On May 20, 2021 On Target Laboratories, Inc., a privately held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, reported results of the 006 Study, a Phase 3, randomized, multi-center, prospective, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer (Press release, On Target Laboratories, MAY 20, 2021, View Source [SID1234580405]).

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!

In 33% of patients (36 of 109), near-infrared imaging with pafolacianine sodium injection identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). Among patients who underwent interval debulking surgery, the rate was higher, at 39.7% of patients (23 of 58; 95% CI [0.270, 0.534]).

"We are proud to share the results of the Phase 3 trial for pafolacianine sodium injection in ovarian cancer, which demonstrated identification of additional cancer that was not planned for resection," said Chris Barys, Chief Executive Officer of On Target Laboratories. "These results get us closer to realizing our mission to make cancer visible during surgery so it can be removed more completely."

The data will be presented on June 7 during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract # 5503).

"The surgeon’s ability to achieve a complete resection in ovarian cancer patients impacts their long-term prognosis," said Dr. Janos L. Tanyi, MD, PhD, an Assistant Professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and Principal Investigator of the trial. "The trial results add to the body of evidence supporting the potential of pafolacianine sodium injection as an adjunct to identify malignant lesions that may otherwise be missed."

About the Phase 3 006 Study

In the Phase 3, randomized, multi-center, open-label study, patients with ovarian cancer who were scheduled to undergo cytoreductive surgery were recruited from 11 sites in the US and Netherlands from March 2018 through April 2020. The primary endpoint was the percent of patients in which ≥1 folate receptor positive ovarian cancer lesion was detected by intraoperative fluorescence imaging on tissue not planned for resection and not detected by normal white light or palpation.

This phase 3 trial of pafolacianine sodium injection with near-infrared imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients.

The safety profile observed was consistent with the Phase 2 trial published in 2019.1 The most frequently reported drug-related adverse events (AEs) were nausea (18.0%), vomiting (5.3%), and abdominal pain (4.7%). The majority (97%) of drug-related AEs were mild or moderate in severity and were transient in nature. No drug-related serious AEs or deaths were reported.

On May 20, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that Phase 1 testing data will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting June 4, 2021 (Press release, AIkido Pharma, MAY 20, 2021, View Source [SID1234580404]). The presentation of the data will be by Dr. Scott Tagawa, a Professor of Medicine & Urology at Weill Cornell Medicine and an AIkido Pharma Scientific Advisory Board member.

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!

ASCO Presentation Details:

Title: "Phase I study of 225Ac-J591 for men with metastatic castration-resistant prostate cancer (mCRPC)"
Tract: Genitourinary Cancer—Prostate, Testicular, and Penile
Presenter: Dr. Scott Tagawa MD, MS, FACP
Abstract Number: 5015
Date and Time: Available Starting June 4, 2021, 9:00 am (EST)

The Abstract from this study has been released on the ASCO (Free ASCO Whitepaper) Annual Meeting website (View Source), a portion of which states: "PSMA-targeted alpha-emitter 225Ac utilizing intact antibody J591 is tolerable with early evidence of clinical activity. Based upon these results, a follow up study [NCT04506567] testing multiple and fractionated dosing of 225Ac-J591 is underway. Clinical trial information: NCT03276572 (View Source )

The full ASCO (Free ASCO Whitepaper) meeting program is available at: www.asco.org

On May 20, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that results from the investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC) (Press release, Medivir, MAY 20, 2021, View Source [SID1234580403]). The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete.

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!

Four patients with five cutaneous SCCs were included in this case series and treated with remetinostat gel 1%. All five tumours, including a range of histological subtypes, demonstrated complete clinical and pathological resolution after up to 8 weeks of treatment. All patients experienced a localized cutaneous reaction in response to the treatment, which required one patient to discontinue therapy. No systemic adverse events were reported. Further details of the study can be found at www.clinicaltrials.gov, reference number NCT03875859.

"These very encouraging results further supports the potential of remetinostat to be used in multiple skin-associated cancers beyond cutaneous T-cell lymphoma (CTCL)", said Magnus Christensen, interim CEO of Medivir.
For more information please contact:
Magnus Christensen, interim CEO, Medivir AB, phone: +46 (0)8 5468 3100.
[email protected]

About squamous cell carcinoma

Squamous cell carcinoma (SCC) is the second most common form of cancer in humans occurring in the skin. Surgical excision is standard of care and there are currently no marketed products approved for the treatment of SCC. Other therapies for SCC exist, such as imiquimod, 5-fluorouracil and photodynamic therapy, however their use is limited to SCC in situ (SCCIS). There is a clear need for efficacious and safe treatments when surgery is impractical, e.g. multiple lesions and/or difficult treatment sites.

About remetinostat

Remetinostat is a topical histone deacetylase (HDAC) inhibitor. A clinical phase II study in mycosis fungoides-cutaneous T-cell-lymphoma (MF-CTCL) has been completed demonstrating that remetinostat reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40%. The study also showed a clinically significant reduction in the severity of pruritus (itching) in 80% of the patients. In addition, two investigator-initiated phase II studies have been conducted at Stanford University in the USA, demonstrating efficacy in both cutaneous Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC). In BCC, 25 patients who were treated with remetinostat showed an ORR of 69.7%.

On May 20, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.62 per share, payable on July 21, 2021 to shareholders of record of Quest Diagnostics common stock on July 7, 2021 (Press release, Quest Diagnostics, MAY 20, 2021, View Source [SID1234580402]).

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!

On May 20, 2021 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported additional data in a sub-population of heavily pre-treated, patients with metastatic castrate-resistant prostate cancer (mCRPC) from its Phase 1b study of PT-112, the company’s lead clinical agent, in combination with PD-L1 inhibitor avelumab (Press release, Phosplatin, MAY 20, 2021, View Source [SID1234580401]). The combination was generally well tolerated and demonstrated meaningful anti-tumor effects. The report from the study, entitled "A Phase 1b study of novel immunogenic cell death inducer PT-112 plus PD-L1 inhibitor avelumab in metastatic castrate-resistant prostate cancer (mCRPC) patients," by lead author Alan H. Bryce, MD et al., is currently available online, as part of the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which is taking place virtually from June 4-8, 2021.

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!

"Such patients with late-stage prostate cancer have limited treatment options and are in need of new approaches to manage what is often aggressive disease," said Matthew R. Price, co-founder and Chief Operating Officer. "We are encouraged by the prospect of using PT-112 in combination with immune-checkpoint inhibition, based upon our Phase 1b data."

The PT-112-103-PAVE-1 study (NCT03409458) enrolled a total of 32 patients with mCRPC during dose-finding: 18 patients in the dose escalation phase, who received 150-200mg/m2 PT-112 on days 1, 8 and 15 of a 28-day cycle, and 14 patients in a supplemental cohort, who received 300 mg/m2 PT-112 on days 1 and 15. (Note: one patient received PT-112 on days 1 and 15 at 200mg/m2.) All patients received avelumab (800 mg) on days 1 and 15. Patients had exhausted available therapies, with a median 7 lines of prior treatment. Key findings included the following:

PT-112 treatment in combination with avelumab was generally well tolerated in this heavily pre-treated, advanced mCRPC patient population with no available life-prolonging therapeutic options
The combination provided meaningful antitumor effects, including decreases in tumor volume as well as reductions in prostate-specific antigen (PSA) and alkaline phosphatase (ALP) serum markers.
Antitumor effects included eight (25%) patients with a PSA reduction of ≥50% (PSA50), five (16%) of which were confirmed. Of 10 patients with RECIST-measurable disease, three had tumor volume reductions, one with a confirmed partial response (PR). Twenty-four (75%) patients showed a reduction in serum alkaline phosphatase (ALP). Reductions in ALP may be indicative of anti-cancer activity at bone sites of disease. Improvement in patient-reported pain was also observed.
At the higher dose level (300 mg/m2 PT-112, given every two weeks) 4 of 13 (31%) experienced PSA50 reduction, confirmed in 3 of 13 (23%) patients.
The PT-112-103-PAVE-1 study has completed the dose escalation phase, and a dose confirmation cohort in non-small cell lung cancer is currently enrolling.

Additionally, the Phase 2 PT-112 monotherapy trial (NCT02266745) is currently enrolling patients with late-stage mCRPC.

"The early results of our immunotherapy combination in this sub-population clearly indicate the potential of such a treatment paradigm for patients with metastatic castrate-resistant prostate cancer," said Joseph F. O’Donnell, MD, Chief Medical Officer at Phosplatin Therapeutics. "We continue our work to demonstrate the effects of PT-112’s immunogenic cell death (ICD) induction, including with immune-profiling analyses, and also believe its osteotropism lends further rationale to treat these patients, most of whom have bone metastatic involvement. We are grateful to our wonderful collaborators and are encouraged to continue further clinical development of PT-112 in patients with advanced prostate cancer with our ongoing Phase 2 monotherapy trial."

"A Phase 1b study of novel immunogenic cell death inducer PT-112 plus PD-L1 inhibitor avelumab in metastatic castrate-resistant prostate cancer (mCRPC) patients" is available for viewing in the ASCO (Free ASCO Whitepaper) Meeting Library at View Source

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase 2 development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy phase 2 development is ongoing in mCRPC, and the anti-PD-L1 combination study is ongoing in a dose confirmation cohort of patients with non-small cell lung cancer (NSCLC).