On September 12, 2024 Epitopea, a transatlantic cancer immunotherapeutics company developing accessible off-the-shelf RNA-based immunotherapies, reported it has been awarded a grant of just over £500,000 (approximately $658,000 USD) from Innovate UK (Press release, Epitopea, SEP 12, 2024, View Source [SID1234646527]).

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Epitopea was selected to receive funding from Innovate UK’s £12 million Cancer Therapeutics programme (1), which will provide a non-dilutive grant in support of research that is aimed at developing both therapeutic vaccines and T cell receptor-based therapies targeting antigens that are differentially presented by stromal cells. This class of therapies has the potential to impact patient outcomes given the well-established role of stromal cells in thwarting a therapeutic response to many established therapies.

The antigens in question were discovered by Epitopea’s CryptoMapTM platform, which enables targeting of a new class of untapped tumor specific antigens, known as CryptigenTM TSAs, that are broadly shared across multiple patients with the same tumor type. Epitopea intends to leverage these aberrantly expressed CryptigenTM TSAs to expand its therapeutic pipeline of RNA immunotherapies aimed at extending the durability of patient responses.

Dr. Jon Moore, Epitopea’s CSO, said:

"We believe better cancer therapies are needed to transform the lives of patients, especially in hard-to-treat solid tumors where overall survival can still be poor. Targeting stromal cells with immunotherapeutics represents an attractive and highly differentiated approach that we believe may translate into a deeper, more durable therapeutic response. We are therefore delighted that we have secured this grant support from Innovate UK’s Cancer Therapeutics programme, in recognition of our work developing life-changing cancer therapeutics."

Dr Karen Spink, Head of Medicines at Innovate UK, said:

"We are excited to see the diversity of businesses that have been supported through our Cancer Therapeutics programme. The industry-led R&D projects will advance transformative treatments for a range of cancers. This portfolio of investments will diversify the pipeline of targeted, safe, and effective therapies for cancer patients."

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 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.

On September 11, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sep. 13-17 (Press release, MEDIAN Technologies, SEP 11, 2024, View Source [SID1234646522]). Median iCRO and eyonis teams will be present to welcome interested parties at Booth #525, Hall 3, from September 13-16 (exhibition dates). The Company will share the most recent advances for iCRO AI-powered clinical trial imaging services as well as latest developments for eyonis Lung Cancer Screening (LCS) Software as Medical Device (SaMD).

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Median eyonis team will present a peer-reviewed poster presentation of the full positive results of the independent verification study for Median proprietary SaMD eyonis Lung Cancer Screening (LCS). Preliminary results of the study were communicated on January 17, 2024. This independent verification study is part of a process in medical device development required by regulators; it ensures devices meet stringent regulatory standards and defined product requirements. The independent verification study was completed prior to the pivotal independent standalone validation study, REALITY, for which highly positive results were communicated on August 29, 2024.

Poster presentation: #1192P: Optimizing Lung Cancer Screening: Independent Verification of an AI/ML Computer-Aided Detection and Characterization Software as Medical Device

Authors: S. BODARD1, C. M VOYTON2, P. BAUDOT2, E. GEREMIA2, P. SIOT2, G. DE BIE2, V. LE2, D. FRANCIS2, B. RENOUST2, B. HUET2 – [1] Université de Paris Cité, AP-HP, Paris, France, [2] Median Technologies, Valbonne, France.

Onsite display date: Sep 15, 2024

Poster Session: New Diagnostic Tools

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered computer aided diagnostic device that uses machine learning (ML) to help analyze imaging data generated with low-dose computed tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About ESMO (Free ESMO Whitepaper): The annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress is one of the most widely attended and highly regarded global oncology conferences. It attracts clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world for presentations and discussions on the latest cutting-edge research from academia and industry. For more information about the ESMO (Free ESMO Whitepaper) Congress 2024, visit View Source