On September 12, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported an update on the safety review of the first 3 participants enrolled in cohort 4 of the SECuRE trial who received 2 doses of 67Cu-SAR-bisPSMA (Press release, Clarity Pharmaceuticals, SEP 12, 2024, View Source [SID1234646526]). Cohort 4 is the final cohort in the dose escalation phase of the study, with participants receiving a minimum of 2 and a maximum of 4 doses of 67Cu-SAR-bisPSMA at 12GBq.

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with prostate-specific membrane antigen (PSMA)-expressing metastatic castrate-resistant prostate cancer (mCRPC) using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 44 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

Cohort 4 is the first to explore the safety and anti-cancer effects of multiple therapy cycles of 67Cu-SAR-bisPSMA at the highest dose of 12GBq. This is the last cohort of the dose escalation phase, before the trial advances into its Phase II stage (cohort expansion) in 14 participants, pending safety evaluation.

Cohort 4 is designed as a "3+3" cohort, where participants will receive a minimum of 2 therapy cycles. Based on the positive safety profile observed in the first 3 cohorts of the SECuRE trial, a change to the dosing schedule of cohort 4 from "2 doses" to "up to 4 doses" has previously been approved by the SRC. This will allow participants who are benefiting from 67Cu-SAR-bisPSMA to receive 2 additional doses under the SECuRE trial (up to 4 doses in total) (Figure 1).

Safety & Efficacy
The SRC has reviewed the safety data of the first 3 participants of cohort 4 who have received 2 cycles of 67Cu-SAR-bisPSMA, and no DLTs have been observed to date. Two participants have completed the DLT period, and 1 participant will complete the DLT period by the end of September. Almost all AEs were mild to moderate, with the majority having resolved or improved at the last assessment. In the final participant who is yet to complete the DLT period, the only AE reported to date was nausea, which has resolved.

Early preliminary efficacy assessment shows a reduction in PSA levels following treatment in both participants who have completed the DLT period. In the weeks following the last therapy dose, these participants have already exhibited PSA drops of more than 60%. The largest drop in PSA to date was a fall of 92.3% (from a baseline PSA of 157.4 ng/mL), and it continues to decline based on the latest assessment. This participant, who had failed several lines of therapy prior to receiving 67Cu-SAR-bisPSMA (i.e. androgen deprivation therapy [ADT], androgen receptor pathway inhibitor [ARPI] and an investigational agent through a clinical trial), has already had a radiographic partial response based on Response Evaluation Criteria in Solid Tumours v1.1 (RECIST) assessment, with a reduction of 60.6% in tumour volume evaluated by PSMA positron emission tomography (PET) imaging thus far (Figure 2).

On September 11, 2024 HanX Biopharmaceuticals reported that HX044 had received clinical trial approval from the Bellberry Human Research Ethics Committee (HREC) in Australia (Press release, HanX Biopharmaceuticals, SEP 11, 2024, View Source [SID1234655962]). HanX’ application, which complies with the requirements of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2023), approved the conduct of a Phase I clinical trial: HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies.

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HX044 is a first-in-class investigational bispecific antibody for cancer immunotherapy developed independently by Hans-Iitra. Preclinical studies have demonstrated enhanced potency and a wider therapeutic window compared to previous-generation immunotherapy inhibitors , while also demonstrating promising results in tumor models refractory to immunotherapy inhibitors ("cold tumors"). Hans-Iitra has completed all necessary preclinical development, including GMP manufacturing and GLP toxicology studies, and plans to initiate Phase I single-agent dose escalation trials in humans across various solid tumors in Australia and China.

Dr. Qixiang Li, CEO/Chief Scientific Officer of HansItai, said: "The approval of HX044 for clinical trials is a new important milestone for HansItai. H044 is a new type of cancer immunotherapy bispecific antibody that we independently developed from molecular design. Through the close cooperation and efforts of all departments of HansItai, HX044 was approved for clinical trials very smoothly, further strengthening the company’s clinical layout in the cancer immunotherapy pipeline, and fully demonstrating the company’s innovation and R&D strength in cancer immunotherapy. We will quickly advance this clinical trial and look forward to seeing the potential for efficacy as soon as possible and helping patients as soon as possible."

On September 11, 2024 ImmuneOnco Biopharma reported on a voluntary basis to inform shareholders and potential investors of the Company about the latest business development of the Group (Press release, ImmuneOnco Biopharma, SEP 11, 2024, View Source [SID1234655703]).

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Reference is made to the announcements of the Company dated August 1, 2024 and August 22, 2024, in relation to the entry into a license and collaboration agreement (the "License and Collaboration Agreement") dated August 1, 2024, between the Company and SynBioTx Inc. ("SynBioTx") and the upfront payment received under the License and Collaboration Agreement.

The board (the "Board") of directors ("Directors", and each a "Director") of the Company is pleased to announce that the Company has received a near-term payment of US$5 million from SynBioTx in line with the License and Collaboration Agreement. As of the date of this announcement, the Company has received an upfront and near-term payment in aggregate of US$15 million under the License and Collaboration Agreement. Pursuant to the License and Collaboration Agreement, the Company expects to receive the remaining potential nearterm payments of up to US$35 million in the future.

ABOUT IMM2510
IMM2510, independently developed by the Group, is a bispecific molecule with a mAbTrap structure targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1). IMM2510 can inhibit angiogenesis, leading to tumor shrinkage, and sensitize tumor cells to immune responses, while activating T cells, NK cells, and macrophages via the blockade of PD-L1/programmed cell death protein 1 (PD-1) interaction and the induction of Fc-mediated antibody-dependent cellular cytotoxicity (ADCC)/antibody-dependent cellular phagocytosis (ADCP) activity.

ABOUT IMM27M
IMM27M is a new generation cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody with enhanced ADCC activity. It can induce potent immune responses targeting CTLA-4 overexpressed immune-suppressive Treg cells and promote Treg depletion from the tumor microenvironment (TME), thus enhancing T-cell antitumor response.

On September 11, 2024 Radiant Biotherapeutics, a preclinical biotechnology company developing an antibody platform to deliver transformative therapies for patients facing life-changing disease, reported it has closed a $35 million Series A financing (Press release, Radiant Biotherapeutics, SEP 11, 2024, View Source [SID1234646524]). The round is co-led by the Bill & Melinda Gates Foundation and Amplitude Ventures of Canada.

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Additional participants in the Series A include new investors BDC Capital, the investment arm of the Business Development Bank of Canada, through its Thrive Venture Fund, and abrdn, an investment fund managed by abrdn Inc.; and existing investors FACIT, Alexandria Venture Investments and Toronto Innovation Acceleration Partners (TIAP).

Radiant has built a best-in-class, proprietary, multi-valent, multi-specific antibody platform called Multabody. The funds will enable Radiant to further develop the company’s lead clinical candidate, 4-1BB, and move it towards clinical trials.

"These supportive investors share our vision of delivering powerful, multi-functional biologics with the potential to advance treatments for patients suffering from debilitating and life-threatening illnesses," said Arthur J. Fratamico, President and CEO of Radiant. "This investment enables us to further demonstrate the unique power and breadth of our platform across multiple therapeutic areas with a focus in oncology, inflammation and immunology, and global health and infectious disease including HIV."

Multabody therapeutics are able to overcome the shortcomings of existing antibody approaches by leveraging remarkable avidity, or binding strength, on their intended targets. Multabodies also exploit multi-specificity, enabling targeting of different disease-modifying proteins as well as multiple epitopes on the same target. Together, these qualities give Multabody therapeutics exceptional potency against both solid tumors and blood cancers, infectious disease pathogens, and other targets in multiple therapeutic areas.

"This financing will enable the next stage in Radiant’s growth and move the company towards the clinic as it continues to demonstrate the superiority of the Multabody platform against therapeutic targets that cannot be treated with traditional antibodies," said Bharat Srinivasa, Ph.D., principal at Amplitude Ventures. "We are investing to accelerate Radiant’s transition to clinical stage and to expand its pipeline in additional therapeutic areas."

Radiant Biotherapeutics was founded in 2020 and is built around foundational science developed at The Hospital for Sick Children (SickKids) in Toronto and the University of Toronto, based on and including work performed at the laboratories of Jean-Philippe Julien, Ph.D., senior scientist at SickKids and associate professor at University of Toronto’s Temerty Faculty of Medicine, and Bebhinn Treanor, Ph.D., a professor at the University of Toronto. The company emerged from stealth mode in 2023 following a seed investment led by Amplitude Ventures, FACIT, TIAP and Alexandria Venture Investments. Radiant maintains offices in Toronto and Philadelphia.

On September 11, 2024 NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, reported that it will present three studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438) (Press release, NeoGenomics Laboratories, SEP 11, 2024, View Source [SID1234646523]). NeoGenomics’ data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization.

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"Emerging technologies leveraging ctDNA and NGS are increasing our ability to identify cancers in high-risk patients, which was previously beyond reach," said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. "Collectively, our findings demonstrate the potential of advanced molecular diagnostics to detect cancer earlier, guide more personalized treatments, and ultimately improve patient outcomes worldwide."

NeoGenomics’ poster presentations include:

Real-World Analysis of Actionable Gene Fusions Identified by NGS and Correlation with IHC in 422 Patients from the Community (78P)
Presentation Date: Sunday, September 15, 2024
Results show that testing for 19 drug-targetable fusions can identify up to four times more patients for matched therapies compared to testing only for NTRK fusions or using IHC, suggesting that NGS testing for multiple fusions could greatly expand treatment options for cancer patients.
ctDNA-Lung-Detect: Profiling of Non-Shedding ctDNA Early Stage Resected Non-Small Cell Lung Cancers (1236P)
Presentation Date: Saturday, September 14, 2024
This study represents one of the largest prospective cohorts of ctDNA assessments in early-stage non-small cell lung cancer (NSCLC), identifying patients at high risk of relapse who may benefit from more aggressive treatment.
CLEAR-Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients with High-Risk Melanoma (226TiP)
Presentation Date: Sunday, September 15, 2024
This Phase II trial evaluated ctDNA as a marker to guide treatment decisions in high-risk melanoma patients. It compares the effectiveness of combining anti-LAG-3 with anti-PD-1 therapy versus anti-PD-1 inhibition alone.
For more details on NeoGenomics’ presentations, visit ESMO (Free ESMO Whitepaper) 2024.