On September 13, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported that positive results from its phase I dose escalation clinical trial of HBM4003 in solid tumors in Australia (the "phase I study") (Press release, Harbour BioMed, SEP 13, 2021, View Source [SID1234587652]). The clinical data abstract has been presented by way of an e-poster at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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The data received from the phase I study, as the first clinical evidence of next generation anti-CTLA-4 fully human heavy-chain only antibody (HCAb) in solid tumors, showed favorable safety and encouraging efficacy profile of HBM4003. All treatment-related adverse events (TRAEs) to the extent discovered during the phase I study were manageable and reversible. The initial anti-tumor efficacy of HBM4003 monotherapy was encouraging, especially two respondents who underwent multiple therapies responded to HBM4003 monotherapy.

The Phase I Study Design

The phase I study is an open-label, multi-center study on subjects with solid tumors to receive HBM4003 at dose levels of 0.3mg/kg QW (28-day cycle), 0.45mg/kg Q3W (21-day cycle), and 0.6mg/kg Q3W (21-day cycle). The primary endpoint for the dose escalation stage is proportion of patients with dose-limiting toxicity (DLT).

Key Results of the Phase I Study

(i) 20 patients with advanced solid tumors have been treated at four Australian sites where the phase I study was conducted, with 13 out of 20 patients (65%) having received 2 or more prior regimens and with 8 patients (40%) having received PD-1 treatment.
(ii) HBM4003 treatment demonstrated favorable safety profile. No toxicity reported was related to lung, kidney, heart or endocrine system.
(iii) A dosage of 0.45 mg/kg Q3W was recommended as the phase II dose for dose expansion.
(iv) A total of 15 patients had post-treatment tumor assessments. One hepatocellular carcinoma (HCC) patient had confirmed partial response (PR) and another prostate cancer patient achieved a prostate surface antigen (PSA) response with tumor remaining stable disease (SD) up to 24 weeks. Nine patients had SD with tumor shrinkage in 3 patients.
(v) For the HCC patient with PR, extended clinical benefit was observed after treatment discontinuation. Tumor reduction reached 64.4% for target lesions and non-target lesions were no longer detectable 16 weeks after the last dose.

"We are extremely pleased to announce the positive results of this study at ESMO (Free ESMO Whitepaper) Congress 2021, one of the top international academic conferences. The anti-tumor efficacy of HBM4003 with the good safety profile and tolerability is encouraging. With high expectations on the promising therapeutic value of HBM4003, the Company has proceeded with multiple global phase Ib/IIa trials in solid tumors." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combo-therapy.

On September 13, 2021 2seventy bio, the planned oncology spin-off of bluebird bio (NASDAQ: BLUE) reported that it will host a series of investor events to share further detail on its research pipeline and strategy (Press release, bluebird bio, SEP 13, 2021, View Source [SID1234587672]).

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Session One: An Introduction to 2seventy’s Pipeline; focus on AML [DARIC33] and Next-Gen Multiple Myeloma Strategy
September 21, 2021, 11:00am-12:00pm ET
Session Two: Focus on bNHL [bbT369] and Solid Tumor Strategy
September 22, 2021, 1:00-2:00pm ET
To access the live webcasts and dial-in information for 2seventy bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

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 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 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.