On July 22, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of four abstracts for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place September 13-17 in Barcelona (Press release, Bicycle Therapeutics, JUL 22, 2024, View Source [SID1234644999]).

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Poster Presentation Details:

Title: BT8009 monotherapy in enfortumab vedotin-naïve patients with metastatic urothelial carcinoma (mUC): Updated results of Duravelo-1
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept. 14, at 9-10 a.m. CEST
Presentation Number: 652P
Speaker: Oscar Reig Torras, M.D., Hospital Clinic de Barcelona

Title: Peripheral neuropathy following treatment with Bicycle Toxin Conjugates BT8009 or BT5528 monotherapy in patients with advanced solid tumors
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept. 14, at 9-10 a.m. CEST
Presentation Number: 654P
Speaker: Bernard Doger de Spéville, M.D., Ph.D., START Madrid-FJD and Hospital Universitario Fundacion Jimenez Diaz

Title: EphA2-targeting Bicycle Toxin Conjugate BT5528 in patients with advanced solid tumors: A phase 1/2 study
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept.14, at 9-10 a.m. CEST
Presentation Number: 647P
Speaker: Elisa Fontana, M.D., Ph.D., Sarah Cannon Research Institute UK

Title: Initial results from a phase 1/2 study of BT7480, a novel Nectin-4/CD137 Bicycle Tumor-Targeted Immune Cell Agonist, in patients with advanced solid tumors
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept.14, at 9-10 a.m. CEST
Presentation Number: 650P
Speaker: Kyriakos P. Papadopoulos, M.D., START San Antonio

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.

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."