On May 13, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that it will host a virtual KOL investor event on Thursday, May 19, 2022, at 4:00 pm ET/ 1:00 pm PT (Press release, Aileron Therapeutics, MAY 13, 2022, View Source [SID1234614519]).

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The virtual event will feature presentations from the company’s President and Chief Executive Officer, Manuel Aivado, M.D., Ph.D., as well as key opinion leaders, Ralf Paus, M.D., DSc, FRSB, Professor of Dermatology, Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine and Eric Anderson, M.D., Ph.D., Medical Oncologist, Assistant Professor of Medicine, School of Medicine Oregon Health & Science University.

The presentations will highlight several topics related to ALRN-6924’s revolutionary potential as the first precision medicine-based supportive care drug, and the current supportive care landscape and unmet need associated with chemotherapy-induced toxicities, including:

New non-clinical data that will be presented in a late-breaking oral presentation at the Society for Clinical Dermatology 2022 Annual Meeting on May 19, 2022, demonstrating ALRN-6924 protected human hair follicles and their stem cells from chemotherapy-induced acute and permanent damage;
An overview of Aileron’s ongoing Phase 1b randomized, double-blind, placebo-controlled clinical trial of patients with p53-mutated advanced non-small cell lung cancer, including the trial design and its composite endpoint;
An introduction to Aileron’s upcoming Phase 1b randomized clinical trial of patients with p53-mutated ER+/HER2- neoadjuvant breast cancer, which is on track to initiate in 2Q 2022, and an update on the ongoing Phase 1 pharmacology study in healthy human volunteers; and
A review of the company’s planned data readouts in 2022
A live webcast of the event will be available on the "Events & Presentations" in the Investors & Media section of the company’s website at investors.aileronrx.com. A replay of the webcast will be available for 30 days following the presentation.

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]).

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"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.

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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.

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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.

On May 13, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2022 (Press release, Leap Therapeutics, MAY 13, 2022, View Source [SID1234614520]).

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Leap Highlights:

Presented positive new data from the DisTinGuish Study of DKN-01 plus BeiGene’s anti-PD-1 antibody tislelizumab and chemotherapy in gastroesophageal junction/gastric (GEJ/G) cancer patients at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium

Completed enrollment in Part B of the DisTinGuish Study evaluating DKN-01 plus tislelizumab in second-line GEJ/G cancer patients whose tumors express high levels of DKK1 (DKK1-high)

Entered partnership on DKK1 companion diagnostic with Leica Biosystems

Presenting initial data from the investigator-sponsored Phase 1b/2a clinical trial of DKN-01 in prostate cancer at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting
"We are making consistent progress in advancing DKN-01 across multiple tumor types and look forward to Dr. David Wise of New York University presenting initial prostate cancer data at the upcoming ASCO (Free ASCO Whitepaper) conference," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "With compelling response and survival data for DKN-01 in combination with BeiGene’s tislelizumab in gastric cancer patients presented in January, and the recent completion of enrollment in our second-line cohort, we are preparing for updated data readouts from our DisTinGuish study in the second half of the year. We are also looking forward to hosting an R&D Day in late June to outline the next phase in the clinical development strategy for DKN-01."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Positive New Data from the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy Presented at the ASCO (Free ASCO Whitepaper) GI Cancer Symposium. In January 2022, the Company presented positive new progression-free survival (PFS) and overall response data from Part A, the first-line cohort of the Phase 2a study in patients with gastroesophageal junction or gastric (GEJ/G) cancer, and initial findings from Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Part A First-Line Patients: Of the 25 first-line patients who received a full cycle of DKN-01 therapy, overall response rate (ORR) was 68.2%, with 90% ORR in DKK1-high patients (9 partial responses (PR)) and 56% in DKK1-low patients (1 complete response, 4 PR). Among those patients with low PD-L1 expression ORR was 79% (with 100% ORR in DKK1-high patients and 57% ORR in DKK1-low patients), and in patients with higher PD-L1 expression ORR was 67% (with 75% ORR in DKK1-high patients and 50% in DKK1-low patients). The preliminary median PFS was 10.7 months in the overall first-line population, and median overall survival had not been reached. The Company expects to present updated survival data from the study in the second half of 2022.

Part B Second-Line Patients: Of the 30 second line DKK1-high GEJ/G cancer patients who received a full cycle of DKN-01 therapy and were response evaluable, ORR was 25%, with an additional patient who experienced an irPR by iRECIST criteria.

Completed Enrollment in the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab in DKK1-high Second Line GEJ/G Cancer Patients. In May 2022, the Company completed enrollment in Part B of the DisTinGuish clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Entered Partnership on Companion Diagnostic with Leica Biosystems to Advance Care for Cancer Patients. In January 2022, Leap and Leica Biosystems, a cancer diagnostics company, entered into an agreement to develop a companion diagnostic to detect DKK1 in patient tumor biopsies. The assay developed by Leica will utilize RNAscope technology on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity to help identify patients for DKN-01 treatment.

Abstract Accepted for Poster Presentation at the Upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Highlighting Initial Clinical Data from the Phase 1b/2a Clinical Trial (NCT03837353) of DKN-01 Plus Docetaxel in Prostate Cancer. The Company will present initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7. Dr. David Wise of NYU Langone Medical Center is the lead investigator on the study.
Selected First Quarter 2022 Financial Results

Net Loss was $10.4 million for the first quarter 2022, compared to $9.1 million for the same period in 2021. The increase was primarily due to an increase in clinical trial costs due to the timing of patient enrollment and the duration of patients on study in the DisTinGuish trial and an increase in the number of research and development employees to support the development of DKN-01.

License revenues were $0.4 million for the first quarter 2021 and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. There were no license revenues recognized in the first quarter 2022, as the upfront payment was fully recognized as of December 31, 2021.

Research and development expenses were $7.8 million for the first quarter 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses was due to an increase of $0.6 million in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, an increase of $0.6 million in payroll and other related expenses, and an increase of $0.2 million in stock based compensation expense during the three months ended March 31, 2022. These increases were partially offset by a $0.4 million decrease in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns.

General and administrative expenses were $2.8 million for the first quarter 2022, compared to $2.7 million for the same period in 2021. The increase in general and administrative expenses was due an increase of a $0.2 million in stock based compensation expense and an increase of $0.1 million in payroll and other related expenses during the three months ended March 31, 2022. These increases were partially offset by a $0.2 million decrease in professional fees.

Cash and cash equivalents totaled $103.2 million at March 31, 2022. Research and development incentive receivables totaled $1.3 million at March 31, 2022.

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.