On February 26, 2024 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company") reported the signing of an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke (NINDS) and National Cancer Institute (NCI), each a component of the National Institute of Health (NIH) (Press release, Lixte Biotechnology, FEB 26, 2024, View Source [SID1234640456]).

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Under the terms of the license agreement, LIXTE has licensed exclusively NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement (CRADA) subject invention co-developed with Lixte, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination with standard anti-cancer drugs. The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for the treatment of cancer.

"This strategic collaboration marks a significant milestone in advancing LIXTE’s mission to advance cancer therapy by developing its first-in-class lead clinical PP2A inhibitor, LB-100, as a potentiator of cancer immunotherapy," said Bas van der Baan, Chief Executive Officer of LIXTE. "We are excited to embark on this journey as it opens up new avenues for advancing our commitment to developing effective and targeted anti-cancer therapies. The agreement reinforces our dedication to pioneering research and delivering innovative solutions to patients battling cancer," he added.

The collaboration harnesses the synergies of LIXTE’s innovative compound, LB-100, and NINDS’s and NCI’s cutting-edge research capabilities. The licensed patent rights provide LIXTE with a unique opportunity to explore and develop novel combination therapies that can potentially transform the landscape of cancer treatment.

LIXTE recently announced the entry of the first patient into a Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, has the ability to enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). Another Phase 1b clinical trial in small cell lung cancer combining LB-100 with Roche’s atezolizumab and chemotherapy is also actively recruiting. The Company intends to develop additional clinical trials with LB-100 to enhance the efficacy of chemotherapy and immunotherapy.

On February 26, 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 that the first patient has been dosed in KOMET-008, the Company’s Phase 1 trial of its menin inhibitor ziftomenib, in combination with gilteritinib, FLAG-IDA or LDAC for the treatment of NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML) (Press release, Kura Oncology, FEB 26, 2024, View Source [SID1234640455]).

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"Roughly half of patients with relapsed or refractory NPM1-mutant AML have co-occurring FLT3 mutations, and the prognosis for these patients is particularly poor," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "Given the potential best-in-class safety and tolerability profile as well as the robust monotherapy activity observed in our Phase 1 study of ziftomenib, we believe an all-oral combination of ziftomenib and gilteritinib may provide an attractive treatment option for these patients."

KOMET-008 is a Phase 1 study designed to assess safety and tolerability, pharmacokinetics and evidence of clinical activity of ziftomenib in combination with gilteritinib, FLAG-IDA or LDAC for two genetically defined cohorts, NPM1-mutant AML and KMT2A-rearranged AML, in the relapsed/refractory setting. Trial participants will be enrolled in one of five dose escalation cohorts, including a cohort of NPM1-mutant AML patients with a documented FLT3 co-mutation, who will be treated in combination with the FLT3 inhibitor gilteritinib. For more information regarding KOMET-008, please visit www.clinicaltrials.gov (identifier: NCT06001788).

Kura is conducting a series of studies to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations. In July, the Company began dosing patients in the first of these studies, KOMET-007, in combination with venetoclax and azacitidine in patients with relapsed/refractory NPM1-mutant and KMT2A-rearranged AML or in combination with standard induction cytarabine/daunorubicin chemotherapy (7+3) in patients with previously untreated NPM1-mutant and KMT2A-rearranged AML. Kura reported positive preliminary data from 20 patients in KOMET-007 on January 30, 2024.

Preclinical data for menin inhibitors in combination with multiple FLT3 inhibitors demonstrate strong synergistic effects compared to either single agent alone. Currently there are no other actively recruiting clinical trials evaluating the combination of a menin inhibitor with a FLT3 inhibitor for the treatment of AML.

About Acute Myeloid Leukemia

AML is the most common acute leukemia in adults and begins when the bone marrow makes abnormal myeloblasts (white blood cells), red blood cells or platelets. Despite the many available treatments for AML, prognosis for patients remains poor and a high unmet need remains. The menin pathway is considered a driver for multiple genetic alterations of the disease, of which NPM1 mutations are among the most common, representing approximately 30% of AML cases and KMT2A rearrangements represent approximately 5-10% of AML cases. While patients with NPM1-m AML have high response rates to frontline therapy, relapse rates are high and survival outcomes are poor, with only 30% overall survival at 12 months in the R/R setting. Additionally, NPM1 mutations frequently occur with co-mutations in other disease-associated genes, including FLT3, DNMT3A and IDH1/2, with prognosis heavily influenced by the presence of co-occurring mutations. Adult patients with NPM1-m AML and select co-mutations and/or R/R disease have a poor prognosis, with median overall survival of only approximately 7.8 months in 2nd line, 5.3 months in 3rd line and 3.5 months following the 4th line1. Adult patients with KMT2A-r AML have a poor prognosis with high rates of resistance and relapse following standard of care, with median overall survival for this patient population of only 6 months following 2nd line and 2.4 months following 3rd line2. No FDA-approved therapies targeting NPM1-m and KMT2A-r AML currently exist.

About Ziftomenib

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. Ziftomenib inhibits the KMT2A/MLL protein complex and exhibits downstream effects on HOXA9/MEIS1 expression and potent anti-leukemic activity in genetically defined preclinical models of AML. Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib.

On February 26, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported positive updated clinical data for both of its clinical programs (Press release, Janux Therapeutics, FEB 26, 2024, View Source [SID1234640454]). Janux will host a virtual event today at 4:30 PM ET. To register for the event, please click here.

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"These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors. The clinical data provide compelling proof-of-concept for the TRACTr platform in a setting where many other approaches have failed due to material safety issues or lack of efficacy," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "Our TRACTr platform provides an entry point to multiple, large solid tumor indications that are intractable with conventional TCE approaches. We look forward to continuing to advance these clinical trials and expanding to additional TCE targets, as we look to fulfill our mission to meaningfully address the unmet medical needs for cancer patients, especially those with late-stage disease."

Updated interim clinical data for PSMA-TRACTr JANX007 in mCRPC as of February 12, 2024.

JANX007 is in a Phase 1a clinical trial in subjects with advanced or metastatic prostate cancer (mCRPC). The subjects enrolled in the trial were heavily pre-treated with a median of 4+ lines of therapy. As of February 12, 2024, 23 subjects were treated with JANX007 in the dose escalation portion of the Phase 1a clinical trial. An increasing depth of PSA declines and RECIST responses at higher doses were observed, while a favorable safety profile was maintained. At a starting dose ≥ 0.1 mg, 14 of 18 (78%) subjects achieved PSA30 declines and 10 of 18 (56%) subjects achieved PSA50 declines. At a starting step dose of ≥ 0.2 mg, 6 of 6 (100%) subjects achieved PSA30 declines and 5 of 6 (83%) subjects achieved PSA50 declines. Initial step doses of JANX007 ≥ 0.2 mg drove deeper and more durable PSA responses, including one subject that achieved a PSA90 decline.

Cytokine Release Syndrome (CRS) was observed to be temporary and mild, presenting only as low-grade 1 or 2 events, and was quickly managed with treatment. These incidents of CRS were mainly reported during the first treatment cycle, with no subsequent occurrences in later cycles. Similarly, the majority of treatment-related adverse events (TRAEs) not associated with CRS were of low severity (Grade 1 or 2)

and also primarily occurred in the initial cycle. There was a low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were observed. JANX007 has been administered at doses up to 3mg, significantly exceeding the anticipated maximum tolerable dose for the parental T cell engager, while the maximum tolerable dose for the TRACTr has not yet been established.

Based on this safety profile, we are continuing dose optimization for JANX007 with the goal of further deepening PSA responses, while maintaining a favorable safety profile. Janux anticipates providing an update on doses for expansion in the second half of 2024.

Interim clinical data for EGFR-TRACTr JANX008 in solid tumors as of February 12, 2024.

JANX008 is in a Phase 1a clinical trial in subjects with advanced or metastatic solid tumors known to express high levels of the EGFR target, including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). As of February 12, 2024, 11 heavily pre-treated, late-stage subjects across all four tumor types have been enrolled. Encouraging signs of clinical activity were observed, while a favorable safety profile was maintained. In one subject with NSCLC treated with JANX008 at 0.15mg once-weekly , a confirmed partial response (PR) by RECIST criteria with 100% reduction of the target lung lesion and elimination of liver metastasis with no CRS or TRAEs has been observed. This subject remains on treatment and their PR has been maintained through their week-18 scan. One subject with RCC experienced a 12% reduction in the size of a large RCC mass and significant clinical benefit with Grade 1 CRS.

The early safety profile for JANX008 is consistent with the TRACTr design principles of tumor-specific activation while avoiding healthy tissue toxicity with a broadly expressed target. In the 11 subjects enrolled at doses up to 1.25mg, which is significantly above the projected maximum tolerable dose of the parental T cell engager, Grade 1 CRS was observed in only two subjects and no Grade 2 or higher CRS was seen. The majority of non-CRS TRAEs were also low-Grade 1 or 2 and occurred predominantly in cycle one. No treatment related serious adverse events or dose-limiting toxicities have been observed.

Based on this safety profile, we are continuing in the dose escalation and optimization portion of the trial for JANX008.

Webcast Information

Janux will host a live webcast today at 4:30 PM ET. A live question and answer session will follow the formal presentation. To register for the event, please click here. There will also be a dial-in:

USA & Canada – Toll-Free (800) 715-9871

International: 1 (646) 307-1963

Conference ID: 8772874

To access the live webcast, please visit the Investors section of the Company’s website. A replay of the webcast presentation will be available on the Company’s website at View Source for at least 30 days.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and squamous cell carcinoma of the head and neck. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells for the treatment of solid tumors. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

On February 26, 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 present at the following investor conferences in March (Press release, In8bio, FEB 26, 2024, View Source [SID1234640453]):

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TD Cowen 44th Annual Health Care Conference
Company presentation
Monday, March 4, 2024, at 9:50 am ET

2nd Annual H.C. Wainwright Cell Therapy Virtual Conference
Virtual company presentation
Tuesday, March 26, 2024

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 February 26, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it has entered into an asset purchase agreement ("Agreement") with Otsuka Pharmaceutical Co., Ltd. ("Otsuka"), pursuant to which Otsuka acquired iBio’s assets related to its early-stage programmed cell death protein 1 ("PD-1" ) agonist program (Press release, iBioPharma, FEB 26, 2024, View Source [SID1234640452]). The transaction closed on February 25, 2024.

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Under the terms of the Agreement, iBio will receive an upfront payment of $1.0 million in cash at closing. iBio will also be eligible to receive additional contingent cash payments totaling up to $52.5 million upon the achievement of certain pre-specified clinical development and commercial milestones.

PD-1 is a pivotal checkpoint in the immune system, acting as a type of "off switch" that helps keep the cells from attacking other cells in the body. By agonizing or enhancing the signaling of PD-1, it is possible to temper the immune response, making it particularly valuable in the treatment of autoimmune diseases. In conditions where the immune system mistakenly wages war on the body’s own cells, such as in autoimmune diabetes or lupus, therapies that target PD-1 can potentially reduce the severity of these autoimmune reactions. However, unlike PD-1 antagonists used in immuno-oncology, PD-1 agonists, like the one iBio is selling to Otsuka, are difficult to find.

"We believe this is an important transaction for iBio, and a win-win for both companies," said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D. "The deal provides iBio with a potential significant new source of non-dilutive capital if all of the milestones are satisfied; further validates the ability of our precision-driven and deeply integrated technology stack to efficiently deliver antibody candidates against challenging targets, including the development of complex antibody modalities such as agonistic antibodies; and allows us to focus our resources squarely on the continued development of our proprietary immuno-oncology pipeline and AI-based drug discovery platform. At the same time, it provides a path forward for the PD-1 agonist program via further development by Otsuka."