On September 4, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that its partner Biogen has had its investigational new drug (IND) application for BIIB142 accepted by the U.S. Food and Drug Administration (FDA) (Press release, C4 Therapeutics, SEP 4, 2025, View Source [SID1234655760]). BIIB142 is a degrader of IRAK4 that Biogen intends to explore for therapeutic use in patients with autoimmune diseases.

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 thrilled to see Biogen quickly advance the IRAK4 degrader that resulted from our collaboration toward the clinic in the hopes this molecule may bring a new treatment option to patients with autoimmune disease," said Paige Mahaney, Ph.D., chief scientific officer of C4 Therapeutics. "Our long-standing collaboration with Biogen helped C4T build and deepen capabilities across our platform as we worked together to develop degraders for a broad range of target classes and therapeutic areas to reach a sizeable number of patients with unmet needs. We look forward to Biogen’s continued progress with BIIB142, as well as the second development candidate delivered under our collaboration."

"Our collaboration with C4 Therapeutics has been both powerful and deeply productive, pairing C4T’s expertise in targeted protein degradation with Biogen’s scientific leadership and drug development capabilities," said Jane Grogan, Ph.D., head of research at Biogen. "I’m proud that we have advanced this program based on a cutting-edge modality for a disease with high unmet need, and we see great promise in continuing to pioneer these types of investigational approaches."

Under the terms of the strategic collaboration established in 2018, C4T provided expertise and research services in targeted protein degradation and Biogen provided scientific and drug development capabilities. C4T delivered two development candidates to Biogen under this collaboration. Biogen is responsible for all future clinical development and commercialization for these development candidates. C4T is entitled to receive a $2 million milestone payment upon Biogen dosing patients in the BIIB142 clinical trial.

On September 4, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a positive clinical readout update assessing the performance of the latest colorectal cancer (CRC) screening algorithm (V2) for its Shield blood test (Press release, Guardant Health, SEP 4, 2025, View Source [SID1234655783]). The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%.

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 pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance," said AmirAli Talasaz, Guardant Health co-CEO. "We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time."

The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%.

The National Comprehensive Cancer Network (NCCN) recently updated its CRC Screening Guidelines to add Shield as the first blood test that is FDA approved for primary screening of CRC. Shield has also received numerous awards recognizing its innovation and power to change lives, including Fast Company’s World Changing Ideas, TIME’s list of the Best Inventions of 2024 and was selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024.

Beyond CRC screening, Guardant Health has a pipeline of activities around the Shield platform, including the Shield multi-cancer detection (MCD) test which was recently granted Breakthrough Device Designation by the FDA and included in the National Cancer Institute’s Vanguard study.

Shield is the first and only blood test that has received full FDA approval as a primary screening option for CRC in average-risk adults aged 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.

On September 4, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported that company management will participate in the below September investor conferences (Press release, Cidara Therapeutics, SEP 4, 2025, View Source [SID1234655761]).

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!

Details are as follows:

Event: H.C. Wainwright 27th Annual Global Investment Conference
Date: September 8, 2025
Time: 4:00 PM ET
Format: Corporate Presentation

Event: Morgan Stanley 23rd Annual Global Healthcare Conference
Date: September 9, 2025
Time: 7:00 AM ET
Format: Fireside Chat

Cidara will also participate in one-on-one investor meetings during the conferences.

On September 4, 2025 Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, reported it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution (Press release, Ibex Medical Analytics, SEP 4, 2025, View Source [SID1234655784]). Ibex’s fully automated "zero-click" AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.

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!

Using digitized images of HER2 IHC stained breast cancer samples, Ibex’s breast HER2 solution detects invasive tumor cell staining patterns and classifies HER2 expression into four standard scores: 0, 1+, 2+ and 3+ (based on ASCO (Free ASCO Whitepaper)/CAP guidelines). It can assist pathologists in the detection and interpretation of cases with HER2 ultralow expression (defined as IHC 0 with membrane staining present). The AI-powered computational tool automates and optimizes case review with:

"Zero-click" invasive tumor detection (automatically excluding ductal carcinoma in situ)
Automated tumor cell identification and cell staining pattern classification
Editable invasive contours and score recalculation
Visualization of AI findings and cell staining pattern percentages for better understanding of score result
Pathologists supported by Ibex’s breast HER2 solution showed improvement in scoring accuracy and consistency, as demonstrated by two clinical studies; one spanning 14 international cancer centers and an additional multi-reader validation study.

The IVDR certificate was received following a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product. Ibex’s breast HER2 solution has been shown to be exceptionally robust, with high performance across multiple labs, scanners, anti-HER2 antibodies, and patient demographics during IVDR clinical studies:

Improved Accuracy (relative to experts): Pathologists supported by AI demonstrated improved sensitivity, when scoring HER2 0 and 1+ slides (91.2% manual score vs. 97.4% with AI) and overall accuracy for all HER2 scores (77.5% manual score vs. 86.6% with AI).
Increased Consistency: Pathologists’ average inter-observer agreement was significantly higher when assisted by AI (94.1%) than with manual scoring (77.3%), in all slides, and specifically for HER2 0 and 1+ slides (97.2% with AI vs. 87.4% for manual score).
"AI can be a valuable decision support tool, aiding pathologists to improve HER2 scoring accuracy and align more closely with expert breast pathologists, as well as enhancing consistency among pathologists, particularly in challenging cases at the lower end of the HER2 expression spectrum," says Dr. Elena Provenzano, lead breast histopathologist at Cambridge University Hospitals NHS Foundation Trust. "Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner."

Ibex’s HER2 biomarker solution is part of Ibex Breast, an integrated AI solution offering a streamlined diagnostic workflow that detects 54 tissue morphologies in breast H&E slides, which has been widely adopted by leading pathology labs worldwide.2,3 Pathologists can review H&E and IHC-stained slides with AI support, facilitating rapid, consistent and objective diagnosis, scoring, and reporting of breast biopsies and excisions.

"Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses," remarked Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics. "We are thrilled to see our HER2 IHC scoring solution’s high performance during IVDR clinical studies, with pathologists noting its ease of use, confidence boost, and smooth workflow integration—underscoring its real-world diagnostic impact. This certification reaffirms our commitment to providing the most accurate and reliable tools for pathologists, ultimately improving patient care."

On September 4, 2025 Cullinan Oncology presented its corportate presentation (Press release, Cullinan Oncology, SEP 4, 2025, View Source [SID1234655762]).

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!