On June 5, 2024 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported a poster on NTX-472, its new preclinical drug candidate for B cell lymphoma, at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Nutcracker Therapeutics, JUN 5, 2024, View Source [SID1234644153]).

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!

Monoclonal antibody immunotherapies can provide an effective treatment for B cell lymphoma. However, by only targeting a single tumor antigen, such as CD19 or CD20, these treatments can place selective pressures on tumors, with cancer cells often down-regulating the expression of those specific antigens to become cold tumors, invisible to the immune system. Multispecific antibodies may be able to mitigate these effects with improved specificity to several antigens at once.

Nutcracker Therapeutics’ scientists engineered a panel of molecules simultaneously targeting CD20, CD19 and CD47 to compare them to existing monoclonal antibody immunotherapies for B cell lymphoma, including rituximab (monospecific anti-CD20) and tafasitamab (monospecific anti-CD19). Of these molecules, the team identified one which had improved tumor killing and B cell depletion in vitro, which became the NTX-472 program. Using its CodonCrackerTM software and the Nutcracker Manufacturing Unit, Nutcracker Therapeutics’ scientists then further studied NTX-472 in vivo, which showed rapid depletion of B cells with no detectable binding to red blood cells in cynomolgus monkeys.

"We’re proud to be one of the first RNA therapeutics companies to engineer a multispecific antibody," said Chief Scientific Officer Samuel Deutsch, Ph.D. "The data on NTX-472 is a testament to the capabilities of Nutcracker Therapeutics’ platform and how it enables our scientists to engineer complex molecules by the dozens, and ultimately pinpoint the best option for a viable drug candidate. We plan to further develop NTX-472 as a trispecific immunotherapy with a differentiated therapeutic and safety profile."

Previously Nutcracker Therapeutics presented preclinical data on NTX-471, an mRNA therapeutic candidate that is being developed to target CD47. Unlike the multispecific approach employed by NTX-472, NTX-471 encodes for a multivalent (octavalent) antibody to achieve high specificity via avidity for target cancer cells. During SITC (Free SITC Whitepaper) 2023, Nutcracker Therapeutics demonstrated similar cytotoxic activity of NTX-471 to existing anti-CD47 molecules, but with little-to-no binding to red blood cells. More information on NTX-471 can be found in this press release.

On June 5, 2024 The University of Texas MD Anderson Cancer Center reported that patients requiring radiation therapy for head and neck cancer benefit from proton therapy based on preliminary data from a multi-institution Phase III trial led by its researchers (Press release, MD Anderson, JUN 5, 2024, View Source [SID1234644152]). The results were presented today at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by Steven Frank, M.D., professor of Radiation Oncology and executive director of the Particle Therapy Institute at The University of Texas MD Anderson Cancer Center.

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!

The trial concluded that proton therapy was effective while producing fewer side effects, emerging as the standard of care treatment that reduces malnutrition and gastrostomy-tube dependence.

"This pivotal trial provides level-one evidence supporting the use of proton therapy for head and neck cancer and demonstrates the positive impact proton therapy can have on a patient’s health during and after treatment," said Director Jennifer Maggiore, executive director of the National Association for Proton Therapy (NAPT). "This is significant because reducing side effects is valuable in supporting patient quality of life. Proton therapy can also lower payor costs and alleviate patient financial toxicity by reducing out-of-pocket spending and loss of income related to side effects."

Of an estimated 71,100 people who will be diagnosed with head and neck cancer in 2024, only 2,200 – less than 5% – are likely to be treated with proton therapy, according to NAPT member data. Lack of access to proton therapy is often due to barriers including insurance prior authorizations and denials, which can lead to harmful delays in care.

"The numbers point to a need not only for greater access, but also to the imperative for additional patient, physician and payor education regarding the value of proton therapy," said Maggiore. "NAPT will continue to advocate for more widespread adoption of proton therapy as the standard of care, while facilitating additional research that continues to prove the value of this life-saving, life-changing cancer treatment."

NAPT is an independent nonprofit organization founded in 1990 to educate and increase awareness about the clinical benefits of proton therapy. Its members include 48 of the nation’s leading cancer centers, many of which are NCI-designated comprehensive cancer centers and NCCN members.

On June 5, 2024 Kangpu Biopharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant prostate cancer (mCRPC) (Press release, Kangpu Biopharmaceuticals, JUN 5, 2024, View Source [SID1234644151]).

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!

Discovered by Kangpu Biopharmaceuticals, KPG-121 is a modulator of the Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN targeting rapid ubiquitination and degradation of casein kinase 1α (CK1α) and transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-121 promotes anti-proliferation and anti-angiogenesis activities and enhances immunomodulatory properties. KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including enzalutamide, abiraterone acetate, apalutamide, or darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone. A Phase I study to evaluate the safety, pharmacokinetics, and efficacy of KPG-121 when combined with enzalutamide, abiraterone, or apalutamide for the treatment of patients with metastatic or non-metastatic castration-resistant prostate cancer was completed in the US (NCT03569280). KPG-121 was generally well tolerated and demonstrated a favorable pharmacokinetic profile as well as promising efficacy.

On June 5, 2024 GC Genome Corporation, a leading diagnostics company, reported new data from its AI-based liquid biopsy platform for non-invasive colorectal cancer (CRC) detection at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, GC Genome, JUN 5, 2024, View Source [SID1234644150]). Conducted in collaboration with Genece Health Inc., a strategic partner based in San Diego, the study demonstrated significant promise for accurate non-invasive CRC and advanced adenoma (AA) detection by analyzing cell-free DNA (cfDNA) whole genome sequencing (WGS) data.

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!

The poster presentation highlighted the potential implementation of its liquid biopsy platform using multimodal deep learning technology to detect colorectal cancer in clinical data. The study incorporates 1,506 colonoscopy-verified normal samples, 130 AA patients, and 302 CRC patients (with a breakdown of stages). This innovative approach demonstrated high sensitivity for CRC detection across all stages, including early-stage lesions, while maintaining high specificity.

"The development of non-invasive screening methods for colorectal cancer is crucial for improving early detection and patient outcomes," said Eun-Hae Cho M.D., Ph.D., Chief Scientific Officer at GC Genome. "By emphasizing the necessity for a non-invasive approach, this research brings us nearer to the development of a convenient, accessible screening option for patients. It has the potential to bridge the current screening gap and surpass the limitations of traditional methods. And we are excited to continue our work to bring this technology to patients as soon as possible."

Key Findings of the Study:

The multimodal deep learning algorithm achieved high sensitivity for CRC detection, ranging from 80.2% to 84.0% across all stages.
The algorithm also demonstrated promising accuracy in detecting AA lesions, with a sensitivity of 63.0%.
The use of colonoscopy-verified normal samples strengthens the study’s foundation and paves the way for future clinical translation.

On June 5, 2024 Pierre Fabre Laboratories reported the filing of an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to initiate a first-in-human (FIH) Phase I/II clinical trial with PFL-002/VERT-002 for solid tumors including non-small cell lung cancer (NSCLC) (Press release, Pierre Fabre, JUN 5, 2024, View Source [SID1234644149]).

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!

The PFL-002/VERT-002 Phase I/II trial is a multi-center, international study aimed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of PFL-002/VERT-002 in NSCLC patients with MET alterations, including those acquired as resistance mechanism to other treatments. The FDA will review the application and determine its acceptability.

"We are looking forward to initiating the first-in-human trial of PFL-002/VERT-002 later this year. We are confident that this new drug holds significant promise, as a novel therapeutic option with a differentiated mechanism of action, for patients facing MET-altered solid tumors, including NSCLC" said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

About PFL-002/VERT-002

PFL-002/VERT-002 is a monoclonal antibody developed by Vertical Bio, offering a unique and differentiating mechanism of action, acting as a degrader of c-MET, a known disease driver in patients with solid tumors, including non-small cell lung cancer (NSCLC) presenting mutations or amplification of MET. The antibody has been optimized preclinically by Vertical Bio, which has been acquired by Pierre Fabre Laboratories.

Pierre Fabre Laboratories is progressing PFL-002/VERT-002 into clinical development and hope to enroll a first patient in the FIH trial by end 2024.