On November 13, 2023 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy benefit, reported an update on its progress (Press release, Lixte Biotechnology, NOV 13, 2023, View Source [SID1234637548]).

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Clinical Trial and Other Advancements

Year-to-date, LIXTE has made advances in the development of LB-100 through important collaborations, including the following:

● Collaboration with GSK and The University of Texas – MD Anderson Cancer Center in an investigator-initiated Phase 1b/2 clinical trial assessing whether adding LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma. GSK will provide dostarlimab and financial support for the clinical trial. In addition to MD Anderson, the trial also will be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center.

● The first patient was enrolled in the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas – GEIS) trial to determine whether LB-100 given with a standard dose of doxorubicin for the treatment of advanced soft tissue sarcomas (ASTS) will improve progression-free survival and overall survival. This trial will enroll up to 170 patients and will begin in partnership with GEIS clinical sites.

● Sarah Cannon Research Institute (SCRI) joined the City of Hope’s ongoing Phase 1b clinical trial evaluating the addition of LB-100 to chemotherapy and immunotherapy for previously untreated, extensive-stage small cell lung cancer. Adding SCRI is expected to reduce the time required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard of care.

● Expanded collaboration with the Netherlands Cancer Institute (NKI) and Oncode Institute to study pre-clinical drug synergies of LB-100 with chemotherapy and immunotherapy in various cancers. The expansion follows a successful two-year collaboration in colon cancer and seeks to discover additional treatment combinations with LB-100 for other cancer types. A recently posted article in BioRxiv detailed that the collaboration demonstrated that inhibition of PP2A in colon cancer cells by LB-100 may lead to an improvement in immunotherapy response.

Bas van der Baan, LIXTE’s recently-appointed President and Chief Executive Officer, said, "Since the beginning of this year, LIXTE has been expanding its collaborations with several prestigious, world-renowned cancer research institutions and pharmaceutical companies that are testing our LB-100 compound to improve chemotherapy and immunotherapy treatment outcomes. We believe that LB-100 may offer broad applicability to many types and stages of cancer, with the potential to benefit a wide range of patients."

Other Corporate News

● Bas van der Baan, 51, was named President and Chief Executive Officer of LIXTE in September 2023. He was subsequently named Chairman of the Board of Directors as a result of the passing of LIXTE’s founder, Dr. John S. Kovach, on October 5, 2023. He had previously joined LIXTE’s Board of Directors in June 2022. With more than two decades of experience in the biotechnology industry, focused on oncology and diagnostics, Mr. van der Baan will lead the Company as it works toward its mission of improving medical outcomes for patients undergoing various chemotherapies and immunotherapies for cancer, while establishing and commercializing LB-100. The Company closed a registered direct offering with an institutional investor for 583,334 shares of common stock (including pre-funded warrants) and a concurrent private placement of common warrants to purchase up to 583,334 shares of common stock at a purchase price of $6.00 per common share in July 2023. The gross proceeds from the offering were approximately $3,500,000, with net proceeds of approximately $3,137,000.

Filing of September 30, 2023 Quarterly Report on Form 10-Q

Additional information with respect to LIXTE’s business, clinical trials and financial condition is contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, which has been filed with the U.S. Securities and Exchange Commission at www.sec.gov.

On November 13, 2023 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2023 (Press release, LianBio, NOV 13, 2023, View Source [SID1234637547]).

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"We continue to make significant progress bringing innovative medicines to patients in our region, including the achievement of critical clinical development and market building milestones," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Following our recent transaction granting development and commercial rights to BMS for mavacamten in our territories, we look forward to conducting a comprehensive strategic review aimed at realizing the value of our platform and product candidates."

Recent Business Highlights and Clinical Development Updates

Entered into agreement with Bristol Myers Squibb for mavacamten in China and other Asian markets
•In October 2023, LianBio entered into an agreement with Bristol Myers Squibb (BMS), whereby BMS obtained LianBio’s exclusive rights to develop and commercialize mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Singapore and Thailand, in conjunction with termination of the exclusive license agreement LianBio previously entered into with MyoKardia, Inc., now a wholly owned subsidiary of BMS, in August 2020 to acquire such rights. Under the terms of the agreement, LianBio is entitled to receive a total consideration of $350 million.
•In August 2023, LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients were presented in a late-breaking science session at the European Society of Cardiology (ESC) Congress 2023 and simultaneously published in a JAMA Cardiology paper titled, "Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy."
Topline data announced from Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients; TP-03 approved in the United States
•In October 2023, LianBio announced topline data from the Phase 3 LIBRA study of TP-03 in Chinese patients with Demodex blepharitis. The co-primary endpoints of the LIBRA trial were mite eradication (mite density of 0 mites per lash) and complete collarette cure (collarette score of 0) at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.001). A positive, although not statistically significant trend (p=0.15) was demonstrated for complete collarette cure. LianBio plans to discuss these results with the China National Medical Products Administration (NMPA) and expects to use these data to support a New Drug Application filing in China.

•In July 2023, LianBio partner Tarsus Pharmaceuticals announced the U.S. Food and Drug Administration’s approval of TP-03 for the treatment of adults with Demodex blepharitis.

Positive topline data presented from Phase 2a trial of infigratinib in Chinese patients with gastric cancer
•In October 2023, LianBio announced data from a Phase 2a study evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. The data demonstrated confirmed objective response rate (cORR) of 23.8% (95% CI: 8.2 – 47.2), disease control rate (DCR) of 76.2% (95% CI: 52.8 – 91.8) and median duration of response (DOR) of 3.8 months (95% CI: 3.6 – NE). Median progression-free survival (mPFS) was 3.3 months (95% CI: 2.3 – 4.5) and median overall survival (mOS) was 8.0 months (95% CI: 4.1 – NE).

Initiated Phase 1 clinical trial of SHP2 inhibitor BBP-398 in combination with EGFR inhibitor osimertinib in Chinese non-small cell lung cancer (NSCLC) patients with EGFR mutations
•In August 2023, LianBio announced the initiation of a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations.
•In July 2023, LianBio entered into a clinical supply agreement with AstraZeneca in China to procure osimertinib for this clinical trial.

Comprehensive strategic review ongoing

•In October 2023, LianBio announced that the company’s Board of Directors initiated a comprehensive strategic review of the company, with an update anticipated in the first half of 2024.
Third Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $9.0 million for the third quarter of 2023 compared to $8.3 million for the third quarter of 2022, and $29.3 million for the nine month period ended September 30, 2023 compared to $49.2 million for the nine month period ended September 30, 2022. The decrease was primarily attributable to increased milestone payments in 2022 and was partially offset by higher development activities to support clinical trials in 2023.

General & Administrative Expenses

General and administrative expenses were $17.3 million for the third quarter of 2023 compared to $16.3 million for the third quarter of 2022, and $48.0 million for the nine month period ended September 30, 2023 compared to $46.9 million for the nine month period ended September 30, 2022. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and was partially offset by lower expenses for legal, consulting and accounting services.

Net Loss

Net loss was $24.0 million for the third quarter of 2023 compared to net loss of $21.9 million for the third quarter of 2022, and $69.7 million for the nine month period ended September 30, 2023 compared to $92.0 million for the nine month period ended September 30, 2022.

On November 13, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the third quarter ended September 30, 2023 (Press release, Leap Therapeutics, NOV 13, 2023, View Source [SID1234637546]).

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"Leap continued to make great strides this quarter including advancing into the 130 patient, randomized controlled Part B of the DeFianCe study evaluating DKN-01 plus bevacizumab and chemotherapy in second-line colorectal cancer, after exceeding our 20% overall response rate threshold in Part A. We are excited by the progress made and plan on presenting new data from Part A at a medical conference in January 2024," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "In addition, we’re focused on executing the DisTinGuish study evaluating DKN-01 plus tislelizumab and chemotherapy in first-line gastric cancer, and we expect to complete enrollment into the 160-patient, randomized controlled Part C of the trial this quarter."

DKN-01 Development Update

● Updated data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer patients to be presented at a medical conference in January 2024. The Company expects to present new long-term follow-up data from Part A of the DeFiance study (NCT05480306), a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced colorectal cancer who have received one prior systemic therapy for advanced disease. Initial results from Part A indicated an overall response rate (ORR) above 20% with a high disease control rate, which exceeded the benchmarks expected for this population. Subsequently, the study expanded into a 130-patient Part B randomized controlled trial.

● Part C of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients is ongoing and enrollment is expected to be completed by the end of 2023. The DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. The Company previously presented long-term follow-up data from Part A of the study in June 2023, showing 73% ORR in the modified intent-to-treat population, and 85% ORR in the PD-L1 low-subgroup. The data also demonstrated 19.5 months median overall survival and 11.3 months median progression-free survival.

Selected Third Quarter 2023 Financial Results

Net Loss was $13.7 million for the third quarter 2023, compared to $15.1 million for the same period in 2022. The decrease was primarily due to decreased research and development expenses and increased interest income.

Research and development expenses were $11.5 million for the third quarter 2023, compared to $12.1 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease of $2.5 million in manufacturing costs related to clinical trial material and manufacturing campaigns. This decrease was partially offset by an increase of $1.1 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees.

General and administrative expenses were $3.3 million for the third quarter 2023, compared to $3.2 million for the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of $0.1 million in payroll and other related expenses due to an increase in headcount of our general and administrative full-time employees.

Cash and cash equivalents totaled $80.7 million at September 30, 2023. Research and development incentive receivables totaled $0.8 million at September 30, 2023.

On November 13, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter 2023 financial results (Press release, Kronos Bio, NOV 13, 2023, View Source [SID1234637545]).

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"This quarter, we made great strides in advancing our clinical programs as well as our discovery projects and Genentech collaboration," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "At the AACR (Free AACR Whitepaper)-NCI-EORTC and CTOS conferences we shared KB-0742 data that demonstrated on-mechanism, single agent anti-tumor activity in pre-treated patients with transcriptionally addicted solid tumors. We are encouraged by the strong investigator interest in KB-0742, and the potential impact of this positive preliminary efficacy data and manageable safety profile for patients."

Dr. Bischofberger continued, "With our resource optimization and extended cash runway, I’m confident that we are well positioned to deliver on our mission to bring forward new and innovative therapies for difficult-to-treat cancers. Our team is committed to realizing the potential of drugging transcription in cancer."

Third Quarter and Recent Company Updates

•Corporate update
◦On November 2, 2023, Kronos Bio announced its plan to optimize its resource allocation, restructure, and contain costs in light of the positive preliminary safety and efficacy clinical data from its Phase 1/2 study of KB-0742.
◦This plan positions the company to maximize the potential of KB-0742 while continuing to advance the development of lanraplenib, currently in the dose escalation portion of a Phase 1b/2 study.
◦The company will also focus its discovery efforts on maturing projects and its Genentech collaboration activities.
◦Kronos Bio expects that these efforts, which include a 19% reduction in force, will extend its cash runway into 2026.

•KB-0742
◦Kronos Bio presented positive preliminary data from the phase 1 dose escalation portion of the ongoing phase 1/2 KB-0742 study at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference in October and at the Connective Tissue Oncology Society Annual Meeting in

November, where it also presented corresponding data from the pre-clinical mechanistic studies.
◦KB-0742 demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in pre-treated patients with transcriptionally addicted solid tumors.
◦Enrollment in two expansion cohorts is ongoing, including Cohort A for patients with MYC-dependent tumors, such as triple negative breast cancer, non-small cell lung cancer and ovarian cancer, and Cohort B for patients with transcription factor fusion-driven cancers and other transcriptionally addicted cancers, including chordomas, sarcomas and small cell lung cancer.
◦The Company plans to share data from both the ongoing dose escalation, beyond the 60 mg dose, and from the expansion portions of the Phase 1/2 KB-0742 study, in mid-2024.

•Lanraplenib
◦Lanraplenib is currently in the dose escalation portion of a Phase 1b/2 trial in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia.
◦Three patients have cleared the 28-day safety window at each of the 20 mg, 40 mg and 60 mg dose levels.
◦The Company is now enrolling at the 90 mg dose. To better understand safety, PK and PD, and to accommodate investigator and patient interest, additional patients may be enrolled at dose levels below 90 mg.
◦Kronos Bio anticipates announcing the recommended expansion phase dose in Q4 2023/Q1 2024 and plans to share data from the phase 1b/2 study in mid-2024.

Third Quarter 2023 Financial Highlights

•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $198.4 million in cash, cash equivalents and investments as of September 30, 2023, the Company reiterates its expected cash runway into 2026.

•R&D Expenses: Research and development expenses were $25.3 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.2 million.

•G&A Expenses: General and administrative expenses were $9.4 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.1 million.

•Net Loss: Net loss for the third quarter of 2023 was $31.4 million, or $0.54 per share, including non-cash stock-based compensation expense of $6.3 million.

On November 13, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal first quarter ended September 30, 2023 and provided a corporate update (Press release, Kintara Therapeutics, NOV 13, 2023, View Source [SID1234637543]).

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RECENT CORPORATE DEVELOPMENTS

•
Announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With this study outcome, Kintara is suspending the development of VAL-083 and turning its focus to its second program, REM-001. In addition to focusing on its REM-001 program, Kintara will evaluate a wide range of strategic options aimed at potentially maximizing shareholder value. (October 2023)
•
Awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC). (June 2023)

"We are looking forward to enrolling the first patient in our 15 patient REM-001 study for cutaneous metastatic breast cancer, a disease with little or no current treatment options" commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "The majority of study expenses will be covered by the $2 million National Institutes of Health grant we were awarded to support the further development of REM-001. We have undertaken efforts to significantly cut costs and are continuing to evaluate strategic options with the goal of maximizing shareholder value."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 FIRST QUARTER ENDED SEPTEMBER 30, 2023

As of September 30, 2023, Kintara had cash and cash equivalents of approximately $0.2 million. In November 2023, the Company has received net proceeds of approximately 1.0 million from the sale of common stock, primarily from its at-the-market (ATM) facility.

For the three months ended September 30, 2023, Kintara reported a net loss of approximately $3.0 million, or $1.83 per share, compared to a net loss of approximately $4.6 million, or $3.39 per share, for the three months ended September 30, 2022. The decreased net losses for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was largely due to lower research and development expenses, primarily lower clinical development costs. General and administrative costs were also lower during the same period primarily due to reduced level of staffing.