On February 20, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, and Nationwide Children’s Hospital ("Nationwide"), one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease, reported that they have partnered and entered into an exclusive worldwide license agreement to develop an oncolytic virus (C134) for the treatment of glioblastoma multiforme (Press release, Mustang Bio, FEB 20, 2019, View Source [SID1234533480]).

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A Phase 1 clinical trial evaluating C134, an attenuated herpes simplex virus type 1 (HSV-1), in recurrent glioblastoma multiforme is being conducted at the University of Alabama at Birmingham ("UAB"). The trial is led by Dr. James Markert, M.D., Chairman of the Department of Neurosurgery at UAB, who developed C134 in collaboration with Dr. Kevin Cassady, M.D., Associate Professor of Pediatrics at Nationwide Children’s Hospital. C134 is a second-generation HSV-1 oncolytic virus that has improved replication in tumors in murine models, but with the same toxicity profile as its first-generation predecessors. In these preclinical studies, it not only demonstrates direct anti-tumor activity, but also elicits an immune response that can reverse tumor-associated immunosuppression.

Subsequent clinical trials will investigate a combination treatment of MB-101 (IL13Rα2-specific CAR) and C134. These trials are supported by preclinical studies that have appeared to demonstrate the synergistic potential of an oncolytic virus, which can induce an anti-tumor immune response when combined with CAR-T therapy to target solid tumors.

"Oncolytic viruses often trigger an immune response directed at tumors that are otherwise refractory to single agent immunotherapies. Our oncolytic virus C134 has demonstrated promising preclinical activity and we look forward to working with Mustang to advance its development in the clinic," Dr. Kevin Cassady said.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are very pleased to partner with Nationwide Children’s Hospital to develop oncolytic virus C134. We also plan to evaluate oncolytic virus C134 in combination with MB-101 to explore the potential synergies of this novel combination to treat patients with glioblastoma. At Mustang, we are committed to evaluating our CAR T therapies alone and in combination regimens with the goal of advancing treatment paradigms for cancers without alternate therapies."

On February 20, 2019 VBL Therapeutics (Nasdaq: VBLT) (the "Company") reported that it has been awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA) for 2019 (Press release, VBL Therapeutics, FEB 20, 2019, View Source [SID1234533496]). The funds will support the continued development of the Company’s lead product candidate, VB-111, a first-in-class targeted anti-cancer gene-therapy agent. The Company is currently evaluating VB-111 in a potential registration study (OVAL) for the treatment of platinum-resistant ovarian cancer, with further plans to study VB-111 in additional solid tumor indications.

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"We are appreciative of the continued substantial support by the IIA of our VB-111 program, which is a vote of confidence in our lead product candidate and its clinical and market potential," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "This $2.9 million grant, combined with the more than $53 million in cash on our balance sheet at September 30, 2018, will support our continued development of VB-111 and our other pipeline candidates, including our MOSPD2 programs in oncology and inflammation, through late 2021."

About the Israel Innovation Authority
The Israel Innovation Authority is an independent and impartial public entity that operates for the benefit of the Israeli innovation ecosystem and the country’s economy. For more information, refer to View Source

On February 20, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at the 8th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 27, 2019 at 10:00 a.m. ET / 7:00 a.m. PT (Press release, Kura Oncology, FEB 20, 2019, View Source [SID1234533516]).

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A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

On February 20, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported its Annual Report for 2018 (Press release, Genmab, FEB 20, 2019, View Source [SID1234533481]). Below is a summary of business progress and financial performance for the year, and financial outlook for 2019 from the report. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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2018 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

FDA and EMA decision on Phase III ALCYONE multiple myeloma (MM) submission – Achieved
Start new Phase III MM study – Achieved
Report early clinical data in solid tumors – Not achieved
Phase III MAIA MM efficacy analysis in frontline – Achieved
Phase III CASSIOPEIA MM efficacy analysis in frontline – Achieved

Optimize ofatumumab value

Complete recruitment Phase III subcutaneous ofatumumab relapsing MS studies – Achieved
Maximize tisotumab vedotin progress

Start two Phase II studies in cervical cancer (recurrent / metastatic & combination study in frontline) – One Phase II study with tisotumab vedotin in cervical cancer was started in 2018. A Phase I/II study in cervical cancer was posted on www.clinicaltrials.gov in 2018, but had not started before year end.
Start Phase II study in additional solid tumor indications – Achieved
Strengthen differentiated product pipeline and technology partnership portfolio

Start HuMax-AXL-ADC expansion phase in ongoing Phase I/II study – Achieved
Progress HexaBody-DR5/DR5 Phase I/II study – Achieved
Progress DuoBody-CD3xCD20 Phase I/II study – Achieved
Accelerate proprietary Immuno-Oncology DuoBody programs towards clinic – Achieved
Enter new technology or product collaborations – Genmab entered one new technology collaboration, with Immatics, during 2018.

Disciplined financial management and building a commercial footprint

Execute controlled company growth with selective investments in product & technology pipeline – Achieved
Continue investing in building commercialization and launch capabilities
Financial Performance

Revenue was DKK 3,025 million in 2018 compared to DKK 2,365 million in 2017. The increase of DKK 660 million, or 28%, was mainly driven by higher DARZALEX royalties under our daratumumab collaboration with Janssen, the payment from Novartis of USD 50 million (DKK 304 million) and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by a decrease in DARZALEX milestones.
Operating expenses increased by DKK 624 million, or 61%, from DKK 1,021 million in 2017 to DKK 1,645 million in 2018 driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support the expansion of our pipeline.
Operating income was DKK 1,380 million in 2018 compared to DKK 1,344 million in 2017. The improvement of DKK 36 million, or 3%, was driven by higher revenue, which was mostly offset by increased operating expenses.
2018 year end cash position of DKK 6,106 million, an increase of DKK 683 million, or 13%, from DKK 5,423 million as of December 31, 2017.

We expect our 2019 revenue to be approximately DKK 4,600 million, compared to DKK 3,025 million in 2018, an increase of DKK 1,575 million or 52%. Our projected revenue for 2019 primarily consists of DARZALEX royalties of DKK 2,685 million, based on estimated net sales of USD 3.0 billion. We project DARZALEX milestones of approximately DKK 1,500 million related to commercial net-sales based milestones for achieving net-sales in a calendar year of both USD 2.5 billion and USD 3.0 billion respectively. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.

Operating Expenses
We anticipate that our 2019 operating expenses will be approximately DKK 2,600 million, an increase of DKK 955 million or 58% compared to 2018. The increase is driven by the advancement of our clinical programs, particularly tisotumab vedotin and enapotamab vedotin.

Operating Result
We expect the operating income to be approximately DKK 2,000 million in 2019 compared to DKK 1,380 million in 2018, an increase of DKK 620 million or 45%.

More information on the Risks and Assumptions for the 2019 Financial Guidance can be found in the 2018 Annual Report available on our website www.genmab.com.

Conference Call
Genmab will hold a conference call in English to discuss the results for the full year results for 2018 today, February 20, 2019 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call dial +1 866 966 1396 (US participants) or +44 2071 928000 (international participants) and provide conference code 8793105.

On February 20, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will participate in the following investor conferences in February and March (Press release, Audentes Therapeutics, FEB 20, 2019, View Source [SID1234533498]):

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8th Annual SVB Leerink Global Healthcare Conference Natalie Holles, President and Chief Operating Officer Format: Fireside ChatThursday, February 28, 2019, at 9:30 am ETNew York, New York
Cowen 39th Annual Health Care Conference Matthew R. Patterson, Chairman and Chief Executive Officer Format: Corporate Presentation Tuesday, March 12, 2019, at 11:20 am ET Boston, Massachusetts
To access live webcasts of the fireside chat and presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. Following each conference, a replay of the live webcast will be available on the Audentes website for approximately 30 days.