On September 12, 2022 Delfi Diagnostics, a pioneering developer of a new class of high-performance, accessible liquid biopsy tests for early cancer detection and monitoring, reported that has been selected as the liquid lung cancer biopsy partner in Europe’s multi-national, randomized, prospective lung cancer screening trial known as 4-IN-THE-LUNG-RUN, or 4ITLR (Press release, Delfi Diagnostics, SEP 12, 2022, View Source [SID1234619476]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through 4ITLR, European investigators are studying how often – every year, or every other year – individuals should get screened if their initial CT scan is negative. Delfi’s technology is paired to the study objectives by measuring whether Delfi can identify individuals in Europe’s screen-eligible population who are most likely to benefit from a CT scan. The collaboration, initiated and facilitated through a partnership between the Netherlands Cancer Institute ((NKI), with Dr. D. van den Broek as PI) and the institute for DiagNostic Accuracy (iDNA), includes Delfi analyzing the first 9,000 subjects enrolled through the trial in the Netherlands and France (Gustave Roussy) – generating data that can support Delfi’s research and subsequent implementation within the European Union.

"One of the goals of our study is to examine how a liquid biopsy test might improve screening in a manner that is cost-effective," said prof. Matthijs Oudkerk, MD, PhD, Chief Scientific Officer at iDNA and leading the Radiology and AI readings of 4ITLR. "We are eager to explore how a low-cost liquid biopsy platform could help us screen more high-risk Europeans."

Based on the results of the NELSON trial, the European Union is expected to initiate a European lung cancer screening program for individuals at risk due to their smoking and age.

"We know that LDCT screening is effective in reducing lung cancer mortality," said Peter B. Bach, Delfi Diagnostics Chief Medical Officer. "This study should lay the groundwork for widespread, cost efficient screening of those at risk in Europe. Delfi is honored to be part of it."

Lung cancer kills more than 380,000 Europeans each year, and more than half of all new lung cancer diagnoses in Europe occur at stage IV, when 5-year survival rates can be as low as 2 percent. But screening older heavy smokers with low-dose CT could save up to 80,000 lives in Europe per year.

On September 12, 2022 Shasqi, a clinical-stage biotechnology company developing oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC ) platform reported it has opened the Phase 2 of their Phase 1/2a clinical study to further assess SQ3370 in anthracycline- naïve patients (Press release, Shasqi, SEP 12, 2022, View Source [SID1234619475]). The Phase 2 study follows the company’s presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held September 9-13, 2022, evaluating the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose for SQ3370 in patients with locally advanced and/or metastatic solid tumors (NCT04106492).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the promising results from our Phase 1 study and preclinical data which indicate that click chemistry in humans has the potential to revolutionize cancer care by expanding the therapeutic index of anti-cancer therapies such as doxorubicin," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "We look forward to further exploring the safety and efficacy of our lead candidate SQ3370 at unprecedented dose levels in the Phase 2 study."

The Phase 1 clinical data were presented as a poster during the congress:

Abstract Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors
Presentation Number: 1499P
Poster Session Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors
Link to full poster details here.
Key Phase 1 study findings include:

SQ3370 was well tolerated among 27 DLT evaluable patients receiving up to 12x (1x equals 75mg/m2/cycle of Dox molar equivalents); maximum tolerated dose has not been reached
Among patients treated with a least one cycle of SQ3370, no protocol defined dose-limiting toxicities, including anthracycline myelosuppression and gastrointestinal (GI) toxicity, were observed and no treatment emergent adverse events (TEAEs) that led to death were considered related to SQ3370; the most frequent Grade ≥3 TEAE was anemia
The highest doses tested of SQ3370 led to immune activation in soft tissue sarcomas which are considered immunologically cold tumors, validating preclinical findings of SQ3370 previously published:
Increased cytotoxic T-cell activity observed at higher dose levels of SQ3370 indicate immune activation and a trend toward increase in tumor cell death in heavily pretreated patients
Immune activation has the potential to improve systemic activity of intra-tumoral administration of SQ3370 which will be explored in Phase 2
"Early data has shown that click chemistry allows for the release of doxorubicin at the tumor site to generate anti-tumor responses. Phase 1 results showing that SQ3370 is well-tolerated among a heavily pretreated patient population further validate this clinical approach and the importance of investigating SQ3370 as a potential treatment option in patients with anthracycline-sensitive- and other solid tumors," said Sant P. Chawla, M.D., FRACP, Principal Investigator, and Head, Sarcoma Oncology Center in Santa Monica, California."

Shasqi is excited to open the Phase 2 study of SQ3370 in anthracycline-naïve patients with advanced soft tissue sarcomas, relapsed or recurrent squamous-cell head and neck cancer, platinum refractory ovarian cancer recurrent and/or metastatic uterine carcinoma, or uterine sarcoma. For more information, visit www.shasqi.com

On September 12, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), reported that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Corbus Pharmaceuticals, SEP 12, 2022, https://www.prnewswire.com/news-releases/corbus-pharmaceuticals-to-present-virtually-at-the-hc-wainwright-24th-annual-global-investment-conference-301621611.html [SID1234619474]). The hybrid conference will take place September 12-14, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A livestream of the virtual presentation is available on-demand beginning today, Monday, September 12, 2022 at 7:00 AM ET for those who are registered to attend the conference and will be accessible for 30 days on the H.C. Wainwright conference platform. For more information, please visit the conference website.

On September 12, 2022 BioMed Valley Discoveries (BVD) reported that the first patient has been dosed in a phase II clinical trial of ulixertinib (BVD-523) in combination with hydroxychloroquine (HCQ) (Press release, BioMed Valley Discoveries, SEP 12, 2022, View Source [SID1234619473]). Ulixertinib is a first-in-class and best-in-class ERK inhibitor, with this clinical trial focusing on patients with advanced gastrointestinal malignancies and mutations in the MAPK pathway. This study builds upon the finding of the phase I study of the combination, which was completed at Huntsman Cancer Institute at the University of Utah.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumors may become addicted to autophagy for survival in context of MAPK inhibition" said Brent Kreider, Ph.D., President of BioMed Valley Discoveries. "Given the favorable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies."

The Phase II efforts build on a successful Phase Ib evaluating ulixertinib monotherapy as a novel targeted cancer treatment in cohorts of patients with genetic alterations that result in aberrant MAPK pathway signaling. Results from phase Ib demonstrated ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range of RAS/MAPK pathway-driven cancers, including atypical alterations in BRAF.

In addition to targeting the terminal node of the RAS/MAPK pathway, ulixertinib’s highly selective kinase inhibition profile is expected to provide potential impact across a number of tumor types in both monotherapy and combination. Previous efforts have also established a recommended phase 2 dose in combination with palbociclib, with additional combination efforts ongoing.

About ulixertinib (BVD-523): Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway.

About the study: This is an open-label, multicenter, prospective phase II basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients recruited must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages and includes pancreatic, colorectal, esophageal, gastric and cholangiocarcinomas . (Clinicaltrials.gov Number NCT05221320).

On September 12, 2022 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12-14, 2022 (Press release, Medivir, SEP 12, 2022, https://www.prnewswire.com/news-releases/medivir-to-present-at-the-hc-wainwright-24th-annual-global-investment-conference-301621947.html [SID1234619472]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!