On November 13, 2024 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, 2024 (Press release, Leap Therapeutics, NOV 13, 2024, View Source [SID1234648281]).

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Leap Highlights:

· Completed enrollment in the expanded randomized controlled Part B of the Phase 2 DeFianCe study evaluating DKN-01, Leap’s anti-DKK1 monoclonal antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC); data expected in mid-2025

· Patient follow-up continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in late 2024 or early 2025

· Initiated development of FL-501, Leap’s anti-GDF-15 monoclonal antibody

"We have made significant progress advancing our pipeline this quarter, including the completion of enrollment in the expanded Part B of the Phase 2 DeFianCe study of DKN-01 in patients with advanced colorectal cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to sharing initial randomized controlled data from the DisTinGuish study and the DeFianCe study in the coming months. In addition, based on positive preclinical data, we are enthusiastically moving FL-501 into development. With a strong cash position that is expected to fund operations into Q2 2026, Leap is well positioned for continued success and long-term growth to deliver personalized medicines to patients fighting against cancer."

DKN-01 Development Update

· Enrollment completed in the expanded randomized controlled Part B of the DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC. Part B of the DeFianCe study (NCT05480306) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. Part B of the study enrolled 188 patients. The Company expects to report initial data in mid-2025.

· Patient follow-up continuing in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with GEJ and gastric cancer, with initial data expected in late 2024 or early 2025. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with tislelizumab and chemotherapy in first-line, HER-2 negative patients with GEJ and gastric cancer. Part C of the study enrolled 170 patients. The Company expects to report initial data in late 2024 or early 2025.

Pipeline Update:

· Advancing FL-501 into development as a potential best-in-class anti-GDF-15 antibody with promising preclinical data. FL-501 is a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases. FL-501 may also enhance the activity of the immune system in the tumor micro-environment. FL-501 was engineered for higher target affinity and a longer plasma half-life compared to competing therapies. In preclinical cachexia models, FL-501 increased body weight and restored muscle mass.

Selected Third Quarter 2024 Financial Results

Net Loss was $18.2 million for the third quarter 2024, compared to $13.7 million for the same period in 2023. The increase was primarily due to an increase in research and development expenses.

Research and development expenses were $14.9 million for the third quarter 2024, compared to $11.5 million for the same period in 2023. The increase of $3.4 million was primarily due to an increase of $1.7 million in manufacturing costs related to clinical trial material and manufacturing campaigns, and an increase of $0.8 million in clinical trial costs due to patient enrollment, the duration of patients on study, the enhancement of correlative studies, increase in site activity associated with Part C of the DisTinGuish study, and the expansion of the size of Part B of the DeFianCe study. There was also an increase of $0.5 million in consulting fees associated with research and development activities and an increase of $0.4 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 $2.9 million for the third quarter 2024, compared to $3.3 million for the same period in 2023. The decrease of $0.4 million in general and administrative expenses during the three months ended September 30, 2024 as compared to the same period in 2023, was due to a $0.4 million decrease in professional fees.

Cash and cash equivalents totaled $62.8 million at September 30, 2024.

On November 13, 2024 Kronos Bio, Inc. (Nasdaq: KRON), a company developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, reported financial results for the third quarter of 2024 and provided a strategic update following a recent assessment of its ongoing Phase 1/2 expansion cohort of istisociclib in patients with platinum-resistant high-grade serous ovarian cancer (Press release, Kronos Bio, NOV 13, 2024, View Source [SID1234648280]). Based on a review of emerging clinical data in the 80mg four-days-on, three-days-off expansion cohort, the Company and its Board of Directors has determined that the benefit-risk profile does not warrant further clinical evaluation of istisociclib. After an overall review of its business and given the clinical development timelines of its additional pipeline candidates, the Company will explore strategic alternatives with the goal of maximizing stockholder value. Kronos Bio will be implementing significant expense reduction strategies while it explores options for the Company and its remaining internally developed preclinical assets, one of which could include partnering the two p300 lysine acetyltransferase (KAT) inhibitor programs: an oncology candidate, KB-9558, for multiple myeloma and HPV-driven cancers expected to be IND-ready by the end of 2024, and an autoimmune disease candidate, KB-7898, for Sjögren’s disease which has begun IND-enabling studies.

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"While we believe istisociclib has provided benefit to a small number of patients in the Phase 1/2 trial, the emerging profile in patients with platinum-resistant ovarian cancer suggests an unfavorable risk-benefit profile and does not warrant further clinical development," said Norbert Bischofberger, Ph.D., chief executive officer. "We are very grateful to the patients, caregivers and medical staff who dedicated their time and energy to make this clinical trial possible and your commitment to evaluating novel approaches to treat cancer."

Charles Lin, Ph.D., Kronos’ chief scientific officer, added, "We continue to believe in the promise of our proprietary discovery technology’s application focused on targeting IRF4 where we have validated the critical role of this transcription factor in driving tumor cell growth in multiple myeloma and HPV-driven tumors or inflammation in autoimmune disease. Data from our early-stage p300 KAT inhibitor programs demonstrate that inhibition of key signaling pathways leads to restoration of tumor suppression activity in cancer cells or reduction of inflammation in autoimmune disease, underscoring the potential of this approach for patients that have limited or no targeted therapies."

The decision to discontinue the development of istisociclib resulted from a recent safety assessment from the ongoing Phase 1/2 clinical trial patients with platinum-resistant high-grade serous ovarian cancer. Out of seven enrolled patients, five exhibited neurological events as characterized by involuntary movements, confusion and hallucinations ranging from Grade 1 to Grade 3. Of those five patients, three discontinued due to adverse events, and two reduced the dose of istisociclib.

Third Quarter 2024 Financial Highlights

•Cash, cash equivalents and investments: Kronos Bio has $124.9 million in cash, cash equivalents and investments as of September 30, 2024.

•R&D expenses: Research and development expenses were $12.3 million for the third quarter of 2024, which includes non-cash stock-based compensation expense of $0.8 million.

•G&A expenses: General and administrative expenses were $5.8 million for the third quarter of 2024, which includes non-cash stock-based compensation expense of $1.2 million.

•Net loss: Net loss for the third quarter of 2024 was $14.1 million, or $0.23 per share, including non-cash stock-based compensation expense of $2.0 million.

Process to Explore Strategic Alternatives

Kronos Bio has an exclusive engagement with a financial advisor to assist in evaluating strategic alternatives which may include, but is not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. There can be no assurance of a transaction, a successful outcome of these efforts, or the form or the timing of any such outcome. The Company does not intend to make any further disclosures that the exploration of strategic alternatives will result in any agreements or transactions, or that, if executed, any agreement or transaction will be successfully consummated or on attractive terms. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company’s board of directors or until the Company determines that further disclosure is appropriate.

On November 13, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported third quarter 2024 financial results and provides a corporate update (Press release, Intensity Therapeutics, NOV 13, 2024, View Source [SID1234648279]).

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Corporate Update

INVINCIBLE-3 Study: a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

•July 2024: the first patients were dosed in the U.S. in the INVINCIBLE-3 Study.
•July 2024: authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada.
•September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe.
•October 2024: authorization received from Australia’s Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia.

INVINCIBLE-4 Study: a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the pathological complete response ("pCR") rate in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.

•September 2024: authorization from the Swiss Medic and the Swiss Ethics Commission to initiate the INVINCIBLE-4 Study.
•October 2024: first patient dosed in the INVINCIBLE-4 Study.

"This has been an excellent quarter of regulatory success in multiple countries. We received the regulatory authorizations needed to initiate sites in eight countries for our Phase 3 global sarcoma study and our Phase 2 breast cancer study in Switzerland," said Lewis H. Bender, Intensity Founder, President, and CEO. "Our efforts now turn to site activation and patient recruitment. We remain committed to exploring our new treatment that causes immunological cell death in severe diseases such as soft tissue sarcoma and triple-negative breast cancer. We are excited that our drug will be tested in multiple countries on three continents. INT230-6’s ability to debulk tumors and activate an immune response is now in late-stage testing for two indications. We expect that the results from these ongoing studies could potentially demonstrate a meaningful clinical benefit for patients with high unmet need in both the metastatic and local disease settings."

Third Quarter 2024 Financial Results

Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023. The increase was primarily due to preliminary work related to the INVINCIBLE-3 Study, and to a lesser extent, increased expenses related to salary, benefits, and stock-based compensation.

General and administrative expenses were $1.4 million for the three months ended September 30, 2024, compared to $1.1 million for the same period in 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, and higher directors and officers insurance.

Overall, net loss was $3.5 million for the three months ended September 30, 2024, compared to a net loss of $2.3 million for the three months ended September 30, 2023.

As of September 30, 2024, cash and cash equivalents totaled $2.8 million, which the Company expects will be sufficient to fund operations into the first quarter in 2025.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.

On November 13, 2024 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel cancer therapies, reported its third quarter 2024 financial results and provided a corporate update (Press release, Instil Bio, NOV 13, 2024, View Source [SID1234648278]).

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"Our recent license of SYN-2510 is a significant milestone for Instil, positioning us with a potentially best-in-class asset in one of the most significant areas of interest in oncology," said Bronson Crouch, CEO of Instil. "As we continue to build our internal team to operationalize the clinical development of SYN-2510, we are excited for the progress ImmuneOnco continues to make in advancing the program in its China trials."

Recent Highlights:

In-licensed SYN-2510/IMM2510 and SYN-27M/IMM27M: In August 2024, SyntBioTx, Inc., a wholly owned subsidiary of Instil, entered into a license and collaboration agreement with ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco") to in-license global development and commercialization rights outside of Greater China for SYN-2510/IMM2510, a potential best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M/IMM27M, a next-generation ADCC-enhanced CTLA-4 antibody. For SYN-2510/IMM2510, ImmuneOnco has identified a recommended Phase 2 monotherapy dose of 20 mg/kg Q2W, and is continuing patient enrollment in China to support dose optimization and dose expansion in multiple solid tumor cancers.
Clinical data update for SYN-2510/IMM2510 in China anticipated in 1H 2025: ImmuneOnco expects to provide a clinical data update for SYN-2510/IMM2510 monotherapy in multiple solid tumors in China in the first half of 2025. Approximately 65 additional patients have been dosed with SYN-2510/IMM2510 monotherapy in addition to the initial 33 patients reported in ImmuneOnco’s ASCO (Free ASCO Whitepaper) 2024 publication.
Initiation of Phase 1b/2 IMM2510/SYN-2510 studies expected in late 2024 and 1H 2025 in China by ImmuneOnco: Instil and ImmuneOnco announced in September 2024 that ImmuneOnco is accelerating clinical development of IMM2510/SYN-2510 into phase 1b/2 studies in China. IMM2510/SYN2510 will be administered in combination with chemotherapy in first-line NSCLC and TNBC, with anticipated start dates in late 2024 and 1H 2025, respectively.
U.S. clinical study of SYN-2510 in NSCLC targeted initiation in 2H 2025: Instil is targeting initiation of a U.S. study of SYN-2510 in NSCLC in 2H 2025.
Clinical update for SYN-27M/IMM27M in breast cancer from ImmuneOnco: Today, ImmuneOnco announced initial clinical results for patients with estrogen receptor positive (ER+) advanced breast cancer treated in the Phase 1 dose escalation of SYN-27M/IMM27M and the initiation of a Phase 2 clinical trial of SYN-27M/IMM27M for patients with ER+ breast cancer that failed after endocrine therapy or have recurred. Additionally, patient enrollment continues in the dose escalation study of the combination of SYN-27M/IMM27M and SYN-2510/IMM2510.
Third Quarter 2024 Financial and Operating Results:

As of September 30, 2024, Instil had cash, cash equivalents, marketable securities and long-term investments of $122.9 million, which consisted of $6.7 million in cash and cash equivalents, $113.7 million in marketable securities, and $2.6 million in long-term investments, compared to $175.0 million in cash, cash equivalents, marketable securities and long-term investments as of December 31, 2023, consisting of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities, and $23.2 million in long-term investments. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of September 30, 2024 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were $10.0 million for both the three and nine months ended September 30, 2024, compared to nil for both the three and nine months ended September 30, 2023.

Research and development expenses were $0.6 million and $10.7 million for the three and nine months ended September 30, 2024, respectively, compared to $8.5 million and $37.6 million for the three and nine months ended September 30, 2023, respectively.

General and administrative expenses were $10.7 million and $33.8 million for the three and nine months ended September 30, 2024, respectively, compared to $11.9 million and $36.7 million for the three and nine months ended September 30, 2023, respectively.

Restructuring and impairment charges were $2.4 million and $7.1 million for the three and nine months ended September 30, 2024, respectively, compared to $46.3 million and $71.8 million for three and nine months ended September 30, 2023, respectively.

Net loss per share, basic and diluted were $3.54 and $9.57 for the three and nine months ended September 30, 2024, respectively, compared to $10.37 and $22.01 for the three and nine months ended September 30, 2023, respectively. Non-GAAP net loss per share, basic and diluted, were $2.55 and $6.51 for the three and nine months ended September 30, 2024, respectively, compared to $2.53 and $8.87 for the three and nine months ended September 30, 2023, respectively.

On November 13, 2024 ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), a leader in AI-driven medical innovation, reported a significant breakthrough in its primary cancer research initiatives (Press release, ImmunoPrecise Antibodies, NOV 13, 2024, View Source [SID1234648277]). This accomplishment not only highlights IPA’s cutting-edge discovery and AI capabilities, but it also strategically places the company in the rapidly growing market for these cancer-combating antibodies, which is projected to reach $20.7 billion by 2028. The TATX-112 program, dedicated to the development of specialized antibodies for cancer treatment, has shown encouraging results, successfully targeting cells that express a protein known as TrkB. This achievement has paved the way for several promising candidates for further development.

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TrkB is a protein commonly found in aggressive cancers. IPA is spearheading two programs that target this protein. The TATX-200 program is centered on developing T cell engagers, which boost the body’s immune response against tumors. The TATX-112 program is focused on creating antibodies that can deliver cancer-killing drugs directly to tumor cells. The recent advancements in the TATX-112 program have led to the discovery of multiple antibodies that can infiltrate and eliminate TrkB-expressing cells in an in vitro surrogate Antibody Drug Conjugate (ADC) assay. This suggests that these antibodies could be used to deliver drugs directly to cancer cells, potentially enhancing the effectiveness and safety of cancer treatments targeting TrkB.

Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies, expressed her excitement: "Our TATX-112 program has reached a significant milestone, demonstrating our ability to target and eliminate TrkB-expressing cells. This breakthrough accelerates our cancer-fighting antibody development efforts. Our innovative discovery process, combined with validation and AI-driven characterization, has enabled us to identify antibodies with high TrkB specificity. We are confident in our leadership position in AI-guided development and within our cancer program. We look forward to reaching many more significant milestones in our journey to revolutionize cancer treatment."

Talem Therapeutics’ recent development of antibodies potentially suitable for cancer treatment marks a significant step in their mission to transform cancer treatment. Talem’s focus on TrkB-expressing tumors addresses a critical need in cancer treatment. IPA remains committed to driving innovation and creating long-term value, as it continues to advance the Talem pipeline and explore commercialization opportunities in the biopharmaceutical sector.