On November 30, 2023 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 that it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE (Press release, Clarity Pharmaceuticals, NOV 30, 2023, View Source [SID1234638051]).

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The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023. As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to commence our first registrational Phase III trial with our optimised SAR-bisPSMA agent. The CLARIFY trial is based on compelling preclinical and clinical data, including our completed PROPELLER trial (NCT04839367)2,3. It demonstrated the excellent safety profile and superior performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 also in patients with prostate cancer prior to radical prostatectomy, guiding the study design for the CLARIFY trial. Despite the improvement of management and staging of patients with prostate cancer introduced by PSMA PET compared to other conventional imaging, low cancerous lesion uptake by PSMA agents may have an impact on clinical management. The PROPELLER trial showed significantly higher uptake of 64Cu-SAR-bisPSMA in PSMA-expressing lesions compared to an approved standard-of-care PSMA imaging agent, potentially enabling the diagnosis of additional and smaller lesions2,3. CLARIFY will also investigate the benefits of delayed imaging in this patient group, a feature that has shown real benefits to patients so far and is not available with the first-generation PSMA imaging agents using gallium-68 or fluorine-18, which have very short half-lives and exhibit low sensitivity in detecting cancerous lesions. Additionally, the extended shelf-life of up to 48 hours offered by 64Cu-SAR-bisPSMA not only provides greater flexibility for clinics in scheduling diagnostic scans, but also improves patient access to care, including areas with limited access to diagnostic radiopharmaceuticals in prostate cancer due to the short shelf-life of existing PSMA PET tracers.

"The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy, and we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients’ lives. We look forward to progressing this trial to validate and expand upon the positive data we have accumulated so far with our SAR-bisPSMA product. With this trial, our aspiration is that with improved diagnostic tools, clinicians will be empowered to make more informed decisions regarding the best course of treatment for their patients."

On November 29, 2023 Oxford BioTherapeutics reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BI 764532 for the potential treatment of advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC-Lung) expressing DLL3 whose disease has progressed following at least one prior line of treatment including platinum-based chemotherapy (Press release, Oxford BioTherapeutics, NOV 29, 2023, View Source [SID1234656434]).

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BI 764532 is an investigational DLL3/CD3 IgG-like T-cell engager for potential treatment of patients with LCNEC-Lung that is being developed by Boehringer Ingelheim. The discovery of BI 764532 (OBT620) was enabled through a successful partnership initiated in 2013, leveraging OBT’s proprietary OGAP drug discovery platform for identification of the DLL3 antigen and Boehringer Ingelheim’s longstanding expertise in oncology and development of biotherapeutics.

As of November 2023, the FDA granted Fast Track designation to BI 764532 for the potential treatment of extensive-stage small cell lung cancer (SCLC) whose disease has progressed following at least two prior lines of treatment including platinum-based chemotherapy, and of advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) whose disease has progressed following at least one prior line of treatment including platinum-based chemotherapy.

BI 764532 was also granted Orphan Drug designation by the FDA for the treatment of SCLC, and is currently being investigated in a Phase 2 study, ‘DAREON-5’ (NCT05882058), in patients with relapsed/refractory extensive-stage SCLC and other relapsed/refractory NEC.

Christian Rohlff, Chief Executive Officer of OBT, commented: "We are delighted about the clinical development to help address unmet needs for people living with small cell lung cancer and other neuroendocrine carcinomas. This is an important milestone for our teams and exciting news for the community"

FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.

On November 29, 2023 Phenomic AI ("Phenomic") reported that they have entered into a strategic collaboration and licensing agreement with Boehringer Ingelheim to discover targets important in stroma-rich cancers (Press release, Phenomic AI, NOV 29, 2023, View Source [SID1234638058]). The partners will leverage Phenomic’s expertise in target identification and stromal biology based on its scTx single-cell transcriptomics platform which will greatly enhance Boehringer’s efforts to develop first-in-class medicines to transform the lives of people with cancer by delivering meaningful advances with the ultimate goal to cure a range of cancers.

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Stroma-rich cancers, such as colorectal and pancreatic cancers, are amongst the hardest to treat in part because of the tumor stroma: a complex tissue that protects cancerous cells from therapies and supports cancer growth and metastasis. Phenomic’s platform aims to address this challenge by identifying targets to potentially overcome the barrier the tumor stroma creates to meaningfully extend patient lives.

"At Boehringer Ingelheim, we are committed to transforming patients’ lives. Through our new partnership with Phenomic, we aim to accelerate and expand our pipeline of first-in-class therapies for patients affected by stroma-rich cancers, which account for the vast majority of cancer deaths every year," said Theresa Goletz, VP Cancer Immunology and Immune Modulation, Boehringer Ingelheim. "This collaboration demonstrates our commitment to innovation by incorporating advanced AI and machine learning tools into drug discovery to address high unmet patient needs."

"Phenomic is committed to breaking through the barriers in drug discovery for cancer and developing novel therapies targeting tumor stroma. We are excited to be working with Boehringer Ingelheim, a global leader with expertise in delivering breakthrough medicines for cancer patients," stated Girish Aakalu, Ph.D., CEO of Phenomic. "Through this collaboration, we believe that we can improve outcomes for patients with difficult-to-treat solid tumors by applying our next-generation drug discovery and development tools."

Phenomic’s scTx platform uniquely integrates one of the world’s largest single-cell RNA datasets from human tissues with comprehensive analysis and validation tools. Advanced AI and machine learning algorithms enable the analysis of this highly diversified database including imaging, RNA sequencing, and spatial transcriptomics data to understand the biology of single cells sitting in complex multi-cell systems. Unique stromal models and experimental capabilities enable Phenomic to then assess the results and identify novel targets for therapeutics through an iterative process involving digital screening and experimental validation.

Under the agreement, Boehringer Ingelheim has the option to license targets discovered and functionally validated by Phenomic as a basis for novel cancer therapeutics. Boehringer Ingelheim will also be responsible for all non-clinical and clinical development, as well as commercialization of associated cancer therapies. Phenomic will receive upfront and near-term payments of approximately $9 million including research funding and collaboration milestones. Phenomic is also eligible to receive more than USD $500 million in licensing fees as well as clinical, regulatory and commercial milestones in addition to royalties on future product sales.

On November 29, 2023 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that its partner Asieris Pharmaceuticals (SSE: 688176) communicated that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix (APL-1706) in China (Press release, PhotoCure, NOV 29, 2023, View Source [SID1234638057]). Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.

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Results of the Hexvix (APL-1706) Phase III clinical trial in China were presented at the 43rd Congress of the Société Internationale d’Urologie (SIU) last month, as a late-breaking abstract. The study confirmed that, in a Chinese patient population, Hexvix blue light cystoscopy (BLC) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.

The highly statistically significant results corroborate the findings of Photocure’s own randomized controlled trials (RCTs) that demonstrated the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events. Moreover, Asieris’ Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.

Hexvix is currently the only approved optical imaging agent for diagnosing and surgical management of patients with bladder cancer worldwide. The combined use of Hexvix (APL-1706) and BLC for the management of non-muscle invasive bladder cancer (NMIBC) has been included in the global expert consensus guidelines and Chinese Urological Association Guideline. The drug has not yet been approved for market launch in China.

"We are glad to see our partners at Asieris driving the submission process with conviction and speed. The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure. "We believe that BLC can make a difference which evident in the robust clinical data from many years of experience and the recent Chinese RCT data presented at SIU earlier this year. Both companies remain committed to bringing Blue Light Cystoscopy with Hexvix to more patients with bladder cancer and elevate the standard of care."

Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.

Read Asieris’ full media release here: View Source

On November 29, 2023 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported the dosing of the first participant in the Phase 1/2 trial of OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody that rescues innate and adaptive immune responses from LILRB2 mediated immune suppression (Press release, OncoResponse, NOV 29, 2023, View Source [SID1234638056]). This Phase 1/2 study is designed to determine the safety, tolerability, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with anti-PD-1 in subjects with advanced solid tumors.

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"Initiating this study in cancer patients reflects our continued commitment to advancing programs that have the greatest potential to improve outcomes for patients undergoing cancer treatment," said Clifford Stocks, Chief Executive Officer of OncoResponse.

"OR502 binds to LILRB2 in a unique way to reverse immunosuppression in cancer and offers a potential treatment option to patients who have otherwise struggled with CPI therapy effectiveness," said Kamal Puri, PhD, Chief Scientific Officer of OncoResponse. "OncoResponse has spent years devising strategies to block or reprogram tumor associated macrophages to drive anti-tumor activity. We are excited by the vast promise of OR502 in the LILRB2 target space with preclinical data showing superiority to other clinically validated anti-LILRB2 antibodies."

About the Phase 1 Trial

This Phase 1/2 study is an open-label, multicenter, first-in-human dose-escalation and expansion study designed to determine the safety, tolerability, and preliminary anti-tumor activity of OR502, a fully human IgG1 antibody that binds specifically to LILRB2. OR502 will be administered as a monotherapy and in combination with anti-PD-1, cemiplimab, in subjects with advanced solid tumors. The study consists of two parts. Part A is a dose-escalation phase to determine the maximum-tolerated dose (MTD) or optimal dose of OR502 for further evaluation as monotherapy and in combination. Part B is an expansion phase in subjects with advanced solid tumors treated with OR502 at two separate doses, to help determine the recommended Phase 2 dose (RP2D) for further development and determine preliminary anti-tumor activity. The role of potential biomarkers will be evaluated throughout the study, and more intensively in a separate biology cohort. Additional details are available on ClinicalTrials.gov, identifier: NCT06090266.

About OR502

LILRB2 is an immunoinhibitory receptor expressed on tumor-associated macrophages (TAMs) found in the tumor microenvironment (TME). TAMs inhibit the activity of checkpoint inhibitor (CPI) therapy and prevent T cells from killing tumors. Blocking the inhibitory activity of TAMs and promoting the activity of tumor-killing T cells reverses inhibition of CPI therapy, potentially leading to more and deeper responses to CPIs in patients. This is the mechanism of OR502, which modulates LILRB2 by blocking its engagement of HLA-G on tumor cells and prevents the suppression of the myeloid cells. Elevated expression of LILRB2 correlates with reduced patient survival in various tumor types. Our humanized monoclonal antibody, OR502, targets LILRB2 and blocks the inhibitory activity of TAMs and promotes the activity of tumor-killing T cells, reversing inhibition of CPI therapy.