Epsilogen announces successful completion of first ever clinical trial of an IgE antibody; phase I data for MOv18 IgE demonstrates potential of IgE therapy in cancer

On July 25, 2023 Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, reported the publication of the final phase I data from the first ever clinical trial of an IgE antibody therapeutic in Nature Communications (View Source) (Press release, Epsilogen, JUL 25, 2023, View Source [SID1234633407]). MOv18 IgE is Epsilogen’s lead IgE antibody drug candidate and binds to anti-folate receptor (FRα), a well validated target for ovarian cancer. It was administered to 26 patients with high grade serous ovarian carcinoma whose cancer had become platinum-resistant.

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Results from the study, entitled "A Cancer Research UK phase I study of MOv18 IgE, a first in class chimeric IgE antibody against folate receptor-alpha, in patients with advanced solid tumours" (View Source), showed a manageable safety profile with transient urticaria being the most common adverse event. The urticaria always resolved within hours of dosing, either spontaneously or with the administration of systemic steroids and antihistamines.

Although the trial was not designed to demonstrate efficacy, tumour shrinkage and an associated fall in CA 125 tumour marker level was seen in one patient. Notably, the authors of the paper observed that the anti-tumour activity "occurred at doses very much lower than typically observed for IgG antibodies", reflecting fundamental differences in Fc-receptor affinity and effector cell biology.

Professor James Spicer, Professor of Experimental Cancer Medicine at King’s College London, Consultant in Medical Oncology at Guy’s and St Thomas’ NHS Foundation Trust (GSTT) and the study’s lead investigator, said: "IgE is a completely new form of antibody therapy which has shown great promise in this phase I trial. Our findings show that the drug was well tolerated in patients and shrunk a cancerous tumour in a patient with ovarian cancer. The results pave the way to development of an entirely new class of anti-cancer drug for people with chemotherapy-resistant cancers. The immunology expertise in King’s College London laboratories allowed us to undertake this trial of a completely new form of antibody therapy."

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "The data published in Nature Communications, are encouraging and add further validation to support our belief that IgE antibodies have the potential to emerge as an entirely new treatment modality for patients with cancer. We have a robust clinical development plan in place to progress MOv18 IgE further into the clinic and the data generated will assist us in the development of our other IgE antibody drug candidates".

Lilly Announces Extension of Tender Offer to Acquire DICE

On July 25, 2023 Eli Lilly and Company (NYSE: LLY) reported the extension of the expiration of the tender offer to acquire all of the issued and outstanding shares ("Shares") of common stock of DICE Therapeutics, Inc. (NASDAQ: DICE), for a purchase price of $48 per share in cash, without interest and less any applicable tax withholding (Press release, Eli Lilly, JUL 25, 2023, View Source [SID1234633406]).

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The tender offer, which was previously scheduled to expire one minute past 11:59 p.m., Eastern time, on July 28, 2023, has been extended until one minute past 11:59 p.m., Eastern time, on Aug. 8, 2023, unless the tender offer is further extended or earlier terminated. The proposed acquisition is expected to close in the third quarter of 2023, subject to customary closing conditions, including the receipt of required antitrust clearance and the tender of at least a majority of the outstanding Shares as of the expiration of the tender offer.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Lilly that, as of 4:30 p.m., Eastern time, on July 24, 2023, approximately 9,581,902 Shares have been validly tendered and not properly withdrawn in the tender offer, representing approximately 20.05% of the issued and outstanding Shares, as of such date and time. Holders that have previously tendered their Shares do not need to re-tender their Shares or take any other action in response to the extension of the tender offer.

Curium announces license and development agreement with Lantheus for AI-based PSMA PET software in Europe

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."

bluebird bio to Host Second Quarter 2023 Financial Results Conference Call and Provide Commercial Update

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.

Corporate presentation

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

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