Prostvac

Ambrx Announces First Patient Dosed in a Phase 1 Trial for ARX517, an ADC in Development to Treat PSMA Expressing Tumors

Retrieved on: 
Tuesday, August 3, 2021

The Phase 1 trial will be a multi-center, open-label, dose escalation and dose expansion study.

Key Points: 
  • The Phase 1 trial will be a multi-center, open-label, dose escalation and dose expansion study.
  • The trial will enroll up to 76 patients with advanced solid tumors whose diseases have failed prior standard therapies.
  • While non-ADC therapies are available to treat mCRPC, there is no approved therapy specifically targeting PSMA to treat prostate cancer.
  • Ambrx undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

Laekna Therapeutics will present two clinical study results in ESMO 2021

Retrieved on: 
Monday, July 26, 2021

This ClinicalTrials NCT03843918 is a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Key Points: 
  • This ClinicalTrials NCT03843918 is a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC).
  • Laekna plan to further develop LAE001 to treat patients with mCSPC, who usually have a much longer treatment duration, and would benefit more from using LAE001.
  • The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world's first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer.
  • Laekna is committed to a science-based, innovation-driven approach to create an international leading clinical research and development platform for the development of first-in-class and best-in-class innovative drugs.

Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

Retrieved on: 
Thursday, July 15, 2021

The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer.

Key Points: 
  • The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer.
  • Our strong foundation of clinical data generated across both prostate cancer and non-small cell lung cancer suggest Lm-based immunotherapy may bring meaningful clinical benefit to patients and we look forward to continued momentum across the ADXS-HOT program.
  • The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.
  • Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products.

Prostate Cancer Clinical Landscape Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 15, 2021

In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.

Key Points: 
  • In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.
  • Prostate cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
  • Pfizer's next-generation androgen receptor (AR) inhibitor Xtandi is the market leader in prostate cancer due to its established efficacy across prostate cancer segmentations and a lack of near-term generic competition.
  • Future expansion opportunities include potential use in combination with PARP inhibitors Talzenna or Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients.

Propella Announces First Patient Dosed in Phase 1/2a Trial of PRL-02 for Treatment of Metastatic Prostate Cancer

Retrieved on: 
Tuesday, June 29, 2021

I am personally intrigued by the PRL-02 profile and its potential to be a clinically meaningful new option for the treatment of patients with metastatic prostate cancer.

Key Points: 
  • I am personally intrigued by the PRL-02 profile and its potential to be a clinically meaningful new option for the treatment of patients with metastatic prostate cancer.
  • According to William Moore, Propella Therapeutics President and CEO, We are pleased to announce that the first patient has been dosed in the Phase 1/2a study evaluating our lead drug candidate, PRL-02, for the treatment of advanced prostate cancer.
  • Although there are several treatment options for metastatic prostate cancer, the reduction of androgen activity remains the most effective approach.
  • Propella is enrolling patients in a Phase 1/2a program studying its lead product candidate, PRL-02, for the treatment of metastatic prostate cancer.

Veru Announces Positive Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer Presented at the 2021 ASCO Annual Meeting

Retrieved on: 
Monday, June 7, 2021

The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule.

Key Points: 
  • The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule.
  • The Phase 1b/2 clinical trial enrolled 80 men and is ongoing with patients in both the Phase 1b and 2 components still on study.
  • Two of these patients on continuous daily dosing of sabizabulin have now reached 27 months and 23 months of treatment without prostate cancer progression.
  • (2) Phase 2 clinical study for the treatment of women with metastatic triple negative breast cancer who have become resistant to at least two systemic chemotherapies.

Harpoon Therapeutics to Present Updated Interim Clinical Data for TriTAC® HPN424 at the 2021 ASCO Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021

b'SOUTH SAN FRANCISCO, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, announced today that updated interim Phase 1 data for HPN424 for prostate cancer will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting beginning on June 4,2021.

Key Points: 
  • b'SOUTH SAN FRANCISCO, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, announced today that updated interim Phase 1 data for HPN424 for prostate cancer will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting beginning on June 4,2021.
  • The poster presentation will show interim data for HPN424 from its ongoing dose escalation Phase 1/2a clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) and will be highlighted in a poster discussion session.
  • ET / 1 p.m. PT on Friday, June 4, 2021 to review the data and provide an update on other pipeline programs.
  • These forward-looking statements are based on Harpoon Therapeutics\xe2\x80\x99 expectations and assumptions as of the date of this press release.

MacroGenics Announces Preliminary Clinical Results from Phase 1 Study of MGC018 to be Presented at ASCO Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021

This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO poster presentation.

Key Points: 
  • This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO poster presentation.
  • Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
  • Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease.
  • Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient.

New Study Demonstrates the Clinical Utility of Predicine Liquid Biopsy Assay to Detect Copy Number Loss in Prostate Cancer

Retrieved on: 
Monday, May 17, 2021

b'HAYWARD, Calif., May 17, 2021 /PRNewswire-PRWeb/ --Predicine, Inc. today announced results from a prostate cancer liquid biopsy study evaluating the landscape of genomic alterations in 231 patients with metastatic castration-resistant prostate cancer (mCRPC) from US and Australian cohorts.\nThe study demonstrated the robust sensitivity and clinical utility of Predicine\'s cfDNA liquid biopsy assay for detecting CNVs in the PTEN-PI3K-AKT pathway in mCRPC patients.

Key Points: 
  • b'HAYWARD, Calif., May 17, 2021 /PRNewswire-PRWeb/ --Predicine, Inc. today announced results from a prostate cancer liquid biopsy study evaluating the landscape of genomic alterations in 231 patients with metastatic castration-resistant prostate cancer (mCRPC) from US and Australian cohorts.\nThe study demonstrated the robust sensitivity and clinical utility of Predicine\'s cfDNA liquid biopsy assay for detecting CNVs in the PTEN-PI3K-AKT pathway in mCRPC patients.
  • The study, "Plasma Cell-Free DNA Profiling of PTEN-PI3KAKT Pathway Aberrations in Metastatic Castration-Resistant Prostate Cancer," was published online in JCO Precision Oncology, a journal of American Society of Clinical Oncology.\nMetastatic prostate cancer is characterized by recurrent gene copy gains and deletions.
  • In particular, PTEN copy number loss is found in 40-60% of the patients.
  • Predicine has developed a breakthrough cell-free DNA and cell-free RNA based liquid biopsy technology for non-invasive cancer profiling, disease monitoring, assessing minimal residual disease, and early cancer detection.

Clarity receives US FDA clearance of IND Application for its next-generation PSMA theranostic products

Retrieved on: 
Tuesday, May 4, 2021

It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients.

Key Points: 
  • It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients.
  • The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease[3].
  • For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC.
  • Clarity\'s Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer.