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 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported data on the newest addition to its End-to-End (E2E) Platform, an Interferon-Gamma (IFN-γ) Biosensor technology that allows real-time monitoring and quantification of IFN-γ release from cytokine-secreting cells at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Conference taking place in Houston, TX, USA from November 6-10, 2024 (Press release, MediGene, NOV 13, 2024, View Source [SID1234648303]).

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The poster "The IFN-γ Biosensor – A universal tool for IFN-γ detection in cellular co-culture assays" is available on Medigene’s website: View Source

"Release of IFN-γ is one of the most common parameters used to measure T cell or NK cell functionality. Current methods for detection of IFN-γ secretion have several drawbacks, including extensive hands-on-time and needs for expensive, temperature-sensitive reagents," said Dolores Schendel, CSO of Medigene AG. "The IFN-γ Biosensor is an innovative tool within our E2E Platform that provides a simple, low-cost, cell-based alternative for quantification of secreted IFN-γ. This biosensor addresses limitations of current methods by reducing time, costs and complexity. The biosensor cells can be added directly as third-party bystander cells to co-cultures of T or NK cells, thereby dramatically reducing assay steps while enabling a dynamic assessment of IFN-γ secretion over time, going beyond standard end-point assays." The presented poster displayed a direct comparison between the conventional standard method Enzyme-linked Immunosorbent Assay (ELISA) and the Company´s proprietary innovative IFN-γ Biosensor to determine IFN-γ release directly in cell co-cultures or in cell supernatants. The biosensor cells were generated to produce a green fluorescent protein (GFP) when exposed to IFN-γ and allow for quantitative analysis of the GFP fluorescent reporter signal

The IFN-γ biosensor demonstrated comparable sensitivity to ELISA, effectively detecting low levels of IFN-γ using standard measurement tools like flow cytometry and fluorescence readings. Detection was highly specific for IFN-γ, with minimal response observed only when exposed to exceedingly high levels of IFN-α or IFN-β, two other interferon types. Further in vitro assays showed that the biosensor produced dose-dependent results comparable to ELISA, that were stable and sensitive to IFN-γ stimulation over extended co-culture periods. The addition of this process optimization technology to the Medigene End-to-End Platform significantly reduces costs and complexity while increasing speed and reproducibility when applied in high-throughput screening assays of T or NK cell functionality. The time from assay completion to analysis of results was significantly reduced, providing faster data processing and is more efficient and streamlined when implemented in robotic workflows.

Overall, with its broad detection range, dynamic measurements over time, and high specificity, the IFN-γ Biosensor technology to provide a sensitive and efficient alternative that extends beyond a traditional ELISA for measuring T cell and NK cell functionality. Simple readouts using either flow cytometry and fluorescence readers-supports its easy integration in high-throughput workflows, cutting costs and handling times.

On November 13, 2024 PhotoCure reported its quarterly results (Presentation, PhotoCure, NOV 13, 2024, View Source [SID1234649494]).

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On November 13, 2024 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the third quarter ended September 30, 2024. The Company will host a live webcast at 4:30 p.m. EST (9:30 p.m. GMT) today (Press release, Adaptimmune, NOV 13, 2024, View Source [SID1234648259]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "With Tecelra’s encouraging launch and the new positive pivotal results for lete-cel to be presented at CTOS, Adaptimmune will redefine itself as a sarcoma-focused business. We have increased confidence in our $400 million peak year sales estimate for the combined sarcoma franchise. We’re creating a new leaner company, investing in only the highest potential programs and reducing our operating expenses by around $300 million over the next four years. With these actions we have a clear path to operating breakeven during 2027."

Company focuses on strategic business plan and restructuring

● Prioritization of commercial sarcoma franchise and R&D programs with highest potential for return on invested capital and transformational benefit to patients. Tecelra launch progress and lete-cel data both support the Company’s projection of combined U.S. peak year sales of $400 million for both products.
● The Company plans to reduce headcount by approximately 33% and total operating expenses by approximately 25% in the first year as compared to anticipated full year 2024 together with a focus towards operations in the U.S.
● The Company expects the aggregate savings over the 4-year period from 2025-2028 will be approximately $300 million, excluding one-time cost of restructuring.
● The Company will cease enrolment in the SURPASS-3 Phase 2 clinical trial (NCT05601752), investigating uza-cel for the treatment of platinum-resistant ovarian cancer.
● Adaptimmune’s collaboration with Galapagos is underway, and plans are progressing to conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation engineered TCR T-cell therapy, formerly ADP-A2M4CD8) using Galapagos’ decentralized manufacturing platform in patients with head & neck cancer.
1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below

● ADP-600 (targeting PRAME) and ADP-520 (targeting CD-70) will continue preclinical development towards IND submissions. The Company is engaged in active discussions to partner and expand these programs.

Tecelra Launch

● Tecelra was approved by U.S. Food and Drug Administration (FDA) approved for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy.
● Tecelra, a single infusion, is the first new treatment option for synovial sarcoma in more than a decade and the first engineered cell therapy for solid tumors.
● 9 Sarcoma centers of excellence across the U.S. are available as Authorized Treatment Centers (ATCs) for Tecelra and are accepting patients and referrals from healthcare providers to initiate the Tecelra treatment journey. The Company is confident the full ATC network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence.
● The first patient has been apheresed and first manufacture of Tecelra is ongoing.

Lete-cel registrational data (details are in a separate press release issued today)

Full primary analysis on 64 patients with long term follow up from pivotal IGNYTE-ESO trial has been completed and will be presented at the Connective Tissue Oncology Society (CTOS) annual meeting, being held in San Diego, CA from November 13 to 16, 2024:

● "Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS)" by Dr. Sandra D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, on Saturday, November 16, 10:30 AM – 12:00 PM PST, Session 12: Immunology.
● Data demonstrate 42% of people with advanced or metastatic synovial sarcoma or MRCLS had clinical responses with lete-cel; Results include six complete responses (6/64) and twenty-one partial responses (21/64). Responses are durable, with a median duration of response of just over a year overall.
● Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel for the treatment of advanced or metastatic MRCLS and synovial sarcoma by the end of 2025.
● Lete-cel will bolster Adaptimmune’s sarcoma franchise by expanding the addressable patient population to NY-ESO-1 positive MRCLS and synovial sarcoma solid tumors.
● Adaptimmune will host a virtual event to review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Dr. Sandra D’Angelo, sarcoma medical oncologist of Memorial Sloan Kettering Cancer Center, an investigating clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, lead author and presenter of the IGNYTE-ESO data update at CTOS. To register & Attend: Adaptimmune Virtual KOL Event – LifeSci Events.

Recent data presentations

● Translational data from the pivotal SPEARHEAD-1 trial, describing mechanisms of anti-tumor activity, durability and persistence for afami-cel (Tecelra), was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th annual meeting by Mihaela Druta, MD, Vice Chair, Sarcoma Center, Moffitt Cancer Center, on November 8.
● This presentation will also be encored at CTOS 2024 annual meeting, on Saturday, November 16 10:30 AM – 12:00 PM PST, Session 12: Immunology.
2

● Jo Brewer, PhD., Adaptimmune’s Chief Scientific Officer, delivered a platform presentation and participated in a panel discussion during SITC (Free SITC Whitepaper)’s Biotech Breakthroughs – Solid Tumor IO at the Tipping Point session.

Today’s Webcast Details

A live webcast and replay can be accessed at View Source Call in information is as follows: +1-844-763-8274 (US or Canada) or +1-647-484-8814 (International). Callers should dial in 10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Virtual KOL Webcast Details November 18th following CTOS

Join Adaptimmune on Monday, November 18, 2024 at 2:30 PM ET for a virtual KOL event featuring Dr. Sandra D’Angelo, M.D. (Memorial Sloan Kettering Cancer Center) who will discuss the unmet need and current treatment landscape for patients with sarcoma, including synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS).Register & Attend: Adaptimmune Virtual KOL Event – LifeSci Events

Financial Results for the three and nine months ended September 30, 2024

● Cash / liquidity position: As of September 30, 2024, Adaptimmune had cash and cash equivalents of $116.7 million and Total Liquidity2 of $186.1 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
● Revenue: Revenue for the three and nine months ended September 30, 2024, was $40.9 million and $174.8 million, respectively, compared to $7.3 million and $60.1 million for the same periods in 2023. Revenue has increased in 2024, compared to the same periods in 2023 primarily due to the termination of the Genentech collaboration in the second quarter of 2024, resulting in the majority of the remaining deferred income for the collaboration being recognized as revenue including a cumulative catch-up adjustment of $101.3 million, and the Mutual Release and Recognition Agreement in the third quarter of 2024 resulting in the remaining deferred revenue of $37.5 million of revenue, including the $12.5 million payment under the Mutual Release and Recognition Agreement, being recognized as revenue in the current quarter. This was significantly higher than the impact from the termination of the Astellas collaboration in 2023, which resulted in $42.4 million of revenue being recognized in March 2023. No revenue from commercial product sales was recognized in the three and nine months to September 30, 2024.
● Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2024, were $34.3 million and $110.0 million, respectively, compared to $37.8 million and $93.3 million for the same periods in 2023. R&D expenses in the three months ended September 30, 2024, decreased due to a decrease in subcontracted expenditures primarily due to a decrease in clinical trial expenses, offset by a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. Conversely, R&D expenses in the nine months ended September 30, 2024, increased due to an increase in the average number of employees engaged in research and development following the acquisition of TCR2 in June 2023, annual salary increases, increases in property costs, increases in manufacturing facility expenditure, an increase in in-process research and development costs and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
● Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and nine months ended September 30, 2024, were $21.2 million and $60.1 million, respectively, compared to $16.2 million and $56.6 million for the same periods in 2023. SG&A expenses increased due to an increase in accounting, legal and professional fees in due to fees relating to business development work and preparation for commercialization, offset by a decrease in restructuring charges recognised in the first quarter of 2023 that were not repeated in 2024 and an increase in offsetting reimbursements.
● Net (loss)/profit: Net (loss)/profit attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2024, was a loss of $17.6 million and a profit of $3.4 million, respectively ($(0.01) and $0.00 per ordinary share), compared to losses of $45.6 million and $66.0 million ($(0.03) and $(0.06) per ordinary share), for the same periods in 2023.

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.