On April 20, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported the first patient has been dosed at City of Hope in a Phase 1 clinical trial of JANX008 in subjects with advanced or metastatic solid tumors including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma (Press release, Janux Therapeutics, APR 20, 2023, View Source [SID1234630373]). JANX008 is an epidermal growth factor receptor (EGFR) directed T cell engager (TCE) and is the second product candidate utilizing Janux’s TRACTr platform to be administered in humans.

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"We are excited to initiate the clinical evaluation of our second product candidate from our TRACTr platform. JANX008 is designed to achieve tumor-selective T-cell activation and tumor killing while sparing healthy tissues," said Wayne Godfrey, M.D., Chief Medical Officer at Janux. "Our preclinical data with JANX008 demonstrated tumor growth inhibition and lower toxicity levels, when compared to an unmasked T cell engager."

Marwan Fakih, M.D., Professor, Medical Oncology and Therapeutics Research, Judy and Bernard Briskin Distinguished Director in Clinical Research and the principal investigator from City of Hope, notes, "EGFR is a validated therapeutic target in several tumor types and highly expressed in many other tumor types, so the opportunity to target EGFR from the T-cell engager axis would be meaningful to address unmet medical needs in various disease types in oncology. We look forward to clinically exploring the safety and activity of JANX008."

"JANX008 is the second therapeutic from our TRACTr platform to enter a first-in-human clinical trial, demonstrating the potential of our platform and the commitment of our team to address critical and urgent unmet needs for patients with advanced or metastatic solid tumors," said David Campbell, Ph.D., President and CEO of Janux. "We are grateful to our team and clinical investigators for their support in bringing another new therapeutic with a novel mechanism of action into the clinic."

About the JANX008 Phase 1 Clinical Trial

The Phase 1 clinical trial is a first-in-human, Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05783622.

Janux’s TRACTr and TRACIr Pipeline

JANX008 is a TRACTr that targets EGFR and is being studied in a Phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s lead candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

On April 20, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 4, 2023, following the release of its first quarter 2023 financial results (Press release, Puma Biotechnology, APR 20, 2023, View Source [SID1234630372]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On April 20, 2023 Daiichi Sankyo (TSE: 4568) reported that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive (Press release, Daiichi Sankyo, APR 20, 2023, View Source [SID1234630371]).

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The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application. No additional efficacy or safety data has been requested.

"We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible," said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. "Quizartinib was shown to improve overall survival when added to standard chemotherapy and continued as monotherapy and has potential to change the standard of care for patients with newly diagnosed FLT3-ITD positive AML."

The NDA is based on results from the QuANTUM-First trial, which demonstrated that quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, resulted in a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone. The results of QuANTUM-First were presented at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.1

The safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable with no new safety signals observed. The incidence of grade ≥3 QT prolongation events was low, with uncommon ventricular arrythmia events. Overall, the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.

About QuANTUM-First
QuANTUM-First is a randomized, double-blind, placebo-controlled global phase 3 study evaluating quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens. Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, also were evaluated. QuANTUM-First enrolled 539 patients at 193 study sites across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.2 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.3,4 In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023 with the five-year survival rate reported at 30.5%.4,5

A number of gene mutations have been identified in AML, and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common, observed in up to 37% of all newly diagnosed patients.6,7 Approximately 80% of FLT3 mutations in AML are FLT3-ITD (internal tandem duplications), an oncogenic driver mutation that presents with a high leukemic burden.7,6 Patients with FLT3-ITD positive AML tend to have a particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.6 The five-year survival rate for patients with FLT3-ITD positive AML has been reported at approximately 20%.8

The conventional treatment for fit patients with newly diagnosed AML is intensive induction and consolidation chemotherapy, with or without targeted therapy, and HSCT for eligible patients.9

About Quizartinib
Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.6

Regulatory applications for quizartinib in newly diagnosed FLT3-ITD positive AML are currently under review in Europe, Japan and the U.S. based on the results of the QuANTUM-First trial. The FDA has granted Priority Review and Fast Track Designation to quizartinib for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy. Orphan Drug Designation has been granted to quizartinib for the treatment of AML in Europe, Japan and the U.S.

Quizartinib is approved for use in Japan for the treatment of adult patients with relapsed/refractory AML that is FLT3-ITD positive, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan. The quizartinib clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

On April 20, 2023 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported it will be presenting data using DCISionRT to examine the decision impact on physician recommendation for adjuvant radiation therapy by race (White vs. Black) in women with ductal carcinoma in situ (DCIS) enrolled in the PREDICT study (Press release, PreludeDx, APR 20, 2023, https://www.prnewswire.com/news-releases/preludedx-to-present-comparative-analysis-of-treatment-recommendations-of-black-and-white-dcis-breast-cancer-patients-using-dcisionrt-at-asbrs-2023-annual-meeting-301802609.html [SID1234630369]). This race/ethnicity data will be presented at the 24th Annual Meeting of the American Society of Breast Surgeons (ASBrS), being held on April 26 – 30, 2023 at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts.

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Poster Presentation
Title: A Comparative Analysis of Changes in Treatment Recommendations for Black and White Patients with Ductal Carcinoma in Situ Using a 7-gene Predictive Biosignature: Analysis of the PREDICT Study
Presenter: Pat Whitworth, MD, FACS, FSSO, Director of the Nashville Breast Center
Date: Friday, April 28, 6:15 PM – 7:30 PM

"While there is a significant body of evidence addressing race/ethnic treatment differences among women with invasive breast cancer, there is limited evidence for DCIS. We are excited to present this new and valuable data for DCIS patients," says Dan Forche, President and CEO of PreludeDx. "We are confident that the new DCISionRT data will help guide physicians and their patients to make more informed treatment decisions."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On April 20, 2023 Samyang Holdings and LG Chem reported their recent execution of strategic partnership agreement on Thursday, April 20th, for development of novel mRNA-based cancer therapeutics that utilizes Samyang’s proprietary drug delivery technology (Press release, Samyang Biopharmaceuticals, APR 20, 2023, View Source [SID1234630370]).

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Under the terms of the agreement, Samyang Holdings grants non-exclusive rights to "NanoReady" technology and is responsible for supplying its key components to LG Chem, and LG Chem will be implementing "NanoReady" technology to develop innovative mRNA-based cancer therapeutics with maximal therapeutic effects. In return, LG Chem is required to pay upfront and a series of milestone payments upon completion of each developmental objective as in the terms agreed by both parties.

mRNA harnesses genetic information that directs the synthesis of specific proteins. Protective drug delivery systems that safely carry the mRNA to the target cell and mediate effective protein expression are crucial in developing mRNA therapeutics.

"NanoReady" is one of Samyang Holdings’ proprietary drug delivery technologies, characterized by its high adaptability to different mRNA molecules. Provided as a pre-made drug delivery formulation, it is expected to significantly reduce development time and time-to-patient, making an impact in the application of personalized therapeutics by streamlining the rigorous mixing process when being compounded with mRNA therapeutic molecules developed by LG Chem.

"LG Chem has exceptional R&D expertise in innovative drug development and a number of promising new drug pipelines," said Young-Joon Lee., CEO, Samyang Holdings Biopharm Division, "Taking this recent deal as a driving force, we will continue to strengthen our partnership with LG Chem. By leveraging the capabilities of the two companies, we hope to accelerate the development of innovative cancer therapy to significantly improve the lives of suffering cancer patients."

Ji-Woong Son, head of LG Chem’s Life Sciences company said, "We hope to maximize success through active collaboration between the two companies, with the aim to provide innovative mRNA-based cancer therapeutics to patients worldwide."