On February 27, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported fourth quarter and full year 2023 financial results and provided a corporate update (Press release, Kura Oncology, FEB 27, 2024, View Source [SID1234640517]).

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"Given its best-in-class safety and efficacy profile as well as optimal pharmaceutical properties, we believe ziftomenib is well positioned to become a cornerstone of therapy for patients with acute leukemias," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This belief is supported by strong enthusiasm among both physicians and patients, as evidenced by rapid enrollment across our ongoing ziftomenib studies. We continue to be encouraged by the rate of enrollment in KOMET-001, our Phase 2 registration-directed trial of ziftomenib in patients with relapsed/refractory NPM1-mutant AML, and we remain on pace to complete enrollment of all 85 patients in the trial by the middle of this year. We also are seeing robust enrollment in our ongoing KOMET-007 study, which is investigating ziftomenib in combination with current standards of care in the frontline and relapsed/refractory settings. And with our recent financing, we remain in a strong financial position, which enables us to invest aggressively in research, development and pre-commercial activities to maximize the value of ziftomenib and support our other pipeline assets."

Recent Highlights

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Encouraging safety and tolerability profile for ziftomenib in combination with 7+3 and ven/aza – In January 2024, Kura reported preliminary clinical data from the first 20 patients in KOMET-007, a Phase 1 dose-escalation trial of ziftomenib in combination with standards of care, including

cytarabine/daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) AML. The first 20 patients were enrolled between July 2023 and November 2023 and included five newly diagnosed patients with adverse risk NPM1-m or KMT2A-r AML and 15 patients with refractory/relapsed (R/R) NPM1-m or KMT2A-r AML. Continuous daily dosing of ziftomenib at 200 mg was well tolerated, and the safety profile was consistent with features of underlying disease and backbone therapies. No differentiation syndrome events of any grade were reported, and no dose-limiting toxicities, evidence of QTc prolongation, drug-drug interactions or additive myelosuppression were observed.

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Encouraging evidence of clinical activity for ziftomenib combinations in NPM1-m and KMT2A-r AML – As of the data cutoff on January 11, 2024, all five newly diagnosed patients treated with ziftomenib and 7+3 achieved a complete remission with full count recovery, for a complete remission (CR) rate of 100%. The overall response rate (ORR) among the 15 R/R patients treated with ziftomenib and ven/aza was 53%, including a 40% ORR in the 10 patients who had received prior venetoclax. The CR/CRh (CR with partial hematologic recovery) rate among the nine R/R patients who were menin inhibitor naïve was 56%. As of the data cutoff, 16 of the first 20 patients remained on trial, including all 11 NPM1-mutant patients. To date, enrollment at the 400 mg dose of ziftomenib is ongoing in the R/R ven/aza cohorts and in the frontline NPM1-mutant 7+3 cohort.

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First patient dosed in KOMET-008 trial of ziftomenib in combination with additional standards of care in AML – Yesterday, Kura announced dosing of the first patient in its KOMET-008 trial of ziftomenib in combination with the FLT3 inhibitor gilteritinib, FLAG-IDA or LDAC for the treatment of relapsed/refractory NPM1-m or KMT2A-r AML. Roughly half of patients with relapsed or refractory hNPM1-mutant AML have co-occurring FLT3 mutations, and the prognosis for these patients is poor. Preclinical data for ziftomenib in combination with FLT3 inhibitors demonstrate strong synergistic effects compared to either single agent alone.

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Completion of enrollment in registration-directed trial of ziftomenib in NPM1-m AML anticipated by mid-2024 – The KOMET-001 registration-directed trial of ziftomenib in NPM1-m R/R AML is expected to enroll a total of 85 patients in the U.S. and Europe. In the Phase 1 trial, ziftomenib demonstrated a 35% CR rate and 45% overall response rate in 20 patients with NPM1-mutant AML treated at the recommended Phase 2 dose (RP2D). NPM1-mutant AML accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists.

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Addressing the continuum of care for patients with acute leukemias– Kura remains committed to developing new treatment options across the continuum of care for patients with acute leukemias, where poor outcomes and significant unmet medical need remain. In December 2023, the Company announced that ziftomenib was selected by the Leukemia & Lymphoma Society for the Pediatric Acute Leukemia (PedAL) Master Clinical Trial. As part of the study, ziftomenib will be evaluated in combination with chemotherapy in pediatric patients with R/R KMT2A-r, NPM1-m or NUP98-rearranged acute leukemia. In addition, Kura recently began dosing with ziftomenib in patients with R/R KMT2A-r acute lymphoblastic leukemia, a relatively small population with a large unmet medical need.

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Positive results from registration-directed trial of tipifarnib in HRAS-mutant HNSCC – In October 2023, Kura presented positive results from its AIM-HN registration-directed trial of tipifarnib as a monotherapy in patients with HRAS-mutant head and neck squamous cell carcinoma (HNSCC). The Company continues to evaluate tipifarnib in combination with alpelisib in patients with PIK3CA-dependent HNSCC as part of its ongoing KURRENT-HN dose-escalation trial.

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Dose escalation continues in first-in-human trial of KO-2806– In October 2023, Kura announced that the first patient was dosed in its FIT-001 Phase 1 dose-escalation trial of its next-generation FTI, KO-2806. Concurrent with dose escalation as a monotherapy in the FIT-001 trial, the Company also plans to evaluate KO-2806 in dose-escalation combination cohorts with cabozantinib in clear cell renal cell carcinoma (ccRCC) and with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC).

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Preclinical data support clinical combinations of KO-2806 with targeted therapies – In October 2023, Kura presented preclinical data supporting its rationale to combine KO-2806 with cabozantinib in ccRCC and with adagrasib in KRASG12C-mutated NSCLC. The new findings illustrate the potential for FTIs to drive enhanced antitumor activity and address mechanisms of innate and adaptive resistance to targeted therapies such as tyrosine kinase inhibitors and KRAS inhibitors.

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Clinical collaboration with Mirati to evaluate KO-2806 and adagrasib in KRASG12C-mutated NSCLC – In November 2023, Kura announced a clinical collaboration and supply agreement with Mirati Therapeutics to evaluate the combination of KO-2806 and adagrasib in patients with KRASG12C-mutated NSCLC. Kura anticipates dosing the first patients with KO-2806 and adagrasib in KRASG12C-mutated NSCLC by mid-2024.

Financial Results

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Research and development (R&D) expenses for the fourth quarter of 2023 were $32.5 million, compared to $22.7 million for the fourth quarter of 2022. R&D expenses for the full year 2023 were $115.2 million, compared to $92.8 million for the prior year.

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General and administrative (G&A) expenses for the fourth quarter of 2023 were $14.2 million, compared to $12.5 million for the fourth quarter of 2022. G&A expenses for the full year 2023 were $50.6 million, compared to $47.1 million for the prior year.

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Net loss for the fourth quarter of 2023 was $42.8 million, compared to a net loss of $33.1 million for the fourth quarter of 2022. Net loss for the full year 2023 was $152.6 million, compared to a net loss of $135.8 million for the prior year.

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Net loss for the fourth quarter and full year 2023 included non-cash, share-based compensation expense of $7.2 million and $28.1 million, respectively. This compares to $6.8 million and $26.3 million for the same periods in 2022.

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As of December 31, 2023, Kura had cash, cash equivalents and short-term investments of $424.0 million, compared to $438.0 million as of December 31, 2022.

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Pro forma for $146 million in approximate net proceeds from the company’s private placement completed in January 2024, Kura had $570 million in cash, cash equivalents and short-term investments at December 31, 2023.

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Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations into 2027.

Forecasted Milestones

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Initiate the post-transplant maintenance program for ziftomenib in the first quarter of 2024.

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Complete enrollment of 85 patients in the KOMET-001 registration-directed trial of ziftomenib in NPM1-m AML by mid-2024.

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Initiate an expansion cohort evaluating ziftomenib as a monotherapy in patients who have neither NPM1-mutant nor KMT2A-rearranged AML by mid-2024.

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Determine the RP2D for ziftomenib in combination with ven/aza and initiate dose validation/expansion in frontline AML by mid-2024.

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Determine the RP2D for ziftomenib in combination with 7+3 by mid-2024.

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Dose the first patients in the FIT-001 dose-escalation trial of KO-2806 in combination with cabozantinib in ccRCC by mid-2024.

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Dose the first patients in the FIT-001 dose-escalation trial of KO-2806 in combination with adagrasib in KRASG12C-mutated NSCLC by mid-2024.

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Complete enrollment of two expansion cohorts to support determination of the optimal biologically active dose for tipifarnib in combination with alpelisib by the end of 2024.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, February 27, 2024, to discuss the financial results for the fourth quarter and full year 2023 and to provide a corporate update. The live call may be accessed by dialing (888) 886-7786 for domestic callers and (416) 764-8658 for international callers and entering the conference ID: 02911668. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On February 27, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, reported that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer (Press release, IMUNON, FEB 27, 2024, View Source [SID1234640516]). IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.

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Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, "We are delighted that such a prestigious institution as Memorial Sloan Kettering has joined this trial, which is testing the combination of IMNN-001 and bevacizumab, known as Avastin, in ovarian cancer. We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab. As an innovative immunotherapy, IMNN-001 may transform the first-line treatment of ovarian cancer and provide new options to women diagnosed with Stage III/IV disease who face cure rates of 15% or less."

This Phase 1/2 trial is designed to enroll 50 patients with Stage III/IV advanced ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second-look laparoscopy (SLL), and the secondary endpoint is progression-free survival (PFS).

Initial SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

The trial’s principal investigator is Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will also be involved in translational analyses using trial samples and animal models of ovarian cancer MRD, including biomarker and genomic analyses, which is expected to expand the Company’s knowledge of the treatment paradigm. These initiatives are a part of the Break Through Cancer Targeting Ovarian Cancer Minimal Residual Disease Using Immune and DNA Repair Directed Therapies TeamLab collaboration.

Dr. Le Goff added, "We are excited about the potential for IMNN-001 in ovarian cancer, in particular following our recently announced encouraging interim PFS and overall survival data for our OVATION 2 Study evaluating the benefits of IMNN-001 in the neoadjuvant setting."

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced Stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stages III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stages III and 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.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 (formerly GEN-1) 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. The Company 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. It announced full enrollment in the OVATION 2 Study in September 2022, interim data in September 2023 and expects to report topline data in the second quarter of 2024.

On February 27, 2024 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the expansion of the clinical trial into Europe (Press release, Greenwich LifeSciences, FEB 27, 2024, View Source [SID1234640515]).

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The Company’s application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this final approval, regulators have cleared the way to activate 105 sites as soon as site contracts and site initiation visits are completed. Site initiation visits have been scheduled as early as the week of March 4, 2024.

CEO Snehal Patel commented, "We have been planning this expansion for over 2 years and are thrilled to be making GLSI-100 available to patients in Europe in these major countries with a total population of approximately 300 million. The interest in developing a vaccine to prevent the recurrence of breast cancer is very high in the European clinical and academic community, especially given the promising efficacy and safety profile from the prior GLSI-100 trials. We look forward to working very closely with our European colleagues and will start by training site staff, pharmacists, and nurses. We hope to open sites as quickly as possible, while applying to open additional sites in the approved countries and potentially adding additional countries in Europe."

About Flamingo-01 and GLSI-100

Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on Flamingo-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On February 27, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that G1’s Chief Executive Officer Jack Bailey will participate in a Breast & Lung Cancer Corporate Panel Discussion during the TD Cowen 44th Annual Health Care Conference on Wednesday March 6, 2024 at 9:10 AM EST (Press release, G1 Therapeutics, FEB 27, 2024, View Source [SID1234640514]).

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The webcast of the event will be accessible on the Events & Presentations page of View Source

On February 27, 2024 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that members of the management team will participate in fireside chats at the following investor conferences (Press release, Deciphera Pharmaceuticals, FEB 27, 2024, View Source [SID1234640513]):

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TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024 at 1:30 PM ET in Boston, MA
Leerink Partners Global Biopharma Conference on Monday, March 11, 2024 at 2:40 PM ET in Miami Beach, FL
Barclays Global Healthcare Conference on Wednesday, March 13, 2024 at 8:00 AM ET in Miami Beach, FL

Live webcasts will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source All webcast replays will be archived on the Company’s website for 90 days following the presentation.