On September 20, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the U.S. Department of Defense ("DOD") has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody ("mAb")-based drug product prototypes targeting plague (Press release, Evotec, SEP 20, 2022, View Source;evotec-biologics-awarded-contract-from-us-department-of-defense-under-accelerated-antibodies-program-6213 [SID1234619677]). Plague, an infectious disease caused by the bacterium Yersinia pestis ("Y. pestis"), is one of the designated targets of interest under the DOD’s Accelerated Antibodies Program .

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!

Under the contract, Just – Evotec Biologics will develop mAb-based drug product prototype(s) from sequence discovery or evaluation of existing mAbs to completion of Phase I first-in-human ("FIH") clinical trials. To enable rapid development, Just – Evotec Biologics will leverage its data-driven, highly automated end-to-end biologics technology platform, J.DESIGN, that includes; antibody discovery (J.HAL), molecular optimisation, cell line and process development, and continuous manufacturing at its J.POD Redmond, Washington (US) facility. In addition, Evotec will provide pre-clinical and clinical capabilities for mAb prophylactic approvals.

The rapid, cost-efficient development of mAb product protypes will yield an accelerated supply of safe and efficacious mAb medical counter measures ("MCMs") for use against plague.

J.DESIGN employs a series of innovative technologies relying on the use of artificial intelligence, machine learning, intensified and continuous bioprocesses specifically designed for flexible and efficient biologics development, from discovery through to clinical and commercial manufacturing. The advanced Just – Evotec Biologics platform is specifically well suited for monoclonal antibodies as well as other protein modalities such as Fc fusion proteins.

Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics commented: "It is an honor to continue our partnership with the JPEO-CBRND team in this new effort to support the DOD’s Accelerated Antibodies program. We are pleased to provide a single integrated discovery, development and manufacturing solution for the DOD."

Dr Craig Johnstone, Chief Operating Officer of Evotec, added: "We are delighted to support the DOD with this work of strategic national importance, and which we feel represents a clear validation of both the efficiency and speed our leading science, technology and expertise offers our partners."

Mr. Bruce Goodwin, Joint Project Lead for CBRND Enabling Biotechnologies, added: "JPEO-CBRND-EB is pleased to work with Just/Evotec on this innovative and significant program to protect the Warfighter. Just/Evotec brings a unique approach, a robust toolset and deep expertise to address a challenging threat in a highly accelerated time frame."

The contract was awarded by the Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND-EB) within the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). Contract number MCDC2203-001.

Just – Evotec Biologics’ J.POD Redmond, Washington biologics development and cGMP manufacturing facility will develop mAb-based drug products for the US Department of Defense. The state-of-the-art facility is joining the DOD’s Advanced Development and Manufacturing network of facilities, providing DOD with the space and tools necessary to rapidly produce quality medical countermeasures at the lowest possible cost of goods.

On September 19, 2022 SHINE Technologies, a next-generation fusion technology company, and Radiopharm Theranostics (ASX:RAD), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, reported that they have entered into a clinical supply agreement (Press release, Shine Medical Technologies, SEP 19, 2022, View Source [SID1234621864]). SHINE will supply Radiopharm with isotope non-carrier-added lutetium-177 (Lu-177).

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!

The isotope will be used by Radiopharm in the development of its clinical pipeline of diagnostic and therapeutic radiopharmaceutical products. Lu-177 is an important isotope utilized in multiple programs across Radiopharm’s portfolio.

"One way or another, nearly everyone has been affected by cancer. SHINE’s efforts in lutetium-177 are all about prolonging the lives of those affected most directly," said Chris Vessell, general manager of SHINE’s Therapeutics Division. "We are excited that our isotopes will play a critical role in Radiopharm Theranostics’ programs that aim to revolutionize cancer treatment."

SHINE, an emerging leader in the production of this medical radioisotope, intends to be the industry’s only vertically integrated producer of Lu-177, aiming to provide a reliable and scalable supply independent of current supply-chain restraints."

"Ensuring supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs unimpeded," said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics. "Lutetium-177 is required for three of our more advanced assets and this clinical supply agreement with SHINE, an experienced player in nuclear technology, is another important step in de-risking our business plan."

On September 19, 2022 Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for solid cancers, reported the submission of an Investigational New Drug (IND) application on its lead product, AGX101, to the FDA (Press release, Angiex, SEP 19, 2022, View Source [SID1234621830]). Pending feedback from the agency, Angiex looks to begin enrolling the first patients in the clinical trial in Q4 of this year. The Phase 1 trial will focus on solid cancer patients with late stage disease who have few or no therapeutic options.

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!

AGX101 is a humanized TM4SF1-directed antibody and microtubule inhibitor antibody drug conjugate (ADC) being developed as an intravenously (IV) administered therapeutic. The TM4SF1-directed antibody is linked to a tubulin-inhibiting maytansine payload via a noncleavable covalent linker and site-specific conjugation to an engineered cysteine.

TM4SF1 is a novel ADC antigen that is highly expressed in tumor cells and tumor associated vascular endothelium, and is differentiated by its internalization to the nucleus. AGX101 has been shown to be highly potent both in vitro and in vivo, and has achieved complete tumor regressions in multiple human tumor xenograft models in mice. AGX101 is the first in Angiex’s pipeline of Nuclear Delivery Antibody-Drug ConjugatesTM, and proof of concept for Angiex’s Nuclear Delivery PlatformTM.

On September 19, 2022 Aesther Healthcare Acquisition Corp. ("Aesther") (NASDAQ: AEHA) entered into definitive merger agreement with Ocean Biomedical, Inc. Aesther reported that it has paid, and that Continental Stock Transfer & Trust Company has received, $1,050,000 from Aesther representing the sum needing to be paid by Aesther to extend the date on which Aesther must consummate its initial business combination from September 16, 2022 to December 16, 2022 (Press release, Ocean Biomedical, SEP 19, 2022, View Source [SID1234621465]).

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!

On September 19, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immunogenic dysregulation that drive cancer, reported that preclinical data on ST101, the company’s first-in-class peptide antagonist of C/EBPβ, were published online in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Sapience Therapeutics, SEP 19, 2022, View Source [SID1234619693]). The published data describe preclinical evidence to support the advancement of ST101 as a novel therapy for treating advanced solid tumors. The full manuscript titled "Anti-cancer activity of ST101, a novel antagonist of CCAAT/enhancer binding protein β", can be found online here.

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!

The data in the manuscript detail ST101-antagonism of CCAAT/Enhancer Binding Protein β (C/EBPβ), a basic leucine zipper family transcription factor that is upregulated or overactivated in many cancers, resulting in gene transactivation that drives oncogenesis. ST101 binds C/EBPβ, preventing its dimerization and enhancing ubiquitin-proteasome dependent C/EBPβ degradation. ST101 exposure significantly decreases expression of C/EBPβ target genes including genes responsible for survival, transcription factors and cell cycle-related proteins. The result of ST101 exposure is potent, tumor-specific in vitro cytotoxic activity in cancer cell lines including glioblastoma, breast, melanoma, prostate, and lung cancer, while normal human immune and epithelial cells are not impacted. In vivo xenograft models indicate that ST101 exposure results in potent tumor growth inhibition or regression, both as a single agent and in combination studies.

"The publication of ST101 in Molecular Cancer Therapeutics is an exciting achievement, highlighting the tremendous unmet need for novel therapies to treat solid tumor cancers and the role that ST101 can play to fill this need," said Jim Rotolo, Ph.D., Sapience’s VP, Translational Pharmacology and Head of Research. "We are thrilled to publish the mechanism of action of ST101 and showcase the therapeutic promise of disrupting C/EBPβ-driven oncogenic activity. We look forward to reporting and publishing additional data on ST101 and advancing the program through its ongoing Phase 1-2 study."

In its ongoing Phase 1-2 study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM, a durable RECIST 1.1-confirmed partial response in a patient with cutaneous melanoma and long-lasting stable disease in several additional patients.

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.