On November 25, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported the outcome of its recent End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of its investigational interleukin-12 (IL-12) immunotherapy IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study (Press release, IMUNON, NOV 25, 2024, View Source [SID1234648610]). IMUNON remains on track to initiate the 500-patient Phase 3 trial in the first quarter of 2025.

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"The collaborative End-of-Phase 2 meeting with the FDA represents another important milestone in our IMNN-001 clinical program, and we are very pleased that the Agency is aligned with the potential for IMNN-001 to address a significant unmet need in ovarian cancer treatment and our Phase 3 plans," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "We are encouraged by the robust safety and efficacy data from our Phase 2 OVATION 2 Study, including the positive survival results recently presented in a late-breaking session at the SITC (Free SITC Whitepaper) Annual Meeting. IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment."

"Our goal is to replicate these remarkable results in a Phase 3 trial, which would be transformative for the current standard of care, substantially improving overall survival and giving hope to thousands of women with advanced ovarian cancer who continue to experience disease progression," Dr. Lindborg added.

The interaction with the FDA included an extensive review of data generated to date, including positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. The OVATION 2 Study results demonstrated that IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in approximately a one-year (35%) improvement in overall survival compared to treatment with standard-of-care chemotherapy alone. Treatment was also generally well tolerated, with no reports of cytokine release syndrome or any other serious immune related adverse events.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On November 25, 2024 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, reported that additional NEXICART-1 NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held in San Diego, California, December 7-10, 2024 (Press release, Immix Biopharma, NOV 25, 2024, View Source [SID1234648609]).

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"NXC-201 is the only CAR-T in development for relapsed/refractory AL amyloidosis patients," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "NXC-201 continues to demonstrate promising results in this underserved patient population." Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are pleased to continue to demonstrate our focus and leadership in relapsed/refractory AL Amyloidosis at the upcoming 66th annual ASH (Free ASH Whitepaper) meeting in San Diego."

ASH Presentation Details (CAR-T NXC-201 in relapsed/refractory AL Amyloidosis)

Event 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, CA
Title "Efficacy and Safety of Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) for the Treatment of Relapsed and Refractory AL Amyloidosis"
Presentation
Date/Time (Pacific Time)
Publication #894
Session Date: Monday, December 9, 2024
Session Name: 652. MGUS, Amyloidosis, and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: Ignored no Longer-Progress in AL Amyloidosis
Session Time: 2:45 PM-4:15 PM
Presentation Time: 4:00PM PT
About NEXICART-1
NEXICART-1 (NCT04720313) is an open-label, ex-U.S. Phase 1b/2 clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis (including AL Amyloidosis patients with impaired cardiac function and including AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and efficacy of NXC-201. NEXICART-1 clinical results are available at View Source .

About NEXICART-2
NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety-run in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells) (both dose levels were evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients). The study aims to evaluate the safety and efficacy of NXC-201. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012).

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated no neurotoxicity of any kind in AL Amyloidosis.

NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into select immune-mediated diseases. The NXC-201 NEXICART-2 (NCT06097832) U.S. clinical trial builds on a robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure, and leads to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

On November 25, 2024 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy (Press release, GlaxoSmithKline, NOV 25, 2024, View Source [SID1234648608]). The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review."

The US application is based on results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care triplet combinations in relapsed or refractory multiple myeloma.

Results from both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in the DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.

In a subsequent planned interim analysis, the DREAMM-7 trial also met the key secondary endpoint of overall survival1 (OS), showing a statistically significant and clinically meaningful OS benefit favouring the belantamab mafodotin combination. Efficacy and safety data from this analysis will be presented at the upcoming 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on 9 December 2024 at 11:15 a.m. PT. A positive trend in OS was observed in DREAMM-8 but was not statistically significant at the time of interim analysis, and follow-up for OS continues.

This is the sixth major regulatory filing acceptance this year for belantamab mafodotin combinations in the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the European Union2, Japan3 (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). In China4, the National Medical Products Administration has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with bortezomib and dexamethasone, as well as priority review for the regulatory application based on the results of DREAMM-7.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Multiple myeloma is a significant and enduring health concern in the US, where more than 35,000 cases are expected to be diagnosed in 2024.6,8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9

About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

Results from DREAMM-7 were first presented10 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to a combination of bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

A total of 302 participants were randomised at a 1:1 ratio to receive either BPd or PVd.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

Results from DREAMM-8 were first presented11 at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Blenrep is approved as monotherapy in Hong Kong. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information.

On November 25, 2024 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer Anthony Pagano will take part in a fireside chat at Citi’s 2024 Global Healthcare Conference on December 3, 2024 at 8:30 PM CET/2:30 PM EST (Press release, Genmab, NOV 25, 2024, View Source [SID1234648607]). A webcast of the event will be available on Genmab’s website at
View Source

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On November 25, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 10 abstracts demonstrating the breadth of its Precision Oncology portfolio at the 2024 annual San Antonio Breast Cancer Symposium (SABCS ) from December 10-13 in San Antonio, Texas (Press release, Exact Sciences, NOV 25, 2024, View Source [SID1234648606]).

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"Exact Sciences is committed to improving breast cancer care by providing actionable insights that support informed treatment decisions and help achieve the best outcomes for patients across all backgrounds," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. "For 20 years, the Oncotype DX test has led the way in personalized treatment planning, and the new findings presented at SABCS reinforce its trusted role among clinicians, research institutions, and patients alike. With the addition of our OncoExTra test and our anticipated molecular residual disease monitoring test, we’re equipping clinicians with innovative solutions to support patient needs throughout every stage of cancer care."

In collaboration with leading breast cancer experts and research groups, Exact Sciences will share data highlighting how the Oncotype DX test helps guide effective chemotherapy use in everyday practice and clinical trials. New findings from Japan will show how the test supports decision making in breast cancer treatment and can help manage costs. Additionally, retrospective findings reveal African American women are more likely to have higher Recurrence Score results than non-Hispanic White women, with similar survival outcomes. These insights emphasize how the Oncotype DX test can support more equitable breast cancer care across diverse populations and the need for further research to better understand factors behind racial disparities that currently exist.

Data presentations across Exact Sciences’ Precision Oncology portfolio include:

Title : (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: Final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial
Session: Late breaking oral presentation GS3-04. Friday, December 13, 9:00-11:45 AM CST; General Session 3, Hall 1

Title: Correlation between the Oncotype DX Recurrence Score categories and progression-free survival of patients with primary metastatic estrogen-receptor positive and HER2-negative breast cancer
Session: Poster P4-12-01. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: The Oncotype DX test to guide adjuvant chemotherapy treatment decisions for early node-negative HR+/HER2- breast cancer patients in Japan: a cost-effectiveness analysis
Session: Poster P4-11-07. December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Comparative analysis of the Oncotype DX Breast Recurrence Score assay for neoadjuvant letrozole/abemaciclib versus chemotherapy in Stage II-III, Ki67≥20%, HR+/HER2- breast cancer: insights from the GEICAM/CARABELA trial
Session: Poster P1-09-12. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Genomic risk score distribution and outcomes of patients with early-stage breast cancer diagnosed during pregnancy
Session: Poster P1-03-30. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX Breast Recurrence Score distribution and prognostic value according to prior pregnancy status in young women with breast cancer
Session: Poster P1-01-23. Wednesday, December 11, 12:30 – 2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX assay association with breast cancer outcomes in different racial and ethnic groups: a retrospective analysis
Session: Poster P2-07-06. Wednesday, December 11, 5:30-7:00 PM CST; Poster Session 2, Halls 2 and 3

Title: Actionable gene alterations affecting the PI3K/AKT and MAPK signaling pathways in breast cancer
Session: Poster P4-03-25. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Molecular landscape of breast cancer in pre- and postmenopausal women
Session: Poster P3-03-30. Thursday, December 12, 12:00-2:00 PM CST; Poster Session 3, Section Row 3 & Poster 30

Title: Economic analysis of germline genetic testing to assess for hereditary breast cancer: a systematic review
Session: Poster P4-04-14. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3