XOMA Licensees to Present Significant Clinical Data at 2021 ASCO Annual Meeting

On May 21, 2021 XOMA Corporation (Nasdaq: XOMA) reported that learned its licensees are presenting at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 4-8, 2021, in a virtual setting (Press release, Xoma, MAY 21, 2021, View Source [SID1234580448]).

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"We congratulate Novartis and AVEO on their recent announcements regarding NIS793 and ficlatuzumab, respectively. We were particularly excited to see the statements each company made in their May 19th press releases regarding the potential for advancing these drug candidates to Phase 3 clinical programs. We look forward to each company’s data presentations at ASCO (Free ASCO Whitepaper) early next month," stated Jim Neal, Chief Executive Officer at XOMA. "We wish both companies continued success with their development activities."

Novartis1

Title: Phase Ib study of the anti-TGF-β monoclonal antibody (mAb) NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in patients (pts) with advanced solid tumors
Abstract: 2509; poster session
Date and Time: June 4, 2021, at 9:00 a.m. Eastern Time

Title: Phase II study of the anti-TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)2.
Abstract: TPS4173

AVEO Oncology3

Title: Randomized Phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Presenter: Julie E. Bauman, M.D., MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center
Abstract: 6015
Date and Time: June 4, 2021 at 9:00 a.m. Eastern Time

NIS793 and ficlatuzumab are investigational compounds. Efficacy and safety have not been established in either drug candidate. There is no guarantee that NIS793 and/or ficlatuzumab will become commercially available.

Allarity Therapeutics Secures Investment from 3i Fund for Recapitalization, Transition to Listing on U.S. Nasdaq, and Advancing Pipeline of Priority Oncology Therapeutics

On May 21, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that it has entered into a definitive Securities Purchase Agreement with 3i Fund (New York, NY U.S.A.) ("3i") for a U.S. $20 million investment ("Securities Purchase Agreement") to support the Company’s recapitalization and reorganization ("Recapitalization") into a U.S holding company (Allarity Therapeutics, Inc., a Delaware corporation, hereinafter "Allarity US Inc.") and an application for listing on the U.S. Nasdaq Stock Market (Press release, Allarity Therapeutics, MAY 21, 2021, View Source [SID1234580447]). The U.S. $20 million investment will be made directly into Allarity US Inc., conditioned on the terms described in this announcement. Although no assurances can be given concering the future trading price of the shares of Allarity US Inc. once listed, the investment by 3i implies a preinvestment value for Allarity US Inc. of US $80 million and a post-investment implied value of US $100 million assuming that the Recapitalization is completed. If the shares of Allarity US Inc., once listed on the US Nasdaq Stock Market, trade below US $100 million, certain market price protection provisions described below would apply that would have the effect of reducing these implied values to values closer to the future market value of Allarity US Inc.

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Allarity US Inc. will initially be organized as a wholly owned subsidiary of the Company. Simultaneously with the execution of the Securities Purchase Agreement, the Company has entered into a Plan of Reorganization and Asset Purchase Agreement with Allarity US Inc. to facilitate Allarity US Inc. becoming a US holding company listed on the U.S. Nasdaq Stock Market. As part of the Recapitalization transaction, Allarity US Inc. will, either directly or indirectly through a special purpose wholly owned subsidiary, purchase all of the assets and assume all of the liabilities of the Company in exchange for shares of common stock of Allarity US Inc., which will be listed for trading on the U.S. Nasdaq Stock Market upon completion of the Recapitalization.

Allarity’s CEO Steve Carchedi noted, "We are grateful to have the investment support of 3i Fund to help transition our Company to listing on the U.S. Nasdaq, and to enable us to uphold our mission of realizing the promise of personalized medicine for cancer patients through advancing our pipeline programs and DRP companion diagnostics. The transition of our Company from a Scandinavian microcap stock market listing to the U.S. Nasdaq, which we have been exploring through a number of paths over the past two years, is a major catalytic event for Allarity. We believe this step will enhance our ability to achieve market values more in line with our U.S. Nasdaq listed peer group, and secure the necessary financing for our future success with greater participation by institutional investors who primarily invest in U.S. listed companies."

The number of shares of Delaware common stock to be issued in exchange for the Company’s assets will be an amount that is equal to an exchange ratio of 0.02 shares of Allarity US Inc. common stock for each ordinary share of the Company, which equates to one share of Allarity US Inc. common stock for every 50 ordinary shares of nominal DKK 0.05 each of the Company. The Allarity US Inc. common stock issued in exchange for the Company’s net assets will, as soon as practically possible, be distributed to the Company’s shareholders either by i) special dividend, ii) share exchange, or iii) liquidation proceeds, and thereafter the Company will be liquidated and dissolved. Based upon the average market price for the Company’s ordinary shares of SEK 0.85 on the First North Growth Market (Stockholm, SE), and based upon a currency conversion rate of SEK 8.5 for 1 USD, the exchange ratio would imply a current market price equivalent of $5 per share of Allarity US Inc. common stock if the common stock were listed and traded on the First North Growth Market today. While the Company believes that a listing on the U.S. Nasdaq Stock Market will provide an opportunity for the shares of common stock of Allarity US Inc. to rise to a level more in line with the Company’s US listed peer group, no assurances can be given that this will occur.

As a result of the Recapitalization transaction, Allarity US Inc. will become the parent holding company or direct holder of all of the assets and liabilities of the Company, and the Company’s shareholders, as of the completion of the Recapitalization, will own the same percentage of Allarity US Inc. as they did in the Company prior to the Recapitalization. Upon the completion of the Recapitalization, 3i will invest U.S. $20 million in Allarity US Inc. in exchange for convertible preferred stock in Allarity US Inc. at an initial fixed conversion price that would be convertible into a 20% ownership of the Allarity US Inc. shares of common stock over time, subject to anti-dilution and market price adjustments upon the occurrence of certain events and an overriding limitation that limits 3i’s beneficial ownership of Allarity US Inc. common stock to a maximum of 4.99% at any time. The remaining 80% to 95% of the outstanding share capital of Allarity US Inc. will be held by the existing shareholders of the Company as of the date the Recapitalization transaction is completed.

3i will, in addition to the convertible preferred stock in Allarity US Inc., receive warrants to purchase an additional $20 million of common stock in Allarity US Inc. at the same price as the fixed conversion price of the convertible preferred stock discussed below, subject to anti-dilution and market price adjustments upon the occurrence of certain events. Both the fixed conversion price of the preferred stock into common stock and the exercise price of the warrants could, according to the applicable anti-dilution provisions, be reduced if the trading price of the common stock to be listed on the U.S. Nasdaq Stock Market trades below the fixed conversion price of the preferred stock, if the average daily trading volume falls below certain levels, or if Allarity US Inc. issues additional common stock at a price less than the fixed conversion price.

The fixed conversion price will be set on the completion of the recapitalization by dividing the pre-investment valuation of the holding company of $80 million by the number of the Company’s ordinary shares issued and outstanding immediately before the recapitalization multiplied by 50 to reflect the exchange ratio in recapitalization and asset acquisition. Based upon the number of the Company’s shares issued and outstanding as of the date of this press release, the fixed conversion price for the conversion of the preferred stock into the common stock in the Allarity US Inc. and the exercise price of the additional warrants would be $16.5437. If the Company completes its previously announced rights offering prior to the completion of the recapitalization, the fixed conversion price will likely be substantially reduced to between $8.00 and $11.00 to reflect the increase in the number of ordinary shares issued and outstanding at the completion of the recapitalization. . In addition, both the fixed conversion price for the conversion of the preferred stock and the exercise price of the warrants may be further reduced in the event that the average share price on the U.S. Nasdaq Stock Market falls below the fixed conversion price or the average daily trading volume falls below certain thresholds which could result in an adjusted conversion price for the preferred stock and exercise price for the warrants of between 80% to 90% of the volume weighted average share price on the U.S. Nasdaq Stock Market. Furthermore, if average daily volume in US dollars falls below US $2.5 million, a one time 8% dividend will be applied to the preferred stock which would be payable in share of common stock upon conversion. Consequently, even though the investment by 3i implies a pre-investment value for Allarity US Inc. of U.S. $80 million and a post-investment implied value of U.S. $100 million assuming that the Recapitalization is completed and the shares of Allarity US Inc. are listed for trading on the U.S. Nasdaq Stock Market, no assurances can be given that the shares of Allarity US Inc. common stock will trade at these levels or that the conversion price of the preferred stock or the exercise price of the warrants will not be reduced.

The 3i Fund investment is conditioned upon i) shareholder approval, ii) the completion of the Recapitalization, iii) acceptance of the listing application for the Allarity US Inc. common stock by the U.S. Nasdaq Stock Market and iv) an effective registration statement filed with the SEC.

The Recapitalization transaction involves the sale of all of the Company’s assets and the assumption of all of the Company’s liabilities by Allarity US Inc. in exchange for the common stock of Allarity US Inc., thereby creating the new holding company structure with Allarity US Inc. as the holder of all assets and liabilities, directly or indirectly, of Allarity Therapeutics A/S, and is conditioned upon the approval of the Company’s shareholders.

A registration statement on Form S-4 will be filed with the U.S. Securities and Exchange Commission ("SEC") covering the shares of common stock to be issued in the Recapitalization, and an application for listing the shares on the U.S. Nasdaq Stock Market will be made to become effective on the completion of the Recapitalization. It is anticipated that the Form S-4 will be filed with the SEC by or before June 5, 2021, with a target date for listing on the U.S. Nasdaq Stock Market by or before August 30, 2021, subject to necessary approvals.

An extraordinary general meeting of the Company’s shareholders will be convened once the registration statement to be filed with the SEC has been declared effective and at that time all shareholders will receive an information statement and prospectus that will describe the Recapitalization transaction and 3iFund investment in greater detail before voting on the transaction at the extraordinary meeting. At the extraordinary general meeting, the shareholders will also be asked to approve the special dividend, liquidation, or share exchange that distributes the shares of common stock issued by Allarity US Inc. to the Company’s shareholders pro rata and the subsequent liquidation of the Company.

Upon the completion of the Recapitalization transaction, the Company anticipates that the Company’s ordinary shares will no longer be listed for trading on the First North Growth Market (Stockholm, SE) and the shares of common stock distributed to the shareholders by special dividend, liquidation proceeds, or share exchange will be listed for trading on the U.S. Nasdaq Stock Market.

The Company believes that this migration, from the Company’s current listing on the First North Growth Market (Stockholm, SE) to the U.S. Nasdaq Stock Market, will enhance the Company’s ability to achieve higher market values more in line with its peer group companies that are already listed on the U.S. Nasdaq Stock Market, and will facilitate future financings to advance with the clinical development of its priority oncology pipeline programs over the next 24 months. The Company has previously informed that it has been exploring pathways to list on the U.S. Nasdaq Stock Market. The Company anticipates that the committed funds will help support advancement of Allarity’s priority oncology pipeline, together with DRP companion diagnostics, to the next major milestones for each program within 18 months of the U.S. Nasdaq Stock Market listing.

The Company expects to file and publish a supplement to the Prospectus published 19 May 2021, concerning the ongoing rights issue, as soon as practically possible.

The Company is advancing a promising, mid-to-late stage pipeline of six cancer therapeutics programs, each together with its drug-specific DRP companion diagnostic, to select and treat patients most likely to respond to the given drug in a true personalized cancer medicine approach. Allarity’s priority pipeline includes three former assets from large pharmaceutical companies, including:

Dovitinib, a pan-TKI inhibitor acquired from Novartis AG, which is being prepared for a U.S. new drug approval (NDA) application, in 2021, for the treatment of renal cell carcinoma (RCC);
Stenoparib, a PARP inhibitor acquired from Eisai Ltd., which is currently in Phase 2 clinical trials for the treatment of advanced ovarian cancer; and,
IXEMPRA (ixabepilone), a microtubule inhibitor acquired (in the European Union (EU)) from R-PHARM U.S., and originally developed and brought to market by Bristol-Myers Squibb, which is currently marketed in the U.S. and is in Phase 2 EU clinical trials for the treatment of metastatic breast cancer.

Additionally, the company is clinically advancing three secondary, Phase 2 pipeline programs, primarily through external development partnerships.

Upon U.S. Nasdaq Stock Market listing, the Company’s new global headquarters will be on the East Coast of the U.S., where a majority of its executive team is currently based. The Company will maintain its existing facilities in Denmark as a research and development (R&D) center, including a clinical diagnostics laboratory that can run DRP companion diagnostic analysis for EU-based clinical trials and/or for marketed drugs.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

VBI Vaccines Announces $12 Million Second Tranche of Debt Financing with K2 HealthVentures

On May 21, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported an agreement to draw down a $12 million second tranche under its previously announced debt financing facility with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company (Press release, VBI Vaccines, MAY 21, 2021, View Source [SID1234580444]). Under the terms of the debt financing facility, dated May 22, 2020 and amended May 17, 2021, K2HV has agreed to provide the Company up to $52 million in multiple tranches.

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The first tranche of $20 million was drawn upon closing of the original agreement in May 2020. The second tranche, upsized to $12 million from the original $10 million, became available following the achievement of certain clinical milestones, including the positive 12-month overall survival data from Phase 2a (Part B) of the Phase 1/2a study of VBI-1901 in recurrent glioblastoma (GBM) patients, and the positive proof-of-concept data from the Phase 1b/2a study of VBI-2601 in chronic hepatitis B (HBV) patients. Press releases for both data announcements can be found here and here, respectively.

"Following the achievement of key clinical development milestones in our effort to develop treatments for GBM and chronic HBV, we are pleased to further strengthen our balance sheet and our partnership with the K2HV team – a team who continues to demonstrate their deep understanding of our business and the science driving VBI," said Jeff Baxter, VBI’s president and CEO.

Two additional tranches of up to $10 million each remain drawable in the future upon certain conditions. The first is contingent upon achievement of a specified regulatory milestone, and the second and final tranche will be available at the discretion of K2HV.

Modeling Data Showed Cologuard® Was Superior to Fecal Immunochemical Test (FIT) on Cost Effectiveness and Colorectal Cancer Incidence and Mortality

On May 21, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that highlights data from one oral and one poster presentation being featured at the 2021 Digestive Disease Week (DDW) virtual annual meeting, taking place May 21-23(Press release, Exact Sciences, MAY 21, 2021, View Source [SID1234580443]).

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Notably, the poster shares data that incorporate real-world patient adherence rates into a colorectal cancer (CRC) microsimulation model. The data showed that Cologuard (mt-sDNA) was cost effective and provided the greatest reduction in CRC incidence and mortality versus annual fecal immunochemical test (FIT) and annual fecal occult blood test (FOBT) in a representative Medicare population.

Additionally, the oral presentation reports data from the New Hampshire Colonoscopy Registry to compare FIT and Cologuard outcomes in clinical practice. In follow-up colonoscopies performed after a positive stool test result, Cologuard was more likely to predict neoplasia than FIT, largely due to an increased detection of serrated polyps.

Colorectal cancer is the second deadliest cancer impacting both men and women in the U.S. It’s also preventable if caught in early stages when it is more treatable.i The disease has been on the rise in younger adults and approximately 44 million average-risk people in the United States remain unscreened.ii

The abstracts are now available on the DDW website. Included below are titles, abstract numbers, and a summary of each abstract.

Cost-Effectiveness of Stool-Based Colorectal Cancer Screening Using Reported Real-World Adherence Rates in a Medicare Population
Abstract Number: Su053

The impact of real-world adherence rates on the cost-effectiveness of specific CRC screening strategies has been unclear. This study used the CRC-AIM microsimulation modeling platform to estimate the cost-effectiveness of stool-based screening strategies using test-specific, real-world adherence data. The analysis found that Cologuard was cost effective and demonstrated the greatest reduction in CRC incidence and mortality versus FIT and FOBT.

The results from the analysis were also published online in the Journal of Medical Economics.

Comparison of Colonoscopy Findings in Patients with Preceding FIT Positive and mt-sDNA Positive Tests to Patients Having Colonoscopy Only: Data From the New Hampshire Colonoscopy Registry
Abstract Number: 886

There are few comparisons of FIT and Cologuard screening test outcomes in clinical practice. Using the New Hampshire Colonoscopy Registry (NHCR), a comprehensive statewide population-based colonoscopy database, the diagnostic yield of colorectal neoplasia in follow-up colonoscopies in patients with a previous positive FIT, Cologuard, or screening colonoscopy were compared. After follow-up colonoscopy, 1.7% of patients with a positive Cologuard test, 1.6% of patients with positive FIT and 0.3% of patients who underwent screening colonoscopy had adenocarcinoma/colorectal cancer. At follow-up colonoscopy, Cologuard tests were more likely to predict neoplasia than either FIT positivity or screening colonoscopy, largely due to an increased yield of serrated polyps.

BeiGene Announces Positive Topline Results from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

On May 21, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the Phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC) met its primary endpoint of progression-free survival (PFS) at the interim analysis, as recommended by an independent data monitoring committee (Press release, BeiGene, MAY 21, 2021, View Source [SID1234580442]). In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC). The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.

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"We are excited to see a clinically meaningful improvement in progression-free survival in our Phase 3 trial for tislelizumab plus chemotherapy in patients with NPC. This is our fifth positive Phase 3 readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "We are grateful for the patients and clinicians who participated in this trial and hopeful that they may have a new treatment option in the future."

BeiGene plans to discuss these data with health authorities and present data at an upcoming medical conference.

RATIONALE 309 Trial of Tislelizumab with Chemotherapy Versus Placebo with Chemotherapy in Recurrent or Metastatic NPC

RATIONALE 309 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT03924986) designed to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC. The trial’s primary endpoint is PFS as assessed by IRC in the ITT population. Key secondary endpoints include overall survival (OS), IRC-assessed objective response rate (ORR) and duration of response (DoR), and investigator-assessed PFS. A total of 263 Asian patients were enrolled and randomized 1:1 to either the tislelizumab plus chemotherapy arm or the placebo plus chemotherapy arm.

About Nasopharyngeal Cancer (NPC)

Nasopharyngeal cancer (NPC) is a malignant, squamous cell carcinoma which arises from the epithelial cells of the nasopharynx, most commonly originating in the pharyngeal recess (the fossa of Rosenmuller).i There were an estimated 60,558 new cases of NPC in China in 2018, accounting for 46.9 percent of the worldwide incidence.ii Despite the heavy public health burden of NPC in southern China and other endemic areas, relatively little is known about the etiology and prevention of NPC.iii The major risk factors for NPC are genetic predisposition, Epstein-Barr virus (EBV) infection, and consumption of salt-preserved food.iv The median overall survival rate is about 20 months in advanced NPCv, however, progressively worsening prognosis falling to a three-year survival of 7-40% were reported in patients with recurrent or metastatic NPC, indicating a high medical unmet needs for more effective treatment.vi,vii,viii

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab market authorization in four indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for patients with previously treated unresectable hepatocellular carcinoma.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.