On October 16, 2023 ImCheck Therapeutics reported that updated data from its ongoing Phase I/IIa clinical trial EVICTION will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in an oral session on October 22nd in Madrid (Press release, ImCheck Therapeutics, OCT 16, 2023, View Source [SID1234636019]). The presentation (8220) entitled: "Activation of γ9δ2 T Cells by ICT01 as a Novel Immunotherapeutic Approach for Relapsed/Refractory Hematologic Cancers (EVICTION Study)" will provide safety and patient response results from the Phase I dose escalation portion of the EVICTION trial of ImCheck’s lead antibody, ICT01, administered as a monotherapy to relapsed/refractory patients with hematological cancers, primarily Acute Myeloid Leukemia (AML).

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"The positive safety profile, consistent with previous data in solid tumor patients, together with the promising clinical activity underscores the potential of ICT01 in hematological malignancies. These results in last-line patients further support the initiation of the ongoing Phase IIa cohort expansion study of ICT01 in combination with standard of care in first-line AML patients," commented Sylvain Garciaz, M.D., Ph.D., member of the Department of Hematology, Institut Paoli-Calmettes, investigator in the EVICTION study, and presenter of the data at ESMO (Free ESMO Whitepaper) 2023.

"We continue to generate highly encouraging clinical signals in both solid and hematological tumors. We remain focused on rapidly advancing ICT01 into late-stage clinical evaluation in combination settings as a unique clinical approach to boost the anti-tumor immune response in cancer patients," commented Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.

EVICTION is an open-label Phase I/IIa trial assessing ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, as a monotherapy in solid and hematological tumors, and as a combination therapy with pembrolizumab in solid tumors. The Phase 1 dose escalation study in relapsed/refractory hematological cancers included 26 patients who failed all available standard of care, 24 of which had acute myeloid leukemia, 1 with diffuse large B-cell lymphoma and 1 with follicular lymphoma. ICT01 was administered at doses ranging from 200 mg to 75 mg every 21 days and primary endpoints consisted of the incidence of treatment-adverse events (AE) and the disease control rate (DCR) defined as the sum of complete response (CR), CR with incomplete recovery (CRi), partial response (PR) and stable disease (SD). Secondary endpoints included circulating γ9δ2 T cell measurements as well as pharmacokinetic and pharmacodynamic analyses. The reported data did not reveal any dose-limiting toxicities and demonstrated a DCR of 30% among the 10 evaluable patients at week 8. Notably, ICT01 treatment safely induced the activation and migration of γ9δ2 T cells from the blood within hours of dosing, suggesting effective target engagement.

Based on these results, the company has started evaluating ICT01 in combination with Venetoclax/azacitidine in a Phase IIa expansion cohort in first-line AML patients.

Details of the presentation are:

Abstract title: "Activation of γ9δ2 T Cells by ICT01 as a Novel Immunotherapeutic Approach for Relapsed/Refractory Hematologic Cancers (EVICTION Study)"
Session title: Proffered paper sessions – Haematological malignancies
Abstract number: 822O
Authors: Sylvain Garciaz (presenter), Stéphane Champiat, Pierre Peterlin, Katrien Lemmens, Aude De Gassart, Patrick Brune, Emmanuel Valentin, Céline Leparquier, Marina Iché, Daniel Olive, Norbert Vey, Paul Frohna
Date/Time: Sunday October 22nd, 2023, 4:30 PM – 6:00 PM CET
Location: Toledo Auditorium – Hall 3
The ESMO (Free ESMO Whitepaper) presentation will be available starting October 22, 2023, at 4:30 pm CET on ImCheck’s corporate website

On October 16, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma (Press release, Perspective Therapeutics, OCT 16, 2023, https://perspectivetherapeutics.com/press-releases/perspective-therapeutics-completes-recruitment-for-first-patient-cohort-in-phase-1-2a-dose-escalation-trial-of-vmt01-in-malignant-melanoma/ [SID1234636018]).

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"We are encouraged by the pace of enrollment in the trial which we believe is indicative of the tremendous unmet need for patients with unresectable and intractable melanomas," said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics. "We are grateful to our clinical collaborators for their diligence in working closely with patients to deliver our targeted alpha-particle therapy, and we look forward to providing an update in the coming months."

"MC1R is a receptor that is displayed on the surface of melanoma cells, making it an attractive target for the treatment of malignant melanomas," said Zachary S. Morris, M.D., Ph.D., Vice Chair and Endowed Professor of Human Oncology, Program Director for the University of Wisconsin Bentson Research Fellowship, and Principal Investigator for the VMT01 clinical study. "Systemic delivery of an MC1R-targeted alpha-particle emitting therapeutic may have potential to eliminate all associated lesions. Given our interactions to date, we are excited to continue our work with Perspective to address this disease with high unmet medical need."

About the study

This ongoing trial (clinicaltrials.gov identifier NCT05655312) is a multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in subjects with histologically confirmed melanoma and positive MC1R imaging scans. The first part of the study is a dose escalation phase to determine the Maximum Tolerated radioactivity Dose (MTD) or Maximum Feasible radioactivity Dose (MFD) following a single administration of 212Pb-VMT01. Patients with stage IV or unresectable stage III metastatic melanoma who have progressed on at least 1 approved first-line therapy will be scheduled to receive up to 3 administrations of 212Pb-VMT01 approximately 8 weeks apart. The first patient cohort is scheduled to receive 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi) respectively, if the MTD or MFD is not reached during escalation. According to the Modified Toxicity Probability Interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.

The second part of the study is a dose expansion phase based on the identified MTD/MFD. Patients may be eligible to receive up to three administrations of 212Pb-VMT01 approximately eight weeks apart. A dosimetry sub-study is included to assess biodistribution, tumor uptake and correlation of uptake with observed toxicities and efficacy.

About Melanoma

Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, the melanin producing cells of the body. Metastatic melanoma is the result of melanoma that has progressed through the layers of skin, infiltrated the blood stream or lymphatic system, and traveled to other areas of the body to metastasize. In the United States, there are approximately 100,000 new diagnoses of melanoma annually and approximately 6,850 deaths annually from metastatic melanoma (cancer.org). In most cases, metastatic melanoma cannot be cured but treatment can support a longer life.

About VMT01

VMT01 is a proprietary clinical-stage low molecular weight peptide that is targeted to the melanocortin subtype 1 receptor (MC1R) which is over-expressed on melanoma cells. VMT01 is in development for the treatment and diagnosis of MC1R-positive metastatic melanoma. VMT01 can be labeled with 212Pb to deliver alpha-particle radiation directly to tumor cells, or 203Pb to enable patient selection, diagnostic imaging and dosimetry via SPECT imaging. The product recently completed a pilot imaging study at the Mayo Clinic Rochester, MN. In August 2023, the Company announced that the first patient was dosed in the Phase1/2a study of VMT01 (clinicaltrials.gov identifier NCT05655312).

On October 16, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has finalized all documentation giving effect to the amendments to certain of the terms and conditions of its credit agreement dated July 20, 2022, as amended from time to time (the "Credit Agreement"), with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager (collectively, "Marathon") (Press release, Theratechnologies, OCT 16, 2023, View Source [SID1234636017]).

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The amendments to the Credit Agreement provide for, inter alia:

revising the minimum liquidity requirements for all times following October 31, 2023 to be between US$15 million and US$20 million, based on thresholds for adjusted EBITDA over the most recently ended four fiscal quarters;
revising the minimum revenue requirements to be based on adjusted EBITDA-based targets instead of quarterly revenue-based targets, beginning with the quarter ending November 30, 2023;
deleting the prohibition against the Company having a going concern explanatory paragraph in the opinion of the independent registered public accounting firm of the Company that accompanies the Company’s annual report.

As disclosed in its September 25, 2023, press release, in consideration of the proposed amendments, the Company agreed to (i) pay an amount equal to US$600,000, or 100 basis points calculated on the outstanding principal amount of the funded debt as of October 16, 2023 (US$60 million), which such amount was added to the outstanding principal amount of the funded debt as payment in kind ; and (ii) reprice the exercise price of the common share purchase warrants (the "Warrants") held by Marathon to US$0.575 per share from US$1.45 per share. Following the share consolidation completed on July 31, 2023, the exercise of four Warrants and the payment of US$2.30 are required to subscribe to one common share of Theratechnologies, for up to a maximum issuance of 1,250,000 common shares. The Warrants can be exercised until February 27, 2030.

On October 16, 2023 Synaffix B.V., a Lonza company (SIX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported to have entered into a licensing agreement with SOTIO Biotech (SOTIO), a clinical stage immuno-oncology company owned by PPF Group (Press release, Synaffix, OCT 16, 2023, View Source [SID1234636016]).

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SOTIO will gain access to Synaffix’s ADC technologies, GlycoConnect, HydraSpace and toxSYN linker-payloads, in an initial ADC program with the option to expand research and commercial licenses into two additional programs at a later date.

Under the terms of the agreement, Synaffix will be eligible to receive up to $740 million in payments spanning signature, target nomination and milestone payments plus additional royalties on commercial sales. SOTIO will be responsible for the research, development, and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies.

Peter van de Sande, Head of Synaffix, said: "The selection of our ADC technologies by a seasoned ADC player like SOTIO is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. We look forward to partnering with SOTIO, and believe that with their singular focus on cancer immunotherapies and robust clinical pipeline, this partnership can deliver innovative medicines for patients in areas of high unmet medical need."

Radek Spisek, Chief Executive Officer of SOTIO, said: "At SOTIO, we are building a broad pipeline of next-generation ADCs to address the challenges of solid tumors – and access to Synaffix’s ADC platform technologies will ensure we remain at the leading edge of this space. This collaboration combining SOTIO’s deep expertise in solid tumor drug development with Synaffix’s clinical-stage platform technology will drive important new innovations for the benefit of patients."

Synaffix was fully acquired by Lonza in June 2023 and represents a newly formed ‘Center of Excellence’ for bioconjugation. As a Lonza company, Synaffix will continue to operate under the Synaffix name and further expand its operations in Oss (NL) to cater for further innovation and growth.

On October 16, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the company will have five presentations and one poster at the 14th Annual World ADC Conference, taking place in San Diego, October 16-19, 2023 (Press release, Sutro Biopharma, OCT 16, 2023, View Source [SID1234636015]).

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Presentation Details:
Development of Next Generation ADCs Using Novel Expression Platforms & Precise Conjugation
Presenter: Gang Yin
Date/Time: October 17, 2023, 12:00pm PT

Discovery of Novel Linker Payloads for Site-Specific ADCs with Improved Efficacy & Therapeutic Index
Presenter: Krishna Bajjuri
Date/Time: October 17, 2023, 2:00pm PT

Precision Engineering for Enhanced Therapeutic Index: Designing STRO-004, a Tissue Factor Targeted ADC for Broadened Efficacy & Safety
Presenter: Alice Yam
Date/Time: October 17, 2023, 5:30pm PT

Stress Free ADC Production with Cell-Free Technology
Presenter: Ganesh Vissvesvaran
Date/Time: October 18, 2023, 12:00pm PT

Preclinical Development of STRO-003, a ROR1 Targeting Antibody-Drug Conjugate for Treatment of Hematologic & Solid Cancers
Presenter: Helena Kiefel
Date/Time: October 18, 2023, 2:00pm PT

Poster Details:
Site-specific Dual Conjugation Enabled by an Integrated in vivo / in vitro Antibody Production Platform
Presenter: Miao Wen
Date/Time: October 17, 2023, 6:00pm PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.