On September 10, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that it will present new data on TEVIMBRA (tislelizumab) at the European Society for Medical Oncology 2024 Congress (ESMO 2024) in Barcelona, ​​Spain, September 13-17, 2024 (Press release, BeiGene, SEP 10, 2024, View Source [SID1234646494]). Seven BeiGene abstracts have been selected for the ESMO (Free ESMO Whitepaper) 2024 Congress, including one that has been selected for the special session revisiting the virtual ESMO (Free ESMO Whitepaper) plenary held in February 2024.

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New data strengthen evidence for TEVIMBRA’s efficacy in multiple conditions

As a reminder of the ESMO (Free ESMO Whitepaper) plenary session, interim results from the RATIONALE-315 study show a statistically significant benefit in terms of event-free survival (EFS) and overall survival (OS) trend supporting neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab compared with placebo plus chemotherapy with adjuvant placebo for patients with resectable non-small cell lung cancer (NSCLC) (session #VP1-2024, 13 September from 16:17 to 16:29 CEST). These results confirm data presented at ESMO (Free ESMO Whitepaper) 2023, showing that the major pathological response (MPR) and pathological complete response (pCR) rates were significantly improved: 56.2% vs. 15.0% (P<0.0001) and 40.7% vs. 5.7% (P<0.0001), respectively. The safety profile of the tislelizumab arm was consistent with that of the individual therapies, with 72.1% (vs. 66.4% in the placebo arm) of patients in the tislelizumab arm experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% (vs. 8.0% in the placebo arm) experiencing serious TRAEs. The most common treatment-related adverse events were neutrophil count decreased, white blood cell count decreased, and alopecia. Symptom improvement achieved with RATIONALE-315 will also be presented as patient-reported outcomes (Poster #1213P, September 14).
Three-year overall survival data from the RATIONALE-305 study continue to demonstrate the long-term efficacy and safety of tislelizumab in combination with chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) (Poster #1437P, September 16), as well as improved patient-reported outcomes (Poster #1449P, September 16).
Long-term results from the RATIONALE-307 study in the ITT population as well as in the population with long-term exposure to tislelizumab plus chemotherapy for the first-line treatment of squamous cell NSCLC show a continued OS benefit, with clinically promising four-year OS rates (Poster No. 1323P, September 14).
Relative efficacy of tislelizumab compared with other anti-PD-1 therapies approved in the European Union and the United Kingdom for the second-line treatment of esophageal squamous cell carcinoma (ESC) using a grounded theory simulated treatment comparison of data from the RATIONALE-302 study and comparative clinical studies (poster #1417P, September 16).
"TEVIMBRA has demonstrated potential in multiple disease states, and the data presented at ESMO (Free ESMO Whitepaper) 2024 reinforce its position as a cornerstone asset in our solid tumor pipeline," said Dr. Jan-Henrik Terwey, Vice President, Medical Affairs, Europe, BeiGene. "As part of our commitment to bring innovative cancer medicines to more patients, we recently launched TEVIMBRA in EMA-approved indications in Germany, Austria and Norway, and are working to make TEVIMBRA available across Europe."

TEVIMBRA in Europe

BeiGene recently launched TEVIMBRA in the first European countries following EU marketing authorizations for the treatment of eligible patients with EOC and NSCLC. TEVIMBRA is also approved in the United Kingdom and Switzerland for eligible patients with advanced or metastatic EOC.

"Advanced or metastatic EOC and NSCLC are aggressive cancers with limited treatment options," said Markus Moehler, MD, PhD, of Johannes Gutenberg University Medical Center Mainz in Germany. "The availability of tislelizumab for these patients represents an important next step in changing the treatment landscape."

The European Commission’s authorisations are based on the results of four randomised phase 3 studies in the RATIONALE programme: RATIONALE-302 ( NCT03430843 ) in EOC and RATIONALE-307 ( NCT03594747 ), RATIONALE-304 ( NCT03663205 ) and RATIONALE-303 ( NCT03358875 ) in NSCLC. The approved indications for TEVIMBRA in the EU are:

In combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with locally advanced squamous cell NSCLC who are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells, without positive EGFR or ALK mutations, and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutation-positive or ALK-positive NSCLC should also have received targeted therapies prior to receiving tislelizumab.
As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic EOC after prior platinum-based chemotherapy.
About TEVIMBRA (tislelizumab)

Tislelizumab is a uniquely designed humanized anti-programmed death protein 1 (PD-1) immunoglobulin G4 (IgG4) monoclonal antibody with high affinity and specificity of binding against PD-1. It is designed to reduce binding to Fc-gamma (Fcγ) receptors on macrophages, which helps the body’s immune cells detect and fight tumors.

On September 10, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported it has been selected for a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Advances in Pancreatic Cancer Research which will be held on September 15-18, 2024, in Boston, Massachusetts (Press release, Purple Biotech, SEP 10, 2024, View Source;id=319393&p=2339869&I=1206939-c7Z3G6f3m8 [SID1234646479]).

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Purple Biotech’s poster titled, "Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer" will be presented during a poster session on Tuesday, September 17 from 6:45-9:00 pm ET.

The Company’s Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy in second line pancreatic ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy alone. Sixty-three patients have been enrolled in the randomized study across 18 centers in the U.S., Spain, and Israel.

Interim data from the Phase 2 study presented in June at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated improvement in overall survival (OS), progression free survival (PFS), objective response rate (ORR) and all other efficacy endpoints in the CM24+nivolumab+Nal-IRI/5FU/LV experimental arm as compared with the SoC control arm. Topline data are expected in the fourth quarter of 2024.

On September 10, 2024 CEL-SCI Corporation (NYSE American: CVM) reported that it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain (Press release, Cel-Sci, SEP 10, 2024, View Source [SID1234646495]). A poster titled "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy" will be presented by the study’s co-author József Tímár MD, PhD, DSc, a prominent and highly respected pathologist.

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"Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy"

Post this
CEL-SCI has received the go-ahead from the U.S. Food and Drug Administration (FDA) to commence a confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from its IT-MATTERS completed Phase 3 study.

Dr. Timar is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.

On September 10, 2024 GC Cell, a leading innovator in cell therapy, has officially reported the execution of a landmark ‘Technology Transfer and License Agreement’ with PT Bifarma Adiluhung (Bifarma), a premier stem cell therapy company in Indonesia (Press release, GC Cell, SEP 10, 2024, View Source [SID1234646480]). This strategic partnership, which began in June, solidifies approximately three months later with the signing of the final license agreement.

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Under the terms of the agreement, Bifarma will be granted the exclusive rights to develop, manufacture, and commercialize Immuncell-LC for 15 years.

GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
Bifarma is recognized for operating Indonesia’s first GMP-certified cell therapy production facility and possesses a comprehensive sales and marketing infrastructure focused on oncology, specializing in a cold chain distribution network that spans across Indonesia. This infrastructure is expected to maximize the accessibility and commercial success of Immuncell-LC.

James Park, CEO of GC Cell, expressed his enthusiasm about the partnership’s potential, stating, "The initiation of technology transfer concurrent with the signing of the license agreement sets us on a path to introduce Immuncell-LC in Indonesia by next year, leveraging both our expertise and a firm partnership with Bifarma. This milestone is pivotal as we work to introduce Immuncell-LC, South Korea’s first anticancer drug cell therapy, to a global audience, offering new treatment avenues to a broader patient demographic."

The Indonesian pharmaceutical market, the largest in Southeast Asia, is rapidly expanding with an average growth rate exceeding 8% annually, representing a significant opportunity for innovative treatments like Immuncell-LC. The introduction of the product is expected to mark a significant advancement in Indonesia’s cancer treatment landscape, particularly for Hepatocellular Carcinoma (HCC), which affects approximately 23,000 new patients annually in the country.

Dr. Sandy Qlintang, MBiomed., President Director of PT Bifarma Adiluhung said, "We are excited to announce our collaboration in Immuncell-LC with GC Cell, focusing on innovative treatments for hepatocellular carcinoma (HCC) in Indonesia. By combining our expertise, we aim to enhance therapeutic strategies and bring groundbreaking advancements to liver cancer treatment through cutting-edge immune cell therapies. Together, we are committed to make a significant impact in the fight against HCC."

Immuncell-LC, an anti-cancer immune cell therapy, has demonstrated significant efficacy in solid tumors, particularly liver cancer, and has been recognized as an FDA-designated orphan drug. It consists primarily of autologous blood-derived T lymphocytes enhanced to improve cancer cell killing capabilities. The therapy has proven its effectiveness in large-scale Phase 3 clinical trials for early-stage Hepatocellular Carcinoma (HCC) patients, significantly reducing recurrence risk and mortality with a favorable safety profile.

As GC Cell continues to engage with major pharmaceutical entities across emerging markets, the partnership with Bifarma is poised to set a precedent for the introduction of innovative therapies in underserved regions, promising enhanced clinical outcomes and increased accessibility to cutting-edge treatments.

On September 10, 2024 Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that the first patient has been enrolled in the Phase 1c study of PRTH-101 for the treatment of patients with advanced or metastatic solid tumors (Press release, Incendia Therapeutics, SEP 10, 2024, View Source [SID1234646496]).

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"In our Phase 1a and 1b studies, we were able to select an optimal dose and identify potential biomarkers to carry forward" said Irena Webster, SVP Development and Operations of Incendia. "The data from this study will inform the design of the Phase 2/3 program, for which planning and global feasibility are currently underway."

Dr. Joseph Paul Eder, CMO, added "Incendia, with its outstanding team of investigators and investigative sites, has determined a recommended Phase 2 dose of PRTH 101. PRTH 101 has shown consistent safety as a single agent and in combination with pembrolizumab. We will now focus on tumor types that have demonstrated signs of clinical activity and patient benefits."

The Phase 1c study will evaluate the safety, tolerability and anti-tumor activity of PRTH-101 as both a monotherapy and in combination with KEYTRUDA (pembrolizumab).

About PRTH-101
PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By allosterically disabling DDR1, PRTH-101 disrupts tumor associated collagen alignment to permit immune cell access into the tumor core. In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1.

About the Phase 1 Trial
The Phase 1 trial (NCT05753722) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment.