On July 22, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Graduate School of Medicine / Faculty of Medicine, Osaka University (President: Shojiro Nishio "Osaka University") reported that Astellas Institute for Regenerative Medicine (a wholly owned subsidiary of Astellas, "AIRM"), Universal Cells (a wholly owned subsidiary of Astellas) and Osaka University have entered into a research collaboration to develop innovative pluripotent stem cell*1-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease (Press release, Astellas, JUL 22, 2024, View Source [SID1234644998]).

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Universal Cells holds the rights to Universal Donor Cell (UDC) technology to create cell therapy products from pluripotent stem cells that have reduced risk of immune rejection by genetically modifying Human Leukocyte Antigen (HLA) using gene editing technology.

Under the terms of the agreement, the three parties aim to combine the cartilage tissue creation protocol established by Professor Noriyuki Tsumaki of (Graduate School of Frontier Biosciences / Premium Research Institute for Human Metaverse Medicine) the Department of Tissue Biochemistry and Molecular Biology, Graduate School of Medicine, Osaka University, a leading researcher in cartilage diseases, Universal Cells’ UDC technology, and AIRM’s exceptional R&D expertise in cell therapy, and jointly create an innovative cell therapy for intervertebral disc degenerative disease.

Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer (CScO) of Astellas
"Astellas is committed to achieving our VISION of being "on the forefront of healthcare change, turning innovative science into VALUE for patients". We hope to provide our cutting-edge UDC technology to academia and startups globally, and deliver next-generation cell therapies to patients. This partnership is an important step in the open innovation using UDC technology."

Professor Noriyuki Tsumaki, M.D., Ph.D., (Graduate School of Frontier Biosciences / Premium Research Institute for Human Metaverse Medicine) Department of Tissue Biochemistry and Molecular Biology, Graduate School of Medicine, Osaka University
"We believe that our cartilage-like tissue has the potential to regenerate intervertebral discs. We hope that combining our research with Astellas’ UDC technology and R&D cell therapy system will accelerate and realize the development of regenerative therapies to treat intervertebral disc degenerative disease."

On July 22, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. ("Amoytop") (Press release, Aligos Therapeutics, JUL 22, 2024, View Source [SID1234644997]).

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Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China.

"We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner," stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. "We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach."

ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date.

PEGBING, independently developed by Amoytop, is the world’s first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer.

"We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need," said Sun Li, Chairman and Chief Executive Officer at Amoytop. "Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations."

The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks.

On July 22, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that positive feedback has been received from the US Food and Drug Administration ("FDA") regarding the planned TACTI-004 Phase III trial of eftilagimod alfa ("efti") in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression (Press release, Immutep, JUL 22, 2024, View Source [SID1234644994]).

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The FDA feedback from this Type C meeting, along with feedback previously received from the Paul-Ehrlich-Institut ("PEI") and the Spanish Agency for Medicines and Health Products ("AEMPS"), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a significant step forward to develop an effective treatment for non-squamous and squamous 1L NSCLC patients who have high, low, or no PD-L1 expression and are eligible for anti-PD-1 therapy.

The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials.

"We are pleased with the FDA’s feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage development process for efti centred on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression," stated Christian Mueller, Immutep’s SVP, Regulatory and Strategy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

TACTI-004 (Two ACTive Immunotherapies-004) Registrational Phase III Trial Design
TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical trial to evaluate Immutep’s efti in combination with KEYTRUDA and standard chemotherapy compared to the standard-of-care, KEYTRUDA in combination with chemotherapy and placebo in first-line metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis. The trial will be conducted globally and enrol approximately 750 NSCLC patients (including both squamous and non-squamous subtypes).

About Eftilagimod Alfa (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

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 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.