Iovance Biotherapeutics to Present at Two Upcoming Investor Conferences in May

On May 2, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that company management will present at two investor conferences in May (Press release, Iovance Biotherapeutics, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346318 [SID1234525942]):

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Deutsche Bank’s 43rd Annual Health Care Conference in Boston, MA on Tuesday, May 8, 2018 at 2:50 p.m. ET
UBS Global Healthcare Conference in New York, NY on Monday, May 21, 2018 at 2:30 p.m. ET
A live audio webcast of both presentations will be available by visiting the Investors section of Iovance Biotherapeutics’ website at View Source A replay of the webcasts will be archived on Iovance Biotherapeutics’ website for 30 days following the presentations.

Exelixis and Invenra Enter Into Collaboration to Discover and Develop Novel Biologics to Treat Cancer

On May 2, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported that it has entered into a collaboration with Invenra, Inc., the Madison, Wisconsin-based biotechnology firm focused on developing next-generation biologics, to discover and develop multispecific antibodies for the treatment of cancer (Press release, Exelixis, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346478 [SID1234525962]). The partnership pairs Exelixis’ fundamental biological insights, clinical development prowess and commercialization expertise with Invenra’s innovative platform technologies and biologics expertise to identify, optimize, and manufacture multispecific therapeutics, including immunotherapy applications. The collaboration is part of Exelixis’ ongoing strategy to build an innovative pipeline beyond its two internally discovered, commercially available compounds, cabozantinib and cobimetinib. The agreement with Invenra creates a biologics discovery capability that complements Exelixis’ in-house small molecule drug discovery efforts.

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This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, Exelixis and Invenra will collaborate to discover and develop multispecific antibodies through the use of Invenra’s B-Body technology platform, which enables high-throughput discovery, functional screening, and in vitro and in vivo preclinical characterization of promising therapeutic candidates. Invenra will be responsible for antibody lead discovery and generation. Exelixis will lead investigational new drug (IND)-enabling studies, manufacturing, clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities.

"Partnering with Invenra to leverage its deep expertise in protein engineering and the discovery of multispecific antibodies is an important step toward adding proprietary biologics to the Exelixis pipeline," said Peter Lamb, Ph.D., Executive Vice President, Discovery Research and Chief Scientific Officer of Exelixis." We are excited to work with the Invenra team and have structured our collaboration to provide relatively small financial support upfront and pay for success down the road. As we rebuild our internal small molecule discovery capability, this partnership provides a complementary approach that enables us to target pathways not accessible to small molecules, increasing our ability to advance novel therapies into the clinic."

Under the collaboration agreement, Exelixis will receive an exclusive, worldwide license to one preclinical asset, and Exelixis and Invenra intend to pursue up to six additional discovery projects during the term of the collaboration, which in total are directed to three discovery programs. In consideration for the exclusive worldwide license and other rights contained in the collaboration agreement, Exelixis will pay Invenra an upfront payment of $2.0 million plus $2.0 million at initiation of each discovery project. Invenra is eligible to receive payments of up to $131.5 million based on the achievement of specific pre-clinical, clinical development and regulatory milestones for any product containing a lead preclinical asset in the first indication. Upon successful commercialization of a product, Invenra is eligible to receive global milestone payments up to $325 million, if certain sales thresholds are achieved as well as single digit tiered royalties on net sales of the approved product.

"We’re very excited to partner with Exelixis on this multi-asset collaboration as the company moves beyond its small molecule expertise to build a biologics pipeline," said Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra. "Invenra’s B-Body platform has been validated internally. Our innovative technologies to discover, characterize, and generate multispecific antibodies pair well with Exelixis’ demonstrated success in oncology clinical development and commercialization. We look forward to working together with the Exelixis team to bring forward potential new anti-cancer therapies."

About Invenra

Invenra, Inc., is a biotechnology company focused on the discovery and development of multispecific antibodies for immuno-oncology. Invenra’s proprietary B-Body and SNIPER technologies are used to develop novel antibodies that can bind to two or more specific therapeutic targets and mimic the natural IgG antibodies made by the human body. The B-Body platform enables the rapid identification of an optimal combination of epitope, affinity and geometry of an antibody using high throughput in-format screening for function in cell-based assays, while maintaining the biophysical characteristics needed for lead development. Importantly, the B-Body platform is designed to create advantages for candidate discovery with novel mechanisms of action and ease of manufacturing. Invenra has developed its own pipeline of lead multispecific antibodies and has partnered with several biotechnology and pharmaceutical companies who leverage Invenra’s technologies to identify molecules with biological relevance for drug development. For more information, please visit www.invenra.com.

Ziopharm Oncology to Announce First Quarter 2018 Financial Results, Host Conference Call May 10

On May 2, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP), reported that management will host a conference call and webcast slide presentation on Thursday, May 10, at 4:30 p.m. ET to provide a corporate update and discuss financial results for the first quarter ended March 31, 2018 (Press release, Ziopharm, MAY 2, 2018, View Source [SID1234525979]).

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The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 4857096. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

Herzuma® (trastuzumab), a biosimilar for the treatment of breast cancer, now available in Europe

On May 2, 2018 The Mundipharma global network of independent associated companies reported that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months (Press release, Mundipharma, MAY 2, 2018, View Source [SID1234526137]). The Mundipharma network has exclusive distribution rights to Herzuma in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.

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Richard Trollope, Head of Oncology and Biosimilars at Mundipharma International Limited, said: "Building on our partnership with Celltrion Healthcare, we are pleased to announce that biosimilar trastuzumab is now available in Europe with national launches commencing in both the UK and Germany. The availability of biosimilar trastuzumab will provide an alternative treatment option to the thousands of eligible patients across Europe with early breast cancer, metastatic breast cancer or metastatic gastric cancer."

Herzuma, a biosimilar of i.v. Herceptin, was granted marketing authorisation on 9th February 2018 for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification, following positive opinion and recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017. Biosimilar trastuzumab has the potential to make significant cost savings for healthcare organisations, releasing healthcare resource for other innovative medicines.3

Alberto Martinez, President and CEO, Mundipharma International Limited, said: "Mundipharma has a proven track record of launching biosimilars successfully in Europe, which is illustrated by Celltrion Healthcare entrusting us once again with the launch of biosimilar trastuzumab across key European markets. As biosimilar trastuzumab continues to launch in additional countries, we look forward to assisting healthcare economies across Europe wanting to deliver better value to patients."

Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, having launched Remsima (infliximab), the first biosimilar monoclonal antibody, in 2015, and Truxima (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in 2017.

Kura Oncology Announces New Patent for Tipifarnib in Hematologic Malignancies

On May 2, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the U.S. Patent and Trademark Office (USPTO) has issued a new patent protecting the company’s lead product candidate, tipifarnib (Press release, Kura Oncology, MAY 2, 2018, View Source [SID1234525943]).

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U.S. patent 9,956,215, "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors," includes multiple claims directed to the use of tipifarnib as a method of treating patients with CXCL12-expressing peripheral T-cell lymphoma (PTCL) or acute myeloid leukemia (AML). The newly issued patent has an expiration date of November 2037, excluding any possible patent term extension. Kura continues to pursue U.S. and foreign patent protection in these and other indications.

"We are excited by the potential opportunity for tipifarnib in hematologic malignancies, and this new patent represents an important milestone in our development plan," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "In addition, the issuance of this patent comes less than one year after the USPTO issued a similar patent for tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC), reinforcing the potential of our broader strategy to generate intellectual property related to the use of our drug candidates in genetically defined patient populations."

"Although tipifarnib has been known to be clinically active in hematologic malignancies for over a decade, a precise molecular mechanism of action was never elucidated and few if any clinical trials using genetic selection were conducted," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "At Kura, we discovered that the CXCL12 pathway is a potential target for tipifarnib, and markers of CXCL12 pathway activation may provide methods to select or stratify patients who are most likely to benefit from tipifarnib therapy."

In December 2017, Kura presented new findings at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that identified activation of the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of tipifarnib’s activity in certain hematologic malignancies, including PTCL, AML, myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Based on these observations, the company is now working to prospectively validate these potential biomarkers in its ongoing Phase 2 trials of tipifarnib in hematologic malignancies. Kura expects biomarker-enriched data from these ongoing Phase 2 trials in the second half of 2018.

About Tipifarnib

Tipifarnib is a potent, selective and orally bioavailable inhibitor of the enzyme farnesyl transferase. Tipifarnib was previously studied in more than 5,000 cancer patients and demonstrated compelling and durable anti-cancer activity in certain patients with a manageable side effect profile. Following a positive Phase 2 trial in HRAS mutant HNSCC and a successful end of Phase 2 meeting with the FDA, Kura is planning to conduct a global, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The trial, called AIM-HN, is expected to initiate in the second half of 2018.