On September 5, 2022 Several academic centers have collaborated with Convert Pharmaceuticals to expand knowledge about its main compound, CP-506, and the biomarkers that will enable selection of patients that would most benefit from the hypoxia activated prodrug under investigation (Press release, Convert Pharmaceuticals, SEP 5, 2022, View Source [SID1234618984]). These research efforts have recently led to three key peer-reviewed academic publications which are referenced here-under.

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The results from the first paper1, published in 2021, demonstrate that CP-506 selectively targets hypoxic tumor cells and has broad antitumor activity.

The second paper2, published in 2022, focusses on the in vivo identification of Adducts from CP-506. The resulting in vitro data suggests that the structural changes performed on CP-506 improved the drug selectivity toward hypoxic conditions compared to its predecessor PR-104, as shown by more adducts being detected in anoxic versus normoxic treatment, but did not completely eliminate its ability to react directly with DNA enabling a bystander-effect.

This favorable bystander efficiency of the new generation pro-drug has been further studied using in silico spatially-resolved pharmacokinetic/pharmacodynamic (SR-PK/PD) modelling and spheroid co-cultures for validation. The results of this study, demonstrating the favourable pharmacological properties of CP-506 in tumour tissue, have been published in a third recently published paper3.

On September 5, 2022 Herantis Pharma Plc, reported An aggregate number of 2,400 new shares of Herantis Pharma Plc ("Herantis") have been subscribed for with option rights under the option program 2010 (Press release, Herantis Pharma, SEP 5, 2022, View Source,c3625675 [SID1234618981]). The new shares have been registered with the trade register maintained by the Finnish Patent and Registration Office today. The new shares will confer shareholder rights in Herantis after they have been issued in the book-entry system, on or about 2 September 2022.

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Trading with the new shares is expected to commence on the Nasdaq First North Growth Market Finland marketplace on or about 6 September 2022, provided that Nasdaq Helsinki Ltd approves the listing application submitted by Herantis.

As a result of the share subscriptions, the total number of shares in Herantis will increase to 16,912,394.

On September 5, 2022 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that an abstract with clinical trial results of its innate cell engager (ICE) AFM24 has been accepted for a poster presentation at the Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) from 9-13 September 2022 in Paris (Press release, Affimed, SEP 5, 2022, View Source [SID1234618970]). The abstract includes phase 1 data on the safety, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) from patients with locally advanced or metastatic, treatment refractory EGFR-positive solid tumors treated with AFM24 monotherapy.

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"These results represent a major milestone for our broad development program further assessing the efficacy of AFM24 as monotherapy and in combinations," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "AFM24 has now demonstrated the ability to activate both innate and adaptive immune cells, which may help to potentially overcome resistance to current therapies."

Additional Details about the Study and Poster Presentation
In the study, AFM24 was administered in doses up to 720 mg intravenously once weekly until disease progression, intolerable toxicity, patient withdrawal, or termination at the investigator’s discretion. Tumor types included mainly colorectal and non-small cell lung cancer.

AFM24-related treatment-emergent adverse events included infusion-related reactions, nausea and acneiform dermatitis. There were no on-study deaths. The maximum tolerated dose was not reached. As of March 2022, stable disease (SD) was observed in 10/27 evaluable patients out of which 4 remained in SD for more than 4 months.

Comprehensive PD studies of cytokines and immune cells in peripheral blood and tumor biopsies indicated the activation of the innate as well as the adaptive immune system starting at 160 mg. These findings supported the selection of 480 mg as the RP2D. Enrollment into three disease-specific cohorts is ongoing at this dose.

In addition, two combination studies with atezolizumab (AFM24-102) and the autologous NK cell product SNK01 (AFM24-103) are being conducted each with three disease-specific cohorts. The combination studies started at 160mg and are planned to be escalated to 480 mg.

Poster title: A Phase 1/2a Dose Escalation Study of AFM24 in Patients with Epidermal Growth Factor Receptor-expressing (EGFR) Solid Tumors: Results from Phase 1

Poster number: 754P

More details about the ESMO (Free ESMO Whitepaper) congress are available online at ESMO (Free ESMO Whitepaper) Congress 2022.

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Affimed is evaluating AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

The first-in-human phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study can be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a phase 1/2a study, investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (AFM24-103, NCT05099549).

On September 5, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with PSMA-negative prostate cancer is open for recruitment (Press release, Clarity Pharmaceuticals, SEP 5, 2022, View Source [SID1234618968]).

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SABRE (Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer.

Dr Andrei Iagaru, Lead Principal Investigator in the SABRE trial, commented, "We are very excited to initiate patient accrual for the SABRE trial which will explore and validate the clinical benefits associated with the novel SAR-Bombesin agent. We have been investigating Bombesin for many years and believe it is an agent with high diagnostic and therapeutic potential. We hope this trial will inform us on the role of SAR-Bombesin in diagnosing disease in PSMA-negative prostate cancer patients by imaging patients on day of injection and at ~24 hours after injection, with the delayed imaging being a novel feature enabled by 64Cu. In addition to investigating the clinical benefits of the product, we also look forward to leveraging centralised manufacture and on-demand delivery advantages of copper-based products. These features have potential to facilitate universal access to SAR-Bombesin and enhance accessibility to treatment facilities throughout the US.

"We look forward to expanding the trial sites and generating data for this next-generation product which could ensure both ease of access and improved treatment outcomes for BCR prostate cancer patients," said Dr Iagaru.

The SABRE trial was developed in response to strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT or MRI). It builds on the data generated in PSMA-negative prostate cancer patients at St Vincent’s Hospital imaged under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).2 This data has demonstrated diagnostic imaging potential in PSMA-negative prostate cancer and highlighted potential utility of the product as a theranostic agent. SABRE also builds on a pilot diagnostic trial of SAR-Bombesin in breast cancer patients, the C-BOBCAT trial, which was recently presented at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting.3

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to commence recruitment into the SABRE trial, having only received our Study May Proceed letter from the US Food and Drug Administration (FDA) in June. SABRE reinforces our commitment to running Clarity’s clinical trials for first approvals in the US under clinical protocols which have been reviewed by the US FDA. Subject to the outcomes of this Phase II trial, we will look to progress this diagnostic product into Phase III trials in the US as soon as possible.

"Given the promising data to date, indicating potential diagnostic and therapeutic benefits of SAR-Bombesin, we are committed to continuing generating data on the product with the SABRE trial following in quick succession from the BOP investigator-initiated trial in PSMA-negative prostate cancer participants that commenced at St Vincent’s Hospital in Sydney earlier this month. In parallel, we are also preparing a submission to the US FDA for an Investigational New Drug (IND) application for a therapeutic clinical trial with the product later this year.

"We look forward to recruiting and imaging participants in the SABRE trial and gathering further evidence of clinical, environmental and logistical benefits of SAR-Bombesin, hoping that it will provide a large patient population with accurate and precise detection and treatment of PSMA-negative prostate cancer," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)4-8. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide9. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease10.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative11-14. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.

On September 4, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported data will be released at ESMO (Free ESMO Whitepaper) Congress 2022 in Paris, France about the efficacy and safety of PNT2002 in the lead-in cohort of the SPLASH trial (Press release, Point Biopharma, SEP 4, 2022, View Source [SID1234618993]). An abstract is now available on the ESMO (Free ESMO Whitepaper) congress website at View Source, and an e-poster which contains updated data will be published and presented on Sunday, September 11th.

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The poster is titled "Efficacy and Safety of 177Lu-PNT2002 Prostate-Specific Membrane Antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P), and is scheduled for presentation on Sunday, September 11 from 9:00-17:00 CEST (Paris) by Dr. Aaron R. Hansen, staff medical oncologist of Princess Alexandra Hospital and an Associate Professor of Medicine at the University of Toronto.

In advance of the publication of the abstract, the Company recently hosted a 45-minute educational webinar entitled "Understanding the PNT2002 SPLASH Trial Control Arm". A replay of the webinar is available online at View Source

About the SPLASH Trial

The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.‍