On June 1, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company focused on novel immunotherapy platforms for the treatment of solid tumors, reported that two PVSRIPO presentations will be made during poster sessions at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually June 4 – 8, 2021 (Press release, Istari Oncology, JUN 1, 2021, View Source [SID1234583317]). PVSRIPO is a viral immunotherapy shown in preclinical studies to activate innate and adaptive immunity to facilitate a polyfunctional antitumor CD8+ T cell response. Clinical trials are underway in recurrent glioblastoma (LUMINOS-101), melanoma (LUMINOS-102) and a range of solid tumors (LUMINOS-103).

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Presentations at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Title: LUMINOS-101: Phase 2 study of PVSRIPO with pembrolizumab in recurrent glioblastoma, Abstract #TPS2065

Virtual Session: Central Nervous System Tumors

Dates: June 4 – 8, 2021

Location ASCO (Free ASCO Whitepaper) Virtual Scientific Program

Title: Safety and efficacy of murine PVSRIPO plus anti PD-1 immune checkpoint inhibitor (ICI) in a melanoma tumor model, Abstract #2560

Virtual Session: Developmental Therapeutics – Immunotherapy

Dates: June 4 – 8, 2021

Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program

Additional information on the meeting can be found on the ASCO (Free ASCO Whitepaper) website. ASCO (Free ASCO Whitepaper) participants and non-participants can also browse Istari’s virtual medical affairs exhibit at https://istarivirtualexhibit.com/ and learn more about PVSRIPO’s mechanism of action, the LUMINOS clinical trials program, and view published studies and posters to be presented at ASCO (Free ASCO Whitepaper) 2021 and other previous congresses. For more information about Istari Oncology and ongoing clinical trials and research, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. 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 nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On June 1, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following virtual conferences in June (Press release, Iovance Biotherapeutics, JUN 1, 2021, View Source [SID1234583316]):

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Jefferies Virtual Healthcare Conference
Fireside Chat: Tuesday, June 1 at 3:30 p.m. ET
Goldman Sachs 42nd Annual Global Healthcare Conference
Fireside Chat: Wednesday, June 9 at 5:30 p.m. ET
JMP Securities Life Sciences Conference
Fireside Chat: Thursday, June 17 at 2:00 p.m. ET
The live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source

On June 1, 2021 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer, Anthony Pagano and Chief Development Officer, Judith Klimovsky, will participate in a virtual fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference 3:50 PM EDT on June 9, 2021 (9:50 PM CEST) (Press release, Genmab, JUN 1, 2021, View Source [SID1234583315]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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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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On June 1, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the virtual symposium, "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," taking place on June 18, 2021, 9:00-1:15 PM ET (Press release, Curis, JUN 1, 2021, View Source,-Inc-Announces-2021-Virtual-Symposium-VISTA-A-New-Immune-Checkpoint-in-Cancer,-Autoimmunity-and-Beyond [SID1234583314]).

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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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Leaders in immunology across industry and academia will gather to discuss emerging checkpoint molecule, VISTA, including its function, the role it plays in several disease areas and current development programs. The event is organized by Curis and will be hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

"Over the last several years, there have been significant advancements from both academia and industry in the understanding and pursuit of VISTA as a target for immunotherapy, including the advancement of our own anti-VISTA antibody, CI-8993, into clinical trials," said James Dentzer, President and Chief Executive Officer of Curis. "This symposium will bring together leading minds on the forefront of VISTA research and development to discuss the latest insights into this emerging checkpoint target and its potential applications in immuno-oncology, autoimmune diseases and other therapeutic areas."

Free to attend, the event features agenda topics including:

Overview of checkpoint therapy
Introduction of VISTA
VISTA regulation of the tumor microenvironment in human cancer
Discovery of anti-VISTA antibodies
VISTA counterreceptors
Industry Panel: VISTA advances into clinical development
To learn more about the symposium and register to attend please visit, https://bit.ly/3hBzIUj.

On June 1, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2021 (Press release, CTI BioPharma, JUN 1, 2021, View Source [SID1234583313]).

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"The U.S. Food and Drug Administration’s (FDA) acceptance of our New Drug Application (NDA) for pacritinib with priority review and a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021 brings us one step closer to providing pacritinib to myelofibrosis patients with severe thrombocytopenia who are underserved by existing therapies," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We continue to work diligently on our commercial preparedness and expect to be ready to launch pacritinib in the United States this year, pending approval by the FDA. To that end, over the last quarter, we progressed key pre-commercial activities to prepare for a successful and rapid launch upon approval, including market access, distribution and supply chain, disease education and field force planning and deployment. We look forward to continuing these efforts, and to work closely with the FDA during its review of our application."

Expected Milestones

PDUFA action date – November 30, 2021
Expected U.S. commercial launch of pacritinib – by the end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – Q3 2021
First Quarter Financial Results
Operating loss was $17.1 million and $11.9 million for the three months ended March 31, 2021 and 2020, respectively. The increase in operating loss resulted primarily from increases in research and development and general and administrative activities associated with continued development and preparation for the commercialization of pacritinib.

Net loss for the three months ended March 31, 2021 was $17.3 million, or $0.23 for basic and diluted loss per share, as compared to a net loss of $12.2 million, or $0.20 for basic and diluted loss per share, for the same period in 2020.

As of March 31, 2021, cash, cash equivalents and short-term investments totaled $37.2 million, as compared to $52.5 million as of December 31, 2020. On April 6, 2021 we completed an equity financing with net proceeds of $53.8 million, which enables us to fund our operations into the fourth quarter of 2021.

Conference Call and Webcast
CTI will host a conference call and webcast to review its first quarter 2021 financial results and provide an update on business activities today, June 1 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 9343326. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50 x 109/L, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to result from treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, and represent an area of significant area of unmet medical need.