On June 3, 2021 Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported the enrollment of the first patient in a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center (Press release, Lixte Biotechnology, JUN 3, 2021, View Source [SID1234583455]). The trial will assess the combination of Lixte’s first-in-class protein phosphatase 2A (PP2A) inhibitor LB-100 with a standard regimen for previously untreated, extensive stage-disease small cell lung cancer (ED-SCLC) (NCT04560972).

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John S. Kovach, M.D., Lixte founder and chief executive officer, said, "In collaboration with City of Hope, we are eager to pursue our well-grounded rationale for adding LB-100 to a standard ED-SCLC regimen of carboplatin and etoposide chemotherapy plus atezolizumab to enhance effectiveness. In preclinical studies, the malignant cells of this uniformly fatal cancer are genetically sensitive to PP2A inhibition by a process termed synthetic lethality and the effectiveness of the standard regimen is enhanced by LB-100.

"Small cell lung cancer comprises approximately 15% of all lung cancers worldwide with about 30,000 new cases annually in the U.S.," Dr. Kovach continued. "The median survival of patients with this especially aggressive type of lung cancer, even with current ‘best’ therapy, is approximately nine months. Because of such rapid disease progression, the therapeutic benefit of adding LB-100 to the standard treatment may be seen early on in this Phase 1b clinical trial."

Ravi Salgia, M.D., Ph.D., City of Hope’s Arthur & Rosalie Kaplan Chair in Medical Oncology, said, "We are hopeful that this trial testing a potentially more effective therapeutic combination could provide another treatment option for small cell lung cancer patients. It is a disease that is currently difficult to treat, particularly after a patient has relapsed, so more therapeutic options are needed."

About the Study

In the Phase 1b trial of LB-100 for the treatment of ED-SCLC, Lixte’s lead compound will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be escalated with fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival. The study is open at City of Hope in Duarte, California.

On June 3, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the Stifel 2021 Virtual Cross Sector Insight Conference webcast (Press release, Leidos, JUN 3, 2021, View Source [SID1234583454]).

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Chris Cage, Corporate Controller and incoming Chief Financial Officer, will participate in a question and answer "fireside chat" on Thursday, June 10, 2021 at 4:40 p.m. ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for 90 days afterward.

On June 3, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) (Press release, Kintara Therapeutics, JUN 3, 2021, View Source [SID1234583453]). The adjuvant arm of the study investigates newly-diagnosed patients suffering from glioblastoma multiforme (GBM) receiving VAL-083 in place of standard of care temozolomide (TMZ) as adjuvant therapy following surgery and chemoradiation TMZ. The trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival.

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The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In February 2021, the Company announced the trial’s second arm (recurrent GBM) enrolled its final patient.

"Enrolling the final patient in the adjuvant arm of the Phase 2 study at MD Anderson is yet another important milestone for the Company as we continue to advance VAL-083 in multiple settings including the GCAR sponsored GBM AGILE study where we have already initiated patient recruitment at 15 sites as the only therapeutic agent currently being evaluated in this adaptive design registration study for all three GBM patient subtypes; newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent," commented Saiid Zarrabian, Kintara’s Chief Executive Officer.

VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

On June 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that three new strength tablets for XPOVIO, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, are now commercially available (Press release, Karyopharm, JUN 3, 2021, View Source [SID1234583452]). The availability of these additional strength tablets follows a U.S. Food & Drug Administration (FDA) approval on April 15, 2021. In addition to the original 20 mg strength tablets, XPOVIO is now available in 40 mg, 50 mg, and 60 mg strength tablets. XPOVIO tablets are available in seven different package sizes to help healthcare providers individualize the dosing and administration of XPOVIO based on patient needs. The additional dosage strength tablets may also increase patient compliance by simplifying their treatment regimen and reducing the pill burden experienced by some patients. With the introduction of these new tablet strengths and additional package sizes, there is no change to the efficacy and safety profile of XPOVIO.

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About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On June 3, 2021 Isofol reported that it will present an abstract at the annual ASCO (Free ASCO Whitepaper) meeting between June 4 – June 8 (Press release, Isofol Medical, JUN 3, 2021, View Source [SID1234583451]). Together with scientists from Sahlgrenska University Hospital and Precision for Medicine/QuartzBio (Geneva, Switzerland), we will present data about the regulation of 5-FU/folate-based treatment in colorectal cancer. MYC activation, a known transcriptional regulator of TYMS (the gene coding for TS), and one of the targets for the treatment, has been identified as a potentially relevant common upstream controller of a group of genes involved in 5-FU/folate efficacy. This relationship opens up for exploring further potential biomarker candidates as factors in 5-FU/Arfolitixorin efficacy and also combinations (including MYC-inhibitors).

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Information about the presentation

Title: MYC as a candidate upstream controller involved in TYMS gene expression and 5-FU/folate treatment efficacy in colorectal cancer

Authors: David A. Drubin, Anne-Katrin Hess, Natalie L. Catlett, Alessandro Di Cara, Yvonne Wettergren, Roger Tell

Abstract Number: e15512

Session title: Gastrointestinal Cancer—Colorectal and Anal