On May 10, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported its financial results for the first quarter ended March 31, 2022 (Press release, Calithera Biosciences, MAY 10, 2022, View Source [SID1234614075]).

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"We made significant headway in the transfer of mivavotinib and sapanisertib materials to Calithera during the first quarter and are well into site start-up activities. We are on track to begin enrolling patients in both mivavotinib and sapanisertib trials in the second quarter of 2022 and expect to share data from these studies by the first quarter of 2023," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We are also excited about our preclinical synthetic lethality program, having presented the first data from our internally-discovered, first-of-their-kind VPS4A inhibitors at the AACR (Free AACR Whitepaper) Annual Meeting. This year has shaped up to be an exciting one for Calithera, given the potential we see in both our clinical and preclinical programs."

First Quarter 2022 and Recent Highlights

Mivavotinib (SYK inhibitor): Based on clinical data showing enhanced activity of mivavotinib in activated B-cell-like (ABC) diffuse large B-cell lymphoma (DLBCL) and preclinical data demonstrating enhanced SYK activity and inhibition in DLBCL with MyD88/CD79 mutations, Calithera designed a phase 2 trial of mivavotinib in relapsed or refractory non-GCB (ABC) DLBCL with enrichment of MYD88/CD79b-mutated tumors using liquid next-generation sequencing (NGS) testing. The phase 2a portion of the study will confirm activity in the biomarker-defined subsets and further refine dose and schedule. The trial will enroll non-GCB (ABC) DLBCL patients based on Hans algorithm, and researchers will collect MyD88 and CD79 mutation status using ctDNA-based liquid NGS to accrue a pre-specified number of patients harboring MyD88 or CD79b mutations. Approximately 50% of all ABC DLBCL tumors have one or both of these mutations. Calithera anticipates the first patient enrolled in the second quarter of 2022. Data generated from this study could position the company to initiate a study with registrational intent in biomarker-specific populations in DLBCL.

Sapanisertib (Dual mTORC 1/2 inhibitor): In a recent investigator-led study, sapanisertib demonstrated durable single-agent activity in patients with heavily pretreated NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (NSCLC). These mutations occur in approximately 15% of patients with squamous NSCLC. Calithera is initiating a phase 2 study intended to strengthen the existing data in patients with NRF2-mutated squamous NSCLC and evaluate its activity in NRF2 wildtype (WT) squamous NSCLC. Sapanisertib has the potential to be a first-in-class treatment for individuals with NRF2-mutated squamous NSCLC, a patient population with poorer prognosis, unmet clinical need, and no targeted therapies. Sapanisertib could also be a possible treatment for other NRF2-mutated cancers beyond NSCLC. Calithera anticipates the first patient enrolled in this study in the second quarter of 2022.

Presented data on its novel series of VPS4A inhibitors. Calithera presented the first data from its preclinical synthetic lethality pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. The presented poster detailed Calithera’s discovery of a novel series of VPS4A (vacuolar protein sorting-associated protein 4A) inhibitors that are currently advancing through lead optimization. These data validate the synthetic lethal interaction between the gene paralogs VPS4A and VPS4B, and we believe, provide the first preclinical evidence supporting a newly discovered series of compounds designed to target these proteins for cancer treatment. To our knowledge, these are the first active, on-target VPS4 inhibitors described to date.
Closed a $10.0 Million Underwritten Public Offering of Common Stock and Warrants to Purchase Common Stock. On April 1, 2022, Calithera closed an underwritten public offering of 18,518,519 shares of its common stock at a combined price to the public of $0.54 per share and accompanying warrants. Each share of common stock is accompanied by a warrant to purchase one share of common stock at an exercise price of $0.54 per share, which is immediately exercisable and will expire 18 months from the date of issuance, or a short-term warrant, and a warrant to purchase one share of common stock at an exercise price of $0.54 per share, which is immediately exercisable and will expire 5 years from the date of issuance, or a long-term warrant. Calithera received gross proceeds of $10.0 million, resulting in $8.5 million of net proceeds after deducting underwriting discounts and commissions and offering expenses.
Selected First Quarter 2022 Financial Results

Cash and cash equivalents totaled $44.7 million at March 31, 2022, which Calithera expects, together with proceeds from its public offering, will be sufficient to meet its operating plan through the second quarter of 2023.

Research and development expenses for the first quarter 2022 were $9.6 million, compared to $15.3 million in the same period prior year. The decrease of $5.8 million was primarily due to a decrease in the telaglenastat program, partially offset by increases in the sapanisertib and mivavotinib programs.

General and administrative expenses for the first quarter 2022 were $4.3 million, compared to $5.4 million in the same period prior year. The decrease of $1.2 million was primarily due to decreases in personnel-related costs.

Net loss for the three months ended March 31, 2022 was $13.8 million.

Conference Call Information

Calithera will host an update conference call today, Tuesday, May 10, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 4979639. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported financial results for the quarter ended March 31, 2022 and announced recent program and corporate developments (Press release, Inovio, MAY 10, 2022, View Source [SID1234614074]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

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In a separate press release, the Company announced the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO). Dr. Shea, INOVIO’s former Chief Operating Officer, succeeds Dr. J. Joseph Kim in these roles.

"We believe in the potential of our DNA medicines and vaccines to combat infectious diseases, cancer and HPV-associated diseases," said Dr. Jacqueline Shea, President and CEO of INOVIO. "To achieve these goals, INOVIO must strategically prioritize our resources to capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses, lack of anti-vector response, tolerability for re-administration and favorable temperature stability for transport, storage and distribution."

First Quarter Program Updates

COVID-19: INNOVATE

INOVIO has decided to prioritize its COVID-19 efforts to advance its heterologous booster strategy. In so doing, the company will discontinue its Phase 3 INNOVATE trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases1, which would necessitate an increase in trial size and costs for INNOVATE. In contrast, the heterologous booster market offers greater opportunities as the world prepares to enter the endemic phase of COVID-19.

COVID-19: Heterologous Booster – Preliminary Data

With its partner, Advaccine, INOVIO reported positive T cell immune response data with INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine. This data came from a heterologous booster clinical trial conducted by Advaccine that assessed the immune responses following a primary series of two doses of an inactivated COVID-19 vaccine followed by a booster with INO-4800 after 3 or 6 months. Interim immunogenicity data showed that using INO-4800 as a booster after 6 months resulted in a 6.3-fold increase in T cell immune response. In a separate Advaccine study where a third dose of an inactivated COVID-19 vaccine was assessed, the cellular response increased by 1.7-fold. The highest booster effect of INO-4800 was observed with a 2 mg dose of INO-4800 delivered 6 months after a primary series with an inactivated vaccine.

Following INO-4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS-CoV-2 variants of concern, including Omicron, without a significant loss in response magnitude. T cells that can recognize SARS-CoV-2 may play a role in reducing disease severity. Therefore, INO-4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise.

INOVIO is continuing discussions with regulators in select countries regarding potential regulatory pathways for licensure. The Company believes the increased global awareness about the importance of T cell immune responses and durability of protection for effective booster vaccines correspond well with INO-4800’s key strength – its ability to generate CD8+ T cell responses against SARS-CoV-2.

INOVIO is planning to expand its partnership with Advaccine beyond INO-4800 to include heterologous boosters and vaccine candidates covering future variants. The expanded partnership will allow both companies to share data, leverage Advaccine’s multiple manufacturing sites in China, and access opportunities globally.

VGX-3100: HPV-associated Cervical High-Grade Squamous Intraepithelial Lesions (HSIL)

Based on feedback from the U.S. Food and Drug Administration (FDA), INOVIO has changed its development plans for VGX-3100 for HPV-16/18-associated cervical HSIL to a biomarker-selected population. In a recent preliminary letter, the FDA advised INOVIO that the REVEAL2 Phase 3 study would not be sufficient to support approval of a potential marketing application for VGX-3100 in that population. The FDA recommended that using REVEAL2 as an exploratory study to evaluate a biomarker-selected population and then conducting one or two additional well-controlled trials in the biomarker-positive population would be more likely to provide sufficient evidence to support approval of a marketing application.

To better assess potential efficacy in a biomarker-selected population, the Company plans to amend the fully enrolled REVEAL2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. Both the biomarker-positive population and the all-comers population will be analyzed.

INOVIO will continue its REVEAL2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the REVEAL2 results. Given the likelihood for at least one additional trial, INOVIO no longer expects to submit a BLA in 2023 for VGX-3100.

INO-3107: Recurrent Respiratory Papillomatosis (RRP)

INOVIO completed enrollment of 32 participants in the open-label, multicenter Phase 1/2 trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in participants with HPV-6/11-associated RRP who have required at least two interventions in the past year for the removal of associated papilloma(s). For this study, adult participants will first undergo removal of their papilloma(s) and will subsequently receive four doses of INO-3107, one every three weeks. The efficacy endpoint will be a reduction in the frequency of therapeutic interventions following the first dose of INO-3107 relative to the frequency prior to study therapy.

INOVIO expects preliminary efficacy, safety and immunogenicity data from a portion of participants from this Phase 1/2 trial in the second half of this year. The Company will share additional clinical development plans after analysis of the data.

INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)

INOVIO’s abstract providing follow-up Phase 1/2 overall survival, safety and immunogenicity data from the Company’s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed GBM has been selected for oral presentation as part of an Oral Abstract Session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting under the title "Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma".

The complete text of the abstract will be posted on the website, meetings.asco.org, on May 26, 2022 at 5:00 PM EDT. The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting will take place on June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.

First Quarter 2022 Financial Results

INOVIO reported total revenue was $199,000 for the three months ended March 31, 2022, compared to $371,000 for the same period in 2021. Total operating expenses were $71.9 million compared to $52.9 million for the same period in 2021.

INOVIO’s net loss for the quarter ended March 31, 2022, was $79.1 million, or $0.36 per basic and diluted share, compared to net loss of $54.4 million, or $0.27 per basic and diluted share, for the quarter ended March 31, 2021.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2022, were $56.0 million compared to $39.0 million for the same period in 2021. The increase in R&D expenses was primarily related to higher drug manufacturing and clinical trial expenses related to INO-4800 and higher employee compensation. The increase was also due to $6.3 million lower contra-research and development expense recorded from grant agreements. These increases were offset by lower engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, among other variances.

General and administrative (G&A) expenses were $16.0 million for the three months ended March 31, 2022, versus $13.9 million for the same period in 2021. The increase in G&A expenses was primarily related to an increase in employee compensation and insurance expenses, among other variances.

Capital Resources

As of March 31, 2022, cash and cash equivalents and short-term investments were $360.4 million compared to $401.3 million as of December 31, 2021. As of March 31, 2022, the Company had 226.5 million common shares outstanding and 247.8 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended March 31, 2022, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Daylight Time today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO) of INOVIO, effective immediately (Press release, Inovio, MAY 10, 2022, View Source [SID1234614073]). Dr. Shea succeeds Dr. J. Joseph Kim in these roles. Dr. Kim has also resigned as a member of the INOVIO board of directors, and the board intends to appoint Dr. Shea as a director following INOVIO’s annual meeting of the stockholders on May 16, 2022.

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Mr. Simon X. Benito, Chairman of the Board of INOVIO, said, "On behalf of the entire Board, I am pleased to announce Dr. Shea’s appointment as President and CEO of INOVIO. Dr. Shea brings more than 25 years of experience in the life sciences and biotech industries. Since joining as Chief Operating Officer in March 2019, Dr. Shea has shown exceptional leadership and technical expertise overseeing INOVIO’s manufacturing, commercial, business development, project and alliance management operations as well as serving as a key member of the executive team. We look forward to Dr. Shea taking the helm during a particularly challenging period in INOVIO’s history. Her tenured leadership, deep knowledge of our business, and broad expertise makes her an excellent choice for the role."

Mr. Benito added, "On behalf of the Board, I would like to thank Dr. Kim for his commitment to INOVIO and his founding vision of a world free from disease through DNA medicines. As a co-founder of the Company, Joseph has been a true entrepreneur and pioneer in the field of vaccines and immunotherapies since its inception. I am pleased that he has agreed to act in an advisory capacity to Dr. Shea during the transition."

Dr. Shea said, "I am honored to take on the role of CEO and grateful for the support of the Board in entrusting me to lead INOVIO for its next chapter. While we have many challenges to face, I believe strongly in the potential of our DNA medicines technology and continue to be inspired by INOVIO’s talented and dedicated team. I look forward to reshaping the future of INOVIO and advancing our efforts across multiple therapeutic areas with the potential to improve the lives of patients globally."

Prior to joining INOVIO in March 2019, Dr. Shea served as the Chief Operating Officer and later the Chief Executive Officer of Aeras, a not-for-profit organization dedicated to developing new vaccines against tuberculosis (TB). During her tenure she oversaw two major clinical trial breakthroughs in the development of TB vaccines. Previously, she held executive roles at Emergent BioSolutions and was also the General Manager and Vice President of The Oxford-Emergent Tuberculosis Consortium. A molecular biologist and cell cycle geneticist, Dr. Shea received a BSc Hons in Applied Biology from the University of Bath and holds a Ph.D. from the National Institute for Medical Research in the United Kingdom. She has been named as an inventor on more than 20 patents, has authored numerous publications, served on multiple advisory boards and currently serves on the board of Trustees for the Sabin Vaccine Institute.

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On May 10, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the first quarter of 2022 and provided an update on recent corporate progress (Press release, Viracta Therapeutics, MAY 10, 2022, View Source [SID1234614072]).

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"We have made encouraging progress in both clinical programs with our all-oral drug product candidate, Nana-val, which are advancing towards potential key catalysts in the second half of the year," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Since the first patient was dosed in January, our Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors has proceeded nicely and we anticipate reporting preliminary safety and efficacy data later this year. In addition, we are pleased to have expanded the clinical reach of NAVAL-1 beyond North America into Europe as well as Asia, and anticipate having an update on cohorts advancing into Stage 2 of the trial later this year."

First Quarter 2022 and Recent Highlights

Clinical

Continued global expansion and enrollment into NAVAL-1, the pivotal trial of Nana-val (nanatinostat and valganciclovir) for the treatment of patients with relapsed/refractory EBV+ lymphoma. NAVAL-1 employs a Simon two-stage design where patients are initially enrolled into six cohorts based on lymphoma subtype in Stage 1. If a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. Lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded. If successful, the Company believes NAVAL-1 could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. Clinical sites are open across the globe, including in the U.S., Canada, Europe, and Asia. The Company anticipates providing an update on the initial cohort(s) that may advance into Stage 2 of the trial in the second half of the year.
Dosed first patient in the Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other EBV+ solid tumors. Enrollment continues in the Phase 1b dose escalation part of the study, which is designed to evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to 60 patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. Viracta anticipates reporting preliminary Phase 1b safety and efficacy data from the trial in the second half of 2022.
Corporate

Hosted key opinion leader webinar on Nana-val for the treatment of advanced EBV+ solid tumors. The webinar featured presentations from key opinion leader Ezra Cohen, MD, FRCPSC, FASCO (University of California, San Diego) and members of the Viracta management team. Topics discussed included the current treatment landscape and unmet medical need in NPC, the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors, and preclinical data supporting the trial. A replay of the webinar is available here.
Anticipated 2022 Milestones

Provide preliminary Phase 1b safety and efficacy data from the Phase 1b/2 trial in advanced EBV+ solid tumors: 2H 2022
Update on NAVAL-1 cohort(s) that may progress from Stage 1 to Stage 2: 2H 2022
First Quarter 2022 Financial Results

Cash Position – Cash and cash equivalents totaled approximately $92.2 million as of March 31, 2022, which Viracta expects will be sufficient to fund its operations into mid-2024, excluding any borrowing under its previously announced $50.0 million credit facility from Silicon Valley Bank and Oxford Finance.
Research and development expenses – Research and development expenses were approximately $6.1 million for the three months ended March 31, 2022, compared to $4.0 million for the same period in 2021. The increase in research and development expenses for the three months ended March 31, 2022, was primarily due to increases in costs incurred to support the initiation of the NAVAL-1 and solid tumor trials as well as an increase in headcount and non-cash share-based compensation.
Acquired in-process research and development – For the three months ended March 31, 2021, the acquired in-process research and development included non-cash and non-recurring cost of $84.5 million associated with the estimated fair value of the in-process research and development projects acquired in the Sunesis asset acquisition with no alternative future use, which was charged to expense on the Sunesis merger date.
General and administrative expenses – General and administrative expenses were approximately $4.3 million for the three months ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase was largely due to incremental costs associated with being a publicly traded company including directors and officers’ insurance costs, and non-cash share-based compensation.
Gain on Royalty Purchase Agreement – For the three months ended March 31, 2021, the gain was associated with upfront proceeds of $13.5 million recorded in connection with the multi-license milestone and royalty monetization transaction with XOMA (US) LLC.
Adjusted loss from operations – There was not a comparative adjustment to loss from operations for the quarter ended March 31, 2022. Adjusted income from operations for the quarter ended March 31, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $5.6 million, compared to an unadjusted loss from operations of $78.8 million.
Net loss – Net loss was approximately $10.5 million, or $0.28 per share (basic and diluted) for the quarter ended March 31, 2022, compared to a net loss of $79.2 million or $5.22 per share for the same period in 2021.
About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.