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.

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 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]).

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!

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.

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 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]).

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!

"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.

On June 26, 2023 AB Science SA (Euronext-FR0010557264-AB) reported that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating (mCRPC) with its lead compound masitinib, based on findings from study AB12003 [1] (Press release, AB Science, JUN 26, 2023, https://www.ab-science.com/ab-science-receives-notice-of-allowance-for-european-patent-covering-masitinib-in-the-treatment-of-metastatic-castrate-refractory-prostate-cancer-mcrpc/ [SID1234632886]). This new European patent provides intellectual property protection for masitinib in the treatment of mCRPC until 2042.

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!

Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy; that is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.

Although there are numerous treatments in the mHSPC treatment space, there is currently no drug registered for use in combination with docetaxel in patients with mCRPC, despite docetaxel having been approvedalmost 20 years ago. Historically, there has been a high failure rate of trials studying combinations of docetaxel and new targeted agents, with study AB12003 being a rare example of a phase 3 clinical trial that showed improvement in progression-free survival (PFS) for masitinib in combination with docetaxel.

The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patentapplication, EP4175639A1, after the completion of certain formal procedural steps. Once granted, the patent can be kept in force until May 2042. A European NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability under the European Patent Convention.

More specifically, this patent provides protection of masitinib and related compounds for treatment of mCRPC in a patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels). This patient population is fully consistent with results from masitinib study AB12003 [1] and the on-going clinical development program of masitinib in mCRPC. As a reminder, key results from study AB12003 include:

Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progression-free survival (PFS) benefit in mCRPC patients with baseline alkaline phosphatase levels (ALP) less than or equal to 250 IU/L; hazard ratio of 0.79 [0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of progression relative to control.

Assessment of PFS rates was convergent with this primary outcome, with 12, 18, and 24-month PFS rates showing significant improvement in favor of masitinib plus docetaxel relative to control: 1.6-fold (p=0.0035), 1.9-fold (p=0.0001) and 1.9-fold (p=0.0028), respectively.

A progressively greater masitinib treatment effect was observed for lower baseline ALP levels (i.e., less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP less than or equal to 100 IU/L (hazard ratio=0.53, p=0.002).

The masitinib plus docetaxel safety profile was acceptable, consistent with the known masitinib profile and with no new safety signals observed.

Although localized disease is associated with high survival rates, metastatic prostate cancer still represents an unmet medical need with a 5-years survival rate of about 32%.

References

[1] Pavic, Michel; Hermine, Olivier; Spaeth, Dominique LBA02-11 Masitinib plus docetaxel as first-line treatment of metastatic castrate refractory prostate cancer: results from study AB12003, Journal of Urology: September 2021-Volume 206-Issue Supplement 3. doi: 10.1097/JU.0000000000002149.11

[2] American Cancer Society. Cancer Facts & Figures 2023. Atlanta: American Cancer Society; 2023. Accessed June 2023. View Source

About study AB12003 Study

AB12003 was a prospective, placebo controlled, double blind, randomized, phase 3 trial, evaluating masitinib (6.0 mg/kg/d) in combination with docetaxel (IV 75 mg/m² plus prednisone for up to 10 cycles) as a first-line treatment of metastatic castrate resistant prostate cancer (mCRPC). Eligible patients were chemo-naïve with confirmed mCRCP, who had progressed on previous abiraterone treatment or were indicated for docetaxel treatment, and had a ECOG ≤1. Primary analysis was performed on a pre-specified targeted subgroup, defined as patients with baseline alkaline phosphatase levels (ALP) ≤250 IU/L, and on the overall population. Primary endpoint was progression free survival (PFS) (PCWG2 definition). The study was successful if improvement in median PFS relative to control reached a 3.9% level of significance for the target subgroup (alpha split with fallback procedure to conserve overall type-I error at 5% for the overall study cohort). Primary analysis was based on 450 patients in the targeted subgroup (ALP ≤ 250 IU/L). There was a total of 712 patients in the overall study cohort.

About masitinib

Masitinib is a orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can bedeveloped in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.