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 22, 2024 NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) reported that they have signed a Master Services Agreement (MSA), which will facilitate the production of actinium-225 (Ac-225), a critical medical isotope used to kill cancer cells while minimizing the impact to healthy tissues (Press release, NorthStar Medical Radiostopes, JUL 22, 2024, View Source [SID1234645010]).

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Medical isotopes are essential for a wide range of diagnostic and therapeutic procedures, including cancer treatments and advanced imaging techniques. Pursuant to the multi-year MSA, the companies will work together to process and purify radium-226 that will be irradiated to produce Ac-225. The scope of the agreement also includes potential target design projects and exploration of opportunities to provide backup supply to each other’s customers.

Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, "We are pleased to enter into this agreement with NorthStar. This collaboration is a significant step forward in our mission to support healthcare providers and patients by providing high-quality medical isotopes. Together, we are accelerating our radium-226 target design and fabrication efforts and establishing another irradiation relationship that will enable us to expand our production of Ac-225."

BWXT Medical will collaborate closely with NorthStar, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, to streamline production processes, enhance safety protocols and innovate new methods of isotope generation. This collaboration will leverage the strengths of both organizations, combining cutting-edge technology with extensive industry knowledge.

"At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialization of effective new radiodiagnostics and radiotherapies that can potentially be applied to devastating cancers and rare, complex conditions," said Dr. Frank Scholz, NorthStar’s president and chief executive officer. "This agreement could be instrumental to the radiopharmaceutical industry and patient health. We are excited to collaborate with BWXT on actinium production and believe our complementary technical capabilities will play a critical role in bringing novel therapies to patients who so urgently need them."

BWXT Medical recently announced that it has submitted a Drug Master File (DMF) for Actinium-225 API to U.S. Food and Drug Administration (FDA). DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.

An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later stage clinical studies and, ultimately, new drug applications.

On July 22, 2024 TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) in a best efforts public offering (Press release, TransCode Therapeutics, JUL 22, 2024, View Source [SID1234645046]). All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company.

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ThinkEquity is acting as the sole placement agent for the offering.

The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from the offering primarily for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, and related investigational new drug (IND) enabling studies, and for working capital and other general corporate purposes.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-268764), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 13, 2022, and declared effective on December 16, 2022. The offering will be made only by means of a written prospectus forming part of the effective shelf registration statement. A preliminary prospectus supplement describing the terms of the offering, and an accompanying prospectus has been or will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

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."