On May 13, 2022 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic allogeneic off-the-shelf Natural Killer (NK) cells, reported that an abstract on further findings of patients treated in its phase I/IIa WiNK trial have been accepted and will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, which will take place 9th – 12th June 2022 in Vienna, Austria (Press release, Glycostem Therapeutics, MAY 13, 2022, View Source [SID1234614540]). oNKord is the company’s first-generation off-the-shelf allogeneic NK cell therapy under clinical development. Glycostem is furthermore developing a range of CAR-NK, combination therapy and TCR-NK products in-house.

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!

"Achieving measurable residual disease (MRD) negativity is associated with longer-term survival in patients with AML. Our initial clinical data shows that all patients in the first dose cohort reached some level of MRD negativity with an excellent safety profile thus far," said Dr. Kai Pinkernell, CMO of Glycostem. "We are looking forward to the results on the following, increased dose levels, which we expect to further support the safety and activity of oNKord as shown in the early follow up."

The EHA (Free EHA Whitepaper) abstract is now available at View Source as EHA (Free EHA Whitepaper)-3555 with the title:

EARLY SAFETY AND CLINICAL COURSE OF PATIENTS WITH ACUTE MYELOID LEUKEMIA AND MEASURABLERESIDUAL DISEASE RECEIVING GTA002, AN OFF-THE-SHELF, EX VIVO-CULTURED ALLOGENEIC NK CELL PREPARATION

Glycostem will present the poster on Friday, 10th June 2022 at 16:30 – 17:45 CEST.

On May 13, 2022 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company, and its majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage cancer prevention medical diagnostics company, reported that PAVmed and Lucid Chairman & Chief Executive Officer Lishan Aklog, M.D. was selected as one of the Top 50 Healthcare Technology CEOs of 2022 by The Healthcare Technology Report (Press release, PAVmed, MAY 13, 2022, View Source [SID1234614538]).

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!

"I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

"I would like to thank The Healthcare Technology Report for this honor," said Dr. Aklog. "I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

The Healthcare Technology Report described this year’s awardees as "some of the most cultivated, intelligent executives in the healthcare and technology industry." Their "leadership and innovation remain crucial in the development of industry leading medical devices, next generation software platforms, cutting-edge drugs and therapeutics, and advanced diagnostics, among other technologies" all while making "momentous contributions and improvements across the globe."

The editors carefully evaluated hundreds of CEOs across the fields of healthcare, medical devices, biotech, healthcare software, and more. The list includes CEOs from industry leaders such as Medtronic, Edwards Lifesciences and ResMed. Like Dr. Aklog, many of the recipients are founders or co-founders of their organizations.

About Lishan Aklog, M.D.
Dr. Lishan Aklog is Chairman & CEO of PAVmed Inc. (Nasdaq: PAVM), a diversified, commercial-stage medical technology company which he co-founded, and its majority-owned subsidiary Lucid Diagnostics Inc., a cancer prevention medical diagnostics company (Nasdaq: LUCD). He also serves on the board of the leading medtech industry group, AdvaMed, and as an independent public company director. He previously co-founded a medtech holding company which founded four medical device companies and led one of its portfolio companies which commercialized one of his life-saving inventions, AngioVac. Dr. Aklog has consulted for leading medtech companies and is an inventor on dozens of patents. The Healthcare Technology Report previously recognized him as a Top Healthcare Technology CEO of 2021. Prior to entering the life sciences industry as an entrepreneur and executive, Dr. Aklog had a distinguished career as an innovator in cardiac surgery, serving on the faculty of leading academic medical centers including Harvard Medical School and Mount Sinai Medical Center, and in professional society leadership positions. He was recognized as an America’s Top Doctor for over a decade. He received his undergraduate degree in Physics, magna cum laude, and M.D., cum laude, from Harvard University. He completed his training at Harvard teaching hospitals and leading medical centers in London and Paris.

On May 13, 2022 Ontada, a McKesson business focused on provider technology and actionable real-world research, education and evidence in oncology, reported the acceptance of seven abstracts for presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (Press release, McKesson, MAY 13, 2022, View Source [SID1234614537]). The leading global conference for health economics and outcomes research, ISPOR 2022 will take place in Washington, D.C., and virtually from May 15-18, 2022.

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 acceptance of these studies showcases the critical role Ontada’s real-world data and evidence solutions play in our life science partners’ ability to accelerate the development and commercialization of oncology therapies," said Susan Shiff, Ph.D., president of Ontada. "The studies highlight a wide range of innovative ways to gain insight into treatment patterns and outcomes. These are critical to support drug development and the advancements of new medicines designed to improve patient care."

In an oral abstract session on Tuesday, May 17 from 4:30 to 5:30pm ET, results will be presented from the study, "Feasibility of Using Oncology Specific Electronic Health Records (EHR) Data to Emulate Clinical Trial Inclusion and Exclusion Criteria." Assessing the utility of both structured and unstructured data from oncology-specific EHR systems, the study examined eligibility criteria of oncology clinical trials to assess the degree to which real-world data can be used to retrospectively replicate the information needed in trials.

"These results demonstrate that oncology-specific EHR data can be leveraged to emulate inclusion and exclusion criteria of clinical trials, which offers the ability to evaluate treatment options using external controls in cases where a randomized clinical trial may not be feasible," said Nicholas Robert, M.D., study co-author and chief medical officer of Ontada. "Complementing clinical trials by capturing data on the effectiveness of drugs with real-world evidence will ultimately improve our understanding of how drugs perform in broader patient groups."

Ontada’s data scientists and researchers leveraged our real-world data and analytics capabilities in additional poster studies to be presented at this year’s ISPOR:

A Proposed Framework for Evaluating Continuity of Data Coverage in Electronic Health Record and Administrative Claims Data in Real-World Evidence (RWE) Studies
Application of Medication History for Comorbidity Assessment in Cancer Patients
HER2 and Other Biomarker Testing Patterns Among Patients with Advanced Gastric Cancer (GC) or Gastric Esophageal Junction Cancer (GEJC)
Lack of Standardization in Quantitative Evaluations of the Efficacy-Effectiveness Gap (EEG) for Cancer Therapies: A Targeted Literature Review (TLR)
Frequency of and Testing Patterns for Microsatellite Instability High (MSI-H) and Deficient Mismatch Repair (dMMR) Among Solid Tumors in a US Community Oncology Setting
Integrating Data from Disparate Sources to Create a Comprehensive Patient Journey: A Case Study in Prostate Cancer
The full schedule of presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Ryan Mathre at 651.335.2338 or [email protected].

On May 13, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported results of additional endpoints from its Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer (Press release, Blue Earth Diagnostics, MAY 13, 2022, View Source [SID1234614536]). Results reporting the impact of 18F-rhPSMA-7.3 PET on upstaging patients were reported in a Late-breaking Abstract oral presentation at the 2022 AUA Annual Meeting (AUA2022). 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent.

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 ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management is key for physicians and their patients, as up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," said Mark T. Fleming, MD, Virginia Oncology Associates, US Oncology Research, Norfolk, Va., on behalf of the SPOTLIGHT Study Group. "Conventional imaging techniques have many limitations in prostate cancer identification and localization, and greater imaging accuracy is needed throughout the care continuum to optimize therapeutic decision-making. These findings from the SPOTLIGHT study showed that 45 – 47% (113 – 117/250) of patients identified as negative on conventional baseline had at least one True Positive (confirmed by Standard of Truth) after lesion identified by 18F-rhPSMA-7.3 PET. This frequently resulted in post-scan upstaging, particularly among patients with intact prostates. Actionable information such as this may help to define sites of disease recurrence and inform salvage therapy decisions."

"These results from the Phase 3 SPOTLIGHT trial are part of a New Drug Application with the U.S. Food and Drug Administration (FDA) for 18F-rhPSMA-7.3 PET imaging, and we are pleased that they are being presented to the clinical community at the prestigious AUA2022 conference," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In line with our mission to help patients with cancer, we continue to develop our uniquely comprehensive prostate cancer portfolio, which includes 18F-fluciclovine and investigational rhPSMA compounds for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy. 18F-rhPSMA-7.3 represents a new class of high affinity PSMA-targeted PET radiopharmaceuticals. Early studies of 18F-rhPSMA-7.3 demonstrated high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity."

The SPOTLIGHT trial (NCT04186845) is a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO (Free ASCO Whitepaper) GU in February 2022.1

The findings presented at AUA2022 included Correct Detection Rate (CDR) assessment (the percentage of all patients scanned with at least one true positive PET finding as compared to the Standard of Truth of histopathology or confirmatory conventional imaging), and its impact on patient upstaging. They were based on individual read results from three blinded, independent PET readers. In total, the Efficacy Analysis Population (EAP) of 366 men had a composite Standard of Truth. Among EAP patients, 68% (250/366) had negative baseline conventional imaging. Among the 250 patients with negative baseline conventional imaging, 18F-rhPSMA-7.3 showed a CDR of 45─47% (113 – 117/250) across the three readers.

Among patients who had undergone prostatectomy, 3.5-8.0% (7-16/201) of 18F-rhPSMA-7.3 positive scans showed lesions in the prostate bed region, with 18-21% (36-43/201) in pelvic lymph nodes and 21-26% (43-52/201) in other sites that led to upstaging. Among patients who had received radiotherapy, these values were 39-41% (18-19/46), 6.5% (3/46) and 20-30% (9-14/46), respectively. Very few patients had an alternative primary therapy and no definitive conclusions could be drawn for them.

The Late-breaking Abstract was discussed in an oral Plenary Session presentation at AUA2022 on May 13, 2022, "Impact of 18F-rhPSMA-7.3 PET on upstaging of patients with prostate cancer recurrence: results from the prospective, Phase 3, multicenter SPOTLIGHT study," by Mark T. Fleming, MD, Virginia Oncology Associates, U.S. Oncology Research, Norfolk, Va., on behalf of the SPOTLIGHT Study Group. The Journal of Urology abstract is available here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

On May 13, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Point Biopharma, MAY 13, 2022, View Source [SID1234614535]).

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!

"There were two very significant milestones for POINT in the first quarter of 2022," said Dr. Joe McCann, CEO of POINT Biopharma. "First, we began supplying doses for the SPLASH trial out of our company-owned manufacturing facility. Second, we reported very encouraging dosimetry data from our Phase 3 SPLASH trial lead-in phase which is evaluating PNT2002 in pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC). The data positions us well as we continue with the randomization phase of SPLASH. The reason these milestones are very significant is they place POINT in the extremely small number of companies which have successfully manufactured their own radioligands, for their own Phase 3 trial. Combined with the upcoming advancement of our pan-cancer FAP-targeting program PNT2004 into the clinic this summer, POINT’s radioligand platform has the potential to be transformative for cancer care in a variety of indications with high unmet need."

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In February 2022, the Company announced publication of the dosimetry results from the lead-in cohort of the Phase III SPLASH trial evaluating PNT2002 for the treatment of mCRPC at the 2022 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mid-Winter & American College of Nuclear Medicine (ACNM) Annual Meeting. The findings presented by Dr. Jean-Mathieu Beauregard concluded that "PNT2002 has a favorable and safe dosimetry profile in the patient population and dose regimen being studied." A link to the Abstract can be found in the Investors section of the company’s website found here: View Source

In March 2022, the Company hosted a virtual education event titled "Introduction to Dosimetry for Radiopharmaceuticals" led by a key opinion leader in the field, Dr. Ana Kiess, M.D., Ph.D. A replay of the event is accessible at View Source

In April 2022, the Company dosed its first European Union patient in the SPLASH trial. The SPLASH trial is currently enrolling patients across 42 sites in North America and Europe, and site activations all in jurisdictions remain ongoing to expedite accrual. The Company continues to expect to report top line data from SPLASH mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program. The clinical trial for PNT2004 is expected to first initiate in Canada in summer 2022.

‍

Manufacturing & Supply Chain Updates:

The Company’s Indianapolis manufacturing facility began supplying n.c.a. 177Lu PNT2002 to its SPLASH clinical trial in January 2022. The approximately 81,000 sq ft facility is licensed for alpha and beta emitting isotopes, and contains dedicated space for commercial-scale manufacturing. A virtual tour of the facility is accessible at View Source

In January 2022, the Company announced that it will receive 225Ac in 2022 from the U.S. Department of Energy Isotope Program to support its early-stage pipeline. The Company remains on track to launch its in-house n.c.a. 177Lu manufacturing program in 2023.

‍
First Quarter 2022 Financial Results

Cash and Cash Equivalents: As of March 31, 2022, POINT had approximately $227.4 million in cash and cash equivalents, which is anticipated to fund operations into the first quarter of 2024.

Net Loss: Net loss was $16.4 million, or $0.18 net loss per share, for the quarter ended March 31, 2022, as compared to a net loss of $5.8 million, or $0.10 net loss per share, for the same period in 2021.

Research and Development Expenses: Research and development expenses were $12.5 million for the quarter ended March 31, 2022, as compared to $4.3 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the quarter ended March 31, 2022, as compared to $1.5 million for the same period in 2021.