On July 21, 2024 GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE 6814) reported that it has formally signed an international strategic cooperation agreement (Press release, GC Cell, JUL 21, 2024, View Source [SID1234644995]).

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GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of the renowned Korean-listed pharmaceutical group GC Biopharma Corp.

This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other’s strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients.

Having successfully completed clinical trials in Japan and Korea, GC Cell’s Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas’s LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement.

Taiwan’s government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas’s LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan’s cell therapy landscape, with a focus on domestic growth and global market expansion. Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital.

Lukas’ Chairman, Dr. Eric Tang, highlighted that GC Cell and Lukas will collaborate through a Joint Committee (JC) to exchange expertise and experience in researching memory T cell technology for various cancers in their respective countries. This collaboration involves sharing clinical and commercial knowledge, insights, and strategies, as well as exploring opportunities for cross-licensing and conducting joint clinical trials (IITs and SITs) in each other’s regions. Moreover, they aim to discuss the opportunities to jointly explore new international markets, joint investment and beyond.

James Park, CEO of GC Cell, stated, "This strategic cooperation agreement represents a pivotal milestone in accelerating the advancement of innovative cell therapies in Korea and Taiwan and also in establishing global network and ecosystem of Cell and Gene Therapy. Looking ahead, we are committed to accelerating the global expansion of Immuncell-LC through the continuous exchange of clinical research data and the establishment of a strong, long-term partnership between our two companies."

Dr. Eric Tang, Chairman of Lukas stated that: "In addition to our clinical trial for preventing liver cancer recurrence, the Taiwanese government’s implementation of the Special Regulations on Regenerative Medicine has allowed us to apply our LuLym-T cell technology on advanced stage cancer patients with various types of solid tumors. We have accumulated vast clinical experience in concomitant use of LuLym-T cell together with conventional treatment, such as: chemotherapy, radiotherapy, and checkpoint inhibitors. We are able to achieve significant prognostic improvements using a multi-modality treatment paradigm for advanced stage cancers and we hope we will be able to help more cancer patients in need by sharing our experience with other countries".

This strategic cooperation represents a significant step toward a shared vision of improving patient outcomes through innovative cell therapies and precision medicine.

About Immuncell-LC

Immuncell-LC is the only commercially available treatment option of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events. 

On July 21, 2024 The University of Oxford ("Oxford"), one of the world’s leading research institutions and Apollo Therapeutics ("Apollo"), a portfolio biopharmaceutical company, reported the signing of a drug discovery and development collaboration aimed at translating breakthroughs made by biomedical researchers at Oxford (Press release, Apollo Therapeutics, JUL 21, 2024, View Source [SID1234644996]).

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Under the agreement, Apollo will identify and assess novel, validated therapeutic targets from Oxford’s researchers for their potential to become important new medicines. Whilst Oxford’s research teams will gain access to therapeutic development expertise and programme funding from Apollo. This will provide more access to clinical trials for patients and deliver faster routes to market for new medicines arising from Oxford’s researchers.

The collaboration is driven by the quality of science and the burgeoning innovation environment at Oxford that has elicited a critical mass of early drug development translational research programmes. Apollo’s drug discovery experts will look for the potential to transform the standard of care globally by supporting the development of new medicines across areas such as oncology and immunological and inflammatory disorders.

Science and Technology Secretary, Peter Kyle, Department for Science, Innovation & Technology, said: "We want to harness life sciences to transform the UK’s healthcare and drive economic growth. Together, Apollo and Oxford University could deliver new medicines to help us tackle cancer, autoimmune disease, and more, improving and saving thousands of lives."

"The life sciences sector is open for business under this Government. We know that the best and boldest breakthroughs happen when industry and academia join forces, backed by government, and this partnership between Apollo and Oxford is proof of exactly what can be unlocked, when we open the doors to collaboration."

Professor Chas Bountra, Pro-Vice Chancellor for Innovation at the University of Oxford, said:

"My amazing colleagues at Oxford have numerous cutting-edge research programmes for producing novel therapeutics for patients. Apollo Therapeutics has assembled a world leading team of drug discovery and development experts. Together we are going to transform the lives of millions of patients. I am immensely excited about this collaboration."

This latest collaboration, Apollo’s sixth agreement with a university or academic research centre, will bring the in-house expertise and resources of Apollo to Oxford’s world class researchers from across the university. It will further bolster Apollo’s scalable R&D platform for the evergreen discovery and development of new medicines.

Dr. Richard Mason, Chief Executive Officer of Apollo Therapeutics, said:

"At Apollo Therapeutics we are ambitious in our mission to translate important new research discoveries into valuable new drugs. We are therefore delighted to be collaborating with the University of Oxford, a university that is consistently at the top of global rankings for scientific research and innovation. We are now working together with six of the world’s top universities and research centres to transform the standard of care in major commercial markets based on breakthroughs in biology and basic medical research made by scientists at these institutions."

The University of Oxford joins Apollo’s other five world-class research institutions: the University of Cambridge, Imperial College London, University College London, King’s College London and the Institute of Cancer Research.

Dr. Mairi Gibbs, Chief Executive Officer of Oxford University Innovation, said:

"We’re keen to provide our academic researchers with multiple avenues to realise the full potential of their cutting-edge research as quickly as possible. If we boost the funding and expertise provided to very early phase drug development programmes this will hasten their progress towards becoming medicines with the potential to licence to industry or become spinout companies. With the support of the research commercialisation team at Oxford University Innovation and our investment partners, we want to speed up the development of more life-saving medicines to help patients most in need."

On July 19, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Bristol-Myers Squibb, JUL 19, 2024, View Source [SID1234644972]). The application was based on results from the Phase 3 CheckMate -9DW trial and validation of the application confirms the submission is complete and begins the EMA’s centralized procedure review.

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"Approximately 62,000 cases of liver cancer are diagnosed annually in the European Union, with HCC being the predominant type. Despite recent treatment advances, the prognosis remains poor for patients in more advanced stages which highlights the need for therapies with better clinical outcomes," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. "We look forward to working with the EMA to advance our application for Opdivo plus Yervoy to provide a new first-line dual immunotherapy combination treatment option for adult patients with unresectable or advanced hepatocellular carcinoma in the European Union."

In the Phase 3 CheckMate -9DW trial, Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to investigator’s choice of lenvatinib or sorafenib, which showed the clinical benefit of the combination treatment option when provided in the first-line setting. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Results were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 CheckMate -9DW clinical trial.

About CheckMate -9DW

CheckMate -9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.

Approximately 668 patients were randomized to receive Opdivo plus Yervoy (Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg for a maximum duration of 2 years) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.

About Hepatocellular Carcinoma

Liver cancer is the third most frequent cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 75% – 85% of all liver cancers. HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.

Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.

On July 18, 2024 – Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; "Ono") reported that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib, a colony stimulating factor 1 receptor (CSF1R), for the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc. ("Deciphera"), a wholly-owned subsidiary of Ono (Press release, Deciphera Pharmaceuticals, JUL 19, 2024, View Source [SID1234644952]). The review of the MAA begins under the EMA’s centralized review process for all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. Vimseltinib was granted Orphan Drug Designation for the treatment of TGCT by the EMA in December 2019.

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"Building upon positive results from the MOTION pivotal Phase 3 study, we are excited to initiate the regulatory review process in the EU and we are one step closer in our mission to bring vimseltinib to TGCT patients in need of an effective and well-tolerated treatment" said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals.

The submission is supported by the data from the pivotal Phase 3 MOTION study, evaluating the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior antiCSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo. In the study, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). Additionally, vimseltinib demonstrated statistically significant and clinically meaningful improvements versus placebo in all key secondary endpoints. The safety profile of vimseltinib is manageable and safety data from MOTION are consistent with data previously disclosed in the Phase 1/2 clinical trial of vimseltinib*. Data from the MOTION study was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

*: Gelberblom, et at. 2024 ASCO (Free ASCO Whitepaper) Annual Meeting

About the MOTION Study

The MOTION study is a two-part, randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed). The primary endpoint of the study is an objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo. The secondaryendpoint includes ORR per tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain, all assessed at Week 25. This study consists of two Parts. In Part 1, patients were randomized to receive either vimseltinib or placebo for 24 weeks. In Part 2, patients randomized to placebo in Part 1 have the option to receive vimseltinib, and all patients receive vimseltinib for a long-term period in an open-label setting.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare disease caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients who are not amenable to surgery, systemic treatment options are limited and a new therapeutic option for TGCT is needed.

About Vimseltinib

Vimseltinib is an investigational, oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform.

On July 19, 2024 GSK plc (LSE/NYSE: GSK) reported that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma (Press release, GlaxoSmithKline, JUL 19, 2024, View Source [SID1234644975]). The EMA’s Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 phase III head-to-head trials."

The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma. The DREAMM-7 trial is evaluating belantamab mafodotin combined with BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex.

A positive overall survival (OS) trend was observed in both trials but was not statistically significant at the time of interim analysis. Follow-up for OS continues. Results also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.1,2 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year, including approximately 50,000 new cases in Europe.3,4 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.5

About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety and patient reported and quality of life outcomes.

Results from DREAMM-7 were first presented6 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with PomDex compared to a combination of bortezomib and PomDex in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 75% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

A total of 302 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety and patient reported and quality of life outcomes.

Results from DREAMM-8 were first presented7 at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Refer to the Blenrep UK Summary of Product Characteristics8 for a full list of adverse events and the complete important safety information in the United Kingdom.