On July 25, 2023 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported a series of actions designed to reduce the Company’s burn rate and enhance our ability to maximize value of eganelisib, following the termination of its previously announced merger agreement with MEI Pharma, Inc (Press release, Infinity Pharmaceuticals, JUL 25, 2023, View Source [SID1234633409]).

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The Company continues to believe, based on the data generated to date, that eganelisib offers a near-term value creation opportunity that would be attractive to potential third-party acquirers. Infinity has advanced eganelisib toward the initiation of a planned global Phase 2 clinical trial in head and neck squamous cell carcinoma, and, following FDA feedback, has submitted the final protocol to the FDA.

Infinity’s Board of Directors (the "Board") intends to seek a strategic transaction to maximize eganelisib’s potential and intends to retain SSG Capital Advisors LLC, an independent investment bank, to lead this process.

In parallel, in order to reduce ongoing expenditures Infinity is implementing the following measures:

A reduction in force of 21 employees or approximately 78% of the current workforce.
A reduction in the size of the Board from eight members to five, with Dr. Brian Schwartz, Dr. Sam Agresta, and Mr. Sujay Kango departing.
The remaining five members of the Board have agreed to serve without compensation for the remainder of their Board service.
The reduction in force and other value preservation measures are expected to result in a one-time charge of $3.4 million in severance and restructuring costs in the third quarter of 2023.

The Company is evaluating whether to withdraw the request that it submitted to Nasdaq for an appeal of Nasdaq’s delisting determination regarding the Company’s common stock. The Company expects that a withdrawal would result in the delisting of its shares from Nasdaq.

On July 25, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. ("Nexcella", "Company", "We" or "Us"), reported that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023 (Press release, Immix Biopharma, JUL 25, 2023, View Source [SID1234633408]).

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"We are delighted to continue to see U.S. and international recognition of the progress we are making," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator. "We are pleased to present clinical data in relapsed multiple myeloma at the upcoming International Myeloma Society Annual Meeting, an important international forum for discussion of novel treatments for multiple myeloma and AL Amyloidosis."

Poster Presentation:

Title: "Safety and efficacy of a locally produced novel anti-BCMA chimeric antigen receptor T-cell (CART) (HBI0101) for the treatment of relapsed and refractory multiple myeloma"
Poster Presentation Date/Time: September 27, 2023 9:00am – 14:30pm; September 28, 2023 10:00 – 13:30pm; September 29, 2023 9:30 – 14:15pm
Event: 20th International Myeloma Society Annual Meeting, Athens, Greece

About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis according to consensus recommendations.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. Nexcella plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. Nexcella plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.

About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.

About Multiple Myeloma
Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

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".

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.

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."