for people living with cancer over the last several decades, there has been a growing interest in developing highly targeted medicines to treat cancer, to further maximize the patients’ clinical benefit. This development is supported by the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes four marketed products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated