endovion (SCO-101) / Scandion Oncology - LARVOL DELTA

Inhibition of ABCG2 by SCO-101 Enhances Chemotherapy Efficacy in Cancer. (PubMed, Int J Mol Sci) - "These findings highlight the therapeutic potential of SCO-101 in overcoming MDR by inhibiting drug efflux mechanisms and metabolism, thereby enhancing chemotherapy efficacy. SCO-101 is currently undergoing clinical trials as an orally administered drug and is considered a promising strategy for improving cancer treatment outcomes in patients with drug-resistant tumors."

Journal • Breast Cancer • Oncology • Solid Tumor • ABCG2 • UGT1A1

PANTAX: a phase Ib clinical trial of the efflux pump inhibitor SCO-101 in combination with gemcitabine and nab-paclitaxel in non-resectable or metastatic pancreatic cancer. (PubMed, Invest New Drugs) - "However, no clear added efficacy signal was observed of the combination. Trial registration number: NCT04652205 (Nov 29, 2020)."

Journal • P1 data • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • ABCG2 • SRPK1 • UGT1A1

Scandion Oncology announces final data from the CORIST trial and is ready to move into a randomized phase II Proof of Concept trial in Colorectal Cancer (Scandion Oncology Press Release) - P1/2 | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "With this update there is no new information on CORIST part 1 (N=18) which was finalized in April 2022. In CORIST part 2 (N=25), as previously reported, we have observed signs of clinical activity with a median Progression Free Survival (mPFS) of 2 months, median Overall Survival (mOS) of 10.4 months and Clinical Benefit Rate (CBR) of 42%. mPFS was increased from 1.80 to 2.04 months when the data was analyzed based on the bilirubin index (BI)....In CORIST part 3 (N=28), two different dosing schedules were evaluated, the 4-day and the 6-day schedule. In both schedules, the MTD was found, and the RP2D of 250mg SCO 101 was established in the 4-day schedule. Importantly, in the 4-day schedule, amongst the 6 patients receiving the RP2D, two patients had a partial response (PR) with more than 30% tumor reduction..."

P1/2 data • Colorectal Cancer

Scandion Oncology achieves Maximum Tolerated Dose for CORIST part 3 (Scandion Oncology Press Release) - P1/2 | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "Scandion Oncology...announced topline data for the CORIST part 3 continuation trial and that the company established the maximum tolerated dose (MTD) of SCO-101 in combination with the chemotherapy FOLFIRI in colorectal cancer patients. The established MTD for a 4-Days schedule of SCO-101 in combination with FOLFIRI was found to be 250 mg daily SCO-101, 50% irinotecan and 100% Leucovorin and 5-FU....The continuation study of CORIST part 3 included 3 patients....Of the 3 patients, 2 experienced a dose-limiting toxicity of neutropenia, which was expected based on previous data. No new safety signals were detected. Final data in the CORIST part 3 continuation trial is expected in the first half of 2025."

P1/2 data • Colorectal Cancer

SCANDION ONCOLOGY ANNOUNCES OUTCOME OF THE RIGHTS ISSUE - The board of directors of Scandion Oncology...today announces the outcome of the rights issue of units that was announced on 19 April 2024...Through the Rights Issue, Scandion will initially receive approximately SEK 30.6 million before issue costs and in the event of exercise of warrants of series TO 2 and TO 3, in November 2024 and April 2025, respectively, the Company will receive additional proceeds....'The new funding will give us the ability to push forward with our clinical development of our lead candidate SCO-101 in drug resistant metastatic colorectal cancer. The next step is the finalization of the extended CORIST Part 3 trial (phase IIa) where we intend to increase the dose of irinotecan to achieve the Maximum Tolerated Dose (MTD) and maximal effect of SCO-101 in combination with FOLFIRI. SCO-101 has a novel dual-acting mode-of-action that we are convinced will play a significant role in the treatment of cancers.'"

Financing • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CDK12-inactivation-induced MYC signaling causes dependency on the splicing kinase SRPK1. (PubMed, Mol Oncol) - "Inhibition of SRPK1 with either of the compounds promotes transcription elongation, and transcriptionally activates the unfolded protein response. In brief, here we discover that CDK12 inactivation promotes MYC signaling in an SRPK1-dependent manner, and show that the clinical grade compound Endovion selectively targets the cells with CDK12 inactivation."

Journal • Castration-Resistant Prostate Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • CDK12 • SRPK1

SCANDION CONFIRMS POSITIVE FINAL PHASE IB DATA FROM PANTAX TRIAL WITH SCO-101 (Scandion Oncology Press Release) - P1b | N=18 | PANTAX-Ib (NCT04652206) | Sponsor: Scandion Oncology A/S | "Scandion Oncology...announces final data from the PANTAX phase Ib trial confirming the good safety profile of SCO-101 and showing good signs of efficacy in hard-to-treat pancreatic cancer...The open-label PANTAX phase Ib international multi-center trial has evaluated Scandion’s lead compound SCO-101 in combination with standard of care chemotherapies gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer...Overall findings include....PK data demonstrated that the exposure of SCO-101 was in line with the expectations; 15 patients were evaluable for response and 1 had a PR resulting in an ORR of 6.7%; Amongst the 15 evaluable patients CBR was 53% (1 PR and 7 SD); Progression-free survival (PFS) was 2.5 months and overall survival (OS) was 9.5 months. Both are in line with historical data for the same patient population."

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

SCANDION ONCOLOGY TO HOST R&D UPDATE MAY 15 (Scandion Oncology Press Release) - "Scandion Oncology...today announced plans to hold a R&D update on May 15, 2024 at 14:00 CEST to present its CORIST program and the recent Phase IIa results with SCO-101 in metastatic colorectal cancer, and inform more about the planned rights issue...The event will be broadcasted live..."

P2a data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SCANDION ONCOLOGY CARRIES OUT A RIGHTS ISSUE OF APPROXIMATELY SEK 60 MILLION SECURED UP TO APPROXIMATELY SEK 30.6 MILLION (Scandion Oncology Press Release) - "In connection with the Rights Issue, the Company has received subscription commitments of approximately SEK 0.4 million...The net proceeds of the rights Issue will be used to further enhance CORIST as described below: Progress the optimized dosing schedule and increase the dose of irinotecan in FOLFIRI to achieve the Maximum Tolerated Dose (MTD) and maximal effect of SCO-101 in combination with FOLFIRI. This continuation of CORIST part 3 will be done in a 3+3 design with the 4-days schedule and 250 mg of SCO-101, increasing irinotecan dosing from currently 50% to 65% then up to 80%, potentially including up to 12 patients...Based on the final data from the above CORIST phase IIa completion, Scandion will design and prepare the phase IIb randomized study including Investigational New Drug (US) preparations aimed at executing together with a potential partner...The proceeds from the exercise of warrants of series TO 2 and TO 3 are are primarily intended to finance...SCO-201..."

Clinical protocol • Financing • Colorectal Cancer • Gastrointestinal Cancer • Human Immunodeficiency Virus • Oncology • Solid Tumor

SCANDION ONCOLOGY REPORTS PROMISING UPDATED PHASE II CORIST DATA, INCLUDING TOPLINE OVERALL SURVIVAL (Scandion Oncology Press Release) - P2a | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "Scandion Oncology... announced updated positive interim results from Part 3 - the last part of the ongoing CORIST Phase IIa trial. Optimized dosing schedules were explored and caused the expected changes in exposure to SCO-101 and the chemotherapy.....The UGT1A1 genotype was investigated and patients with UGT1A1 wildtype had both longer PFS and OS than patients with mutated UGT1A1. Noteworthy, in the UGT1A1 wildtype patients the current mPFS is 7.04 months and the mOS is 13.74 months. These interim data are very promising, and final data are expected in H2 2024....The topline data for mPFS included censored patients and was reported to 4.6 months. Un-censoring changed the mPFS to a final value of 3.8 months for the 21 evaluable patients."

Biomarker • P2a data • Colorectal Cancer

SCANDION ONCOLOGY REPORTS SECOND CONFIRMED PARTIAL RESPONSE IN THE PHASE IIA CORIST PART 3 TRIAL (Scandion Oncology Press Release) - P2a | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "Scandion Oncology...today announced the second confirmed partial response in the last cohort in the ongoing Part 3 of the CORIST Phase IIa colorectal cancer trial with Scandion’s lead compound SCO-101. This further supports the concept of combining SCO-101 with chemotherapy. In the last trial cohort, two of the six total patients have had a partial response, i.e. tumor reduction of more than 30%, which is considered an important measurement of the effect of cancer treatments...The CORIST Part 3 trial evaluates Scandion’s lead compound SCO-101 as a combination treatment with FOLFIRI chemotherapy in 25 patients with metastatic colorectal cancer (mCRC) and previously demonstrated resistance to FOLFIRI....Based on the positive outcome of part 3 we will design next steps of the study in one or more smaller patient cohorts to further optimize the dose of irinotecan in combination with SCO-101."

Clinical protocol • P2a data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SCO-101 Plus FOLFIRI Shows Signs of Efficacy in Metastatic Colorectal Cancer (OncLive) - P1/2 | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "The combination of SCO-101 and leucovorin, fluorouracil, and irinotecan (FOLFIRI) resulted in tumor reduction and increased progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC), according to data from a preliminary analysis of part 3 of the phase 2 CORIST study....The overall median PFS experienced with the combination was 4.6 months. In one of the cohorts in part 3, the median PFS was 5.0 months. In a cohort of patients where the MTD dose had been determined, the clinical benefit rate (CBR) achieved with the regimen at week 8 was 76%; after 8 weeks, the CBR was 100%."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SCANDION ONCOLOGY RECEIVES NOTICE OF ALLOWANCE FOR PATENT TO ENHANCE US PATENT EXCLUSIVITY ON SCO-101 (Scandion Oncology Press Release) - "Scandion Oncology...will significantly enhance the patent protection of its lead compound SCO-101 in the important US market. Scandion has received a Notice of Allowance from the United States Patent and Trademark Office meaning a patent will officially be granted following payment of the issue fee, which will be done shortly. The patent will cover methods of using SCO-101 and any other so-called VRAC modulator to sensitize cancer cells to any anti-cancer agent or potentiate the therapeutic effect of any anti-cancer agent. The patented methods will cover treatment of a comprehensive range of specific cancers, including colorectal and pancreatic cancer, regardless of whether the cancers are resistant to current treatments or not....When granted, the patent will offer a very broad intellectual protection until at least 2037."

Patent • Colorectal Cancer • Pancreatic Adenocarcinoma

CORIST PART 3 TOPLINE DATA ARE EXPECTED IN THE SECOND HALF OF JANUARY 2024 (Scandion Oncology Press Release) - "Scandion Oncology (Scandion)...is close to presenting topline data in the ongoing CORIST part 3 study. Final patient data is expected in the second half of January 2024 following which the results will be published. The topline data will therefore be delayed a few weeks compared to previously expected before year-end 2023."

P2 data • Colorectal Cancer

SCANDION ONCOLOGY IDENTIFIES POTENTIALLY EFFECTIVE TREATMENT OF GASTRIC CANCER (Scandion Oncology Press Release) - "Scandion Oncology...has completed pre-clinical studies confirming that the company’s lead compound, SCO-101, could also potentially be an effective treatment for gastric cancer. SCO-101 is currently being clinically developed as a combination treatment for metastatic colorectal cancer and pancreatic cancer, presenting gastric cancer as an appealing new opportunity for Scandion."

Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

LRRC8A promotes Glaesserella parasuis cytolethal distending toxin-induced p53-dependent apoptosis in NPTr cells. (PubMed, Virulence) - "Pharmacological inhibition of VRAC with either PPQ-102 or NS3728 largely attenuated CDT-induced apoptosis in NPTr cells...Conversely, re-expression of Sus scrofa LRRC8A in LRRC8A NPTr cells efficiently complemented the CDT-induced apoptosis. In summary, these findings suggest that LRRC8A is pivotal for G. parasuis CDT-induced apoptosis, providing novel insights into the mechanism of apoptosis caused by CDT."

Journal • LRRC8A

SCANDION ONCOLOGY IS GRANTED NEW COMPOSITION OF MATTER-PATENT ON LEAD COMPOUND SCO-101 EXTENDING ITS EXCLUSIVITY UNTIL AT LEAST 2042 (Scandion Oncology Press Release) - "Scandion Oncology...has now formally been granted the Composition of Matter-patent for its lead compound SCO-101, for which the company applied last year, by the European Patent Office (EPO). The new patent covers solid crystal and amorphous forms of SCO-101, which includes the form of the compound that Scandion expects to commercialize. Expiring in 2042, the patent will extend the potential exclusivity period for SCO-101 in its expected commercial crystal form and significantly strengthen the intellectual property portfolio covering it. This may allow Scandion to expand the development of SCO-101 into new indications and drug combinations, potentially making a future treatment available to more patients."

Patent • Oncology

SCO-101 Plus FOLFIRI Provides Survival Benefit in Metastatic Colorectal Cancer (OncLive) - P1/2 | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "SCO-101 in combination with leucovorin, fluorouracil, and irinotecan (FOLFIRI) provided a clinically meaningful overall survival (OS) benefit in heavily pretreated patients with metastatic colorectal cancer (mCRC) who had no other active treatment options available, according to final data from part 2 of the phase 2 CORIST study...In 25 evaluable patients, the median OS was 10.4 months, with 7 patients still alive 15 months after treatment initiation....Moreover, the median progression-free survival (PFS) experienced with the regimen was 2.0 months. Historical data have showcased a median PFS ranging from 1.7 to 1.8 months. After 16 weeks, the clinical benefit rate (CBR) was reportedly 21% with the SCO-101 regimen; after 8 weeks, the CBR was 42%. Historical controls have had CBRs ranging from 11% to 16% after 6 weeks."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ABCG transporter and SRPK1 kinase inhibition of chemotherapy resistance: A phase Ib clinical trial of safety and maximum tolerated dose for SCO-101 in combination with gemcitabine and nab-paclitaxel in inoperable pancreatic cancer (ESMO 2023) - P1/2 | "SCO-101 is a compound for oral use that was shown to revert drug resistance in preclinical studies: In taxane-resistant cancer cells SCO-101 resensitized tumor cells to taxane and reduced the active efflux of ATP Binding Cassette G2 substrate molecules from irinotecan resistant colon cancer cells. DLTs were observed in 2 pts in the cohort treated with 250mg of SCO-101, hence MTD for SCO-101 concurrent with Gem-Nab was determined to be 200mg once daily for 6 days on a bi-weekly schedule. A full description of toxicities is pending."

Clinical • Combination therapy • P1 data • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • SRPK1

PHASE IB PANTAX TRIAL IS SUCCESSFULLY COMPLETED AND ESTABLISHES THE MAXIMAL TOLERATED DOSE WITH POSITIVE SAFETY PROFILE AND PHARMACOKINETIC DATA (Scandion Oncology Press Release) - P1b/2 | N=18 | PANTAX-Ib (NCT04652206) | Sponsor: Scandion Oncology A/S | "Scandion Oncology...announces the poster presentation of clinical safety and PK data from its PANTAX trial at the European Society for Medical Oncology (ESMO) Congress 2023....The poster presents data analysis from the PANTAX phase Ib trial, studying Scandion’s lead compound SCO-101 in combination with standard of care chemotherapies gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer....The data confirms that SCO-101 is safe and well-tolerated in this indication and combination, thereby also supporting the general profile of SCO-101 as well-tolerated in combination with different chemotherapies in patients with late-stage disease....Scandion expects to present a final analysis of all safety and efficacy outcomes from PANTAX in the first half of 2024."

P1 data • P1/2 data • Pancreatic Cancer

Scandion Oncology A/S Announces Data from PANTAX Trial to Be Presented At ESMO Congress 2023 (Market Screener) - "Scandion Oncology A/S will have clinical safety data for its lead compound SCO-101 presented at the European Society for Medical Oncology (ESMO) Congress 2023 taking place in Madrid on October 20-24, 2023. This will be a good opportunity for Scandion to make the safety data available to a large number of international physicians and other stakeholders. Safety data from the PANTAX phase 1b trial in patients with pancreatic cancer will be announced at a poster presentation at the congress....Scandion expects to perform a full analysis of all safety and efficacy outcomes late in 2023 with the final data to be presented in first half 2024."

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Scandion Oncology's EU Patent Application for Solid Form of SCO-101 Receives Favorable Opinion (Market Screener) - "Scandion Oncology...said Thursday its application for an international patent for the solid crystal form of SCO-101 received a favorable opinion from the European Patent Office. If granted, the patent will extend the potential commercial exclusivity period for the solid form of SCO-101 to at least 2042."

Patent • Oncology • Solid Tumor

Evaluation of SN-38 PK profile in patients with RAS wild-type metastatic colorectal cancer treated with a combination of SCO-101 and FOLFIRI. (ASCO-GI 2022) - P2 | "Background: The FOLFIRI regimen (5-fluorouracil, leucovorin and irinotecan) is a predominant treatment regimen for metastatic colorectal cancer. SCO-101 in combination with FOLFIRI has demonstrated the ability to modulate the PK profile of SN-38 in mCRC patients with RAS wild-type tumors, by significantly increasing the half-life, the peak plasma concentration, and area under the curve of SN-38. The combined treatment was well tolerated, and the drug is now being tested for efficacy in the CORIST trial."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ABCG2

SCO-101 Plus FOLFIRI Will Continue to Be Studied Despite Missing Primary End Point in mCRC (OncLive) - P1/2 | N=35 | CORIST (NCT04247256) | Sponsor: Scandion Oncology A/S | "The addition of SCO-101 to FOLFIRI chemotherapy was safe and tolerable but failed to elicit a greater than 30% reduction in tumor volume in patients with metastatic colorectal cancer (mCRC), failing to meet the primary end point of part 2 of the phase 2 CORIST trial (NCT04247256). Improvements in progression-free survival (PFS) and rates of stable disease-key secondary end points of the trial-were also shown. The data were collected from 25 patients enrolled in part 2, most of whom had been evaluated after only 8 weeks of treatment....The first patient is expected to enroll in part 3 soon. Notably, part 3 of the study may conclude by the third quarter of 2023....An update on the timeline is expected in the first quarter of 2023, which will include the timeline for part 4 of the trial..."

P2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"SCO-101 Plus FOLFIRI Will Continue to Be Studied Despite Missing Primary End Point in mCRC #crcsm #oncology https://t.co/X094Y4FVUY" (@OncLive)

Colorectal Cancer • Gastrointestinal Cancer • Oncology