On October 8, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that additional clinical results from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, CytomX Therapeutics, OCT 8, 2018, View Source [SID1234529821]). The conference will take place from October 19-23 in Munich, Germany.

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Two posters will provide additional results from the ongoing monotherapy dose escalation arm and the combination arm with Yervoy (ipilimumab) of the PROCLAIM-CX-072 trial, each in patients with advanced unresectable solid tumors.

CytomX’s ESMO (Free ESMO Whitepaper) poster presentations will include longer follow-up periods from additional patients treated in both the monotherapy and combination arms, new patient data from the combination arm and will reflect a data cutoff approximately three months after the abstract data cutoff.

Poster 435P – Preliminary Results of PROCLAIM-CX-072: The First-In-Human, Dose-Finding Trial of PD-L1 Probody Therapeutic CX-072 as Monotherapy in Patients with Advanced Solid Tumors
Presenter: Valentina Boni, M.D., Ph.D., START Madrid-CIOCC HM University Hospital Sanchinarro, Madrid, Spain
Date/Time: Monday, October 22, 12:45 p.m. – 1:45 p.m. CEST/ 6:45 a.m. – 7:45 a.m. EDT
Location: Hall A3

Poster 436P – Preliminary Results of the First-In-Human, Dose-Finding PROCLAIM-CX-072 Trial Evaluating the PD-L1 Probody Therapeutic CX-072 in Combination with Ipilimumab in Patients with Advanced Solid Tumors
Presenter: Ruth Plummer, M.D., Northern Centre for Cancer Care, Newcastle, United Kingdom
Date/Time: Monday, October 22, 12:45 p.m. – 1:45 p.m. CEST/ 6:45 a.m. – 7:45 a.m. EDT
Location: Hall A3

Poster abstracts can be located by searching The ESMO (Free ESMO Whitepaper) 2018 Online Program Session and using the Poster numbers above.

CytomX’s posters will be available online under the Events and Presentations section of the CytomX website at the time of presentation at www.CytomX.com.

Conference Call and Webcast

CytomX will host a conference call and webcast to discuss these presentations on Monday, October 22, 2018 at 2:30 p.m. CEST/ 8:30 a.m. EDT. Participants can dial 1-877-809-6037 U.S. Toll Free or 1-615-247-0221 International using the Conference ID: 1275596.

A live webcast can be accessed under the Events and Presentations Section of CytomX’s Investor Relations section at View Source Access the website 15 minutes prior to the start of the call to download and install any necessary audio software and slides. A replay of the webcast will be archived and available on CytomX’s website for 30 days following the event.

About PROCLAIM

PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module is the PROCLAIM-072 clinical program, an open-label, dose-finding Phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.

Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.

Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical models.

On October 8, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported the initiation of a phase 3 pivotal trial (COSMIC-311) of single-agent cabozantinib in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies (Press release, Exelixis, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370576 [SID1234529814]). The co-primary endpoints for the trial are progression-free survival and objective response rate.

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"Cabozantinib has demonstrated encouraging clinical activity in patients with radioiodine-refractory differentiated thyroid cancer in phase 1 and 2 studies, suggesting it may be a promising treatment option for patients who have progressed after prior VEGFR-targeting therapy," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We look forward to enrolling patients in this global trial to learn more about the potential of cabozantinib for this intractable form of thyroid cancer."

COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aims to enroll approximately 300 patients at approximately 150 sites globally. Patients will be randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily.

"With the incidence of thyroid cancer increasing more rapidly than any other type of cancer in the U.S., and limited options available to patients whose disease has progressed following anti-VEGFR therapy, there is an urgent need for new treatments," said Marcia Brose, M.D., Ph.D., Associate Professor of Otorhinolaryngology: Head and Neck Surgery and Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania, and principal investigator of the trial. "Given the positive results from earlier stage trials, we are eager to learn more from this phase 3 study about cabozantinib’s potential benefit in this patient population."

More information about this trial is available at ClinicalTrials.gov.

About Differentiated Thyroid Carcinoma

Thyroid cancer is commonly diagnosed at a younger age than most other adult cancers and is the most rapidly increasing cancer in the U.S., tripling in incidence in the past three decades.1 Approximately 54,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2018.1 Nearly three out of four of these cases will be in women.1 Cancerous thyroid tumors include differentiated, medullary and anaplastic forms.1

Differentiated thyroid tumors, which make up about 90 percent of all thyroid cancers, are typically treated with surgery followed by ablation of the remaining thyroid with radioiodine.2 Approximately 5 to 15 percent of differentiated thyroid tumors are resistant to radioiodine treatment.3 For these patients, life expectancy is only three to six years from the time metastatic lesions are detected.4,5,6

About CABOMETYX (cabozantinib)

CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in: the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union for previously untreated intermediate- or poor-risk advanced RCC; and in Canada for adult patients with advanced RCC who have received prior VEGF targeted therapy. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. In May 2018, the FDA accepted Exelixis’ supplemental New Drug Application for CABOMETYX as a treatment for patients with previously treated HCC and assigned it a Prescription Drug User Fee Act action date of January 14, 2019. On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC in the European Union; on September 20, 2018 the CHMP provided a positive opinion for CABOMETYX as a monotherapy for the treatment of HCC in adults who have been previously treated with sorafenib. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

CABOMETYX is not indicated for radioiodine-refractory DTC.

Please see Important Safety Information below and full U.S. prescribing information at View Source

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment

On October 8, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will present new data from its clinical development program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, October 19-23 (Press release, Eli Lilly, OCT 8, 2018, View Source [SID1234529809]). Data presented showcase how Lilly is taking a global, patient-centric research approach to drive advances in cancer care. Data include presentations on abemaciclib, pemetrexed and ramucirumab, as well as investigational compound pegilodecakin – used as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy – across multiple tumor types. Pegilodecakin joined the Lilly Oncology pipeline with the company’s acquisition of ARMO BioSciences earlier this year.

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Key abemaciclib data include findings from the Phase 3 MONARCH 2 trial evaluating abemaciclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Additionally, results will be presented from Lilly’s ongoing immuno-oncology clinical collaboration with Merck (known as MSD outside the U.S. and Canada) on the KEYNOTE-189 trial evaluating pemetrexed plus platinum chemotherapy in combination with pembrolizumab in the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Ramucirumab data include Phase 3 findings from several patient populations with aggressive disease such as the REACH-2 study of ramucirumab as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer, and the RANGE study evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Pegilodecakin data include new results from an early-phase study in patients with renal cell, non-small cell lung, pancreatic, ovarian and breast cancers.

"The breadth and depth of our data being presented at ESMO (Free ESMO Whitepaper) underscores this year’s congress theme of ‘securing access to optimal cancer care’ by demonstrating how we are working to develop innovative new medicines that will make a difference to patients and doctors," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We’re also excited to share data for the first time from our promising next generation clinical immunotherapy asset pegilodecakin, which examines its potential in several tumor types in combination with existing treatments and as a monotherapy. We are encouraged by the results and look forward to further investigating pegilodecakin in a wide range of settings."

Select studies, along with the dates, times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract #329P: Abemaciclib with fulvestrant in patients with HR+, HER2- advanced breast cancer (ABC) that exhibited primary or secondary resistance to prior endocrine therapy (ET)

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #339P: Management of abemaciclib associated adverse events in patients with hormone receptor positive (HR+), HER2- advanced breast cancer: analysis of the MONARCH trials

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Pegilodecakin

Abstract #1130O: Responses and Durability of Clinical Benefit in Renal Cell Carcinoma Treated with Pegilodecakin in Combination with Anti-PD-1 Inhibitors

Monday, October 22; 12:18-12:30 p.m. CEST; Exhibit Hall A2 ­– Room 18
Abstract #1145P: Responses and Durability of Cinical Benefit in Triple Negative Breast Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1144P: Responses and Durability of Clinical Benefit in Non-Small Cell Lung Cancer Treated with Pegilodecakin in Combination With Anti-PD-1 Inhibitors

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1143P: Responses and Durability of Clinical Benefit in Pancreatic Ductal Adenocarcinoma (PDAC) Patients Treated With Pegilodecakin (AM0010) in Combination With 5-FU/LV and Oxaliplatin (FOLFOX)

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1146P: Durability of Clinical Benefit in Metastatic Epithelial Ovarian Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1180P: Combination of Pegilodecakin and Docetaxel Shows Synergy in Tumor Rejection in Immune Resistant TNBC model

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Pemetrexed

Abstract #1464P: KEYNOTE-189 study of pembrolizumab (pembro) plus pemetrexed (pem) and platinum vs placebo plus pem and platinum for untreated, metastatic, nonsquamous NSCLC: does choice of platinum affect outcomes?

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1381PD: Gefitinib With or Without Pemetrexed in Nonsquamous (NS) Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (mut): Final Overall Survival (OS) Results From a Randomized Phase II Study

Friday, October 19; 2:00-4:00 p.m. CEST; ICM – Room 14b
Ramucirumab

Abstract #622PD: Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: patient reported outcome results across two phase 3 studies (REACH-2 and REACH)

Friday, October 19; 3:45-5:25 p.m. CEST; ICM – Exhibit Hall B3 – Room 21
Abstract #708P: Relationship between change in α-fetoprotein (AFP) and patient (pt) survival in hepatocellular carcinoma (HCC): a real-world electronic medical records (EMR) database study

Sunday, October 21; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #865PD: RANGE, a phase 3, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): overall survival results

Saturday, October 20; 2:45-4:05 p.m. CEST; ICM – Room 1
Abstract #616PD: Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase 3 study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Friday, October 19; 3:45-5:30 p.m. CEST; Exhibit Hall B3 – Room 21

On October 8, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) reported that updated clinical data from the innovaTV 201 Phase II study evaluating tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer will be presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19 to 23, 2018 (Press release, Genmab, OCT 8, 2018, View Source [SID1234529808]). Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen, which is expressed on a broad range of solid tumors.

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"We look forward to presenting an update on the expanded cervical cancer cohort data showing that tisotumab vedotin continues to demonstrate tolerability and clinical activity in heavily pretreated patients with cervical cancer. We anticipate publishing the final data from this cohort in the future," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In the past year, the development program of tisotumab vedotin has also been expanded with additional trials and indications, and we are excited about the continued growth of this program."

"In the recurrent and metastatic cervical cancer setting, there remains an unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are pleased to be collaborating with Genmab to advance tisotumab vedotin in the potentially pivotal innovaTV 204 clinical trial in cervical cancer and to evaluate its potential in a broad range of other solid tumors."

Details of Poster Presentation:

Title: A Phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: updated analysis of full cervical expansion cohort
Presenter: Nicole Concin, M.D. Medical University of Innsbruck, Austria
Abstract #: 963P
Session: Poster Display Session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Date and Time: October 20, 12:30-13:30 CEST
Location: Hall A3 Poster Area

The abstract is available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org.

About the innovaTV 201 (GEN701) Study

The innovaTV 201 study is a 170 patient, two-part Phase I/II study of tisotumab vedotin in eight types of solid tumors: ovarian, cervical, endometrial, bladder, prostate, esophageal, lung, and head and neck. Part 1 is a classical 3+3 dose escalation design testing various doses of tisotumab vedotin once every three weeks to establish the recommended Phase II (RP2D) and maximum tolerated dose as well as the safety profile of tisotumab vedotin. Part 2 of the study investigates all eight indications in parallel expansion cohorts. The cervical cancer cohort includes 55 patients. Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three weeks. The primary objective of this part of the study is to further investigate the safety profile of tisotumab vedotin and preliminary efficacy.

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor cell signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is being evaluated in ongoing or planned Phase II trials in recurrent and/or metastatic cervical cancer, ovarian cancer and other solid tumors. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics.

On October 8, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that it will present final results from the Phase 1 study of AB928, its dual adenosine receptor antagonist, in healthy volunteers during a poster display session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, being held October 19-23, 2018, in Munich, Germany (Press release, Arcus Biosciences, OCT 8, 2018, View Source [SID1234529806]). The safety data to be presented will demonstrate that in this study, there was no evidence of the physiological effects of blocking adenosine that have been observed clinically with earlier adenosine receptor antagonists. Physiological effects associated with the earlier adenosine receptor antagonists that were initially designed for CNS indications may potentially limit their optimal dosing in the oncology setting.

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The pharmacokinetic and pharmacodynamic correlations generated from this study, which will be described in the poster presentation, were used to guide dose selection in the Company’s four Phase 1/1b trials in patients.

Details of the poster presentation are as follows:

Abstract Number: 1880P
Poster Title: Final results of the Phase 1 study in healthy volunteers of AB928, a dual antagonist of the A2aR and A2bR adenosine receptors being studied as an activator of anti-tumor immune response.
Poster display session: Biomarkers, Gynecological cancers, Hematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research (ID 259)
Session Date and Time: Saturday, Oct. 20, 2018, 12:30 – 1:30 pm CEST
Location: Hall A3

The poster will be available at www.arcusbio.com/publications.

About AB928

AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits an optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties for efficacy in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue and low penetration through the healthy blood-brain barrier. In a Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen. The Company has initiated four phase 1/1b trials evaluating AB928 in combination with other agents in selected tumor types.