On July 25, 2023 Curium, a world leader in nuclear medicine, reported a ‘License and Development’ agreement with EXINI Diagnostics AB, a Lantheus company (EXINI), to customize EXINI’s artificial intelligence (AI) platform for use in Europe (Press release, Curium, JUL 25, 2023, View Source [SID1234633405]). The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

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Today’s announcement follows the May 2023 decision by the Committee for Medicinal Products for Human Use of the European Medicines Agency that recommended granting a marketing authorization for PYLCLARI (piflufolastat (18F)), intended for the diagnosis of prostate cancer.

Under the terms of the agreement, EXINI’s deep learning platform will be tailored to meet the specific needs of the European market. The clinical value proposition of the platform is to increase the efficiency and reproducibility of PSMA PET/CT image assessments in prostate cancer and establish the standard for comprehensive reporting across the US and Europe. The deep learning algorithm will be trained on anonymized data from Curium’s European Phase III PYTHON (NCT04734184) clinical trial, in addition to the existing dataset from the two U.S. registrational studies (OSPREY – NCT02981368 and CONDOR – NCT03739684) of piflufolastat F18.

The AI-enabled assessment will assist in bringing increased consistency, reliability, and efficiency in reporting PSMA-avid total disease burden and in monitoring its change with treatments.

Benoit Woessmer, CEO PET Europe at Curium commented: "By leveraging artificial intelligence and the extensive anonymized data from our European PYTHON clinical trial, this is an important milestone in enhancing prostate cancer diagnosis, and indeed for the patients themselves. We are excited about using deep learning to help us redefine the experience of cancer through our trusted legacy in nuclear medicine."

Etienne Montagut, Chief Business Officer at Lantheus commented: "PSMA PET has had an important impact on prostate cancer management. With the expanding treatment options in prostate cancer, including PSMA RLT, there is increasing demand for efficient, standardized quantitative assessment of PSMA disease burden. Our partnership with Curium expands the pool of patient data informing our AI algorithm and enables more widespread access to our software."

On July 25, 2023 bluebird bio, Inc. (Nasdaq: BLUE) reported that it will hold a conference call to discuss second quarter 2023 financial results and provide a commercial update on Tuesday, August 8 at 8:00 a.m. ET (Press release, bluebird bio, JUL 25, 2023, View Source [SID1234633404]). In addition to providing an overview of the business, the conference call will highlight the Company’s ongoing commercial launches of SKYSONA and ZYNTEGLO and the market opportunity for lovo-cel.

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To access the call via telephone, please register at this link https://register.vevent.com/register/BI4fa1d86317c74333813f6827624e43ae to receive a dial in number and unique PIN to access the live conference call.

The live webcast of the call may be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the bluebird website at View Source A replay of the webcast will be available on the bluebird website for 90 days following the event.

On July 25, 2023 Akari Therapeutics presented its corporate presentation (Presentation, Akari Therapeutics, JUL 25, 2023, View Source [SID1234633403]).

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On July 24, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), and SpectronRx, a leading radiopharmaceutical developer and manufacturer, reported a global strategic partnership agreement to support manufacturing of components of ARTBIO’s AlphaDirectTM isotope isolation technology (Press release, ARTBIO, JUL 24, 2023, View Source [SID1234637912]).

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As part of the agreement, SpectronRx will be responsible for manufacturing a critical component of ARTBIO’s proprietary AlphaDirectTM technology. AlphaDirectTM is a first-of-its-kind system that delivers highly pure Pb212 from widely available raw materials. The multi-year agreement covers an initial technology transfer and development phase, followed by qualification and release of the technical components.

"We have a long history in managing complicated technology projects involving radioactive materials," said SpectronRx co-founder and CEO John Zehner. "We understand the importance of collaboration for companies developing new technologies aimed at creating radioligand therapies. SpectronRx is well-equipped and proud to partner with ARTBIO to develop and supply key components of AlphaDirectTM."

ARTBIO pioneered the AlphaDirectTM technology to create an optimized and proprietary Pb212 isotope isolation technology with unique advantages, including:

Benchtop format, which can be operated in facilities of any size.
Simple process with no fluid separation that results in 99.9%+ purity.
Streamlined supply chain with starting materials derived from accessible nuclear industry stockpiles that minimize uncertainty and cost.
SpectronRx will tap into its expertise for handling and producing rare medical radioisotopes such as Ac-225 (actinium-225) and Pb-212, along with its infrastructure for Radiopharmaceutical Contract Development (rCDMO) and Radiopharmaceutical Contract Manufacturing (rCMO). This unique combination and its extensive regulatory track record will enable ARTBIO to effectively improve and validate its manufacturing processes to get them ready for FDA and EMA review.

"We are pleased to partner with SpectronRx, a company with extensive experience and capabilities in managing nuclear chemistry projects," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Handling high doses of radioactivity is an extremely complex process, and it was critical that we work with a partner that understands the specific requirements needed and can create a customized solution for our proprietary AlphaDirectTM technology. With SpectronRx’s expertise, we are a step closer to the establishment of the ARTBIO manufacturing network."

"ARTBIO’s technology has the potential to revolutionize the field of cancer treatment," added SpectronRx President Anwer Rizvi. "We are thrilled to be a part of their incredible journey."

On July 24, 2023 Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA (NYSE: ADCT), reported that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China (Press release, ADC Therapeutics, JUL 24, 2023, View Source [SID1234634578]). The BLA has been granted priority review by the NMPA.

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The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA. The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL.

Professor Zhu Jun, principal investigator of the OL-ADCT-402-001 study and Party Secretary of Beijing Cancer Hospital and Director of Internal Medicine, said: "Safer and more effective treatments are still urgently needed to address significant unmet medical needs among r/r DLBCL patients after two or more lines of systemic therapy in China. I hope ZYNLONTA will be accessible to Chinese r/r DLBCL patients soon."

"We are pleased with the swift progress of the development program for ZYNLONTA in China as evidenced by the NMPA’s recent acceptance of the BLA and priority review designation," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This is a significant step forward in our commitment to making ZYNLONTA available to benefit patients worldwide."

Ed Zhang, Co-founder and CEO of Overland Pharmaceuticals, said: "This is a meaningful milestone. Our partnership with ADC Therapeutics began in December 2020, and it took us only two and a half years to complete the clinical study and submit the first BLA. We would like to extend our sincere gratitude to participating patients, clinical investigators, the health authority and our partner ADC Therapeutics for their strong support in making this achievement possible. We look forward to our continued collaboration with all stakeholders to maximize the potential benefits of ZYNLONTA for patients in China."

Overland ADCT BioPharma holds the exclusive rights to develop and commercialize ZYNLONTA in Greater China and Singapore. The BLAs for ZYNLONTA have already been submitted in Singapore, Hong Kong and Taiwan. It is expected to address the unmet needs of patients with r/r DLBCL across these regions.

About ZYNLONTA (loncastuximab tesirine-lpyl)

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.