Alligator Bioscience’s Announces Henlius Biotech has Received FDA IND Clearance for Phase 3 Initiation to Evaluate HLX22 (AC101) in 1st Line HER2+ Advanced Gastric Cancer

On May 21, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients (Press release, Alligator Bioscience, MAY 21, 2024, View Source [SID1234643480]).

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Gastric/gastroesophageal junction (G/GEJ) cancer is one of the most common cancers and approximately 20% of these patients show HER2 amplification or overexpression. Despite the approval of Herceptin (trastuzumab) in the US in 2010, the median overall survival of patients suffering from HER2+ gastric cancer remains limited.

HLX22 (AC101) is an innovative monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius Biotech.

In January 2024, Henlius Biotech presented promising Phase 2 results at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), which were also published in the Journal of Clinical Oncology. The data demonstrated that the addition of HLX22 (AC101) to HLX02 (a biosimilar of trastuzumab) and XELOX (Oxaliplatin and capecitabin) in 1st line treatment of HER2-positive locally advanced or metastatic G/GEJ cancer led to a dose-dependent increase in Progression Free Survival, meeting the study’s main efficacy endpoint.

"We are very pleased to see the highly encouraging progress Henlius Biotech are making with the development of HLX22 in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "The Phase 2 results presented at ASCO (Free ASCO Whitepaper) earlier this year followed by this Phase 3 IND clearance demonstrate our ability to deliver an asset like HLX22 with a highly differentiated profile and a great deal of potential to improve treatment outcomes for patients suffering from a devastating disease like gastric cancer."

Glenmark and BeiGene Enter into an Agreement for Marketing and Distribution of Tislelizumab and Zanubrutinib in India

On May 21, 2024 Glenmark Specialty S.A. (Glenmark), a subsidiary of Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, reported an exclusive marketing and distribution agreement with BeiGene, a global oncology company (Press release, Glenmark, MAY 21, 2024, View Source [SID1234643468]). Under this agreement, Glenmark will register and commercialize BeiGene’s oncology medicines, Tislelizumab and Zanubrutinib in India.

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Speaking on this partnership, Alok Malik, President and Business Head – India Formulations, Glenmark Pharmaceuticals Ltd. said, "We are excited about our partnership with BeiGene, signifying our commitment to advancing healthcare in India. The addition of Tislelizumab and Zanubrutinib to our oncology portfolio underscores our dedication to the cancer patients’ community and our commitment to provide access to novel therapies across India"

"This collaboration is a testament to our shared vision of enhancing healthcare access across Asia," said Adam Roach, Vice President, and Head of Asia-Pacific at BeiGene. "We take great pride in advancing mission-driven access, especially given the significant disease burden in India, where rising cancer rates require comprehensive healthcare solutions – a commitment we share with our partners at Glenmark," Mr. Roach said.

With a population exceeding 1.43 billion, India stands as the world’s most populous country and the largest lower-middle-income nation.1,2 This partnership is timely, as many low-and middle-income countries, including India, are experiencing an increasing cancer burden. Recent statistics indicate that India has the third highest number of cancer cases worldwide, with predictions suggesting this could reach 2.08 million cases by 2040 – a 57.5 per cent increase from 2020.3 Currently, cancer claims approximately 900,000 lives annually in India.4

While solid tumors remain the majority of cancers diagnosed, of particular concern is the burgeoning prevalence of blood cancer, ranking third highest globally, following only the US and China.5 In India, a blood cancer diagnosis strikes every five minutes, claiming an estimated 70,000 lives each year.5 Amidst this grim reality, Glenmark envisions a future where affordable and effective therapies serve as a beacon of hope for those in need.

About Tislelizumab

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

About Zanubrutinib

Zanubrutinib is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, zanubrutinib has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

First Made-in-Singapore Antibody-Drug Conjugate EBC-129 progresses to Phase 1B Dose Expansion

On May 20, 2024 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported that the Phase 1 trial for EBC-129 has progressed into dose expansion (Press release, Experimental Drug Development Centre, MAY 20, 2024, View Source [SID1234654037]).

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EBC-129 is the first made-in-Singapore ADC to enter clinical development. The tumour antigen it targets is a specific N-glycosylated site conserved on both CEACAM 5 and 6 which is selectively expressed on cancer cells, over normal cells. This allows EBC-129 to address a broad range of solid cancers expressing either one or both tumour markers, including cancers prevalent in Asia like gastroesophageal and lung cancers, as well as cancers with very limited treatment options like pancreatic cancer and cholangiocarcinoma.

The Phase 1 trial began with a dose escalation study which evaluated the safety and tolerability of EBC-129 in patients with unresectable metastatic solid tumours. The first patient for the dose escalation was dosed at the National Cancer Centre Singapore (NCCS) in May 2023. EBC-129 is also being tested at the National University Cancer Institute, Singapore (NCIS), as well as the MD Anderson Cancer Center and the University of Colorado Cancer Center in the United States. The dose escalation study showed that EBC-129 is well-tolerated by cancer patients. Tumour shrinkage was observed in an oesophageal cancer patient as well as a pancreatic cancer patient.

The Phase 1 trial has now progressed into dose expansion, with the first patient for this part of the study dosed on 13th May 2024. The dose expansion study comprises three groups of 15 patients each with gastroesophageal cancers, pancreatic ductal adenocarcinomas, and solid tumours expressing the tumour antigen at moderate or high levels.

The ADC and the immunohistochemistry (IHC)-based test used for patient selection were developed collaboratively by NCCS, A*STAR’s Bioprocessing Technology Institute (BTI) and the Institute for Molecular and Cell Biology (IMCB), as well as EDDC.

"Our team at NCCS has been very encouraged by the progress of this ongoing trial for EBC-129 which has shown good tolerability and early signs of efficacy in the dose escalation study," said Clinical Assistant Professor Matthew Ng, Head, Department of Gastrointestinal and Neurological Medical Oncology, NCCS. "We have strong patient interest for participation in the dose expansion study and look forward to the development of EBC-129 as a potential treatment for cancer patients in the future."

"I am excited to delve deeper into EBC-129’s promise as a therapeutic option for pancreatic and gastroesophageal cancers through the dose expansion study. The demand for safe and effective treatments in these cancer types remains substantial, and we are dedicated to addressing these unmet needs," said Dr Yong Wei Peng, Senior Consultant, Department of Haematology-Oncology, NCIS.

"We are thrilled by the positive developments we have seen in the dose escalation study, and grateful for all our collaborators as well as the team at EDDC, who have been instrumental for us to reach this milestone", said Prof Damian O’Connell, EDDC’s Chief Executive Officer. "We will continue to work with our clinical partners to progress the dose expansion study and advance the potential of EBC-129 as an effective, targeted therapy for cancer patients."

About EBC-129
EBC-129 targets a specific N-glycosylated site conserved on CEACAM5 and CEACAM6 and is highly tumour-specific. This epitope has functional importance in tumour formation, migration and metastasis. Thus, EBC-129 is able to address a wide range of solid tumours with high unmet medical needs, including lung, gastric, oesophageal, pancreatic, breast, ovarian and biliary tract cancers. The payload used in EBC-129 is monomethyl auristatin E (MMAE), which has been extensively tested and approved for clinical use in other marketed ADCs, and has shown synergy with PD-1 inhibitors.

For more information on EBC-129 and its development, please refer to View Source

For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.

BioCity to Present Preliminary Phase I Results of BC3195 (CDH3 ADC) and Clinical Results from Two Trials of SC0245 (ATR Inhibitor) at 2024 ASCO Annual Meeting

On May 20, 2024 BioCity Biopharma reported that the preliminary Phase I data of BC3195 (CDH3 ADC) as a monotherapy for advanced solid tumors, and the data from two clinical studies of SC0245 (ATR inhibitor) will be exhibited at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 (Press release, Biocity Biopharmaceutics, MAY 20, 2024, View Source [SID1234644485]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held in Chicago, USA, from May 31 to June 4, 2024.

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Detailed information is as below:

(1)Abstract Title:

BC3195, a novel ADC targeting CDH3: Preliminary results of a first-in-human phase I study in patients with advanced solid malignancies.

Abstract #:e15008

Session Type:

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

lt will be published on meetings.asco.org/abstracts-presentations at 5:00 PM EDT on May 23,2024.

(2)Abstract Title:

An open-label, single-arm, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the ATR inhibitor SC0245 in advanced solid malignancies.

Session Type:

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Abstract #:e15126

lt will be published on meetings.asco.org/abstracts-presentations at 5:00 PM EDT on May 23,2024.

(3)Abstract Title:

An open-label, multicenter, phase Ib/II study of the ATR inhibitor SC0245 in combination with irinotecan in patients with relapsed and refractory extensive stage small cell lung cancer (ES-SCLC).

Session Type:

Poster Session—Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session date and time:

June 3,2024,from 1:30 p.m.~4:30 p.m. (Central Daylight Time)

Poster Bd #:364

About BC3195

BC3195 is currently the only ADC targeting CDH3/P-Cadherin in clinical development globally. In preclinical studies, BC3195 binds to cell surface CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%.

BC3195 is in parallel clinical development in both China and the US. Prof. Yilong Wu from Guangdong Provincial People’s Hospital and Prof. Bob Li from MSK Cancer Center are leading the studies in these territories, respectively.

About SC0245

SC0245 is the first small molecule ATR Kinase inhibitor that entered clinical development stage in China and ranked in the top tier globally.

SC0245 exhibited strong ATR kinase inhibition potency in preclinical studies. In multiple animal models, SC0245 demonstrated favorable safety, tolerability, and pharmacokinetic profiles. SC0245 also exhibited strong antitumor activity as a single agent or in combination with other therapeutics in these models.

In a phase I clinical study led by Prof. Lin Shen at Beijing Cancer Hospital, SC0245 demonstrated favorable safety and tolerability profiles, and a high disease control rate.

SC0245 is now in a phase Ib/II clinical study in combination with irinotecan for the treatment of small cell lung cancer. This study is led by Prof. Shun Lu, oncology department director at Shanghai Chest Hospital.

ERS Genomics and IRBM Sign CRISPR/Cas9 License Agreement

On May 20, 2024 ERS Genomics Limited (‘ERS’), the CRISPR licensing Company, and IRBM, a leader in the field of drug discovery, reported a non-exclusive CRISPR/Cas9 license agreement (Press release, IRBM, MAY 20, 2024, View Source [SID1234643476]). The agreement grants IRBM access to ERS’ CRISPR/Cas9 patent portfolio.

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IRBM is a drug discovery CRO with expertise ranging from target validation and hit finding to preclinical candidate nomination across various therapeutic areas, including oncology, infectious diseases, and neuroscience. The company has contributed to the discovery and development of four marketed therapeutics for HIV, HCV, ovarian cancer, and cutaneous T-cell lymphoma.

Carlo Toniatti, MD, PhD, CSO, IRBM, said: "We are committed to delivering high quality drugs by leveraging our broad range of expertise and capabilities across the entire preclinical drug discovery continuum. With the integration of CRISPR/Cas9 gene editing technology we are increasing our capability to identify and validate potential drug targets, to generate more predictive pre-clinical models and to elucidate the mechanisms of action of novel therapeutics."

John E Milad, CEO, ERS Genomics, commented: "We are committed to supporting cutting-edge research and expanding the horizons of medical innovation by providing companies such as IRBM with the ability to take advantage of CRISPR/Cas9 technology. We look forward to seeing the innovative ways in which our gene editing technology will be utilised in various stages of drug discovery, providing candidates for a wide range of therapeutic areas."

ERS Genomics provides licensing to CRISPR/Cas9 technology for companies interested in pursuing its use in their commercial programs. Comprising 100+ patents globally, ERS’ portfolio encompasses CRISPR/Cas9 usage in all cells, including eukaryotic and prokaryotic cells such as mammalian cells, bacteria, archaea, yeasts, algae, and insects. ERS Genomics licenses these patents via its direct license from Emmanuelle Charpentier and now has nearly 150 licenses in place worldwide.

Financial details of the agreement are not disclosed.