On June 24, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, reported database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer (Press release, IMUNON, JUN 24, 2024, View Source [SID1234644503]). Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024.

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OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022.

The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response.

Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, "Reaching data lock for the OVATION 2 Study is a significant achievement for our team and a step forward in our mission to bring an innovative treatment to patients battling ovarian cancer. With the last patient enrolled in September 2022, the analyses generated using the ITT population, an industry gold standard, will now have sufficient data maturity to analyze both PFS and OS endpoints with a good level of confidence. We are hopeful that IMNN-001 will offer improved outcomes and a much-needed alternative to those affected by this deadly disease."

Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, added, "Given the maturity of our data, OS will be important in the readout of the trial and in planning the Phase 3 trial. As the definitive endpoint, OS has been observed across all tumor types as most reflective of the long-term benefit of immunotherapies. We look forward to the trial readout and sharing learnings from the trial with the patient and medical community."

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an interleukin-12 (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 fifth deadliest malignancy among women in the United States. There are approximately 22,000 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 tumor in the peritoneal cavity with a high risk of recurrence (75% in 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 June 24, 2024 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, reported its new Residual Acute Myeloid (RAM) Application (Press release, Sophia Genetics, JUN 24, 2024, View Source [SID1234644519]). The new offering expands the company’s comprehensive oncology portfolio to support measurable residual disease (MRD) capabilities and will be available to customers worldwide this summer.

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Acute Myeloid Leukemia (AML) represents about one percent of all cancers worldwide, yet is one of the most common forms of leukemia in adults1. Over 50 percent of AML patients relapse within 3 years after achieving complete remission2, therefore post-treatment monitoring is imperative for AML patients, particularly within the first two years, to help quickly detect any signs of relapse3. MRD solutions can help inform post-remission therapy and identify early relapse, and serve as a primary endpoint in clinical trials, helping researchers detect even the smallest trace of cancer and support better patient outcomes.

"AML unfortunately still remains an area of high unmet medical need today, with associated suboptimal patient outcomes. MRD measurement and monitoring has a critical role to play, for example by enabling research into the most optimal sequencing of therapies," said Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS. "We are proud to contribute to the fight against AML through our SOPHiA DDM RAM Solution. In particular we feel that the capability to seamlessly track longitudinally the evolution of individual mutations over time through a dedicated add-on module of our SOPHiA DDM Platform has the potential to be a game-changer for clinical researchers."

Next-generation sequencing (NGS)-based MRD testing is among the most advanced in cancer screening and monitoring, and can be found only with highly sensitive methods. The SOPHiA DDM RAM Solution provides users with the confidence that MRD will detect even one cancer cell among 10,000 cells. This application will allow users to stay ahead of disease response with the analytical capabilities of the SOPHiA DDM Platform, enabling sensitive variant detection down to 0.01% VAF and covering guideline-recommended genes to deliver robust insights for residual acute myeloid.

Customers using the SOPHiA DDM RAM Solution will have access to longitudinal variant monitoring, allowing them to visualize the mutational landscape for each patient and its evolution over time. The solution also provides users with the most up-to-date databases and customizable reporting features to generate graphical representations and comprehensive MRD reports.

Additionally, the SOPHiA DDM RAM Solution will continually hone its machine learning algorithms to provide the most accurate MRD results in just four days.

Representatives from SOPHiA GENETICS are available at AMP (Association for Molecular Pathology) Europe June 24-27 to discuss AML monitoring with this new application.

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.com and connect on LinkedIn.

On June 24, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and Co-founder, will participate in a fireside chat during the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference on Tuesday, June 25, 2024 at 2:30 p.m. ET (Press release, In8bio, JUN 24, 2024, View Source [SID1234644504]).

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A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On June 24, 2024 Sustained therapeutics reported that the first patient has entered the Phase II/III trial of ST-02, innovative cancer medication targeting Upper Tract Urethral Carcinoma (UTUC) (Press release, Sustained Therapeutics, JUN 24, 2024, View Source [SID1234644520]).

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A rare form of cancer, UTUC affects over 7,000 individuals annually across North America. UTUC is a cancer of the inside lining of the kidney (the "collecting system" – where urine starts to drain after it is made by the kidney) and the ureter (the tube that carries urine from the kidney to the bladder). Its location in the upper collecting system makes it challenging to access and completely remove with traditional laser resection.

"This is a new opportunity in the treatment of UTUC," says Dr. Peter Black, lead investigator of the clinical trial and a Senior Research Scientist with the Vancouver Prostate Centre. "Currently we have limited treatment options for this uncommon and challenging cancer, and this approach may allow better disease control without having to remove a kidney."

The first patient in the clinical trial has been enrolled at the Vancouver Prostate Centre, and it is anticipated that 5 other sites will take part in the study. The company plans on enrolling approximately 75 patients in the combined Phase II/III trial and believes that ST-02 may be designated an orphan drug. Orphan drug designation can qualify the company for incentives such as tax credits, exemption from user fees, and seven years of market exclusivity after approval.

Sustained Therapeutics’ ST-02 product for UTUC is a sustained release formulation that enables direct delivery of chemotherapy to the site of the carcinoma via a catheter. Using the company’s proprietary platform technology, the medication releases slowly over about 24 hours exactly where the cancer is located, coating the tissue and delivering chemotherapy at higher concentrations and for longer than the current standard of care. The company believes that this direct sustained delivery may be more effective and result in fewer side effects than other forms of chemotherapy that are a current standard of care.

"ST-02 is Sustained Therapeutic’s second product to reach Phase II trials, and demonstrates our potential to develop multiple products using our novel drug delivery platforms. As such, it is a very important development in our portfolio," says Dr. Martin Gleave, Founder and Chief Medical Office of Sustained Therapeutics and Distinguished Professor in the UBC Department of Urologic Sciences and Director of the Vancouver Prostate Centre (VPC). "This new therapeutic, designed specifically for UTUC, could address an important unmet need for patients. It’s an exciting time to be a part of this work."

On June 24, 2024 Nerviano Medical Sciences S.r.l. ("NMS" and "the Company"), a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc., a wholly owned subsidiary of NMS Group, focused on the discovery and development of oncology drugs and the largest oncological R&D company in Italy, reported that the United States Food and Drug Administration (FDA) has cleared the protocol for investigational new drug (IND) application for NMS-812, a first-in-class orally bioavailable and highly potent small molecule dual inhibitor of PERK/GCN2 (Press release, Nerviano Medical Sciences, JUN 24, 2024, https://www.nervianoms.com/nerviano-medical-sciences-announces-fda-protocol-clearance-of-new-ind-application-for-nms-812-a-first-in-class-dual-inhibitor-of-perk-gcn2-brian-sherer-phd-appointed-to-lead-and-accelerate-the-dev/ [SID1234644505]).

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NMS-812 has very strong scientific rational in the multiple myeloma indication by modulating the unfolded protein response via PERK in the integrated stress response (ISR) pathway since this is a high protein production setting. In addition, NMS-812 inhibits GCN2, another ISR component, affecting mainly amino acid deprivation stress, to augment cell death. Together the double inhibition likely overcomes resistance. The first in human (FIH) study showed excellent pharmacokinetic profile allowing daily oral dosing and likely permissive safety for further development. The multiple myeloma indication was deprioritized because it would require significant resources due to multiple treatment lines, but NMS is fully committed to continuing in partnership with other companies interested in the multiple myeloma space.

NMS-812’s ability to inhibit two key components, PERK and GCN2, of the ISR, may offer superiorapoptosis in other cancer settings such as AML. In addition, NMS-812 modulates the immune response via direct and indirect mechanisms which may contribute to anti-cancer activity.

Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy. According to American Cancer Society, in 2024, an estimated 20,800 new cases of leukemia will be diagnosed in the US and 11,220 people will die from the disease.

NMS expects to initiate enrollment of patients with relapsed/refractory AML including patients with TP53 mutations in the Phase I PERKA-812-003 trial in the second half of 2024.

NMS today also announces the discontinuation of the FIH clinical trial with NMS-812 in the setting of relapsed/refractory multiple myeloma (NCT05027594) due to strategic reasons.

"Acute Myeloid Leukemia (AML) remains an aggressive hematological malignancy with tremendous unmet medical need especially in the p53 mutant patient population. Based on preclinical data and unique dual Integrated Stress Response mechanism, NMS-812 may represent a novel strategy for AML through the unfolded protein response and amino acid deprivation stressors , with potential for synergies with other drugs and potential to overcome drug resistance." said Lisa Mahnke, MD, Ph.D., Chief Medical Officer at NMS. "We are thrilled to have Brian to join the NMS team to lead the development."

Brian has had leadership roles with Exelixis, EMD Serono, and AstraZeneca over a 25 year career. He has been instrumental in the discovery and early development of more than 10 small molecule clinical candidates.

In addition to PERK/GCN2, Brian will also lead NMS’ MPS1 asset, leveraging his extensive expertise.

"Both PERK/GCN2 and MPS1 assets hold potential as first-in-class drugs for subsets of cancers with high unmet medical needs. Our teams have made remarkable progress in developing these novel assets, and we are excited about the future under Brian’s leadership." said Lisa Mahnke.