On April 10, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported that David Urso, president and chief executive officer of MEI Pharma, will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on Tuesday, April 16 at 1:30 PM Eastern Time (Press release, MEI Pharma, APR 10, 2024, View Source [SID1234642001]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section of the Company’s investor relations website View Source A replay of the webcast will be made available following the event.

On April 10, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that first preclinical data for its asset IPH45, a novel and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4, were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (Press release, Innate Pharma, APR 10, 2024, View Source [SID1234642000]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In preclinical studies, data demonstrated that IPH45 effectively inhibits Nectin-4 expressing tumor growth both in vitro and in vivo, including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma PDX (patient-derived xenografted) mice models, across Nectin-4high and Nectin-4low expression levels. In addition, IPH45 has an additive anti-tumor effect to anti-PD1 treatment in vivo and has a favorable safety profile in relevant animal toxicology models.

"IPH45 is a novel and differentiated Nectin-4 ADC with preclinical efficacy in tumor types with various expression levels of Nectin-4. Its exatecan payload allow for higher bystander-effect and a broader therapeutic index than MMAE-ADCs," commented Prof. Eric Vivier, DVM, PhD, Chief Scientific Officer at Innate Pharma. "These promising results underscore the potential of IPH45 to provide new solutions for patients in a variety of Nectin-4 expressing cancers, beyond Nectin-4high expressing bladder. Based on these encouraging data, we are eagerly advancing IPH45 towards clinical trials."

The presentation is available on Innate Pharma’s website.

About IPH45

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. IPH45 is a novel exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4. In non-clinical models, IPH45 is well tolerated and shows anti-tumor efficacy in vitro and in vivo. IPH45 is progressing towards First in Human study.

On April 10, 2024 Neuboron Medical Group (Neuboron) reported significant progress in the commercialization of its comprehensive Boron Neutron Capture Therapy (BNCT) solution, marking a new era in the treatment of refractory tumors. On March 26, the Beijing Institute of Medical Device Testing (BIMT) granted Neuboron’s NeuPEX Block-I, an electrostatic accelerator-based BNCT system, its Medical Device Testing Reports (Press release, Neuboron Medtech, APR 10, 2024, View Source [SID1234641999]). Concurrently, the Center of Drug Examination of the National Medical Product Administration, China, approved the Investigational New Drug (IND) application for Neuboron’s boronophenylalanine (NBB-001, also known as BPA). This approval facilitates the commencement of Phase-I Clinical Trials targeting recurrent head-and-neck cancer at the Xiamen Humanity Hospital, the premier operational BNCT Center in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Founded in 2014, Neuboron stands at the forefront of BNCT innovation, dedication, and patient care. Neuboron’s decade of research and development has established Neuboron as the only entity globally to develop a proprietary Accelerator-Based BNCT (AB-BNCT) system alongside boron drugs, offering hospitals a complete BNCT solution. This solution encompasses the NeuPEX AB-BNCT System, the NeuMANTA Treatment Planning System, treatment boron drug NBB-001 (BPA), and diagnostic NBB-002 (18F-BPA).

Neuboron’s inaugural AB-BNCT System, NeuPEX Block-I, was operational by 2021, and by October 2022, it had successfully administered its first patient treatment under an Investigator Initiated Trial (IIT), marking China as the second nation to achieve a full spectrum of BNCT clinical capabilities. NeuPEX distinguishes itself by its efficiency and ‘green’ credentials, capable of conducting over 2,400 irradiation sessions annually, thanks to its advanced patient positioning and simulation capabilities. The NeuMANTA Treatment Planning System, with its COMPASS Monte Carlo dose engine, delivers swift and precise dose calculations, reducing processing times to approximately five minutes.

A pivotal advancement has been the development of a high-yield, nucleophilic reaction process for synthesizing 18F-BPA for PET scans, enhancing availability and critical diagnostic and treatment planning capabilities. Additionally, Neuboron’s BPA formulation as a freeze-dried powder ensures ease of transport and extended shelf life, preventing Maillard reactions.

Prof. Yuan-Hao Liu, Founder and CEO of Neuboron, anticipates the initiation of its first clinical trial this April, with Phase I completion expected within the year. "Our entry into the Phase-I trial represents a significant stride towards our commitment to making BNCT accessible, affordable, and advanced," Prof. Liu remarked. "Our collaboration with global academic, research, and healthcare institutions, alongside industrial partners like TAE Life Sciences, underscores our dedication to fostering an open, cooperative BNCT ecosystem."

Looking forward, Neuboron, in collaboration with the Xiamen Humanity Hospital, will extend its IIT trials to explore BNCT applications across a broader range of solid tumors and refine treatment methodologies. While the IND trial is restricted to domestic patients, the IIT trials are open internationally, widening access to this innovative treatment modality. Neuboron aims for market approval by late 2025 to early 2026.

Discover more about Neuboron Medical Group’s revolutionary impact on cancer therapy at www.neuboron.com. New drug cooperation please contact [email protected]. BNCT system cooperation please contact [email protected].

On April 10, 2024 NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, reported the signing of a Clinical Supply Agreement with Clarity Pharmaceuticals for the production of 67Cu-SAR-bisPSMA drug product for Clarity’s Phase I/II and Phase III trials (Press release, NorthStar Medical Radiostopes, APR 10, 2024, View Source [SID1234641998]). The overarching Master Service agreement and associated Clinical Supply Agreement are effective immediately and the initial production of supply to support Clarity trials is expected to occur before the end of calendar 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Given Clarity’s outstanding clinical trial data to date, NorthStar is very excited to play a pivotal role in securing the supply of Cu-67 and final drug product for the trials with 67Cu-SAR-bisPSMA in prostate cancer," said Frank Scholz, President and Chief Executive Officer of NorthStar. "We share Clarity’s vision of making more innovative, highly effective radiopharmaceutical treatments available for children and adults with cancer, and our passion is to reduce barriers and increase the speed with which companies like Clarity can develop and deliver these new medicines and diagnostic agents to patients who need them."

Recent years have seen an explosion of radiopharmaceutical research and clinical trials and yet today far too many patients still suffer from diseases without effective treatments. This is partly because the processes to develop, manufacture and deliver effective radiotherapeutics at a scale that meets patient needs are highly specialized and complex, and require a level of process precision above that required by most sophisticated small molecule or biologic manufacturing. Additionally, because the therapeutic nature of these therapies decays at a precise, known rate, there is a level of sophistication required to effectively manage supply chain volatility and uncertainty for radiopharmaceuticals that doesn’t exist for other medicines.

"These unique characteristics and requirements, and the specialized facilities, equipment, processes, talent, technology and know-how that it takes to manufacture and supply radiopharmaceuticals at scale, are what NorthStar does best," continued Scholz. "We are building out our contract development and manufacturing (CDMO) capabilities so that the biopharma innovators like Clarity can focus on discovering the next breakthrough. As we build our business, our goal is for NorthStar to be recognized as a leader in reliable production and delivery of high-quality radiotherapeutics and acknowledged as an essential success factor by our partners."

On April 10, 2024 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer therapeutics, reported promising preclinical data in two programs, OPN-6602, a dual EP300/CBP inhibitor in multiple myeloma, and OPN-9840, an oral, non-covalent TEAD inhibitor in malignant mesothelioma and metastatic melanoma (Press release, Opna Bio, APR 10, 2024, View Source [SID1234641997]). Data were shared at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5-10, 2024 in San Diego.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OPN-6602 Significantly Reduced Tumor Growth in Multiple Myeloma Models

OPN-6602 is an orally active, small molecule dual inhibitor of the E1A binding protein p300 (EP300) and CREB-binding protein (CBP) that demonstrated potent in vitro and in vivo anti-tumor activity in preclinical models of multiple myeloma. Multiple myeloma is an aggressive blood cancer derived from malignant plasma cells in the bone marrow.

Significantly reduced tumor growth as single agent (71% tumor growth inhibition, or TGI) in the OPM-2 multiple myeloma cell xenograft model
Demonstrated increased anti-tumor activity (>100% TGI) and sustained duration of response in combination studies with dexamethasone, pomalidomide and mezigdomide
Displayed synergy with dexamethasone and lenalidomide in growth inhibition of MM1.S cells
Showed downregulation of key drivers of the multiple myeloma signaling pathway including MYC, IRF4 and MYB in OPM-2 xenograft tumors
A first-in-human Phase 1 study of OPN-6602 is planned for mid-2024 in patients with multiple myeloma.

"We are excited to begin our Phase 1 study of OPN-6602 in patients with multiple myeloma this summer. While we will study OPN-6602 initially as monotherapy, preclinical data supports testing the compound as a single agent and in combination with standard of care and next generation myeloma therapies," said Jackie Walling, MBChB, PhD, chief medical officer. "The unique pharmacokinetic profile of the compound, with a high c-max and short half-life, in particular, is anticipated to provide a distinct advantage in the combination setting."

OPN-9840 Demonstrated Single Agent Efficacy in Malignant Mesothelioma

OPN-9840 is an oral, non-covalent, pan transcriptional enhanced associate domain (TEAD) inhibitor that demonstrated dose-dependent and on-target in vitro and in vivo efficacy in preclinical models of malignant mesothelioma. Malignant mesothelioma is a rare and aggressive cancer that primarily affects the lining of the lungs or abdomen. In 40% of malignant mesotheliomas, neurofibromatosis 2 (NF2) gene mutations cause dysregulation of the Hippo pathway and increased TEAD-dependent transcription. This aberrant signaling ultimately leads to increased tumor growth and resistance to therapies.

Significantly inhibited tumor growth (88% to >100%) in an NF2-mutant malignant mesothelioma mouse xenograft model. Tumor regression was observed in the 15 mg/kg (2/8 mice) and 50 mg/kg (4/8 mice) dose groups.
OPN-9652, an analog of OPN-9840, showed increased anti-tumor activity (134% TGI) and synergistic inhibition of downstream target genes in a combination study with trametinib
Showed no in vitro cytotoxicity; is well tolerated in vivo while showing potential for blood brain barrier penetration
Additional studies presented through a collaboration with Dr. Andrew Aplin’s laboratory at Thomas Jefferson University demonstrated that Opna TEAD inhibitors enhance BRAF/MEK inhibition in melanoma models by targeting drug-resistant persister cells. Dr. Aplin is a professor in cancer research and deputy director at Jefferson’s NCI-designated Sidney Kimmel Cancer Center.

OPN-9840 is set to begin IND-enabling studies and Opna is currently seeking partnerships for development.

Abstract Information

Title: OPN-6602, a potent dual EP300/CBP bromodomain inhibitor, targets multiple myeloma through concomitant suppression of IRF4 and c-MYC
Abstract Number: #660
Date and time: April 7, 2024; 1:30-5:30 pm PT
Presenter: Bernice Matusow, MS

Title: OPN-9840, a non-covalent potent pan-TEAD inhibitor, exhibits single agent efficacy in preclinical malignant mesothelioma models
Abstract Number: #7264
Date and time: April 10, 2024; 9 am-12:30 pm PT
Presenter: Pan-Yu Chen, PhD

Title: Targeting TAZ-TEAD in minimal residual disease enhances the duration of targeted therapy in melanoma models
Abstract Number: #7201
Date and time: April 10, 2024; 9 am-12:30 pm PT
Presenter: Connor Ott, PhD candidate, Thomas Jefferson University