On April 25, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing DecisionDx-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM) (Press release, Castle Biosciences, APR 25, 2023, View Source [SID1234630503]). DecisionDx-Melanoma uses a patient’s tumor biology to provide the patient’s personalized risk of recurrence and metastasis, while AJCC staging is based on the clinical and pathologic risk factors of a patient’s melanoma tumor.

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"Patients with stage I cutaneous melanoma are considered to have a lower risk of recurrence and melanoma-specific mortality; however, due to the large number of patients diagnosed with stage I disease, this patient group accounts for the largest number of deaths from melanoma," said Sebastian Podlipnik, M.D., Department of Dermatology, Hospital Clinic of Barcelona, Spain. "As the study showed, DecisionDx-Melanoma provides more precise risk stratification over staging alone to better predict which patients have a low risk of experiencing a poor outcome and those with more aggressive tumor biology who may benefit from increased clinical surveillance."

The data were presented at the 19th European Association of Dermato-Oncology (EADO) Congress, held in Rome, Italy, in a poster titled, "The 31-gene expression profile outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma." In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with stage I CM. Additionally, as reported in the study, the test added valuable prognostic information to AJCC staging to better stratify recurrence-free survival (RFS) and melanoma-specific survival (MSS) among patients with stage I CM.

RFS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB RFS rates of 93.3% vs. 87.6%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of RFS with low-risk Class 1A vs. high-risk Class 2B RFS rates of 97.3% vs. 77.3%.

MSS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB MSS rates of 97.6% vs. 97.9%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of MSS with low-risk Class 1A vs. high-risk Class 2B MSS rates of 98.0% vs. 92.3%.

Importantly, the data demonstrate that patients with AJCC stage I CM who had a high-risk (Class 2B) DecisionDx-Melanoma test result were 5.4 times more likely to die from melanoma compared to patients staged as IB according to AJCC staging. The results of the study support the use of DecisionDx-Melanoma to guide better risk-aligned care in patients considered low risk by staging by identifying high-risk patients who may be missed using only AJCC staging criteria.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On April 25, 2023 Parthenon Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that the first patient has been dosed with PRTH-101 in a Phase 1, first-in-human clinical trial for patients with immune-excluded solid tumors (Press release, Parthenon Therapeutics, APR 25, 2023, View Source [SID1234630502]).

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PRTH-101 is a first-in-class Discoidin Domain Receptor 1 (DDR1) antagonist monoclonal antibody that is expressed at very high levels in solid tumors with low levels of T cell infiltration. PRTH-101 is the first development candidate from Parthenon’s broad TME-focused pipeline to enter clinical development. PRTH-101 uniquely targets DDR1 and has demonstrated, in preclinical models, anti-tumor activity as a single agent and in combination with an anti-PD-1 checkpoint inhibitor.

"The initiation of a Phase 1 trial for PRTH-101 is an important step forward for cancer patients with DDR1-associated tumors, immune-excluded solid tumors, that have been shown to respond poorly to existing immuno-therapies," said J. Paul Eder, MD, Chief Medical Officer of Parthenon Therapeutics. "With no FDA-approved therapies that target DDR1-associated tumors, we believe that PRTH-101 could uniquely improve patient outcomes by breaking down the barrier that various types of tumors construct to protect them from immune attack. Parthenon continues to focus on an unmet need in cancer that hasn’t been successfully targeted therapeutically, namely, direct modulation of the tumor microenvironment to overcome immune exclusion."

About PRTH-101
PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a physical barrier that prevents immune cells from interacting with and attacking tumor cells. By disabling DDR1, the collagen fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T-cells to enter and naturally attack the tumor. The creation of DDR1-directed collagen alignment does not appear to have a normal physiological surrogate and may therefore be unique to pathologies such as neoplasia, potentially allowing for relatively safe interventions. Thus, blockade of DDR1 represents a unique and "orthogonal" approach to stimulating the immune-based antitumor activity, and such blockade shows both single agent anti-tumor activity as well as marked augmentation of immunity enhanced by PD-1 blockade.

Tumor types which show particularly high levels of DDR1-associated collagen barriers include colorectal, ovarian, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1.

About the Phase 1 Trial
The Phase 1 trial (NCT05753722) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment.

On April 25, 2023 Albatroz Therapeutics, a biotechnology company targeting tissue remodeling to stop cancer growth and treat arthritis, reported that it has secured $3 million USD in funding led by Outram Bio and SEEDS Capital to accelerate the development of therapeutic antibodies against a novel target that degrades the extracellular matrix, a key contributor to cancer and arthritis (Press release, Albatroz Therapeutics, APR 25, 2023, View Source [SID1234630501]). The company also received the first Golden Ticket prize from Amgen in Singapore, recognizing the viability of its science and business plan.

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Cancer that has metastasized, spreading to other parts of the body, is notoriously difficult to treat and accounts for most cancer deaths. Albatroz has secured exclusive rights on a highly specific and novel target that blocks tumor growth and recurrence, including a range of therapeutic antibodies that inhibit this target.

"Degradation of the extracellular matrix is a critical component of both tumor growth and arthritis, however candidate drugs against this process have been limited in their use due to toxicity profiles," said Dr. Fred Bard, CEO and Scientific Co-Founder of Albatroz. "We are thrilled with the industry support that is allowing us to accelerate development of Albatroz’s novel therapeutic antibodies in order to move toward the clinic. We look forward to collaborating with pharmaceutical and biotech innovators in order to maximize the impact of this science."

While at the Institute of Molecular and Cell Biology (IMCB), Agency for Science, Technology and Research (A*STAR) in Singapore, Dr. Bard published prominently on a pathway that controls protein glycosylation and drives extracellular matrix degradation. The study of the GalNAc-T Activation (GALA) glycosylation pathway led to the discovery of a new target, which becomes exposed at the cell surface after glycosylation. Activation of the target occurs specifically in tumors and arthritic synovial membranes, connective tissue that lines the joint capsule. Albatroz’s targeted antibodies have high specificity for this target selectively reducing extracellular matrix degradation while minimizing toxicity.

"Albatroz is building on careful, fundamental research comparing normal and cancer tissues, which led to the exciting discovery of a novel and broadly distributed target present on the surface of diverse solid tumors," said David Virshup, Director of the Programme in Cancer and Stem Cell Biology (CSCB) and Professor at Duke-NUS Medical School. "The therapeutic antibodies that Albatroz has developed may prevent the growth and metastasis of these cancers. These first-in-class agents have enormous potential to improve our ability to treat patients with cancer.

On April 25, 2023 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that the Compensation Committee of the Company’s Board of Directors granted six new employees options to purchase a total of 17,600 shares of the Company’s common stock at an exercise price per share of $19.31, which was the closing price on April 24, 2023, and restricted stock units to acquire a total of 8,800 shares of the Company’s common stock (Press release, Arcus Biosciences, APR 25, 2023, View Source [SID1234630500]). The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the "inducement exception" under NYSE Listed Company Manual Rule 303A.08.

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On April 25, 2023 J INTS BIO reported the poster presentation of its novel, orally administered TKI ‘JIN-A04’ targeting NSCLC with HER2 exon 20 insertion mutation at the annual meeting of the American Association of Cancer Research 2023, which was held in Orlando, USA from April 14 to 19 (Press release, J INTS BIO, APR 25, 2023, View Source;presentation-of-preclinical-study-results-of-jin-a04-an-oral-target-therapy-for-her2-exon-insertion-mutation-nsclc-301807638.html [SID1234630499]).

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Approximately 2-4% of NSCLC patients have mutations in HER2, and 90% of these mutations are exon 20 insertions. Unfortunately, treatment options for patients with HER2 exon 20 insertion mutations are limited, and there is currently no approved oral targeted therapy.

The data presented showed that "JIN-A04" has potent efficacy against HER2 Exon20 insertion mutant NSCLC cell lines while showing no activity in normal cell lines in an in-vitro study, and in-vivo mouse models using HER2 Exon20 insertion mutation cell lines showed strong inhibitory activity with significant tumor regression.

J INTS BIO said, "JIN-A04, an oral TKI for NSCLC, is expected to provide a powerful treatment option for NSCLC patients with HER2 exon 20 insertion mutations," and expressed strong aspirations that "it could be the most promising Best-in-Class TKI in the treatment of NSCLC."