On November 30, 2020 Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the appointment of Arvin Yang, M.D., Ph.D., as Senior Vice President and Chief Medical Officer effective immediately (Press release, Mersana Therapeutics, NOV 30, 2020, View Source [SID1234571968]). Dr. Yang succeeds Dirk Huebner, M.D., who has stepped down as Chief Medical Officer but will remain with the Company until January 15, 2021, to assist with a smooth transition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited to welcome Arvin to our leadership team as we enter this next crucial and exciting stage for Mersana," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Arvin’s deep experience in leading late-stage global registration trials combined with his early stage and immuno-oncology experience will be instrumental in guiding the advancement of XMT-1536 into the planned fast-to-market registration-enabling study as well as driving the rest of Mersana’s first-in-class innovative pipeline."

Dr. Yang spent over a decade at Bristol Myers Squibb in various roles with increasing responsibility for the clinical development of oncology and immuno-oncology therapies. Most recently, he was Vice President and Head of Clinical Hematology, where he was responsible for the clinical development of the late stage hematology pipeline. Before that, he was Vice President and Development Lead for Melanoma and GU cancers, and played a critical role in the global approval of nivolumab and nivolumab plus ipilimumab combinations in a number of indications. Earlier, he was responsible for the nivolumab and ipilimumab life-cycle clinical development plans including those in gynecological cancers. Finally, he has held leadership roles overseeing a pipeline of early clinical programs as well as roles in medical affairs. Dr. Yang received his M.D. and Ph.D. from Rutgers Robert Wood Johnson Medical School and completed training in internal medicine at Beth Israel Deaconess, Harvard Medical School and in oncology at Memorial Sloan-Kettering Cancer Center.

"Mersana’s XMT-1536 is poised to make a meaningful difference for people living with ovarian cancer. I am excited about the opportunity to work with the talented Mersana team to bring this important medicine to patients," said Dr. Yang. "I am equally excited about the potential of the NaPi2b target in non-small cell lung cancer adenocarcinoma, Mersana’s robust pipeline of early-stage candidates developed using innovative and differentiated ADC platforms, and the potential of these candidates to make a significant impact in the lives of people living with cancer."

"I would also like to take this opportunity to thank Dirk for his many contributions at Mersana. Over the past two years, Dirk has played a significant role in bringing XMT-1536 to proof of concept in ovarian cancer and in building a strong clinical development team. I wish him all the best in his future endeavors," added Anna Protopapas.

On November 30, 2020 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the first patient was dosed in the LUMINOS-101 Phase 2 clinical trial, assessing the safety and efficacy of PVSRIPO in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with recurrent glioblastoma multiforme (rGBM) (Press release, Istari Oncology, NOV 30, 2020, View Source [SID1234571967]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response. The study seeks to determine whether PVSRIPO and pembrolizumab will be able to generate anti-tumor response in patients with rGBM, given their complimentary mechanisms of action.

"The initiation of this Phase 2 trial represents a significant milestone in the advancement of PVSRIPO and our quest to treat this formidable opponent," said Matt Stober, President and Chief Executive Officer at Istari Oncology. "Currently the treatment options for patients with rGBM are limited and outcomes are grim, so following the encouraging results of our Phase 1 trial, we are eager to see the effectiveness of PVSRIPO in combination with pembrolizumab."

"Combining PVSRIPO’s ability to generate antitumor immune response with a checkpoint inhibitor holds the promise of more effective therapy for this devastating disease," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "Achieving rapid disease control is critical in patients with rGBM, one of the most aggressive and treatment-refractory tumors."

LUMINOS-101 is a Phase 2, single arm trial (clinicaltrials.gov NCT04479241) in patients with rGBM that aims to characterize the safety, tolerability and initial efficacy of PVSRIPO intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every three weeks thereafter.

LUMINOS-101 follows a Phase 1 trial of PVSRIPO in rGBM, conducted at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, that found survival rates were significantly higher in rGBM patients who received an intratumoral infusion of PVSRIPO compared to similar patients receiving standard treatment. Overall survival among patients who received PVSRIPO plateaued at 21 percent, 24 to 36 months after injection based on a publication of the interim trial results (Desjardins, et al., 2018 NEJM). The overall survival rate was sustained at 36 months in these patients. A multicenter Phase 2 study of PVSRIPO in patients with rGBM (n=120) completed enrollment in June 2020; follow-up of those patients is ongoing.

The Phase 2 LUMINOS-101 trial will be conducted across multiple research sites, including Ohio State University Comprehensive Cancer Center, University of California San Francisco, Baptist MD Anderson Cancer Center, Duke University Medical Center, Oregon Health and Science University and University Hospitals Seidman Cancer Center (UHSCC) in Cleveland, Ohio. The first patient has been dosed at UHSCC, which treated seven patients with rGBM as part of the previous Phase 2 trial.

"The Phase 1 trial of PVSRIPO yielded survival rates like we’ve never seen before," says Andrew E. Sloan, MD, FACS, Director of the Brain Tumor & Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and UH Neurological Institute, and Professor and Vice Chairman, Department of Neurosurgery at Case Western Reserve University School of Medicine. "Glioblastoma is one of the most aggressive tumors known to man. Following the encouraging results of PVSRIPO to date, we are very interested to see if those results improve further in combination with pembrolizumab."

For more information about Istari Oncology and their ongoing clinical trials, visit istarioncology.com.

About PVSRIPO
PVSRIPO is a virus based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen presenting cells in the tumor, which unleashes an inflammatory cascade resulting in sustained systemic antitumor immunity. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma.

About Glioblastoma
Glioblastoma is the most common and aggressive form of brain cancer, comprising 52% of patients with primary brain tumors. There are approximately 13,000 patients diagnosed with GBM in the United States annually and approximately 18,000 in the European Union. Despite aggressive treatment, survival for newly diagnosed glioblastoma patients is usually less than 20 months, and for patients with recurrence, which occurs in 98% of patients, survival is usually less than 12 months.

On November 30, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) and Viracta Therapeutics, Inc., a privately held precision oncology company targeting virus-associated malignancies, reported they have entered into a definitive merger agreement (the "Merger Agreement") pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the "Merger") (Press release, Sunesis, NOV 30, 2020, View Source [SID1234571965]). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of Epstein-Barr virus (EBV)-positive relapsed/refractory lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Viracta recently completed a $40 million Series E Preferred Stock equity financing led by aMoon, Israel’s leading healthtech and life sciences venture fund, with participation from Taiwania Capital Management, Latterell Venture Partners, LifeSci Venture Partners and other existing investors.

Concurrent with the execution of the Merger Agreement, Viracta entered into an agreement for the sale of common stock in a private placement with an investor syndicate of institutional accredited investors led by BVF Partners L.P., with participation from aMoon, Ridgeback Capital Management, Surveyor Capital (a Citadel company), Logos Capital, Samsara Biocapital, Sectoral Asset Management, Janus Henderson Investors, LifeSci Venture Partners, and Serrado Capital LLC, as well as other institutional investors. The private placement is expected to result in gross proceeds to Viracta of approximately $65 million prior to the close of the Merger, subject to customary conditions. Upon the close of the Merger and related financing, the total cash balance of the combined company is expected to be approximately $120 million with an expected cash runway into 2024.

Viracta’s lead program evaluates the all-oral combination of nanatinostat, its proprietary investigational drug, and valganciclovir in a Phase 2 clinical trial for the treatment of EBV-positive relapsed/refractory lymphomas. There are currently no approved therapies for EBV-associated cancers, which are responsible for over 140,000 deaths each year. Viracta’s precision oncology and biomarker-driven combination product candidate targets EBV-positive cancer cells with an inducible synthetic lethality approach. Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.

"This is a transformational event for Viracta, and I am very pleased to see the company brought forward into the public market," said Roger Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "Importantly, Viracta’s novel approach to targeting viral latency represents a completely new medical modality in the landscape of precision oncology, and today is the beginning of an important and exciting new phase in the company’s evolution. EBV-induced malignancies are a high unmet medical need area, and the patients are waiting for novel therapies."

"After a thorough evaluation of strategic alternatives, the Board of Directors of Sunesis believes this merger is in the best interest of Sunesis’ stockholders and has the potential to deliver near- and long-term value," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "This transaction will provide the resources for the combined company to leverage Viracta’s scientific platform and pipeline to treat a range of virus-associated cancers and other serious diseases. Viracta shares our mission to develop important new targeted treatments for patients living with cancer, and we are enthusiastic about the prospect of carrying on that mission."

Ivor Royston, M.D., President and Chief Executive Officer of Viracta added, "The merger and our private financings represent a significant step in Viracta’s growth as a late-stage development company. Our ongoing Phase 2 clinical trial for the treatment of EBV-positive lymphomas has produced encouraging efficacy and safety, and these transactions provide meaningful capital as we advance this program towards registration and expand our clinical pipeline. We look forward to building upon our clinical and corporate momentum to create shareholder and patient value, as we advance our important work to address the significant unmet needs in virus-associated malignancies."

About the Merger

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

MTS Health Partners, L.P. is serving as the financial advisor to Sunesis, and Cooley LLP is serving as legal counsel to Sunesis. SVB Leerink LLC and Evercore Group LLC served as placement agents in Viracta’s private financings. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Viracta.

Management and Organization

The combined company will be led by Viracta’s current management team and will be headquartered in Cardiff, California. The Board of Directors is expected to consist of seven members, including six members from Viracta’s board and one member from Sunesis’ board.

Conference Call and Webcast Information

Sunesis and Viracta will host a conference call and webcast today at 8:30 a.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 5742158. To access the live webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com, or the "News/Media" section of the Viracta website at www.viracta.com. The webcast will be recorded and available for replay on the respective company’s website for two weeks.

On November 30, 2020 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it will host a live conference call and webcast on Monday, December 7, 2020, at 8:00 a.m. ET to highlight several presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including data on its lead candidate loncastuximab tesirine (Lonca) for the treatment of relapsed of refractory diffuse large B-cell lymphoma and updated preliminary data from a pivotal Phase 2 trial of camidanlumab tesirine (Cami) in Hodgkin lymphoma (Press release, ADC Therapeutics, NOV 30, 2020, View Source [SID1234571964]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The event will feature a presentation from key opinion leader Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology.

To access the conference call, please dial (833) 303-1198 (domestic) or +1 914 987-7415 (international) and provide the pin number 1486164. A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.adctherapeutics.com. The archived webcast will be available on the ADC Therapeutics website after the completion of the event.

On November 30, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012) (Press release, MacroGenics, NOV 30, 2020, View Source [SID1234571951]). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte’s Phase 3 global study in patients with metastatic squamous cell anal carcinoma (SCAC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic non-small cell lung cancer, SCAC, microsatellite instability high endometrial cancer and Merkel cell carcinoma. MacroGenics is conducting a potentially registration-enabling study of retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 mAb, in HER2-positive gastric cancer.

"We are excited to see the continued advancement of the development of retifanlimab across a broad set of monotherapy and combination regimens," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We look forward to continued progress on this program over the coming months."

Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $365 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.