On April 27, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported presentations from the Company’s global clinical development programs in hematologic malignancies and solid tumors at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) being held on June 3-7, 2022 (Press release, BeiGene, APR 27, 2022, View Source [SID1234613074]).

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"We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

"We have more than 800 oncology researchers at BeiGene, and these data presentations highlight our important work to deliver potential new therapies to patients worldwide," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

BeiGene presentation highlights:

ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia.
ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial.
RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer.
BeiGene Poster and Oral Presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title and Number

Session

Date and Time
(all times CDT)

Presenting Author

Hematologic Malignancies Clinical Data

Zanubrutinib plus obinutuzumab (Z-O) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): primary analysis of the phase 2 randomized ROSEWOOD trial

Abstract Number: 7510

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM
and
3:00 PM – 4:30 PM

Pier L. Zinzani, M.D., Ph.D.

ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) vs ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM)

Abstract Number: 7521

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4

3:00 PM – 4:30 PM
and

8:00 AM – 11:00 AM

Constantine S. Tam, M.D.

Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a phase 2 study

Abstract Number: 7552

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM

Emmanuel Bachy. M.D., Ph.D.

Solid Tumor Clinical Data

RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Abstract Number: 384950

Plenary Session

Sunday, June 5
1:00 PM – 4:00 PM

Li Zhang, M.D.

Clinical outcomes associated with tislelizumab in patients (pts) with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (SOR) or lenvatinib (LEN) in RATIONALE-208.

Abstract Number: 4072

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Julien Edeline, M.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study.

Abstract Number: 1031

Poster session – Breast Cancer – Metastatic

Monday, June 6
8:00 AM – 11:00 AM

Keun Seok Lee, M.D., M.S., Ph.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) and tislelizumab (TIS) as first line (1L) therapy for patients (pts) with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC): Preliminary results from a Phase 1b/2 study.

Abstract Number: 4032

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Keun-Wook Lee, M.D., M.S., Ph.D.

AdvanTIG-206: Anti-TIGIT monoclonal antibody (mAb) ociperlimab (BGB-A1217; OCI) plus anti-programmed cell death protein 1 (PD-1) mAb tislelizumab (TIS) plus BAT1706 versus TIS plus BAT1706 as first-line (1L) treatment for advanced hepatocellular carcinoma (HCC)

Abstract Number: TPS4172

Poster session – Gastrointestinal cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Jia Fan, M.D.

BeiGene Online Only Abstracts at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title

Abstract Number

Lead Author

Hematologic Malignancies Clinical Data

A phase 2 expanded access study of zanubrutinib (ZANU) in patients (pts) with Waldenström Macroglobulinemia (WM)

e19522

Jorge J. Castillo, M.D.

Solid Tumor Clinical Data

Clinical outcomes in patients (pts) with previously treated advanced hepatocellular carcinoma (HCC) experiencing hepatitis B virus (HBV) DNA increases during tislelizumab (TIS) treatment in RATIONALE-208.

e16181

Ann-Lii Cheng, M.D.

RATIONALE 302 PRO (encore): Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life

e16095

Eric Van Cutsem, M.D., Ph.D.

Randomized, Phase 3 study of second-line tislelizumab versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (ESCC), RATIONALE 302: Asia subgroup.

e16107

Kuaile Zhao, M.D.

Updated analysis from a Phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.

e14556

Jian Li, M.D., Ph.D

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is 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. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab is currently in regulatory review in first line recurrent/metastatic nasopharyngeal cancer in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S. and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe, and Japan.

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 for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. 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. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the 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, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On April 27, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported that updated safety and efficacy data from the Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s Lymphoma (NHL) will be delivered as an oral presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago and online June 3-7, 2022 (Press release, Adicet Bio, APR 27, 2022, View Source [SID1234613073]).

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Details of the oral presentation are as follows:
Abstract Number: 7509
Abstract Title: A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) t cells in adults with B-cell malignancies
Presenting Author: Sattva Neelapu, MD, MD Anderson Cancer Center
Session Type/Title: Clinical Science Symposium/ Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies
Date: June 6, 2022
Time: 8:00 AM-9:30 AM CDT

The abstract will be available on Thursday, May 26 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

On April 27, 2022 Repertoire Immune Medicines announced today that Science Advances published preclinical research demonstrating the company’s cell-tethering technology can deliver the potent cytokine interleukin-12 (IL-12) to solid tumors without eliciting the severe systemic toxicities typically associated with the use of this cytokine (Press release, Repertoire, APR 27, 2022, View Source [SID1234613072]). The research, conducted in mouse models, found that the use of cell-tethered IL-12 elevated anti-tumor activity in the immunosuppressive tumor microenvironment (TME).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"A tumor has multiple mechanisms that help it avoid recognition and elimination by the immune system. These defense mechanisms remain a major challenge for cellular immunotherapies to achieve a durable clinical response," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire Immune Medicines. "In this preclinical research, Repertoire’s cell-tethering technology delivered dose-controlled amounts of IL-12 onto the surface of tumor-targeted T cells. These IL-12-tethered T cells were associated with pronounced repolarization of the tumor microenvironment, ultimately resulting in enhanced T cell response, which has the potential to improve the efficacy of the cellular immunotherapies."

Tumors have immunosuppressive microenvironments that can limit the efficacy of cellular immunotherapies used in cancer treatment. Immune-stimulating cytokines such as IL-12 have been shown to counter the immunosuppressive conditions within the tumor. However, the dose of IL-12 required to achieve these beneficial effects has been associated with severe systemic toxicities.

In the publication, "Cell-surface tethered IL-12 repolarizes the tumor immune microenvironment to enhance the efficacy of adoptive T cell therapy," Repertoire’s tethering technology achieved direct and localized delivery of IL-12 to tumors without systemic toxicities. The use of tethered IL-12 was also associated with repolarization of myeloid-derived suppressor cells into activated inflammatory monocytes that support anti-tumor activity in the TME.

Repertoire is currently investigating the use of cell-tethered IL-12 in an ongoing Phase 1 study of its investigational candidate RPTR-168 for human papillomavirus-positive tumors.

About RPTR-168

RPTR-168 is an autologous multi-targeted T cell (MTC) therapeutic candidate derived from rare peripheral blood T cells. The T cells are collected from each patient through apheresis and are primed and expanded by a set of five tumor-associated antigens known to be expressed on human papillomavirus (HPV)-16-positive tumors. RPTR-168 is designed to deliver interleukin-12 (IL-12), a potent immunomodulatory agent that has been shown to improve anti-tumor activity by promoting T cell function inside the tumor microenvironment.

On April 27, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the release of titles of abstracts on neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, APR 27, 2022, View Source [SID1234613071]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held at McCormick Place in Chicago and online from June 3-7. Posters will be available on Puma’s website following presentation.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Full abstracts of the following posters will be available online at View Source on May 26.

Abstract 1028: Neratinib + fulvestrant + trastzuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial
Presenter: Komal L. Jhaveri, FACP, MD | Memorial Sloan Kettering Cancer Center
Abstract 4079: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT ‘basket’ trial
Presenter: James J. Harding, MD | Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College

On April 27, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors (Press release, SQZ Biotech, APR 27, 2022, View Source [SID1234613070]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Fast Track Designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment currently exists or where the treatment in discovery may be better than what is currently available.

"We are thrilled to receive FDA Fast Track Designation for our SQZ Antigen Presenting Cells product candidate," said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. "This designation adds to our exciting clinical data presented at ESMO (Free ESMO Whitepaper)-IO last year where we first demonstrated the potential of our Cell Squeeze technology to drive clinical benefit while maintaining favorable tolerability. The FDA Fast Track program can potentially expedite future review processes and accelerate the registrational path for SQZ-PBMC-HPV."

Data presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 has shown that the company’s lead APC cell therapy candidate induced radiographic, symptomatic and immune response as monotherapy in a post-checkpoint HPV16+ solid tumor patient. The company continues to enroll patients in its highest dose monotherapy cohort and is simultaneously enrolling patients for combination therapy in the company’s Phase 1/2 SQZ-PBMC-HPV-101 clinical trial.

SQZ-PBMC-HPV-101 Trial Design

SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.