On September 7, 2022 Integral Molecular, the leader in antibody discovery against membrane proteins, reported that it has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND pilot program (Press release, Integral Molecular, SEP 7, 2022, View Source [SID1234623249]). This program supports Innovative Science and Technology Approaches for New Drugs and was created to expand the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these tools, thus facilitating regulatory review by allowing them to be used in regulatory (IND, NDA or BLA) applications without needing the FDA to reconsider and reconfirm their suitability.

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Despite their reputation for ‘exquisite specificity’, antibodies and antibody-based therapies, such as CAR-T cells, frequently demonstrate unexpected off-target binding. Integral Molecular’s Membrane Proteome Array (MPA) for antibody specificity and safety profiling intends to address ICH-FDA’s in vitro testing recommendations to assess unintended binding of monoclonal antibodies that can result in safety and toxicity issues.

The MPA is one of the largest collections of membrane proteins used for specificity profiling of antibody-based therapeutics, with over 6,000 native-conformation membrane proteins encompassing nearly the entire human membrane proteome. This technology is intended to be compatible with numerous biotherapeutic modalities, including monoclonal antibodies, bispecifics, and CAR-T therapeutics.

"We are thrilled to be working with the FDA’s ISTAND program," said Benjamin Doranz, CEO of Integral Molecular. "We share the FDA’s interest in developing in vitro technologies to better assess the safety of antibody drugs at an earlier and less costly stage of development."

On September 7, 2022 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the selection of an abstract for a poster presentation at the 34th EORTC/NCI/AACR Symposium on Molecular Targets and Cancer Therapeutics (Press release, Merus, SEP 7, 2022, View Source [SID1234619268]).

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Presentation Details:

Title: MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors: an ongoing phase 1/2 study
Session: New Therapies in Immuno Oncology
Date: Friday, October 28, 2022
Time: 10:00-15:00 CET
Abstract #: 341
Poster #: PB121

The abstract will be available starting Wednesday, October 12, 2022 at 9:00 a.m. CET and the poster available at the start of the conference on October 26, 2022 and on-demand throughout the conference, both on the conference website. The poster will also be available on the Merus website contemporaneously.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant non-small cell lung cancer (NSCLC) in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

On September 7, 2022 INmune Bio (NASDAQ: INMB), a clinical- stage immunology company focused on developing treatments that harness the patient’s immune system to fight disease, reporte that RJ Tesi, M.D., Chief Executive Officer will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference being held on September 12 – 14, 2022, and the Baird Global Healthcare Conference being held on September 13 – 14, 2022 (Press release, INmune Bio, SEP 7, 2022, View Source [SID1234619227]).

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H. C. Wainwright Global Healthcare Conference

Baird Global Healthcare Conference

Management will be available for one-on-one meetings. To request a meeting and to register for the conference, click here: View Source

On September 7, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that the Company presented advances within its conditionally-activated ADC portfolio, including the next generation EpCAM-ADC, CX-2051, at the World ADC conference taking place September 6-9, 2022, in San Diego, CA (Press release, CytomX Therapeutics, SEP 7, 2022, View Source [SID1234619223]).

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"The momentum in the field of ADC therapeutics is incredibly exciting and holds great promise for the innovation and development of novel oncology therapeutics. Our pioneering work and experience in applying our versatile Probody platform to the ADC modality has the potential to expand the universe of addressable targets and to further increase the therapeutic window of future molecules entering the clinic," said Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX. "CX-2051, our EpCAM-targeted, conditionally activated ADC, is strategically tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing epithelial cancers, which is an area of high unmet need where, to date, efforts have not been successful due to dose-limiting toxicities."

"Our strategy with CX-2051 is to match payload mechanism of action with tumor sensitivity, and we have selected the topoisomerase-1 inhibitor, camptothecin, as the payload for our newest ADC," Dr. Belvin continued. "Topoisomerase-1 inhibitor-conjugated ADCs are showing impressive clinical activity, and importantly, the safety profiles of camptothecin and its derivatives have been well characterized. Additionally, two camptothecin derivatives, irinotecan and topotecan, have been approved by the U.S. Food and Drug Administration for clinical use – irinotecan for pancreatic and colorectal cancer, and topotecan for ovarian, cervical, and small cell lung cancer. We plan to pursue multiple indications with this new therapeutic candidate and look forward to progressing to an investigational new drug application submission in the second half of 2023."

Presentation highlights include:

Review of clinical activity for the conditionally activated ADCs CX-2029 and praluzatamab ravtansine (CX-2009), targeting CD71 and CD166, respectively. CD71 and CD166 have historically been inaccessible targets for traditional ADCs due to their high expression levels on normal tissues. The data presented demonstrate clinical anti-cancer activity and a therapeutic window for these previously undruggable targets.
The molecular structure of CX-2051, a masked, conditionally activated, EpCAM-targeting ADC with a next generation camptothecin-based linker payload. CX-2051 highlights the potential for CytomX’s Probody technology to unlock a new ADC target (EpCAM/Trop-1), which is a target that has previously yielded promising clinical results only through locally administered therapies.
CX-2051 preclinical data indicating strong anti-cancer activity and tolerability with a favorable predicted therapeutic index.
The full presentation is available at the following link:

Tailoring the Selection of Target, Payload, & Tumor Type to Maximize the Therapeutic Index of Conditionally Activated ADCs
Marcia P. Belvin, Ph.D., Senior Vice President, Head of Research, CytomX Therapeutics
Presentation Link

On September 7, 2022 Lytix Biopharma ("Lytix") (Euronext Growth Oslo: LYTIX), a Norwegian immuno-oncology company, reported the regulatory approval from European authorities to commence the ATLAS-IT-05 study in three European countries (Press release, Lytix Biopharma, SEP 7, 2022, View Source [SID1234619222]).

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ATLAS-IT-05 is a Phase II combination study evaluating LTX-315 and pembrolizumab in patients with advanced melanoma. The study was initiated at MD Anderson Cancer Center in 2021 and is currently ongoing in the US. The objective of the study is to document whether LTX-315 in combination with pembrolizumab is effective in inducing responses in patients who have failed prior anti PD 1/PD L1 immune checkpoint therapy.

The clinical trial application (CTA) has now been approved according to the European Clinical Trial Regulation, and the national authorities in Spain, France and Norway have commended the CTA for ATLAS-IT-05.

The approval will enable the expansion of the site network and clinical impact field for LTX-315, mitigate recruitment challenges and drive enrollment in the ATLAS-IT-05 Phase II trial towards completion. The study will be performed at highly recognized sites with intratumoral immunotherapy expertise in the three European countries. It will be led by melanoma experts at each site and follow the same protocol as in the US.

The regulatory application in Europe was submitted in Q2 2022 and six leading clinical sites in Europe are expected to open during the 4th quarter of 2022. Efforts to prepare the sites for initiation of the study and recruitment of patients is ongoing with the aim to complete enrollment in the study in early 2023.

"We are very pleased to have received the regulatory approval to commence studies in three European countries. Lytix has mobilized internal resources and moved extraordinary fast in the face of the need to broaden the impact of this study among clinicians and key opinion leaders. The speed with which we were able to move from the start of this expansion program to this approval speaks to the high level of engagement from the team at Lytix. Now that the European approval has been granted, we are looking forward to and actively preparing for the upcoming start of this clinical study at the European sites," says CEO and Co-founder of Lytix Biopharma, Øystein Rekdal.