Indapta Therapeutics Announces First Patients Treated with IDP-023 Allogeneic Natural Killer (NK) Cell Therapy for Cancer

On January 11, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, reported that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma (Press release, Indapta Therapeutics, JAN 11, 2024, View Source [SID1234639209]). The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia.

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The first patient received a single dose of IDP-023. The second patient has received the first of three planned doses of IDP-023. Subsequent cohorts of patients will receive three doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive treatment with IDP-023 in combination with the monoclonal antibodies rituximab and daratumumab, respectively.

"We are excited to transition to a clinical stage company," said Dr. Mark Frohlich, CEO of Indapta. "Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase 1 trial."

Indapta also announced that it has successfully manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024. "We are very pleased with the high yields we are achieving in our GMP production runs," added Frohlich. "The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch."

Indapta’s Differentiated G-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "G minus" NK cells, or "g-NK" that markedly improve the cancer killing power of monoclonal antibody (mAb) therapy, without the need for genetically engineering the cells. G-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells. Indapta’s off-the-shelf g-NK cell therapy is further differentiated from other NK cell therapies in that it is a cryopreserved product with low variability.

Indapta’s g-NK are capable of releasing dramatically more immune activating cytokines and cancer-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2020, View Source)

Xcell Biosciences Announces Collaboration with ElevateBio to Advance Technology Development for Cell and Gene Therapies

On January 11, 2024 Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, reported a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies (Press release, Xcell Biosciences, JAN 11, 2024, View Source [SID1234639210]). As part of this collaboration, ElevateBio becomes the first member of Xcellbio’s beta program for its new AVATAR Foundry device. In addition, Michael Paglia, Chief Technology Officer at ElevateBio’s BaseCamp, has joined Xcellbio’s Scientific Advisory Board.

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ElevateBio is a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate the development of genetic medicines. The company’s integrated ecosystem combines its BaseCamp process development and current Good Manufacturing Practice (cGMP) manufacturing business with its technology stack that includes gene editing, cell engineering technologies, and viral and non-viral delivery.

"At BaseCamp, we work with industry partners to design the best process for their product and recognize the importance of emerging technologies that will revolutionize how cell and gene therapies are manufactured," said Mr. Paglia. "I am excited to join the Xcellbio advisory board and look forward to joining Brian and the team on the collaboration with BaseCamp."

As part of this collaboration, ElevateBio BaseCamp scientists will have access to Xcellbio’s AVATAR incubator system for cell therapy research and development as well as two new platforms: the AVATAR Ai system for measuring the potency of cell therapies and the AVATAR Foundry system for cGMP cell therapy manufacturing. The AVATAR and AVATAR Foundry systems are used to metabolically reprogram therapeutic cells to improve their potency and persistence in the tumor microenvironment (TME), while the AVATAR Ai provides real-time analysis of tumor cytotoxicity under TME conditions. These collaborative efforts should streamline manufacturing protocols for cell and gene therapies.

Brian Feth, co-founder and CEO at Xcellbio, commented: "We are delighted to collaborate with ElevateBio, a true leader in the cell and gene therapy field, and we look forward to one day having a collective impact in how these important treatments are used to improve healthcare. We also welcome Mike to our advisory board and are eager for his contributions to our own R&D programs in that capacity."

The beta program for Xcellbio’s AVATAR Foundry system is now open. To learn more, meet with the Xcellbio team at Advanced Therapies Week taking place in Miami from January 16-19 or visit View Source

Puma Biotechnology to Present at B. Riley Securities 4th Annual Oncology Conference

On January 11, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the "Company"), reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company on January 18, 2024 at the virtual B. Riley Securities 4th Annual Oncology Conference: Tumor-ow’s Titans – Finding Value in (Near-) Commercial Oncology Companies (Press release, Puma Biotechnology, JAN 11, 2024, View Source [SID1234639211]).

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For access to Mr. Auerbach’s live presentation at 2:00 p.m. ET on January 18, please contact your B. Riley representative. A replay of the presentation will be available on Puma’s website after 5:00 p.m. ET at View Source

Ariceum Therapeutics files for UK Clinical Trial Authorisation (CTA) to test its First-in-Class Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma

On January 10, 2024 Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported it has submitted an application with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 trial of 123I-ATT001, its Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma (Press release, Ariceum Therapeutics, JAN 10, 2024, View Source [SID1234639178]).

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The application comes shortly after Ariceum acquired Theragnostics Ltd, announced in June 2023, the private UK-based biopharmaceutical company which undertook the initial development work on 123I-ATT001. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics said: "Glioblastoma is the most aggressive and most common type of malignant brain tumour in adults, with a very poor prognosis for survival and currently no cure. 123I-ATT001 is a targeted Auger electron therapy that has demonstrated promising pre-clinical results, and we are delighted to be in a position to file for clinical trial authorisation in the UK so soon after integrating Theragnostics into Ariceum Therapeutics. Not only is this an important step towards finding a cure for glioblastoma patients but it paves the way for Ariceum to further investigate this powerful molecular radiotherapy for the treatment of other solid tumour indications."

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair themselves. This radioisotope then emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a regular cyclotron.

Ariceum is exploring 123I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.

The announcement comes as Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, is in San Francisco attending the Biotech Showcase from 8-10 January 2024. Please get in touch if you would like to arrange a meeting.

Dxcover Announces Three New Clinical Trials for Brain, Colorectal and Lung Cancer Detection

On January 10, 2024 Dxcover Limited, a clinical-stage diagnostics company pioneering multi-omic spectral analysis (MOSA) for early detection of multiple cancers, reported that it is initiating three pivotal clinical trials measuring efficacy of the company’s liquid biopsy technology for the detection of brain, colorectal and lung cancer (Press release, Dxcover, JAN 10, 2024, View Source [SID1234639195]).

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The company has launched its EMBRACE study, a 2,200-patient trial focused on the early detection of brain cancer. Dxcover Brain Cancer is a qualitative in vitro diagnostic (IVD) test analyzing blood serum by infrared spectroscopy to detect the signals indicative of brain cancer. This highly sensitive test is to help determine the necessary treatment of patients presenting vague symptoms in primary care environments. The results of the test would prioritize individuals who require a confirmatory brain scan, potentially enabling earlier detection to save lives and reduce healthcare costs. The Dxcover Brain Cancer test has been developed over four years with clinical support from NHS Lothian. This pivotal study is partially funded by a €2.5m grant from the European Innovation Council.

The CREATE2 trial will be conducted to evaluate diagnostic accuracy for colorectal cancer and high-risk adenoma in patients undergoing a colonoscopy. The study will have two recruitment pathways, one in the US and one in the UK, each with 700 patients. The US cohort will be assessed in the average risk population 45-84 who are intending to undergo a screening colonoscopy, while the UK cohort will be assessed post-referral at colonoscopy. CREATE2 aims to validate the previous CREATE study which showed Dxcover’s ability to achieve accurate detection of pre-cancerous lesions and stage 1 colorectal cancer, detection at these stages will enable a positive impact on patients’ lives.

The SPIRALS trial is focused on the management of indeterminant pulmonary nodules by scanning for nodules in the size range between 0.8 – 3.0 mm range. At this size range the nodules are small, however 80% have an intermediate risk score where next steps are unclear resulting in unnecessary surgery and missed cancer diagnoses. Dxcover will be analyzing more than 1,800 samples in order to provide a rapid, cost-effective tool that can help patients receive the correct next steps in their journey.

"Each cancer follows a unique development path, and these are important trials to assess brain, colorectal and lung cancer separately to zero in on the distinct triggers of each disease and, based on the results, identify the most effective treatment for each patient," said Professor Matthew Baker, Founder and CEO, Dxcover. "As the medical community gathers this week in San Francisco for what is always one of the most significant gatherings in the healthcare industry, I’m looking forward to meeting with like-minded partners whose mission is to eradicate the devastating effects of cancers. At Dxcover, we are firm believers that the key to improving patient outcomes lies in the early detection of cancer, expanding intervention and treatment options. Not only does this have the potential to enhance the efficacy of medical intervention, but also contributes to prolonging and promoting healthier lives."

The Dxcover Cancer Liquid Biopsy test uses Fourier transform infrared (FTIR) spectroscopy and machine learning algorithms to build a classifier of the resultant spectral profiles to detect cancer and can be fine-tuned to maximize either sensitivity or specificity depending on the requirements of specific disease pathway.