On May 20, 2024 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported that it will present results demonstrating the ability of its tissue-agnostic MRD assay to predict recurrence in head & neck cancer, during an Oral Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2024 (Press release, Adela, MAY 30, 2024, View Source;neck-cancer-at-the-american-society-of-clinical-oncology-2024-meeting-302158653.html [SID1234643884]).

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"MRD tests have the potential to enable clinicians to individualize patient treatment based on a patient’s likelihood of a future recurrence. In addition, these tests can assist with identifying patients who may benefit from being more closely monitored with imaging to detect and treat a recurrence as early as possible," said Geoffrey Liu, MSc, MD, Senior Scientist, University Health Network – Princess Margaret Cancer Centre. "We are highly encouraged by these results demonstrating the ability of this genome-wide methylome enrichment platform to identify recurrences in head & neck cancer in advance of clinical presentation or routine imaging."

The ability of Adela’s assay to quantify cfDNA cancer signal and predict recurrence was evaluated in individuals diagnosed with stage I-IVB human papillomavirus (HPV)-negative and HPV-positive head and neck cancer treated at University Health Network – Princess Margaret Cancer Centre. This training analysis included 432 plasma samples collected from 130 patients (a subset of the full cohort of >1,100 plasma samples from >300 individuals). Blood draws occurred before and after curative intent treatment, and in a subset of patients, at 12 and 24 months post-curative intent treatment. Adela’s MRD assay demonstrated the ability to identify patients more likely to recur than not, based on the landmark blood draw (mean 3 months following curative intent treatment), and also at the surveillance timepoints.

Significant differences in recurrence-free survival (RFS) were observed, with a hazard ratio (HR) of 6.31 (P<0.001) at the landmark timepoint, and an HR of 12.95 (P<0.001) for surveillance timepoints, when patients were stratified by MRD positivity. MRD status correlated with RFS in both HPV-positive and HPV-negative disease. Lead time between MRD positivity and recurrence was up to 19.3 months, with a mean lead time of 5.1 months.

"Up to 80% of recurrences in patients with head & neck cancer are not detected until symptoms or physical findings are reported by the patient1. Routine surveillance for recurrences with MRD testing can enable earlier detection and treatment of recurrences with immunotherapy," said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. "We are excited about the potential of our tissue-agnostic approach to MRD detection for both HPV-positive and HPV-negative head & neck cancer to address this strong unmet need."

Validation results from a held-out test set from the cohort will be presented at a future meeting. A Research Use Only (RUO) version of Adela’s MRD test is currently available to biopharmaceutical companies and other investigators for use in biomarker discovery and drug development. Adela plans to commercialize the test for clinical use in 2025.

Presentation Details

Abstract # 3009: Performance characteristics of a tissue-agnostic genome-wide methylome enrichment MRD assay for head and neck malignancies.
Geoffrey Liu2
Mon June 3, 2024 4:42 PM CDT
Hall D2

On May 30, 2024 Actym Therapeutics, reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to start a Phase 1 clinical trial of its lead drug candidate, ACTM-838 (Press release, Actym Therapeutics, MAY 30, 2024, View Source [SID1234643883]). The open-label monotherapy dose escalation study is designed to evaluate the safety, tolerability, payload delivery, and preliminary anti-tumor activity of escalating doses of ACTM-838, which represents the first drug candidate based on the company’s proprietary S. Typhimurium-Attenuated Cancer Therapy (STACT) platform to reach the clinic. ACTM-838 delivers immunomodulatory payloads, engineered IL-15plex (IL-15/ IL-15Ra) and STING, specifically to tumor-resident phagocytic antigen-presenting cells (APCs) in the tumor microenvironment (TME).

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"The immunosuppressive TME is a key challenge in the treatment of solid tumors, limiting the efficacy of many potentially effective anticancer drugs. Actym Therapeutics has developed an innovative technology to specifically deliver and express constitutively active STING in tumor-resident myeloid cells using a systemically administered therapy. IL-15plex expression adds complementary activity on B, T, and NK cells, achieving durable anti-tumor immunity," said Jason J. Luke, MD, FACP, a leading international physician-scientist specializing in the clinical development of immunotherapies for solid tumors. "Actym’s approach to modulating the TME has a unique potential to overcome these immunological barriers. Their lead candidate, ACTM-838, was shown to be safe and effective in preclinical studies and is now ready to enter the clinic."

"The IND clearance for ACTM-838 is a major milestone for Actym and potentially a significant step forward in harnessing the power of immunotherapy to treat patients with solid tumors more effectively," said Tom Smart, CEO of Actym. "It is terrific to see the vision and impressive work pioneered by Actym’s founders translated into a promising clinical-stage asset. As we advance our lead clinical program, we also look forward to further expanding the potential applications of our STACT biological platform by developing new product candidates in-house and in collaboration with pharmaceutical companies."

The Phase 1 (NCT06336148) open-label monotherapy dose escalation study with ACTM-838 will be conducted at clinical sites in the United States and Australia and will enroll patients with advanced solid tumors who have failed prior lines of therapy and have no clinically beneficial treatment options.

About STACT Biological Platform
Actym Therapeutics has engineered a new drug modality, STACT (Salmonella Typhimurium-Attenuated Cancer Therapy), harnessing the power of a genetically modified bacterial vehicle that safely introduces therapeutic payloads to activate the immune response in the tumor microenvironment (TME). It is a modular multi-faceted platform enabling cell-, microenvironment-, and tissue-targeted delivery of large combinatorial multiplexed payloads via safe systemic administration with engineered auxotrophy allowing for tissue-specific localization and enrichment for oncology and non-oncology indications. Expression of payloads, including therapeutic DNA, RNA, protein, peptide, and gene editing effectors, can be enabled in either the bacterial vehicle or targeted human cells. Actym’s proprietary platform enables tumor-localized expression of payloads at levels that are not tolerated systemically, and the ensuing local engagement of both innate and adaptive anti-tumor immunity.

About ACTM-838
ACTM-838 is Actym’s first clinical asset utilizing the STACT Platform to deliver immune-modulatory payloads specifically to the tumor-resident, phagocytic antigen-presenting cells (APCs) in the TME. After a rigorous process to identify optimal payloads, the locally expressed IL-15 superagonist, IL-15plex (IL-15/ IL-15Ra), and the constitutively active engineered STING (eSTING) were selected. Separately, each payload has been clinically validated to mediate anti-tumor immunity when administered locally. Combined, Actym has shown these payloads have exceptional synergistic activity in preclinical models. When expressed in the TME by ACTM-838, their complementary mechanisms result in an effective durable anti-tumor immunotherapy that can be safely administered systemically.

Engineered to be auxotrophic for adenosine metabolites, ACTM-838 localizes to the TME where it survives and proliferates in the adenosine-rich tumor milieu. It is phagocytosed by APCs and delivers IL-15-plex and eSTING transgenes to these cells that subsequently express the proteins in the local TME. Phagocytosis of the accumulated STACT chassis in the TME initiates activation of innate immunity. Local expression of eSTING further stimulates the innate immune system by triggering type I interferon (IFN) pathways and other cytokines. This switches the immunosuppressive TME from a pro-tumor Th2/M2 TME to an anti-tumor Th1/M1 and activated NK immune phenotype, priming a new T cell response. Locally expressed IL-15-plex additionally supports the activation and viability of NK and B cells as well as existing and newly primed T cells. Through this multifaceted mechanism, ACTM-838 engages both innate and adaptive immunity to generate a comprehensive, robust, and durable anti-tumor immune response in the body. The Phase 1 clinical study of ACTM-838 is designed to establish safety, payload delivery, and proof-of-mechanism of the STACTÔ biological platform and ACTM-838 in humans.

On May 30, 2024 Precision Biologics, Inc. reported that novel findings from its ongoing phase 2 clinical trial, combining NEO-201 with pembrolizumab for the treatment of patients resistant to prior checkpoint inhibitor therapy, will be presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, McCormick Place Convention Center, Chicago, Illinois, USA, June 1st, 2024 (Press release, Precision Biologics, MAY 30, 2024, View Source [SID1234643882]).

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Poster title: Reduction of circulating naïve Tregs and gMDSCs and low levels of soluble MICA are prognostic for efficacy of combined NEO-201 and pembrolizumab

Presentation of the poster in person will be made at the McCormick Place Convention Center in Chicago, Illinois, USA, on Saturday June 1st, 2024, Hall A from 9am – 12pm, Session: Developmental Therapeutics-Immunotherapy, poster board #9, poster # 2530.

BACKGROUND:

The employment of immune checkpoint inhibitors (ICIs), such as pembrolizumab (anti-PD-1 mAb), in cancer immunotherapy has been shown to enhance activity of the immune system against cancer cells.

Although ICIs show efficacy and improved survival of certain cancer patients, the response rate of PD-1/PD-L1 blockade against solid tumors is around 20-30% in the first line setting and significantly lower in checkpoint refractory disease. One cause identified for this low response rate is the infiltration of the tumor microenvironment (TME) by immunosuppressive cells, such as regulatory T cells (Tregs) and granulocytic myeloid-derived suppressor cells (gMDSCs). The accumulation of these immunosuppressive cells in the TME impairs the antitumor immunity triggered by ICIs.

A strategy to restore antitumor immunity and overcome tumor resistance to ICIs is to combine ICIs with anticancer drugs able to bind to and deplete Tregs and gMDSCs.

NEO-201 is a humanized IgG1 monoclonal antibody that binds to Core 1 and/or extended Core 1 O-glycans expressed by several human solid and blood tumors, as well as mature granulocytes, but it does not bind to most normal tissues and human immune cell subsets (B cells, CD4+ T cells, CD8+ T cells, NK cells, monocytes). Previous studies showed that NEO-201 can bind and mediate the killing of Tregs via CDC. Further studies presented at AACR (Free AACR Whitepaper) in 2023 showed that NEO-201 can bind and mediate the killing of gMDSCs via ADCC.

The ability of NEO-201 to mediate the killing of immunosuppressive cells served as the rationale for combination of NEO-201 with pembrolizumab in the ongoing phase II clinical trial (NCT03476681) for the treatment of patients with NSCLC, head and neck, cervical and endometrial cancers who were refractory to multiple lines of standard treatment, including ICIs.

Preliminary findings from this ongoing clinical trial presented at the CRI-ENCI-AACR in September 2023 in Milan, Italy and at the SITC (Free SITC Whitepaper) annual meeting in November 2023 in San Diego, CA, USA, revealed that, after combination treatment with NEO-201 and pembrolizumab some patients experienced durable stable disease (SD). Patients with durable SD (>84 days) demonstrated a decreasing trend in circulating gMDSCs and Tregs. Conversely, patients with progressive disease (PD) exhibited an increasing trend of circulating gMDSCs and Tregs. This preliminary data suggests that elimination of circulating gMDSCs and Tregs mediated by NEO-201 may enable patients to overcome resistance to PD-1/PD-L1 checkpoint inhibitors, in subjects for whom pembrolizumab is currently indicated and with solid tumors resistant to prior ICIs treatment.
STUDY PRESENTED AT ASCO (Free ASCO Whitepaper) 2024:

NEO-201 uses Natural Killer (NK) cells as effector cells to mediate the killing of its target cells through ADCC. Several studies reported that cancer cells inhibit NK cell antitumor activity by releasing soluble factors into the bloodstream, such as soluble MHC class 1 chain-related protein A (MICA.) Elevated serum levels of soluble MICA (sMICA) have been correlated with impairment of NK cell activity, cancer progression and metastasis.

This study reports that median serum levels of sMICA pre-treatment were 33-fold higher in patients with PD compared to patients with SD and that levels of sMICA remained elevated in patients with PD and low in patients with SD at all time points post treatment.

High levels of sMICA in patients with PD can impair NK cell activity. This impairment negatively impacts the NK cell mediated ADCC triggered by NEO-201 against cancer cells, Tregs and gMDSCs. Consequently, the effectiveness of NEO-201 and pembrolizumab treatment is reduced, leading to disease progression in these patients.

Conversely, low levels of sMICA pre- and post-treatment do not hinder the antitumoral activity of NK cells. This allows NEO-201 to effectively mediate the killing of its target cells, including cancer cells, Tregs and gMDSCs, through ADCC. As a result, this phenomenon can lead to the durable stabilization of the disease.

This study reports that low levels of sMICA, together with the reduction of both circulating Tregs and gMDSCs mediated by NEO-201, were associated with durable SD in cancer patients refractory to prior ICIs and that they could be favorable prognostic markers for clinical benefit following combination treatment with NEO-201 and pembrolizumab. Ongoing enrollment in this clinical trial will validate these findings in larger cohorts.

On May 30, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported additional positive data from the ProstACT SELECT trial ("SELECT") of TLX591 (177Lu rosopatamab tetraxetan), a lutetium-labelled rADC therapy for the treatment of adult patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Telix Pharmaceuticals, MAY 30, 2024, View Source [SID1234643881]). SELECT is a radiogenomics study intended to evaluate lesion concordance between 68Ga (gallium)-based PSMA-PET[4] imaging and TLX591 dosimetry for the purpose of validating PET imaging for patient selection for rADC therapy. The Company has previously reported final safety data from this study3.

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The study has reported a median rPFS of 8.8 months, representing an encouraging signal of the potential efficacy of TLX591 in this patient population. The evaluable sample size for rPFS comprised 23 patients with previously treated, progressive mCRPC and who received two 76 mCi intravenous (IV) infusions of TLX591, 14 days apart[5]. The SELECT trial included a heterogeneous population of low, medium and high disease burden patients to facilitate imaging cross-comparison, with the majority having undergone two prior lines of therapy.

Nat Lenzo, MD, Nuclear Oncologist and General Internal Medicine Physician and lead recruiter onto the SELECT trial, commented, "We are encouraged by this rPFS result, which compares favourably to small molecule radioligand therapy (RLT) Phase I and II studies at similar stages of development[6]. This is a compelling signal of the potential efficacy of TLX591 in this heavily pre-treated population. The results further support the development of this candidate in an earlier mCRPC patient population which is the focus of the ProstACT GLOBAL[7] Phase III trial and where there remains significant unmet need for effective treatment."

Dr David N. Cade, MD, Group Chief Medical Officer at Telix, stated, "TLX591 is a radio-ADC with significant potential advantages compared to small molecule radiopharmaceuticals in treating prostate cancer. TLX591 is differentiated by a patient-friendly dosing regimen with far lower cumulative radiation exposure compared to small molecule radioligand therapies[8]. This positive signal of efficacy from SELECT builds on prior studies that demonstrated the potential for TLX591 to deliver improved quality of life and durable tumour control in this advanced patient population[9]."

TLX591 is being further evaluated in the Phase III ProstACT GLOBAL trial in first and second line mCRPC, which is now preparing to enrol patients at its first U.S. sites. This innovative trial design allows physicians a choice of androgen receptor inhibition or docetaxel chemotherapy, thus integrating with real-world standard of care, reflective of Telix’s continued innovation in prostate cancer care and commitment to patient outcomes.

About TLX591

TLX591 (INN: lutetium Lu 177 rosopatamab tetraxetan) is Telix’s lead investigational radio antibody-drug conjugate (rADC) for the treatment of mCRPC, composed of a high-specificity PSMA-targeting antibody, chelator linker, and cytotoxic lutetium (177Lu) payload. TLX591 is administered intravenously under a two-dose fractionated regimen, potentially enabling the delivery of a highly targeted and potent dose with improved off-target organ radiation exposure. The mAb-based approach may offer distinct advantages in selectivity, internalisation, and retention time over small molecule RLTs for the treatment of mCRPC.

A total of 242 patients have been treated with TLX591 across eight Phase I and Phase II trials9 including a previously published Phase II (open-label, single-arm) trial, which reported a 42.3 month OS in 17 patients with advanced mCRPC when TLX591 was delivered under a fractionated dosing regimen[10].

About ProstACT SELECT

The purpose of the ProstACT SELECT trial is to evaluate the utility of PSMA-PET imaging with Illuccix to select patients for TLX591 rADC therapy. The primary objectives are to determine whole body biodistribution and organ radiation dosimetry, and assess the safety and tolerability of TLX591 in patients with advanced mCRPC. Radiographic progression-free survival (rPFS) is a secondary study objective.

Previously reported data from the SELECT trial includes3:

Confirmation of biodistribution and safety profile with a low rate of off-target side effects.
Confirmation of internalisation and long retention, delivering a payload to the tumour, potentially maximising cell killing effect.
Lower rates of haematologic toxicity than prior, later-line studies of TLX591.

On May 30, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-3110, a next generation oncolytic viral immunotherapy, for the treatment of recurrent high-grade glioma (rHGG) (Press release, Candel Therapeutics, MAY 30, 2024, View Source [SID1234643880]). Glioblastoma (GBM) is the most common and aggressive form of high-grade glioma.

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CAN-3110 was previously granted Fast Track Designation by the FDA for the treatment of rHGG. Candel is currently evaluating CAN-3110 in a multi-institutional phase 1b clinical trial in rHGG. Results from Arm A of the ongoing phase 1b clinical trial in rHGG exploring the clinical and biomarker activity of a single dose administration of CAN-3110 were published in Nature, demonstrating a strong anti-tumoral response associated with extended survival.1 The Company will present data on the feasibility and safety of multiple doses of CAN-3110 in patients with rHGG, supported by the Break Through Cancer Foundation, in a trials-in-progress poster presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

"Building on the momentum of the FDA’s Fast Track Designation, recently granted to this program, the Orphan Drug Designation for CAN-3110 further reinforces the potential of this therapy and underscores the urgent need for novel and effective treatments for patients with rHGG," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "This designation not only reinforces our commitment to offering new hope and potential patient treatment options, but it also enables us to leverage development incentives and accelerate our efforts to evaluate new indications in the clinic. We are continuing our work in the phase 1b clinical trial of CAN-3110 and look forward to sharing further clinical updates in the second half of 2024."

E. Antonio Chiocca, M.D., Ph.D., Chair of the Department of Neurosurgery at Brigham and Women’s Hospital, Professor at Harvard Medical School, and Principal Investigator on the phase 1b clinical trial, said: "We are grateful to the FDA for recognizing the urgent need for new treatments in rHGG. Patients, and their families, affected by this disease, face immense challenges that the standard of care and conventional therapies have failed to adequately address. The early clinical data suggests that CAN-3110’s unique dual mechanism of action, combining oncolysis and immune activation, has the potential to overcome these challenges for rHGG patients."

About Orphan Drug Designation

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is ultimately approved for its designated indication.

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with recurrent high-grade glioma (rHGG). In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed median overall survival after a single CAN-3110 injection of more than 12 months in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in rHGG, supported by the Break Through Cancer Foundation. CAN-3110 has previously received FDA Fast Track Designation for the treatment of rHGG.

Details on the CAN-3110 ASCO (Free ASCO Whitepaper) poster are as follows:

The trials-in-progress poster presentation will focus on cohort C of the ongoing phase 1b clinical trial of CAN-3110 in patients with rGBM, the most common form of rHGG. Previously presented data showed the ability of a single CAN-3110 injection to double median overall survival (mOS) in the rGBM population, as compared to contemporary control cohorts. Patients presenting with seropositivity to HSV1, reached mOS of 14 months, largely exceeding expected survival of 6 to 9 months or less for this population.

In cohort C, supported by the Break Through Cancer Foundation, two cohorts of 12 patients will receive up to six injections of CAN-3110 over a four-month period. Cohort C is currently exploring the safety and tolerability of CAN-3110 in patients with rGBM. Patients in cohort C are treated with up to six doses of CAN-3110 delivered by stereotactic injections on days 0, 15, 30, 60, 90 & 120, along with concomitant biopsies over the four-month treatment period.

Two sub-cohorts (1&2) of patients who will receive 1×107 pfu or 1×108 pfu per injection of CAN-3110 have been planned for six patients per cohort, using a Bayesian optimal interval (BOIN) design for dose ranging.

Six patients have accrued, completing cohort 1; no dose-limiting toxicities or severe adverse events were observed.
More than 300 core biopsies were obtained from all six patients across the planned time points.
Biopsies were processed for "-omic" analyses, including single-cell RNA sequencing, proteomics/phophoproteomic/immunopeptidomics, metabolomics, spatial transcriptomics, and cell profiling.
ASCO Presentation details are as follows:

Trials-in-Progress Poster Presentation Title: Longitudinal stereotactic injections of oncolytic immunoactivating rQNestin34.5v.2 (CAN-3110) with concomitant biopsies for "-omic" analyses in recurrent glioblastoma (GBM)
Presenter: David A. Reardon, MD, Professor of Medicine at Harvard Medical School; Clinical Director, Center for Neuro-Oncology at Dana Farber Cancer Institute
Session Title: Poster Session – Central Nervous System Tumors
Session Date/Time: Saturday, June 1, 2024; 9:00 AM – 12:00 PM CT