On September 13, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported updated data from its Phase 1 SURPASS trial in multiple solid tumors to be presented in a digital poster at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting (Press release, Adaptimmune, SEP 13, 2021, View Source [SID1234587584]). The poster will be displayed on the ESMO (Free ESMO Whitepaper) congress web site on Thursday, September 16th. The Company has also released a video of Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer (CEO), and Elliot Norry, Adaptimmune’s Chief Medical Officer, describing these data in more detail that can be accessed here: https://bit.ly/38ZQCGt.

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"It is no longer a question of whether our SPEAR T-cells are effective against a range of MAGE-A4 expressing tumors — they undoubtedly are. Now, our focus is on turning them into approved therapies. This begins with ongoing recruitment in this SURPASS trial for people with lung, bladder, gastroesophageal, head and neck, and now ovarian cancer, and continues with the recently initiated SURPASS 2 trial in esophageal and EGJ cancers," said Adrian Rawcliffe, Adaptimmune’s CEO. "These data bring us closer to identifying further indications to take into late-stage development and confirm our expertise in developing and enhancing cell therapies. ADP-A2M4CD8 does exactly what we designed it to do — kill cancer cells and more effectively engage the broader immune system to deliver improved potency and clinical benefit."

Dr. David Hong, Professor, Deputy Chairman in the Department of Investigational Cancer Therapeutics (Phase I Program) at The University of Texas MD Anderson Cancer Center said, "We are encouraged by these promising early data from the SURPASS trial. Having previously seen strong responses with afami-cel, this next-generation cell therapy appears safe and demonstrated antitumor activity for a majority of patients across many cancer indications."

Topline results from the Phase 1 SURPASS trial (data cut-off August 2, 2021)
Emerging efficacy and durability data are promising with responses in five solid tumor indications

As of the data cut-off date, 25 patients had received the next-generation cell therapy, ADP-A2M4CD8, in the Phase 1 SURPASS trial, 22 patients were evaluable for efficacy with at least one post-baseline scan meeting the ≥4-week duration for evaluation of stable disease
All patients had advanced metastatic disease and had received multiple prior regimens of systemic therapy (median: 3; range 1-6)
The overall response rate was 36% and the disease control rate was 86%
There was a complete response reported in a patient with ovarian cancer, which remains ongoing at 6 months post‑infusion (data on file at Adaptimmune)
Initial durability is encouraging. As of the data cut-off, 11 patients remain on study. Of the 8 responders, 5 remain in response with some remaining progression free >24 weeks

Best Overall Response (n=22)* Overall, n (%) Cancer Indication
(n=1 unless otherwise noted)
Complete response (CR) 1 (4.5) Ovarian
Partial response (PR) 7 (31.8) Ovarian (2); head and neck (2)**; esophagogastric junction (EGJ)**; bladder; synovial sarcoma
Stable disease (SD) 11 (50.0) Ovarian cancer (3); EGJ (2); esophageal (2); lung cancer, MRCLS, melanoma,
Progressive disease (PD) 3 (13.6) EGJ, lung, ovarian
Overall response rate (CR, PR) 8 (36.4)
Disease control rate (CR, PR, SD) 19 (86.4)
* Of 25 patients who received ADP-A2M4CD8, 3 were not evaluable at the time of data cut-off: 2 patients (ovarian or esophageal cancers) did not have post-baseline scans; 1 patient (EGJ) had a post-baseline scan that did not meet the ≥4-week duration for evaluation of stable disease
** One PR in head and neck cancer and one PR in EGJ cancer were reported previously at SITC (Free SITC Whitepaper) 2020

ADP-A2M4CD8 demonstrated an acceptable safety profile

Eighteen (72%) patients experienced cytokine release syndrome (CRS) related to T-cell infusion, most of which were lower grade: Grade 1 or 2 (n=14); Grade 3 (n=4)
The most common serious adverse event (SAE) of any grade (> 30% of patients) was CRS
Four (16%) patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS) related to T-cell infusion: Grade 1 (n=1); Grade 2 (n=1); Grade 3 (n=2)
Five (20%) patients experienced prolonged cytopenia at Week 4
One patient experienced a fatal (Grade 5) SAE of pancytopenia (previously reported in the Company’s 10K Report filed with the Securities and Exchange Commission on February 25, 2021)
ADP-A2M4CD8 was designed to be more potent than the first-generation product

Adaptimmune’s Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cell therapies are a mix of CD8+ ("killer") and CD4+ ("helper") T-cells engineered with a T-cell receptor (TCR) designed with Adaptimmune’s proprietary affinity enhancement technology to recognize a cancer target
ADP-A2M4CD8 is a next-generation T-cell therapy engineered to target MAGE-A4 positive tumors, and to express a CD8α co-receptor
ADP-A2M4CD8 uses the same engineered T-cell receptor that recognizes MAGE-A4 as Adaptimmune’s first-generation T-cell therapy, afami-cel, which has shown compelling results in synovial sarcoma and myxoid/round cell liposarcoma (presented at ASCO (Free ASCO Whitepaper) 2021)
Co-expression of CD8α adds CD8+ killer cell capability to CD4+ helper T-cells, while maintaining or enhancing the CD4+ helper function (i.e., producing the inflammatory cytokines IFN-γ and IL-2)
Initial translational data confirm that ADP-A2M4D8 is more potent and better engages the immune system, compared to the first-generation product

Patient manufactured product and serum samples from the first-generation Phase 1 afami-cel trial and the next-generation SURPASS trial were compared
In vitro tumor cell killing assays confirm that the next-generation product results in greater tumor cell killing by CD4+ SPEAR T-cells
Analyses of patient serum samples demonstrate increases in a subset of 22 measured serum cytokines confirming increased helper function of the next-generation CD4+ T-cells and engagement of the broader immune system
Additional serum analyses showed increased serum IL-12 in the SURPASS trial versus the first-generation Phase 1 trial, which is also consistent with engagement of the broader immune system, including dendritic cells, as IL-12 is not known to be produced by T-cells
Conclusions from the Phase 1 SURPASS Trial Data at ESMO (Free ESMO Whitepaper)

Initial efficacy and durability data are encouraging with responses across five different solid tumors including a complete response in a patient with ovarian cancer ongoing at 6 months
The safety profile of the next-generation ADP-A2M4CD8 cell therapy was acceptable
Data confirm preclinical observations that the enhanced TCR interaction in ADP-A2M4CD8 results in a more potent product
Safety and efficacy, including duration of response, will continue to be evaluated in the ongoing SURPASS trial, which is enrolling eligible patients with gastroesophageal, head and neck, lung, bladder, and ovarian cancers
A Phase 2 trial, SURPASS-2, has initiated for patients with esophageal and EGJ cancers
Overview of Phase 1 SURPASS trial design

This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and antitumor activity of ADP-A2M4CD8 in patients with MAGE-A4+ tumors in the context of HLA-A*02
This is a first-in-human dose-escalation trial using a modified 3+3 design, with 2 dose cohorts plus an expansion cohort
The number of transduced cells ranged from 0.8×109 to 1.2×109 (Cohort 1 complete), 1.2×109 to 6.0×109 (Cohort 2 complete), and 1.2×109 to 10.0×109 (Expansion)
Dose-limiting toxicities are adjudicated by a Safety Review Committee, regardless of the investigator’s attribution
Responses are assessed per RECIST v1.1

On September 13, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that data from the Company’s RXC004 Phase 1 monotherapy study will be presented at the forthcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, 16-21 September 2021 (Press release, Redx Pharma, SEP 13, 2021, View Source [SID1234587580]).

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RXC004 is the Company’s lead drug candidate and is a potent, orally active porcupine inhibitor being developed as a targeted therapy for Wnt-ligand driven cancer. Based on the safety profile observed in the Phase 1 study, Redx has selected the 2mg dose of RXC004 for its planned Phase 2 monotherapy, proof of concept clinical trials which are expected to start during the second half of 2021.

The presentation at the ESMO (Free ESMO Whitepaper) Congress 2021 will be made by the Study Principal Investigator, Dr Natalie Cook, Consultant Medical Oncologist at the Christie Hospital NHS Trust, Manchester, UK.

Presentation No: 517MO
Authors: N Cook, S Blagden, J Lopez, D Sarker, A Greystoke, N Harris, F Kasmi, A Naderi, G Nintos, A Ortego Franco, R Pihlak, R Shinde, L Goodwin, C Phillips, J Robertson, A Saunders, C Tilston, S Woodcock, R Plummer
Title: Phase 1 study of the Porcupine (PORCN) inhibitor RXC004 in patients with advanced solid tumours
Day/Date: Monday 20 September 2021
Presentation Time: 17:50pm to 17:55pm (CET)
Session Channel: Channel 3
Session Title: Developmental therapeutics
Session Type: Mini oral session
Session Time: 17:30pm to 18:30pm (CET)

Redx to host R&D Event
Presented data will be discussed by Medical Experts during Redx’s online R&D Event to be held on Monday 11 October 2021 at 1:00pm BST / 8.00am EDT. The event will also cover the Company’s pipeline beyond RXC004.

On September 13, 2021 Novartis reported that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in people who had received prior systemic therapy (Press release, Novartis, SEP 13, 2021, View Source [SID1234587579]).

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"This is an encouraging step forward in our mission to deliver transformative therapies for people living with cancer, and especially for people with esophageal cancer, an aggressive disease with limited treatment options," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy. We will work with regulatory authorities to ensure it is available for people with esophageal cancer as soon as possible."

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.4 The BLA submission was based on data from the Phase III RATIONALE 302 trial, which demonstrated a 30% reduction in the risk of death (HR=0.70, 95% CI: 0.57-0.85, p=0.0001) and extended median overall survival by 2.3 months compared to chemotherapy in people with unresectable recurrent locally advanced or metastatic ESCC who had received prior systemic therapy.1

About Esophageal Cancer
ESCC is the most common type of esophageal cancer globally and the sixth leading cause of cancer-related death worldwide.2 There are approximately 17,000 people living with ESCC in the United States and in 2021, and it is estimated that there will be 19,000 new esophageal cancer cases diagnosed and more than 15,000 deaths from esophageal cancer.3,5 Globally, in 2020, there were more than 604,000 new cases of esophageal cancer and 544,000 deaths from esophageal cancer.2 More than two-thirds of people with ESCC have advanced or metastatic disease at the time of diagnosis.6 The five-year survival rate for esophageal cancer is 19.9%, and the five-year survival rate for metastatic disease is even lower at 5.2%.3

About Tislelizumab
Tislelizumab 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. The clinical impact of these features is not yet known.4

BeiGene filed the BLA on behalf of Novartis in the United States for tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic ESCC in people who had received prior systemic therapy. In an agreement finalized earlier this year, BeiGene granted Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan through a collaboration and license agreement.

On September 13, 2021 Boehringer Ingelheim, a global leader in animal health, reported that its FRONTLINE brand was named global Brand of the Year 2021-2022 in the Animalis Edition of the World Branding Awards (Press release, Boehringer Ingelheim, SEP 13, 2021, View Source [SID1234587571]).

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The organizer of the World Branding Awards, World Branding Forum, headquartered in London, UK, is a global non-profit organization dedicated to advancing branding standards for the good of the branding community as well as consumers. It organizes and sponsors a range of educational programs, including collaborations with leading universities and museums.

The winners are judged through three streams: brand valuation, consumer market research and public online voting. Over 115,000 pet and animal lovers from around the world voted for their favorite brands, in 41 countries, across six continents. This year, more than 1,100 brands were nominated by the public but only 150 were named "Brand of the Year".

"This is a celebration of the best marketers of pet and animal brands from across the globe. As consumer votes constitute 70 percent of the final score, winners of the Awards must have strong brand recall amongst their consumers," explains Richard Rowles, Chairman, World Branding Forum.

Michael Horn, Global Head of Pet Parasiticides, shares: "We are absolutely delighted to have won this global Award again. It recognizes our teams who work tirelessly ensuring brand awareness is high and consumers know what our brands stand for in the ever-changing pet segment and animal health industry."

Brand of the Year logo

World Branding Forum

The World Branding Forum (WBF) is a global, non-profit organization dedicated to advancing branding standards for the good of the branding community as well as consumers. This includes those who work in the branding, design, marketing, advertising, public relations and communications disciplines worldwide. The WBF produces, manages and supports a wide range of programs covering research, development, education, recognition, networking and outreach. For more information visit www.brandingforum.org

Boehringer Ingelheim Animal Health

The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. Across the globe, our 9,700 employees are dedicated to delivering value through innovation, thus enhancing the well-being of both.

Respect for animals, humans and the environment is at the heart of what we do. We develop solutions and provide services to protect animals from disease and pain. We support our customers in taking care of the health of their animals and protect our communities against life- and society-threatening diseases.

Boehringer Ingelheim Animal Health is the second largest animal health business in the world, with net sales of 4.1 billion euros in 2020 and presence in more than 150 countries. For more information visit: www.boehringer-ingelheim.com/animal-health/overview

On September 13, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy (Press release, BeiGene, SEP 13, 2021, View Source [SID1234587561]). The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.

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"Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there. We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world."

"Our uniquely designed anti-PD-1 antibody tislelizumab has been shown to significantly improve survival compared to chemotherapy for people with a variety of solid tumors and hematologic malignancies. We previously shared the compelling results at ASCO (Free ASCO Whitepaper) 2021 with tislelizumab significantly prolonging survival and demonstrating a favorable safety profile over chemotherapy in patients with locally advanced or metastatic ESCC, a devastating disease with an average five-year survival rate of just five percent. This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there. We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world."

The BLA submission is based on results from RATIONALE 302, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. Results of this trial were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2021). The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

In addition to the United States, tislelizumab is also under regulatory review in China as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors in the digestive tract, with more than 18,400 new cases diagnosed each year in the United States.1 There are two main types of esophageal cancer, based on the cells where cancer develop: squamous cell carcinoma (ESCC) and adenocarcinoma (EAC).2 ESCC accounts for up to 30% of esophageal cancer cases in the United States, and is the most common form of esophageal cancer worldwide.2,3,4 Because many patients are diagnosed at later stages of disease, management of ESCC is challenging and the overall prognosis remains poor.3,4

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 approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, 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, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. 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 are under review by the Center for Drug Evaluation (CDE) of the NMPA, including as second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors and for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy.

In the U.S., a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022.

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 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.