On September 12, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody, in first-line HER2-expressing GEA. An updated and expanded data set will be presented at the ESMO (Free ESMO Whitepaper) Annual Congress taking place virtually on September 16-21, 2021 (Press release, Zymeworks, SEP 12, 2021, View Source [SID1234587560]).

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Abstract highlights from March 18, 2021 data cut:

Thirty patients had been treated with zanidatamab in combination with standard of care chemotherapy (either mFOLFOX6, CAPOX, or FP), and 14 patients remained on treatment.
The confirmed objective response rate was 68.2% and the disease control rate was 90.9% in 22 HER2-positive response-evaluable patients.
Treatment related adverse events were generally consistent with previous reports of zanidatamab and/or the chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.
"The initial data from the abstract highlight an encouraging objective response rate for zanidatamab combined with standard of care chemotherapy in patients with metastatic HER2-positive GEA," said Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer. "We’re looking forward to presenting at the Congress the full updated data, which further support zanidatamab’s potential as the new foundational HER2-targeted therapy."

ESMO Presentation
The abstract is available on the ESMO (Free ESMO Whitepaper) conference website. The presentation will be available on Thursday, September 16 at 8:30 am CEST, 2:30 am ET, to conference registrants on the ESMO (Free ESMO Whitepaper) conference website as well as to the general public on the Zymeworks website at View Source

Title: Phase (Ph) 2 Study of Zanidatamab + Chemotherapy (chemo) in First Line (1L) HER2-expressing Gastroesophageal Adenocarcinoma (GEA)
Lead Author: Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center, New York, NY, US
Abstract: 3678
E-poster: 1380P

Conference Call and Webcast
The company will host a conference call and webcast to discuss the updated data after it is published on September 16. The event will be led by Ali Tehrani, Ph.D., Zymeworks’ President and CEO and Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer, and will include a presentation by medical oncologist and principal investigator, Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center. Dr. Ku and members of Zymeworks’ executive team will be available to answer questions at the conclusion of the call.

Date: Thursday, September 16th
Time: 7:30 am ET

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the FDA, as well as Orphan Drug designation for the treatment of biliary tract and gastric cancer from the European Medicines Agency.

On September 12, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results and subgroup analyses from the Company’s robust lung cancer program will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, BeiGene, SEP 12, 2021, View Source [SID1234587558]).

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"We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program of seven Phase 3 trials in NSCLC. Driven by growing clinical insights, we are working to accelerate the development of tislelizumab in novel combinations in lung cancer, including with our internally discovered potent investigational anti-TIGIT antibody ociperlimab and therapeutic agents from collaborations, such as sitravatinib," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "In addition, our scientists are exploring new modalities for potential combinations with tislelizumab in lung cancer and other solid tumors, and with the ongoing Novartis collaboration, tislelizumab can be leveraged with their oncology pipeline for more combination opportunities. We plan to work to realize the therapeutic potential of this differentiated checkpoint inhibitor through combinations in various tumor types for patients worldwide."

To learn more about BeiGene’s research and development and activities around ESMO (Free ESMO Whitepaper), please visit View Source

Broad Lung Cancer Program Focused on Tislelizumab Combination Treatments

BeiGene is pursuing diverse mechanisms of action in combination with tislelizumab to complement targeting of the PD-1 pathway for potentially improved clinical outcomes or to overcome resistance associated with disease progression.

In NSCLC, many patients who have achieved a response to front-line anti-PD-1 antibody treatment eventually relapse due to resistance. Through its collaboration with Mirati Therapeutics, BeiGene is investigating the combination of tislelizumab and sitravatinib, a spectrum-selective tyrosine kinase inhibitor potentially capable of reversing immunosuppressive tumor microenvironment to overcome immune resistance. BeiGene is conducting a Phase 3 trial of this novel combination in NSCLC, and clinical results from an ongoing Phase 1b trial in patients with metastatic NSCLC, both naïve and refractory or resistance to anti-PD-(L)1 treatment, will be presented at ESMO (Free ESMO Whitepaper) Congress 2021.

Another novel combination of tislelizumab that BeiGene is investigating in lung cancer is with ociperlimab, a potent, Fc-intact investigational anti-TIGIT-antibody in Phase 3 clinical development. TIGIT is a co-inhibitory immune checkpoint receptor expressed on multiple immune cells and has recently emerged as a new therapeutic target that in collaboration with PD-1 has the potential to further suppress antitumor immune response. Tislelizumab’s broad combination portfolio in lung cancer also includes PI3K-delta inhibitor BGB-10188, anti-TIM-3 antibody BGB-A425, and chemotherapy.

Growing NSCLC Program Driven by Scientific Excellence and Clinical Insights

To address the prevalence of NSCLC worldwide and the clinical unmet need despite treatment progress in recent years, BeiGene is currently evaluating tislelizumab in a comprehensive NSCLC program of more than 10 clinical trials covering disease settings from early to late lines.

To gain key insights into how different patient characteristics can impact treatment outcomes, BeiGene’s immuno-oncology team reviews clinical results from NSCLC trials by geography, disease stage, smoking status, and using biomarkers.

Subgroup analyses on BeiGene’s RATIONALE 307 trial recently presented at the 2021 World Conference on Lung Cancer (WCLC) showed that tislelizumab in combination with chemotherapy provided consistent survival benefits in treatment-naïve patients with squamous NSCLC, regardless of PD-L1 expression, blood tumor mutation burden (TMB), tissue TMB, and disease stage (IIIB or IV).

At the ESMO (Free ESMO Whitepaper) Congress 2021, additional analyses on smokers vs. nonsmokers in the two Phase 3 clinical trials in first-line NSCLC, RATIONALE 304 and RATIONALE 307 will be reported.

In addition, the Company is exploring tislelizumab’s potential as an early treatment option, with an ongoing global Phase 3 trial RATIONALE 315 in neoadjuvant or adjuvant settings.

BeiGene’s ePoster Presentations at ESMO (Free ESMO Whitepaper) Congress 2021

Abstract #

Title

Lead Author

3649

Sitravatinib + tislelizumab in patients with anti-PD-(L)1 refractory/resistant metastatic NSCLC

Bo Gao, M.D., Ph.D.
Blacktown Cancer and Hematology Centre (Australia)

3457

Sitravatinib + tislelizumab in patients with metastatic NSCLC

Qing Zhou, M.D., Ph.D.
Guangdong Lung Cancer Institute (China)

2562

Effects of tislelizumab monotherapy on health-related quality of life in patients with previously treated unresectable HCC

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

3786

RATIONALE 304: Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for non-squamous NSCLC in patients who are smokers vs non-smokers

Shun Lu, M.D.
Shanghai Lung Cancer Center (China)

4053

Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients who were smokers vs non-smokers

Xinmin Yu, M.D.
Zhejiang Cancer Hospital (China)

1587

Association between use of antibiotics and clinical outcomes with tislelizumab monotherapy

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

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 team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. 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. We currently market 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 granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On September 12, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held from September 13-15, 2021 (Press release, Precision Biologics, SEP 12, 2021, View Source [SID1234587545]).

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The pre-recorded presentation will be made available for on-demand viewing starting Monday, September 13, 2021 at 7:00 a.m. ET on the Company’s website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcast will be available for approximately 90 days.

On September 12, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported poster presentations relating to multiple investigational product candidates at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Conference, taking place September 16-21, 2021 (Press release, MacroGenics, SEP 12, 2021, View Source [SID1234587532]).

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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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Posters will be available on September 16, 2021. Details are as follows:

620P – MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion
Preliminary clinical results from the Phase 1 cohort expansion study of MGC018 in patients with metastatic castration-resistant prostate cancer and non-small cell lung cancer will be presented in this poster. The abstract submitted to ESMO (Free ESMO Whitepaper) included data as of May 3, 2021, while the final poster will include updated results as of August 16, 2021.
Presentation Topic: Genitourinary tumours, prostate

1379P – Margetuximab with Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A
Results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab in combination with retifanlimab in treatment-naïve patients with locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) who are positive for both HER2 and PD-L1 will be presented in this poster. The efficacy data and safety cutoff dates for this poster were July 19, 2021 and August 3, 2021, respectively.
Presentation Topic: Oesophagogastric cancer

627P – Phase 2 Neoadjuvant Trial of the Anti-B7-H3 Antibody, Enoblituzumab, in Men with Localized Prostate Cancer: Safety, Efficacy, and Immune Correlates
Results of a Phase 2 neoadjuvant trial of enoblituzumab in men with localized prostate cancer will be presented in this poster by Johns Hopkins University School of Medicine.
Presentation Topic: Genitourinary tumours, prostate

926TiP – Phase 2 Trial of Enoblituzumab Plus Retifanlimab or Tebotelimab in First-Line Treatment of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A trial-in-progress poster regarding the Phase 2 study of enoblituzumab, an Fc‐engineered, anti‐B7‐H3 monoclonal antibody, will be presented.
Presentation Topic: Head and neck cancer, excluding thyroid

The abstracts referenced above were submitted to ESMO (Free ESMO Whitepaper) in May 2021 and are available on the ESMO (Free ESMO Whitepaper) website. The posters will be available for on-demand viewing on the ESMO (Free ESMO Whitepaper) website and on the "Events & Presentations" page in the Investor Relations section of MacroGenics’ website at View Source on or around September 16, 2021.

On September 10, 2021 Immunocore Holdings plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported that management will present at the following investor conferences in September (Press release, Immunocore, SEP 10, 2021, View Source [SID1234590901]).

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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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H.C. Wainwright 23rd Annual Global Investment Conference
Fireside Chat available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Fireside Chat: Wednesday, September 22, 2021 at 2:05 p.m. ET
The investor conferences will each be held in a virtual format and a live webcast of each presentation can be accessed in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. For conferences that offer replays, presentations will be made available for a limited time.