4SC provides Q3 highlights and financial forecast

On October 4SC AG (4SC, FSE Prime Standard: VSC) reported a business update for the three months ended 30 September 2021, as well as its current outlook (Press release, 4SC, OCT 19, 2022, View Source [SID1234622188]). The full report is available for download on 4SC’s website.

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Key highlights of Q3 2021

185 patients were enrolled into the pivotal RESMAIN study
18 patients were enrolled into the MERKLIN 2 study
The first patients were recruited into the TURANDOT study
Data from the DONIMI study was presented at the ESMO (Free ESMO Whitepaper) Congress of the European Society of Medical Oncology

Cash balance development in Q3 2021 and financial forecast

As of 30 September 2021, 4SC holds cash balance/funds of €32,381 thousand as compared to €36,545 thousand as of 30 June 2021.

The average monthly use of cash from operations amounted to €918 thousand on average in the first nine months of 2021 (9M 2020: €1,172 thousand). Excluding the cash contribution received from the transaction with Immunic signed in Q1 2021, the average monthly use of cash from operating activities was €1,731 thousand.

The decrease of cash funds in the first nine months of 2021 is mainly a result of the expenditures for the ongoing clinical study RESMAIN as well as for the expansion of the clinical program for domatinostat, particularly in MCC.

Based on current financial and operating activities and taking into account the additional funds provided by the settlement agreement with Immunic in the first half-year 2021, the Manage­ment Board of 4SC estimates that current funds should be sufficient to finance 4SC into the second half of 2022.

Kintara Therapeutics Pauses REM-001 Program to Conserve Funds to Support VAL-083 International Registrational Study

On October 19, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the REM-001 program in Cutaneous Metastatic Breast Cancer (CMBC) was paused to conserve cash which will be used to support the funding of the Company’s ongoing international registrational study for VAL-083 in glioblastoma (GBM) (Press release, Kintara Therapeutics, OCT 19, 2022, View Source [SID1234622187]). By pausing the REM-001 program, the Company expects to save approximately $3.0 million through 2023.

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"Unfortunately, we decided to pause our REM-001 program at this time. CMBC patients and treating physicians have little or no treatment options for this underserved disease area. We will continue to explore ways to restart REM-001, including use of grants from applications currently under review to support the funding of the planned 15-patient CMBC study. Although this was a difficult decision, we believe saving approximately $3.0 million through calendar year 2023 is prudent given the current capital market conditions," stated Robert E. Hoffman, President and CEO of Kintara. "We continue to look forward to announcing top-line data for VAL-083 in GBM from the international registrational GBM AGILE study around the end of calendar year 2023."

INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines for INKmune

On October 19, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that positive solid tumor data in multiple cancer lines resistant to NK killing that can be overcome with administration of INKmune (Press release, INmune Bio, OCT 19, 2022, View Source [SID1234622186]).

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Solid tumors represent approximately 90% of adult human cancers while the majority of cell therapies focus on the 10% of cancers that are hematologic tumors, or "liquid tumors." The current data provides insights into why the Company believes that INKmune arms Natural Killer (NK) to override immunosuppression and hypoxia in an active Tumor Microenvironment (TME) to kill solid tumors.

The interaction of the TME with cancer cells and immune cells can drive tumor progression and prevent many cell therapies from being effective. These complex interactions should be considered when designing cell therapies to treat solid tumors. In solid tumors, the TME is hostile to cell therapies because of (i) the presence of immunosuppressive immunoregulatory cells, and (ii) the low levels of oxygen (hypoxia). A cell therapy must operate in this hostile environment to successfully treat solid tumors,

INKmune converts patient’s normal resting NK (rNK) cells into potent memory-like NK cells that target solid tumors directly, even in the presence of immunosuppressive immunoregulatory cells and hypoxia associated with the TME. The Company’s pre-clinical data show that INKmune primes NK cells from patients and from healthy donors to lyse NK-resistant ovarian (CaOva), prostate (CaPros), renal (RCC) and nasopharyngeal (NPC) cancer cells. When compared to rNK cells, which are normal NK cells from healthy donors or patients before treatment with INKmune, the INKmune primed NK cells demonstrated enhanced ability to kill these resistant tumor cell lines.

The value in the tables is percent of tumor cells killed. For instance, in the table below looking at laboratory assay using healthy donor NK cells killing of a prostate cell line called DU145, resting NK cells that have not been primed with INKmune kill fewer than 4% of the DU145 cells in 4 hours. INKmune primed NK cells kill approximately 66% of DU145 cells in the same amount of time. Negative values mean that the tumor cells grew faster than the NK cells could kill them.

The Company identified more than1,500 proteins that are upregulated in NK cells following INKmune priming and subsequent analysis compared them to NK cells primed with a cytokine cocktail of IL-12, IL-15 and IL-18. Of the 250 most upregulated proteins, 141 are completely unique to INKmune priming and are not upregulated by the cytokines IL-12, IL-15 and IL-18. Many of these unique proteins are involved in cell survival and the enhanced metabolism likely to protect INKmune primed NK cells in the TME. "We believe the upregulation of key proteins associated with enhanced metabolic fitness and mitochondrial repair in the NK cells are critical for NK survival in the TME of solid tumors," said Dr. Mark Lowdell, the Company’s CSO.

There remains an unmet need for novel treatments in prostate, renal and nasopharyngeal cancers. The number of patients who could benefit exceeds 4 million annually in the US alone. These data support INmune Bio’s decision to transition INKmune trials into the treatment of solid tumors.

The company presented the data at the Innate Killer Summit Europe on October 19th. A video of the presentation will be uploaded to the company’s website by Wednesday next week.

About INKmune

INKmune is a proprietary pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer and the solid tumors shown above.

Hepion Pharmaceuticals to Participate in the ThinkEquity Conference

On October 19, 2022 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported that its CEO, Robert Foster, PharmD, PhD, will present at the ThinkEquity Conference in New York City on October 26, 2022, at 1:30 p.m. Eastern Time (Press release, Hepion Pharmaceuticals, OCT 19, 2022, View Source [SID1234622185]).

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The presentation will be broadcast live and archived on the Company’s website at www.hepionpharma.com under "Events" in the Investors section.

AusBiotech 2022

On October 19, 2022 EVERSANA reported that sponsor of AusBiotech 2022 taking place 26-28 October in Perth, WA (Press release, EVERSANA, OCT 19, 2022, View Source [SID1234622184]).

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The 2022 event will bring the biotech community together with inspiring speakers, networking opportunities, and face-to-face delegate engagement with our partners in the Bioindustry Exhibition Hall.

Connect with EVERSANA at AusBiotech 2022

With our regional headquarters in Singapore and offices across Asia Pacific and worldwide, EVERSANA provides integrated services and solutions to accelerate clinical and commercial success. We are constantly evolving and adapting to solve the complex challenges our Asia Pacific clients are facing in local and global markets.

Connect with EVERSANA’s experts in-person at Australia’s largest life sciences conference.