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.

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"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 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2022 (Press release, Soligenix, MAY 13, 2022, View Source [SID1234614521]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We remain focused on our significant upcoming milestones for 2022. We anticipate submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) in the second half of this year. We expect to initiate a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) in the second half of this year as well. With approximately $22.9 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones, including NDA filing and expansion into psoriasis with the initiation of the Phase 2a clinical study."

Dr. Schaber continued, "Supported by funding from the National Institute of Allergy and Infectious Diseases, our Public Health Solutions business segment continues to achieve key objectives with our heat stable vaccine platform technology, ThermoVax. Recently, we announced results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in non-human primates (NHPs) demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. As always, we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On April 19, 2022, the Company announced it had received approximately $1.4 million, net of transaction costs, in non-dilutive funding via multiple government tax programs. To view this press release, please click here.
On March 17, 2022, the Company announced the results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in NHPs demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. To view this press release, please click here.
Financial Results – Year Ended March 31, 2022

Soligenix’s revenues for the quarter ended March 31, 2022 were $0.2 million as compared to $0.1 million for the quarter ended March 31, 2021. Revenues primarily included payments on government contracts and grants received to support the development of: RiVax, our ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $4.3 million, or ($0.10) per share, for the quarter ended March 31, 2022, as compared to $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021. The increase in net loss was primarily attributed to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries as well as an increase in research and development expenses associated with preparation of the upcoming HyBryte NDA filing.

Research and development expenses were $1.7 million as compared to $1.3 million for the quarter ended March 31, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended March 31, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.

General and administrative expenses were $2.6 million and $1.0 million for the quarter ended March 31, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.

As of March 31, 2022, the Company’s cash position was approximately $22.9 million.

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.

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"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 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2022 (Press release, HCW Biologics, MAY 13, 2022, View Source [SID1234614522]).

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"We continue to successfully execute our clinical development strategy which is based on our unique approach toward inflammaging," stated Hing C. Wong, Founder and CEO of HCW Biologics Inc. "HCW Biologics is developing immunotherapeutics that do not treat a single indication or symptom. Our approach is to treat a patient systemically to remove the underlying problems causing a condition."

Dr. Wong continued, "Our plan is to use difficult-to-treat cancer indications as the gateway for clinical development of our lead product candidate, HCW9218. In preclinical studies, we have demonstrated that HCW9218 can effectively reduce therapy-induced cancer and normal tissue cellular senescence to augment the anti-tumor activities of chemotherapies and alleviate their side effects. In addition, HCW9218 has been shown to significantly enhance anti-tumor activity of immune checkpoint therapies in a preclinical setting."

Dr. Wong further stated, "We believe that HCW9218 also has potential as a treatment for a broad range of age-related pathologies beyond cancer, through our discovery that HCW9218 can reduce accumulated senescent cells due to the naturally aging process or metabolic dysfunction, leading to the improvement of health span of experimental animals."

Business Highlights:

At the 105th Annual Meeting of the American Association of Immunologists held on May 6 -10, 2022, HCW Biologics showcased two novel groups of fusion molecules invented with the Company’s proprietary and versatile TOBI discovery platform. Two posters were presented which are available on the Company’s website:

A "kick and expand" strategy to generate large numbers of CIML NK cells for adoptive cell therapy for the treatment of cancer using novel fusion proteins HCW9201 and HCW9206.

Robust human regulatory T cell expansion with fusion proteins HCW9302 and HCW9213 circumvents need for magnetic-bead or feeder cell approaches for adoptive cell therapy.

On April 19, 2022, Dr. Hing Wong presented, "Bifunctional Immunotherapeutic HCW9218 for Cancer and Inflammaging," at the Third Annual International Conference on Cell and Experimental Biology. Dr. Wong presented preclinical data for the first time that showed results of the Company’s investigational work related to the treatment of inflammaging indications in naturally-aged mice. The Company believes these results demonstrate the potential of HCW9218 to fundamentally change the treatment of a broad range of diseases and conditions associated with aging, even aging itself, by enhancing health span that has been diminished with aging.

First Quarter 2022 Financial Results:

Cash and cash equivalents: On March 31, 2022, the Company’s cash balance was $18.1 million, short-term investments were $17.0 million and long-term investments were $9.8 million. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance is sufficient to fund operations through the end of 2023.

Revenues: Revenues were $3.1 million for the three-month period ended March 31, 2022, and there were no revenues in the three-month period ended March 31, 2021. Revenues were derived from the sale of clinical development material to our licensee, Wugen.

Research and development (R&D) expenses: R&D expenses were $1.8 million for the three-month period ended March 31, 2022, as compared to $2.3 million for the three-month period ended March 31, 2021. The 22% decrease in R&D expenses was driven primarily by a decrease in manufacturing and materials expenses and preclinical expenses.

General and administrative expenses (G&A): G&A expenses were $1.9 million for the three-month period ended March 31, 2022, as compared to $1.1 million for the three-month period ended March 31, 2021. The 73% increase reflects higher salaries, benefits and related expenses as a result of stock-based compensation expense associated with an equity award to the Company’s CEO upon completion of the Company’s IPO and an increase for Board compensation under our non-employee director compensation program, with a partial offset resulting from a decrease in performance-related bonuses.

Net loss: Net loss was $2.1 million for the three-month period ended March 31, 2022, compared to $2.8 million for the three-month period ended March 31, 2021.

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]).

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"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.