On March 8, 2023 SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), reported that the first cohort in SDT-202 was fully enrolled. SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM) (Press release, SonALAsense, MAR 8, 2023, View Source [SID1234628365]). The objectives of SDT-202, which builds upon a previous proof-of-concept (POC) trial conducted by Nader Sanai, MD, Chief Scientific Officer and Director at the Ivy Brain Tumor Center at Barrow Neurological Institute, are to evaluate the safety, optimal dose, and efficacy of SDT.

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 first cohort in SDT-202 was enrolled at Cleveland Clinic by principal investigator Matthew Grabowski, MD.

"In the previous POC study, Dr. Sanai and his team demonstrated that SONALA-001 SDT was well tolerated and led to targeted oxidative stress and cell death in human high-grade glioma tissue without harming surrounding tissue," said Dr. Mitchel Berger, MD, FAANS, who chairs SonALAsense’s Scientific Advisory Board. "Within four days after a single treatment, there was tumor cell death. The speed of action and repeatability of this unique therapy has the potential to be a game-changer for patients living with rGBM."

At the start of the SDT procedure, a patient is given an injection of SONALA-001, an intravenous formulation of aminolevulinic acid (ALA). The drug is taken up selectively by cancer cells because they need ALA to make the heme molecule. Next, MR-guided ultrasound is used to focus ultrasound waves to create light in the brain through a process called sonoluminescence. The light activates a byproduct of SONALA-001 to create a "smart bomb" that is designed to trigger immediate and programmed cell death only in cancer cells.

"At SonALAsense, we are excited to further develop SONALA-001 SDT as a potential approach to treat this devastating brain cancer. Current options for rGBM, such as surgery, radiation, chemotherapy, and antibody drugs have significant side effects," said Mark de Souza, PhD, Chief Executive Officer at SonALAsense. "Our goal is to offer patients a good quality of life and make rGBM manageable, rather than lethal."

Dr. Grabowski at the Cleveland Clinic, along with other investigators at collaborating sites including the University of California San Francisco, Mayo Clinic, Ivy Brain Tumor Center, MD Anderson, NYU, and West Virginia plan to enroll approximately 50 participants in SDT-202. Patients interested in the trial can learn more at clinicaltrials.gov.

"Recurrent glioblastoma multiforme is a devastating brain cancer. We in the brain tumor community are eager for alternative treatments to prolong and improve our loved ones’ quality-of-life," said Ralph DeVitto, President and Chief Executive Officer of the American Brain Tumor Association (ABTA). "We look forward to the outcomes of this clinical trial and learning more about the potential benefits of sonodynamic therapy."

On March 8, 2023 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported that Chief Executive Officer Masoud Toloue will present at Barclays Global Healthcare Conference on Wednesday, March 15, 2023 at 4:35 p.m., EDT (Press release, Quanterix, MAR 8, 2023, View Source [SID1234628364]). In addition, the company will also host in-person one-on-one meetings with institutional investors on March 15.

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!

For those interested in tuning in to the presentation virtually, please register here: View Source;tp_key=ffe17ea0e1&tp_special=8. Replays of the presentation will be available for a limited period following the conference. The webcast and presentation will also be made available through the Investor Relations section of Quanterix’s website.

To learn more about Quanterix, visit www.quanterix.com/about. To learn more about Quanterix’s Simoa technology, visit: View Source

On March 8, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2 (Press release, BioThera Solutions, MAR 8, 2023, View Source [SID1234628363]). The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors.

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!

BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2 designed for the treatment of solid tumors. Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, EGP-1, is a member of tumor associated calcium signal transduction protein (TACSTD) family, which is related to the regulation of intracellular calcium concentration.

Trop2 is not expressed or has low expression levels in normal human tissues while overexpressed in a variety of solid tumors, especially epithelial tumors including breast cancer, cervical cancer, colorectal cancer, esophageal cancer, gastric cancer, lung cancer, oral squamous cell cancer, ovarian cancer, prostate cancer, pancreatic cancer, thyroid cancer, urinary bladder cancer, uterine cancer, glioma, etc. High expression levels of Trop2 in tumors is correlated with poor prognosis for patients. Trop2 is a validated drug target with one approved drug for the treatment of solid tumors and is a target of high interest for new drug discovery.

BAT8008 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8008 has a strong cell membrane penetration ability. Consequently, when targeted cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8008 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Preclinical data generated using BAT8008 was presented in a poster at the 2022 San Antonio Breast Cancer Conference (View Source).

Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Her2, Nectin-4. All the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

On March 8, 2023 JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported the initiation of clinical study of Carteyva (relmacabtagene autoleucel injection) for first-line treatment in patients with high-risk large B-cell lymphoma and the first patient infusion (Press release, JW Therapeutics, MAR 8, 2023, View Source [SID1234628362]).

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!

High-risk large B-cell lymphoma includes large B-cell lymphoma with International Prognostic Index (IPI) score ≥3, and high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 translocations (double-/triple-hit lymphomas; DHL/THL). Patients with high-risk large B-cell lymphoma (IPI≥3) have a low response to standard first-line chemotherapy, with complete response rate (CRR) 47.3%, 3-year overall survival (OS) rate 58.9% and progression-free survival (PFS) rate 40.7%. HGBL patients with MYC and BCL2 and/or BCL6 translocations (DHL/THL) tend to have poor prognostic indicators (e.g. bone marrow involvement, central nervous system (CNS) involvement, and elevated lactate dehydrogenase) and no recommended standard first-line therapies, with poor efficacy (CRR 59.6%) to traditional standard first-line R-CHOP chemotherapy. CRR of these patients remains <60% when treated with DA-EPOCH-R therapy and there is no significant survival benefit with the more aggressive induction regimen compared with standard R-CHOP. Therefore, there are substantial unmet clinical needs in the first-line treatment of high-risk large B-cell lymphoma patients, and new treatment options are urgently needed.

In its pivotal clinical study (RELIANCE study), Carteyva has demonstrated manageable safety profiles and high efficacy in patients with relapsed/refractory large B-cell lymphoma who have received at least two lines of therapies. The encouraging results have inspired CAR-T therapy destined for earlier lines of therapies in high-risk large B-cell lymphoma.

The study is an open-label, single-arm, multicenter, and investigator-initiated trial (IIT) in China, aiming to evaluate the efficacy and safety of Carteyva as first-line therapy in adult subjects with high-risk large B-cell lymphoma.

References

McMillan, A. K., et al. Favorable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3-5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial. Ann Oncol, 31(9), 1251-1259 (2020).

Ying Zhao, et al. Prognostic analysis of DLBCL patients and the role of upfront ASCT in high-intermediate and high-risk patients. Oncotarget, 8(42), 73168-73176 (2017).

China Anti-cancer Association Lymphoma Committee, et al. Clinical practice guideline for lymphoma in China (2021 Edition). Chin J Oncol, 43(7), 707-735 (2021).

Bartlett, N. L. et al. Dose-adjusted EPOCH-R compared with R-CHOP as frontline therapy for diffuse large B-cell lymphoma: clinical outcomes of the phase III Intergroup Trial Alliance/CALGB 50303. J. Clin. Oncol. 37,1790–1799 (2019).

Ying Z, et al. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 10(3):999-1011 (2021).

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

On March 8, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will be presenting at the virtual Oppenheimer 33rd Annual Healthcare Conference on Wednesday, March 15, 2023, at 11:20 a.m. Eastern Time (Press release, ESSA, MAR 8, 2023, View Source [SID1234628361]).

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!

David R. Parkinson, President and Chief Executive Officer of ESSA Pharma; Peter Virsik, ESSA’s Chief Operating Officer; and David S. Wood, ESSA’s Chief Financial Officer, will host and participate in one-on-one meetings.

A live webcast of the Oppenheimer presentation can be accessed in the Investors/Events & Presentations section of ESSA’s website at www.essapharma.com. Following the event, the webcast will be archived on the ESSA website for 90 days.