On July 20, 2022 The Upstate Foundation reported that it has received an $81,770 grant to expand the Upstate Cancer Center’s She Matters breast cancer outreach and education program as well as support the launch of You Matter, a health careers pathway initiative for Syracuse youth (Press release, SUNY Upstate, JUL 20, 2022, View Source [SID1234616811]).

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The grant was awarded by Hologic, a global medical technology innovator primarily focused on improving women’s health and well-being through early detection and treatment.

"We are grateful for Hologic’s support of She Matters and You Matter," said Linda Veit, MPH, Upstate assistant vice president of community relations and interim chief of staff. "The generous gift from Hologic will help us to enhance and strengthen these important programs that benefit women’s health and provide youth with skills and opportunities to prepare them for careers in health care."

She Matters is a peer-to-peer outreach and education program created by the Upstate Cancer Center to reduce breast cancer disparities and improve health outcomes by making annual breast cancer screening a priority among low-income, primarily Black and Hispanic women living in public housing in Syracuse. The program, founded in 2014, works closely with the residents of the Syracuse Housing Authority.

Key to the success of the program is the recruitment of public housing residents to serve as specially trained Resident Health Advocates. As advocates, they provide culturally appropriate breast health education; navigation to screening mammography; and, when necessary, access to prompt diagnostic and treatment services. The goal of the program is to eliminate barriers to health care, change behavior, and make annual breast cancer screening a priority. Over the past eight years, She Matters has reached more than 6,000 women and facilitated breast screening in more than 800 women over 40.

Also funded by the Hologic grant is You Matter, a healthcare careers pathway for local youth. The program reaches out in non-traditional ways to elementary, middle, and high school-aged students, and works one-on-one with each student in exploring and identifying the academic pathway needed to gain a rewarding healthcare career. Upstate says that are more than 1,000 local youth are eligible to participate in the program.

The grant is part of Hologic’s pledge to donate $5 million to improve women’s health; science, technology, engineering and math (STEM) education, and social and racial inequity initiatives, particularly in healthcare.

"With support of these two important initiatives, we look forward to building a long-term relationship with Hologic, a new funding partner of the Upstate Foundation," said Terry Toscano Shenfeld, director of foundation relations at the Upstate Foundation.

On July 20, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the quarter ended March 31, 2022, as well as research and development progress on nomacopan and long-acting PAS-nomacopan (Press release, Akari Therapeutics, JUL 20, 2022, View Source [SID1234616810]). Investigational nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) currently being investigated in two Phase 3 clinical trials for use in severe pediatric hematopoietic stem cell transplant related (HSCT) thrombotic microangiopathy (TMA) and bullous pemphigoid (BP). Akari also is advancing long-acting PASylated nomacopan for geographic atrophy (GA) in dry age-related macular degeneration (dAMD).

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"Akari is advancing our two Phase 3 programs with urgency, opening 10 clinical trial sites and beginning the screening of bullous pemphigoid patients, while also enrolling and dosing in the pediatric HSCT-TMA study at a rate that has exceeded my expectations and positions us well to meet our recruitment objectives," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Akari also has made significant strides in the pre-clinical work on long-acting PAS-nomacopan as we advance the potential of this novel therapeutic to address significant unmet patient needs in geographic atrophy and build a solid foundation for human studies."

Akari Pipeline Highlights

Phase 3 Part A clinical trial in severe pediatric HSCT-TMA
Four patients have been enrolled in the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA. The Phase 3 Part A clinical trial has a recruitment goal of seven patients over six months old. Sites are open and recruiting in the U.S., U.K., and Poland for the open-label study of pediatric patients who have undergone allogeneic or autologous HSCT and develop HSCT-TMA within a year of transplant.

Thrombotic microangiopathy following a stem cell transplant procedure is a rare but serious complication of HSCT that appears to involve complement activation, inflammation, tissue hypoxia and blood clots, leading to progressive organ damage and death. The mortality rate in patients who develop severe transplant-related TMAs is 80%.1 Currently, there are no approved treatment options in the U.S. or Europe.

ARREST-BP Phase 3 Part A clinical trial in BP
After resolving third-party supply chain issues, in May 2022 Akari began opening clinical trial sites. Ten of the clinical trial sites across the U.S., Germany, and the Netherlands are now opened and screening patients for the placebo-controlled Phase 3 Part A study of investigational nomacopan in BP. The Phase 3 Part A clinical trial is enrolling 48 patients with moderate-to-severe BP and will compare the efficacy and safety of nomacopan plus oral corticosteroids (OCS) against placebo plus OCS.

While BP is the most common autoimmune blistering skin disease, it is a rare disease. Prevalence rates vary in specific regions around the world and it has been estimated to be 12 to 23 cases per million people in the general population. It primarily affects people over the age of 65 and prevalence rises with age to approximately 190 to 312 cases each year per million people who are over 80 years of age.2 The mortality rate in BP is approximately three-fold higher than the general population, due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high-dose OCS.3 There are no approved treatment options for BP.

Pre-clinical program in GA/dAMD
Akari has made significant progress on the pre-clinical program that is laying a foundation for potential clinical trials of long-acting PAS-nomacopan for geographic atrophy (GA) in dry age-related macular degeneration (dAMD). Recent progress was focused on tolerability and half-life of PAS-nomacopan to further clarify the potential of addressing three areas of significant unmet patient needs in GA: less frequent intravitreal injections into the back of the eye, lower dose volume of intravitreal injections, and, through LTB4 inhibition4, reduced risk of sight-threatening choroidal neovascularization (CNV), also known as wet age-related macular degeneration (wAMD), which can be a complication of certain complement-only inhibitors.5,6

Geographic atrophy is a chronic progressive degeneration of the macula, which occurs during late-stage dry AMD. GA can lead to irreversible vision loss. Approximately 5 million people are affected worldwide with GA,7 nearly 1 million in the U.S.8 There are no approved treatment options.

References

Rosenthal J. Hematopoietic cell transplantation-associated thrombotic microangiopathy: a review of pathophysiology, diagnosis, and treatment. J Blood Med. 2016;7:181-186. Published 2016 Sep 2.
Gudi VS, et al. Annual incidence and mortality of bullous pemphigoid in the Grampian Region of North-east Scotland. Br J Dermatol. 2005;153(2):424-427.
Tedbirt B, Gillibert A, Andrieu E, et al. Mixed Individual-Aggregate Data on All-Cause Mortality in Bullous Pemphigoid: A Meta-analysis. JAMA Dermatol. 2021;157(4):421-430.
Sasaki F, Koga T, Ohba M, et al. Leukotriene B4 promotes neovascularization and macrophage recruitment in murine wet-type AMD models. JCI Insight. 2018;3(18):e96902. Published 2018 Sep 20.
Liao DS, Grossi FV, El Mehdi D, et al. Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial. Ophthalmology. 2020;127(2):186-195.
Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128(4):576-586.
Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116.
Friedman DS,, et al. Prevalence of age-related macular degeneration in the United States [published correction appears in Arch Ophthalmol. 2011 Sep;129(9):1188]. Arch Ophthalmol. 2004;122(4):564-572.
First Quarter 2022 Financial Results

At March 31, 2022, the Company had cash of approximately $16.7 million, compared to cash of approximately $9.4 million at December 31, 2021.

In March 2022, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 7.4 million of the Company’s ADSs for gross proceeds of approximately $8.9 million.

Research and development expenses for the first quarter of 2022 were approximately $2.1 million, as compared to approximately $3.5 million for the same period the previous year. This decrease was primarily due to lower manufacturing expenses to support ongoing clinical trials.

General and administrative expenses for the first quarter of 2022 were approximately $3.1 million, as compared to approximately $2.0 million for the same period the previous year. The increase was primarily due to expenses associated with the appointment of the Company’s new chief executive officer and the departure of the previous CEO.

For the first quarter of 2022, total other income was approximately $68,000, as compared to total other loss of approximately $290,000 for the same period the previous year. This change was primarily due to foreign currency exchange gains in the current period as compared to foreign currency exchange losses in the prior period.

Net loss for the first quarter of 2022 was approximately $5.2 million, as compared to net loss of approximately $5.8 million in the same period the previous year.

On July 20, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported follow-on data from its previously published single-center named patient program (Press release, AIM ImmunoTech, JUL 20, 2022, View Source [SID1234616809]). For the study, patients with locally advanced pancreatic cancer or metastatic disease were treated following FOLFIRINOX (See: Cancers 2022).

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The enrollment of additional patients in the Early Access Program (EAP) was approved by the Inspectorate of Healthcare in the Netherlands and new patients have been treated at Erasmus M.C.

The Overall and Progression-Free Survival was recently presented by Professor C.H.J. van Eijck, MD, PhD, of Erasmus Medical Center (Lead Investigator) at the 5th Dutch Multidisciplinary Gastrointestinal Oncology Congress held in Ermelo, Netherlands.

Professor C.H.J. van Eijck commented, "We have learned quite a lot from the original study data we published in March and the new data provide further hope for treating late-stage patients. Multi-year survival rates for LAPC and metastatic pancreatic cancer patients are historically low, with 5-year survival typically less than 3%. These additional data, indicating major improvements to survival at 24 months and beyond, point to the potential value of Ampligen as a therapy for pancreatic cancer patients. The data bolster our confidence in the potential of Ampligen for the treatment of late-stage pancreatic cancer and represents a big step forward in Ampligen’s therapeutic development program."

In addition, AIM has evaluated the initial data reported from Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and that data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months.

AIM Chief Executive Officer Thomas K. Equels added, "As we progress in the immuno-oncology development of Ampligen, there has been a lot of intention and thoughtfulness related to our selection of LAPC as our primary indication target. We believe that the LAPC standard of care, FOLFIRINOX or gemcitabine + nab-paclitaxel, followed by simple observation with no additional therapy until progression, allows for a much clearer comparison to the randomized control, in contrast to a multi-faceted primary standard of care for metastatic pancreatic cancer patients. This provides an opportunity to investigate Ampligen’s effect more accurately on pancreatic cancer in the LAPC patients in the United States. Now more than ever, we are dedicated to progressing this program forward with the hope of bringing significant benefit to LAPC patients on a global scale."

Based on the data demonstrated to date, the Company is advancing the development of Ampligen in a Phase 2 study to evaluate its potential as a therapy for locally advanced pancreatic cancer (AMP-270). AMP-270 is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe (60 subjects in the Ampligen group and 30 subjects in the control group). The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.

To manage the AIM-sponsored Phase 2 study, on April 7, 2022, the Company engaged Amarex Clinical Research LLC, a CRO with a strong track record on advising sponsors through the product development process and providing customized solutions for clinical studies. The AMP-270 clinical trial is on track to commence in Q3 2022.

On July 20, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that Young Kwang Chae, MD, MPH, MBA, Associate Professor of Medicine (Hematology and Oncology) Feinberg School of Medicine, Northwestern University will present the results of a retrospective analysis at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC2022) on August 8, 2022 in Vienna, Austria (Press release, Biodesix, JUL 20, 2022, View Source [SID1234616808]).

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The analysis from Northwestern University included patients with advanced-stage non-small cell lung cancer (NSCLC) who received Immune Checkpoint Inhibitors (ICIs) as monotherapy or in combination with chemotherapy with PD-L1 <50%. Patients underwent Biodesix’s blood-based VeriStrat proteomic testing from 2016 to 2021. This data demonstrated that the VeriStrat test result was predictive of Progression Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC with low or negative PD-L1 treated with ICIs. Patients whose VeriStrat status results were VeriStrat Good (VS-G) had significantly greater PFS and OS as compared to the patients whose status was VeriStrat Poor (VS-P).

The VeriStrat test is a blood-based test utilizing a proteomic signature identified using MALDI-ToF mass spectrometry coupled with machine learning. Results from this test have been shown to have predictive and prognostic utility in different stages, histologies, and treatment types for patients with NSCLC. More recently, the VeriStrat test has also shown to be predictive of outcomes in patients receiving ICI treatment. Data in this study further enhances the existing data by showing the role of this blood-based test among lung cancer patients with low PD-L1 expression.

"The overall efficacy of ICIs in patients with low PD-L1 expression needs further investigation. Immune-checkpoint inhibitors targeting PD-1 or PD-L1 have already substantially improved the outcomes of patients with many types of cancer, although only 20-40% of patients derive benefit from these new therapies. A lower percentage of patients with low PD-L1 expression respond to checkpoint inhibitors, however those who do respond derive significant benefit," said Young Kwang Chae, MD, MPH, MBA. "We need additional diagnostic tests, beyond PD-L1 testing alone, to better identify those likely to respond to checkpoint inhibition ahead of treatment initiation. This data shows potential for the VeriStrat test to play a role in this decision."

On July 20, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, reported dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV) (Press release, Immunomic Therapeutics, JUL 20, 2022, View Source [SID1234616807]). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

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The eight-patient, open label, first-in-humans (FIH) study is designed to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with MCC who have undergone surgery. The study’s primary endpoints include the number of participants experiencing dose limiting toxicities (DLTs), the number of occurrences of adverse events/serious adverse reactions, (AEs/SARs), as well as other standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, which fuses sequences from the mutated form of the large T antigen (LT) of the MCPyV into the sequence of the LAMP-1 gene. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo.

"Despite recent advances in cancer immunotherapy, there remains a need for therapies to treat this rather rare, but aggressive form of skin cancer, and we believe that our proprietary approach, utilizing nucleic acid vaccines with the power to leverage the body’s natural biochemistry to develop a broad immune response, holds tremendous potential in this indication," said Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics. "We look forward to reporting top-line results from the Phase 1 trial in the second quarter of next year."