On June 26, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. ("Nexcella", "Company", "We" or "Us"), a biopharmaceutical company pioneering cell therapies targeting oncology and other diseases, reported that it has completed a Pre-Investigational New Drug ("Pre-IND") meeting with the FDA (Press release, Immix Biopharma, JUN 26, 2023, View Source [SID1234632893]). The subject of the Pre-IND meeting was planned NXC-201 US manufacturing and US clinical trials in AL amyloidosis and multiple myeloma.

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"Completion of our planned Pre-IND meeting with FDA is an important milestone towards opening U.S. clinical trial sites for NXC-201," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We appreciate the FDA’s guidance and believe that with regulatory clarity in hand, our next step is to proceed with submitting a US IND application to the FDA for NXC-201."

A pre-IND meeting provides an opportunity for communication between a drug development company and the FDA to discuss an investigational new drug (IND) proposed filing and plan to obtain the agency’s guidance for the initial clinical studies of a novel drug candidate. The FDA reviewed the pre-IND package submitted by Nexcella including clinical data, manufacturing plan and the phase 1b/2 study protocol synopsis for NXC-201, provided guidance and recommendations, as well as addressed Nexcella’s questions on the development plan of NXC-201 in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

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/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

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.

On June 26, 2023 IDP Pharma, based in Barcelona’s Science Park (PCB) and a pioneer in the development of drugs targeting intrinsically disordered proteins (IDPs), reported the starting of clinical trial of its first-in-class drug IDP-121, first to degrade cMyc oncoprotein, a Holy Grail oncogene long-quested by the pharma industry (Press release, IDP Pharma, JUN 26, 2023, View Source;utm_medium=rss&utm_campaign=idp-pharma-starts-the-clinical-trial-of-idp-121-the-first-drug-that-degrades-the-oncogene-cmyc-a-key-disease-driver-responsible-for-the-initiation-and-progression-of-several-hematological-tumors [SID1234632892]). The study will include patients with diffuse lymphoma, chronic lymphocytic leukaemia and multiple myeloma.

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On June 26, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that on June 16, 2023, filed with the SEC its financial results and related management’s discussion for the first quarter ended March 31, 2023 (Press release, Enlivex Therapeutics, JUN 26, 2023, View Source [SID1234632891]).

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First Quarter 2023 Financial Results:

Research and development expenses were $5.2 million for the three months ended March 31, 2023, as compared to $4.7 million for the same period in 2022. The increase of 11% was primarily due to an increase in expenses for clinical studies and pre-clinical studies, offset by a decrease in lease payments and overhead expenses related to our plant space.

General and administrative expenses were $1.6 million for the three months ended March 31, 2023, as compared to $1.7 million for the same period in 2022. The decrease of 7% was primarily due to decrease in stock-based compensation expense with respect to equity granted to employees and directors, and decrease in professional fees.

Net loss for the three months ended March 31, 2023 was $7.2 million, as compared to a net loss of $8.2 million for the three months ended March 31, 2022. This decrease resulted primarily from a decrease in other expenses, net, which was partially offset by an increase in the costs of clinical and pre-clinical studies and material consumption.

As of March 31, 2023, Enlivex had cash and cash equivalents, short term bank deposits and long term interest-bearing bank deposits of $43.2 million. The Company believes its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements potentially into 2025.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On June 26, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer (Press release, Alligator Bioscience, JUN 26, 2023, View Source [SID1234632888]). The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma.

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The second interim analysis conducted on the 23 patients included in the interim analysis reported in January 2023, with a follow-up period of nine to 17 months, demonstrated the following:

Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients
Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months
The interim analysis conducted on all 57 evaluable patients with a follow-up period of two to 17 months demonstrated the following:

25 patients responded to treatment resulting in an interim ORR of 44%.
Median Duration of Response (DoR)[1] was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies[2], indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits
In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR)
Furthermore, mitazalimab’s manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed.
In both interim analyses, patients were evaluated as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone[2].

"Our OPTIMIZE-1 Phase 2 study has produced another set of very encouraging data to add to the growing body of compelling clinical evidence supporting our lead drug candidate mitazalimab in pancreatic cancer. Especially, we are excited to see that tumor responses continue to develop suggesting a longer benefit for the patients, and we are looking forward to seeing the data from the full cohort mature as the trial progress," said Søren Bregenholt, CEO of Alligator Bioscience. " With our planned discussions with regulators and the expected top-line readout from OPTIMIZE-1 due at the beginning of next year, we continue to make excellent progress with the clinical development of mitazalimab and its route to market."

"Several compounds have failed to show clinical benefit in pancreatic cancer. These second interim results from OPTIMIZE-1, in which mitazalimab again demonstrates a consistent response rate, together with the durable responses in several patients with extremely aggressive disease is particularly encouraging," said Prof. Jean-Luc van Laethem, coordinating investigator, Erasmus University Hospital, Brussels (BE). "The consistent objective response rate together with the positive signal on duration of response of approximately 9 months gives us further crucial insight into the efficacy of mitazalimab and provides more evidence of the potential of this CD40 agonist to be further developed for becoming a therapeutic option for first line pancreatic cancer patients."

Completion of patient enrolment in OPTIMIZE-1 was reported in April 2023, and in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.

These data will form the basis of discussions with regulators in the U.S. and Europe on the optimal development and approval pathway for mitazalimab in pancreatic cancer.

OPTIMIZE-1 remains on track for top-line readout in early Q1 2024.

On June 26, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM, ‘Actinium’), a leader in the development of targeted radiotherapies, reported that the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting selected Abstract 685 titled "Individualized dosing for high-dose targeted radiation of hematopoietic cells with Iomab-B (I131-apamistamab) prior to HCT in relapsed/refractory acute myeloid leukemia (R/R AML): Safety and efficacy results from the pivotal phase 3 SIERRA trial" as the Abstract of the Year (Press release, Actinium Pharmaceuticals, JUN 26, 2023, View Source [SID1234632887]).

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"It is a great honor for this SIERRA data abstract and this team of esteemed abstract authors to have received this award highlighting Iomab-B’s potential for people with relapsed and refractory AML," said Sandesh Seth, Chairman and Chief Executive Officer. "Today’s SNMMI honor represents the fourth oral presentation of the SIERRA trial data at prestigious medical conferences in 2023, including TCT, EBMT, and EHA (Free EHA Whitepaper). The extensive global recognition of the SIERRA results highlights Iomab-B’s potential to transform outcomes for the significant number of people with relapsed or refractory AML by enabling increased access to bone marrow transplant via a targeted radiotherapeutic. We are committed to file our BLA submission with U.S. Food and Drug Administration in the second half of this year in our endeavor to bring this new radiotherapeutic to people with great need."

"Elderly patients with active, relapsed/refractory AML have a very poor prognosis and currently have very limited treatment options. In routine clinical practice, these patients are not being considered for potentially curative bone marrow transplant," said Neeta Pandit-Taskar, MD, lead abstract author, attending physician, Molecular Imaging and Therapy Service, in the Department of Radiology at Memorial Sloan Kettering Cancer Center, and professor at Weill Cornell Medical College, in New York, New York. "This pivotal study showed that a single personalized dose of Iomab-B enabled all patients who received the therapeutic dose to have access to potentially curative bone marrow transplant, compared to only 17 percent of patients who received conventional care. Iomab-B also demonstrated long-term survival benefit for patients who met the primary endpoint, and safety of the Iomab-B led regimen was excellent. In addition, the visibility and cross-functionality of nuclear medicine was clearly demonstrated, strengthening the collaborative effort between nuclear medicine, nursing, and transplant teams. This will add further growth and impetus to use of nuclear medicine in planning and administration of theranostic radioimmunotargeted therapy."

AML is one of the most lethal forms of leukemia in adults. The American Cancer Society estimates that 20,380 people will be diagnosed with AML and more than 11,300 will die from the disease in 2023. Patients with relapsed or refractory disease represent the largest segment of AML patients.