Kriya Appoints Pedro Huertas M.D., Ph.D., as Chief Medical Officer of its Rare Disease Division

On August 17, 2022 Kriya Therapeutics, Inc., a fully integrated gene therapy company advancing a broad portfolio of innovative therapeutics, reported that it has appointed Pedro Huertas, M.D., Ph.D., as Chief Medical Officer of its Rare Disease Division (Press release, Kriya Therapeutics, AUG 17, 2022, View Source [SID1234618463]). In his role, Dr. Huertas will be responsible for the direction and execution of the company’s clinical, medical and scientific plans to advance its rare disease pipeline.

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Dr. Huertas brings to Kriya three decades of experience advancing therapies for rare conditions across a spectrum of roles, including in preclinical and clinical research, clinical development, post-marketing development, and regulatory strategy. Prior to joining Kriya, Dr. Huertas served as Chief Medical Officer at Inozyme Pharma, Sentien Biotechnologies, and Eloxx Pharmaceuticals. Earlier in his career, Dr. Huertas also held clinical and development roles at Pfizer, Shire, Amicus, and Genzyme Corp.

"Pedro brings a wealth of experience to Kriya as we continue to advance our rare disease gene therapy portfolio," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "His track record of success in developing impactful medicines has earned him the respect of the rare disease community – and we look forward to supporting him within our unique ecosystem to deliver transformative gene therapies to patients."

Dr. Huertas’ extensive experience working with regulatory agencies around the world will further bolster Kriya’s mission to advance gene therapies to patients. While at Genzyme, he helped lead the successful effort to file for approval of Fabrazyme (agalsidase beta), an enzyme replacement therapy for Fabry disease, in the United States, Europe, and Japan.

"I’m excited to join a company with the potential to deliver several innovative, life-changing therapies to patients with rare diseases," said Dr. Huertas. "Kriya’s fully integrated technology platform, advanced manufacturing capabilities and accomplished team offer significant advantages as it pursues its mission – and I am eager to deploy these capabilities to accelerate the delivery of gene therapies to patients who need them."

Genexine Announces Dosing of First Patient in Phase 2 clinical trial with Triple Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)

On August 17, 2022 Genexine (KOSDAQ: 095700), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported the dosing of the first patient in phase 2 clinical trial using triple combination therapy in patients with recurrent/metastatic HNSCC (Press release, Genexine, AUG 17, 2022, View Source [SID1234618462]). The combination therapy consists of two of Genexine’s proprietary drugs, GX-188E (a first-in-class therapeutic DNA vaccine), GX-I7 (a first-in-class long-acting interleukin 7), and OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor.

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The phase 2 clinical trial is being conducted in South Korea under the leadership of Professor Hye-Ryun Kim of the Department of Oncology at Yonsei Severance Hospital Cancer Center. The trial will evaluate the safety and efficacy in 21 patients with HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Endpoints assessed during the study include those related to safety and efficacy, including the overall rate of response.

"I am very pleased to be leading this study with such a unique approach of combining a DNA vaccine, a long-acting Il-7 T-cell amplifier and a proven checkpoint inhibitor," said Professor Hye-Ryun Kim. "Based on the potential synergy of the mechanisms of action of the three therapies, we could expect that the overall response rate in this patient population will be further enhanced versus the standard of care. The unmet medical need in HNSCC patients is substantial, so this landmark study will be an important milestone for these patients."

"This study is very important for Genexine as it represents a unique approach to treating a very complicated and difficult cancer," said Neil Warma, President and CEO of Genexine. "We are running separate trials with GX-188E in cervical cancer and GX-I7 in triple-negative breast cancer and glioblastoma, but the idea to combine both with a checkpoint inhibitor in HNSCC could challenge the standard of care and truly provide an important alternative for these patients and possibly to numerous other HPV related cancers."

Recurrent/metastatic head and neck squamous cell carcinoma is considered an incurable disease with a very poor prognosis and limited treatment options. It requires active treatments from the early stages. Since tumor cells develop in the oropharyngeal region, it significantly impacts patients’ lives, causing functional disability and a high mortality rate.

According to the National Institute of Health (NIH), around 70% of oropharyngeal cancer which takes a major portion of head and neck cancers in the United States are caused by human papillomavirus (HPV) infection. In addition, the unmet medical needs for HPV-positive head and neck cancer are very high due to the increasing incidence rate around the world.

Genexine’s proprietary immuno-oncology drug GX-I7 is being developed globally as a first-in-class drug. It amplifies absolute lymphocyte counts, therefore, increasing the number of T cells and has a mechanism to penetrate them into the tumor microenvironment. Another innovative drug being used in the triple combination is GX-188E. It is an anticancer DNA vaccine and has a mechanism of preferentially targeting HPV antigens to dendritic cells. Therefore, it is expected that the triple combination of the two novel pipelines with PD-1 immune checkpoint inhibitor OpdivoR will be an effective treatment strategy for HPV-positive head and neck cancer patients.

Gilead Sciences Announces Collaboration With Morehouse School Of Medicine And Xavier University Of Louisiana College Of Pharmacy To Address Inequities In HIV Care

On August 17, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported a new health equity collaboration with the Satcher Health Leadership Institute (SHLI) at Morehouse School of Medicine and the Center for Minority Health and Health Disparities Research and Education (CMHDRE) at Xavier University of Louisiana’s College of Pharmacy (Press release, Gilead Sciences, AUG 17, 2022, View Source [SID1234618461]). The collaboration is focused on addressing the inequities in HIV care for Black communities in the Southern United States. Gilead has a broad and long-standing commitment to advancing global health equity, which it regards as critical to helping to end the HIV epidemic and improving health outcomes for all. The company’s health equity strategy focuses on collaborating with organizations that reach underrepresented and disproportionately impacted communities.

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Research shows that inequities drive higher rates of HIV infection, as well as worse HIV clinical outcomes among Black Americans. The COVID-19 pandemic has further highlighted and exacerbated such health inequities, especially in the Southern United States. SHLI and CMHDRE are at the forefront of efforts to improve access to HIV care for Black communities in the Southern U.S. region. Gilead will award a total of $4.5 million in funding over a three-year period to support their work in three cities: Atlanta, Baton Rouge, La., and New Orleans.

The partnership between SHLI and CMHDRE, with support from Gilead, is intended to close critical gaps in care by:

Increasing understanding of the impact of COVID-19 on the healthcare delivery system in the Black community
Realigning HIV services to reflect the impact of the COVID-19 pandemic
Providing training focused on culturally appropriate HIV care, inclusive of stigma-reducing strategies
Increasing access to, and utilization of, culturally appropriate care for Black people impacted by the HIV epidemic
"Gilead knows that scientific innovation has the most impact on patients when we help remove societal barriers to care, such as discrimination and stigma. We are committed to investing in organizations, community leaders and experts working to address the underlying determinants of health outcomes," said Rashad Burgess, Vice President of Advancing Health and Black Equity, Gilead Sciences. "This collaboration will focus on the barriers that are most prevalent in Black communities and help increase access to HIV care to produce better outcomes for Black people."

"Though the COVID-19 pandemic was a setback to the American healthcare system overall, we must bring to the forefront disproportionately impacted communities who were already historically marginalized prior to the pandemic, including people living with HIV," said Daniel E. Dawes, J.D., Executive Director, Satcher Health Leadership Institute at Morehouse School of Medicine, and author of The Political Determinants of Health. "The Satcher Health Leadership Institute will collaborate with Gilead and Xavier University of Louisiana to ensure these communities are not an afterthought."

"Xavier’s Center for Minority Health and Health Disparities Research and Education in the College of Pharmacy is proud to partner with Gilead and the Satcher Health Leadership Institute at Morehouse School of Medicine for such an important initiative," said Dr. Kathleen Kennedy, Dean of Xavier University of Louisiana’s College of Pharmacy. "Xavier is a top producer of African Americans with a Doctor of Pharmacy degree, and we instill in our graduates the mission of Xavier and the desire to serve the underserved with an effort to mitigate health disparities for underrepresented communities."

This latest collaboration is part of Gilead’s broader health equity strategy to support community organizations across the globe in addressing social determinants of health. A recent report commissioned by Gilead, "HIV In The Time of COVID-19: Leaving No-One Behind to Truly End the HIV Epidemic," details a broad range of barriers to health equity including social and economic factors. While predictors of health outcomes such as race, ethnicity and gender have long existed, the COVID-19 pandemic has exacerbated health inequities, especially for marginalized communities and those affected by HIV. Gilead is increasing investment to address these underlying inequities highlighted by the intersection of the two health crises.

Other Gilead programs that address health equity include the COMPASS Initiative, a ten-year, $100 million commitment toward addressing HIV/AIDS inequities in the U.S. South, which continues to challenge the structural barriers that are most prevalent in Black communities. Gilead’s Zeroing In program supports communities in 41 countries that have been hit doubly hard by HIV and the COVID-19 pandemic. Gilead also created a $10 million Racial Equity Community Impact Fund to support organizations fighting the racial inequities that affect Black communities. In its most recent report, the Funders Concerned About AIDS named Gilead the number one overall philanthropic funder of HIV/AIDS programs.

Provectus Biopharmaceuticals Expands Sponsored Research Collaboration with University of Calgary (Canada) to Investigate Systemic Administration of Pharmaceutical-Grade Rose Bengal for Treatment of Pediatric Leukemia

On August 17, 2022 Provectus (OTCQB: PVCT) reported that the Company has expanded its sponsored research program with Aru Narendran, MD, PhD, Professor, Departments of Pediatrics, Oncology, Biochemistry & Molecular Biology, and Physiology & Pharmacology at the Cumming School of Medicine of the University of Calgary in Calgary, Alberta, Canada to investigate systemic administration of Provectus’ pharmaceutical-grade rose bengal for the treatment of pediatric leukemia (Press release, Provectus Biopharmaceuticals, AUG 17, 2022, View Source [SID1234618460]). The Company’s innovatively-assembled and proprietary rose bengal is the lead member of a class of small molecules called halogenated xanthenes.

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As part of this new sponsored research, the Narendran team plans to:

Identify clinically-feasible drug combinations and synthetic lethality that have synergistic activity with Provectus’ rose bengal,
Evaluate systemic drug administration routes for maximal tolerability,
Evaluate the modulation of WNK1 (lysine deficient protein kinase 1) and other related pathways induced by the Company’s rose bengal, and
Complete demonstration of STING (stimulator of interferon genes) dimerization in leukemia cells.
The Narendran team has previously shown:

In vitro activity and target modulation effects of Provectus’ rose bengal against several different pediatric leukemia‐derived cell lines and primary cells,
Proof‐of-concept of several potential mechanisms that may be involved in this process,
Rose bengal’s ability to induce STING dimerization and the molecule’s association with heat shock proteins, and
Preliminary evidence of in vivo activity in mouse xenograft models using the pediatric leukemia cell line SEM following oral doses of the Company’s rose bengal.

Oncotelic Participating at Biotechgate Digital Partnering

On August 17, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), developer of treatments for rare and orphan indications, including Parkinson Disease and various cancers, reported that the Company will be participating at Biotechgate Digital Partnering – a business development & licensing event – Aug 29 – Sep 2, 2022 (Press release, Oncotelic, AUG 17, 2022, View Source [SID1234618459]). An updated investor slide deck will be available at our website after the event.

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