Lefitolimod

– Clinical Data Include Analyses of Novel, Investigational Long-acting Therapies and Combination Cure Strategy Research with the Potential to Help Address the Diverse and Unmet Needs of People with HIV – – Real-World Evidence Evaluating the Effectiveness of Veklury in Broad Range of Hospitalized Patient Populations Being Presented, Including Those at High Risk for COVID-19 Disease Progression – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc., (Nasdaq: GILD) today announced the upcoming presentation of new clinical and real-world data from the company’s HIV, COVID-19 and viral hepatitis research and development programs at the 30th Conference on Retroviruses and Opportunistic Infections (CROI) from February 19-22. Seventy abstracts, including late-breaking data, demonstrate Gilead’s continued expertise and leadership in virology with a commitment to advance the next wave of scientific discovery to treat, prevent, cure and help eradicate viral diseases. “Positioning people at the center of the research and development process is helping us to fuel the next wave of innovation in virology,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Our scientific advances are grounded in collaboration with community and research partners around the world and highlight the importance of developing innovative solutions for the unmet and evolving needs of those most affected by viral diseases. The data selected for presentation at CROI include real-world evidence in the treatment of COVID-19, the investigational evaluation of existing therapies for HIV/hepatitis B co-infection, and new HIV treatment, prevention, and cure data evaluating long-acting options as well as novel combination therapies.” HIV Research Gilead is committed to continuous scientific discovery to provide solutions for the evolving needs of people affected by HIV around the world, with the goal of ending the HIV epidemic for everyone, everywhere. At CROI 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure. HIV treatment research and development data include proof-of-concept Phase 1b data on the safety and efficacy pro lenacapavir in combination with investigational broadly neutralizing antibodies (bNAbs) – teropavimab and zinlirvimab – dosed twice-yearly in virologically suppressed adults for the treatment of HIV. Insights from Gilead’s cure research program include new data from multiple collaborative studies evaluating novel combination therapies aimed at targeting the HIV viral reservoir and enhancing the immune response to maintain virologic control in the absence of antiretroviral therapy. The findings support the continued investigational evaluation of broadly neutralizing antibodies, vaccine candidates, and toll-like receptor agonists. Additionally, Gilead will present data from a pre-clinical in vivo assessment of a single subcutaneous administration of lenacapavir for pre-exposure prophylaxis (PrEP). As part of the company’s HIV prevention research program, Gilead will also present the results of a multinational pooled analysis of real-world adherence to PrEP and HIV incidence in cisgender women. COVID-19 Research Gilead will present data that reinforce the critical role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19. Real-world insights on Veklury’s use will provide important, up-to-date evidence from large, hospitalized populations – including patients with immunocompromised conditions – across different periods of the pandemic and different variants of concern. A separate study will evaluate the likelihood of all cause readmission among hospitalized patients who received Veklury compared to those who did not. Additionally, Gilead will present a new in vitro analysis that evaluates the antiviral activity of Veklury against common variants of concern, and data assessing the resistance pro Veklury and other antiviral compounds. Viral Hepatitis Research Gilead will present new data from the ALLIANCE trial, which is an ongoing Phase 3 trial evaluating Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) versus dolutegravir (50 mg, DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection who are initiating treatment. The sub-analysis of Week 48 results complements the initial data presented at the 24th International AIDS Conference (AIDS 2022), with a focus on the HBV outcomes in this coinfected population. Accepted abstracts at the 30th Conference on Retroviruses and Opportunistic Infections include: HIV Research Long-Acting HIV Treatment Research Lenacapavir with bNAbs – teropavimab and zinlirvimab – dosed every 6 months in people with HIV Susceptibility screening to – teropavimab and zinlirvimab – in ART-suppressed patients Population PK analysis to guide dosing window following lenacapavir SC administration Antiviral activity of lenacapavir against HIV-2 isolates Long-acting lenacapavir in a combination regimen for treatment naïve PWH: week 80 Week 52 subgroup efficacy of lenacapavir in heavily treatment-experienced PWH Six-month outcome of F/TAF cobicistat-boosted darunavir in children 14 to <25kg HIV Prevention Research 8+ years pooled analysis: Adherence and HIV incidence in 6000 women on F/TDF for PrEP Lenacapavir protects against rectal sHIV acquisition in macaque model HIV Cure Research The impact of 3BNC117, 10-1074 and lefitolimod on HIV-1 persistence – the TITAN trial Vesatolimod pharmacodynamic response is associated with time to HIV rebound Heterologous ChAd/samRNA vaccine induces robust T-cell responses in macaques A placebo controlled randomized trial of the HTI immunogen vaccine and vesatolimod (late-breaker) Rebound dynamics following immunotherapy with an HIV vaccine, TLR9 agonist, and bNAbs (late-breaker) COVID-19 Research Remdesivir is Associated with Reduced Readmission After COVID-19 Hospitalization Remdesivir Reduces Mortality in Hospitalized COVID-19 Patients Across Variant Eras Remdesivir Reduces Mortality in Immunocompromised Patients Hospitalized For COVID-19 Pharmacokinetic Analysis Informs the Dose of Remdesivir in Severe Renal Impairment Incidence of Diagnosed Long COVID Symptoms in Patients Previously Hospitalized for COVID-19 Remdesivir Resistance Analyses From the PINETREE Study in Outpatients With COVID-19 Remdesivir Retains Potent Activity Against SARS-COV-2 Omicron Subvariants Viral Hepatitis Research Predictors of Hepatitis B treatment response in people with HIV/HBV coinfection For more information, including a complete list of abstracts and their corresponding oral and poster sessions, please visit . Teropavimab, zinlirvimab, lefitolimod, vesatolimod, GS-5423, GS-2872, VRC07-523LS are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Gilead is studying the safety and efficacy of lenacapavir for HIV prevention in multiple ongoing clinical studies. The use of Biktarvy in individuals with HIV-1/HBV coinfection is investigational, and the safety and efficacy of Biktarvy for this use have not been established. Please see below for the U.S. Indication and Important Safety Information for Veklury and Sunlenca. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS. About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. About Sunlenca® Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor approved in the United States, the United Kingdom, Canada and the European Union, for the treatment of HIV infection, in combination with other antiretroviral(s), in people with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. Sunlenca is the only HIV treatment option administered twice-yearly. The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is an investigational agent being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's prevention and treatment research program. Lenacapavir is being developed as a foundation for future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as monotherapy, that help address individual patient needs and preferences. About Veklury Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is a foundation for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety pro minimal known drug interactions in diverse populations. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money. Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to nearly 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir. There remains a significant need to develop new and effective oral treatment options for people with COVID-19. Gilead is also working to advance an oral nucleoside prodrug inhibitor of the SARS-CoV-2 polymerase, GS-5245, which once metabolized targets SARS-CoV-2 virus replication via an identical mechanism as remdesivir. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Biktarvy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration: Do not use Biktarvy with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Biktarvy therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate Biktarvy in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Biktarvy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of Biktarvy during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using Biktarvy during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population. Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. U.S. Indication for Sunlenca Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. U.S. Important Safety Information for Sunlenca Contraindications Coadministration: Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with Sunlenca: Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information: Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions. Dosage and administration Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation: Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. U.S. Indication for Veklury Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. For more information, please see the U.S. full Prescribing Information available at . U.S. Important Safety Information for Veklury Contraindication Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Warnings and precautions Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications). Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation. Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury. Adverse reactions The most common adverse reaction (≥5% all grades) was nausea. The most common lab abnormalities (≥5% all grades) were increases in ALT and AST. Drug interactions Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Dosage and administration Dosage: For adults and pediatric patients weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion. For pediatric patients ≥28 days and weighing ≥3 kg: 5 mg/kg on Day 1, followed by once-daily maintenance doses of 2.5 mg/kg from Day 2, administered only via intravenous infusion. Treatment duration: For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19. For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset. Testing prior to and during treatment: Perform eGFR, hepatic laboratory and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate. Renal impairment: Veklury is not recommended in individuals with eGFR <30 mL/min. Dose preparation and administration: There are two different formulations of Veklury: Veklury for injection (supplied as 100 mg lyophilized powder in vial) and Veklury injection (supplied as 100 mg/20 mL [5 mg/mL] solution in vial). The only approved dosage form for pediatric patients weighing 3 kg to ≤40 kg is the lyophilized powder formulation; See full Prescribing Information. Administration should take place only under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Pregnancy and lactation Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of Veklury during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease and fetal death. Lactation: It is not known whether Veklury can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases and address unmet needs in virology, oncology and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead has a long history in virology and has pioneered inventions once thought impossible, including antiviral treatments for people and communities affected by some of the most challenging public health concerns including HIV, viral hepatitis and COVID-19. Gilead helps people and communities across the full continuum of care in virology by developing bold advances that treat, prevent, cure and eradicate viral diseases and collaborating with community and research partners around the world. Gilead is deploying decades of antiviral expertise to provide solutions that help address the unmet and evolving needs of those impacted by viral diseases. Our work in virology has helped to transform the global health landscape and we are committed to advancing person-centered science and actionable education programs that make a difference for people and communities affected by viral diseases. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy, Veklury, lefitolimod, lenacapavir, vesatolimod, GS-5423, GS-2872 and VRC07-523LS; uncertainties relating to regulatory applications and related filing and approval timelines, and; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. Prescribing Information for Biktarvy, including BOXED WARNING, U.S. full Prescribing Information for Sunlenca, and U.S. full Prescribing Information for Veklury are available at . Biktarvy, Sunlenca, Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s). For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) and LinkedIn, or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Privately-held Oncologie will conduct a Phase II study of the combination study for patients who have failed at least one line of treatment for gastric or gastroesophageal cancer. Waltham, Mass.-based Oncologie, Inc. will pair its investigational phosphatidylserine inhibitor Bavituximab with Merck ’s venerable checkpoint inhibitor Keytruda as a potential therapy for patients with advanced gastric or gastroesophageal cancer. Oncologie, Inc., a company focused on developing treatments the tumor microenvironment, announced the formation of a clinical collaboration with Merck this morning. Privately-held Oncologie will conduct a Phase II study of the combination study for patients who have failed at least one line of treatment for gastric or gastroesophageal cancer. The study will be conducted across multiple sites in the United States, Korea, U.K. and Taiwan. The Phase II trial will begin enrolling patients in the second half of 2019, Oncologie said in its announcement. No financial terms of the collaboration were disclosed. Laura Benjamin, founder and chief executive officer of Oncologie, said the collaboration with Merck reflects a “shared commitment” to improve the lives of cancer patients. Pointing to the difficulty of treating gastric cancer, Benjamin said Oncologie and Merck are committed to “understanding the clinical benefit” of the combination of Bavituximab and Keytruda. Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses, Oncologie said. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Bavituximab has demonstrated a manageable safety and tolerability pro previous clinical trials, the company noted. For Oncologie, the collaboration with Merck comes hard on the heels of an announced $80 million financing round in June. The company closed a Series B financing round that will support development of the company’s three assets. In addition to Bavituximab, Oncologie’s other programs include a TLR9 activator, lefitolimod, and a VEGF-targeting antibody, varisacumab. In addition to those programs, the company is also developing a biomarker platform. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic “driver” mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Series B funding was led by Nan Fung Life Sciences and Pivotal BioVentures China. Those financiers were joined by new investors including Panacea Venture Healthcare and Korea Investment Partners, the company said in June. Last year, Oncologie and Germany-based Mologen AG signed a licensing deal for the development of lefitolimod for the Chinese market. Last week, Mologen announced that lefitolimod failed to hit its primary endpoint against standard of care as a maintenance therapy in patients with metastatic colorectal cancer presenting with an objective tumor response following first-line induction therapy.