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.

On November 13, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, reported financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, Immunome, NOV 13, 2024, View Source [SID1234648276]).

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"Immunome continues to advance its pipeline," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "Topline data for the RINGSIDE Part B trial of AL102 is expected in the second half of 2025, and IND submissions for IM-1021 and IM-3050 are on track."

"Our discovery team is focused on discovering ADCs that effectively pursue the novel targets we believe will define the next generation of transformative cancer therapies. In particular, the differentiated profile of HC74, our proprietary TOP1 payload, offers exciting opportunities for portfolio expansion when combined with our large repertoire of antibodies."

Pipeline Highlights

Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.

Third Quarter 2024 Financial Results

· As of September 30, 2024, cash, cash equivalents and marketable securities totaled $240.1 million. Immunome’s current cash runway is expected to extend into 2026.
· Research and development expenses for the quarter ended September 30, 2024 were $37.2 million, including stock-based compensation costs of $1.8 million.
· In-process research and development expenses for the quarter ended September 30, 2024 were $6.7 million. These expenses were related to Immunome’s business development activity.
· General and administrative expenses for the quarter ended September 30, 2024 were $9.5 million, including stock-based compensation expense of $3.1 million.
· Immunome reported a net loss of $47.1 million for the quarter ended September 30, 2024.

On November 13, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present three abstracts highlighting significant advancements in the development of a multi-cancer early detection (MCED) test (Press release, Exact Sciences, NOV 13, 2024, View Source [SID1234648275]). The results of a study evaluating a new multi-biomarker class approach showed improved sensitivity for early-stage and overall cancer detection. In addition, new modeling data estimate that adding MCED testing to recommended screening may reduce the incidence of stage IV cancer and, subsequently, cancer mortality over 10 years. Another new analysis from the DETECT-A study suggests that adding MCED testing complements guideline-recommended lung cancer screening without affecting adherence to current standard of care. These findings will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Liquid Biopsy from November 13-16, 2024, in San Diego, Calif.

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"Cancer is on pace to be the leading cause of death in the U.S. by 2030 1 . Currently, only an estimated 14% of all cancers in the U.S. are diagnosed through screening, 2 revealing a glaring gap in patient care," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "We believe MCED testing is our single biggest opportunity to combat these stark statistics, and the Exact Sciences team is committed to taking a rigorous, comprehensive approach to multi-cancer screening. The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice."

A new study demonstrates the ability of a multi-biomarker class MCED test to improve early-stage sensitivity by incorporating a DNA mutation reflex approach to methylation and protein (MP) test results. When excluding breast and prostate cancer and at a 98.5% specificity, sensitivity increased by 28% for stage I cancers and 12.5% for early-stage cancers (stages I and II) in a case-control study, underscoring the potential of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) test to improve the detection of cancer in earlier stages.

Cancer stage

MP-r sensitivity

MP sensitivity

% improvement

Stage I

22.1%

17.2%

28.0%

Stage II

54.7%

51.9%

5.5%

Stage I/II

35.9%

31.9%

12.5%

Overall

62.3%

59.3%

5.0%

This new research will help inform the final design of Exact Sciences’ Cancerguard test, which is currently in development and intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages.

The abstracts featured at the AACR (Free AACR Whitepaper) Special Conference: Liquid Biopsy 2024 are as follows:

Title: Performance of multi-biomarker class reflex testing in a prospectively-collected cohort
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A056
Key findings: A new analysis from a case-control study demonstrated the ability of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) MCED test approach to increase sensitivity for early-stage detection. When excluding breast and prostate cancer, stage I sensitivity increased by 28%, and stage I/II increased by 12.5%.

Title: The potential of multi-cancer early detection screening for reducing cancer mortality
Oral presentation: Friday, November 15, 9:35 a.m. PT (Plenary Session 4: Early Detection of Primary Cancer and Relapse)
Presenter: Tyson, C
Poster number: PR006, A073
Key findings: New modeling points to the potential to reduce the burden of cancer by demonstrating an estimated 42% reduction in stage IV cancer incidence and a 17% estimated 10-year reduction in cancer mortality with the addition of MCED testing to usual care.

Title: Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A064
Key findings: Analysis from the prospective, interventional DETECT-A study showed lung cancer screening adherence was not reduced in participants who received an MCED test compared to controls.

About the DETECT-A study

The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting. The DETECT-A study enrolled more than 10,000 women with no history of cancer to determine if a blood test in combination with standard-of-care screenings could detect cancers before signs and symptoms appeared. The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the Cancerguard test, the MCED test currently in development at Exact Sciences.

About the Cancerguard test

The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research, Exact Sciences intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, which may result in fewer follow-up procedures. The test is being developed to provide high specificity to help minimize false positives while detecting multiple cancers, including those with the biggest toll on human health. These features describe current development goals. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority. To learn more, visit View Source