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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Scilex Holding Company, a Sorrento Company, Announces Exclusive Product Distribution Agreement with CH Trading Group LLC to Expand Commercialization of ZTlido® across certain designated territories including Middle East and North Africa

On August 17, 2022 Scilex Holding Company ("Scilex"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, reported the signing of a Product Distribution Agreement ("Agreement") for certain designated territories with CH Trading Group LLC ("CH Trading"), an international import, export and trading company focused on the Middle East and North Africa (MENA) Region and other markets, to distribute Scilex’s lead non-opioid commercial pain management product, ZTlido (Press release, Sorrento Therapeutics, AUG 17, 2022, View Source [SID1234618457]). Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento").

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"Our Agreement with CH Trading is another significant step in our continuing efforts to expand our global presence with our portfolio of innovative non-opioid pain management products, to address unmet medical needs. We are extremely pleased to collaborate with CH Trading, whose deep expertise and relationships will help us build a solid foundation in key MENA Region and other markets," said Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento.

"We are pleased to work with CH Trading to help support us through the processes of obtaining global Halal certification as well as regulatory approval in the overseas designated territories, so that we may continue to fulfill our mission to address patient pain management needs with ZTlido," said Jaisim Shah, Chief Executive Officer of Scilex.

"We are delighted to work with a non-opioid pain management leader like Scilex for distribution of ZTlido into these markets," said Elsayed Zayan, CEO of the CH Group family of companies, which include CH Trading. "Our mission is to promote healthy, ethical and productive lifestyle, including bringing innovative products to people throughout the OIC countries and the GCC and MENA Regions. Aligning with Scilex’s global ambitions means that together we can help more patients, partners, and public health systems collectively benefit."

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol "SCLX" and "SCLXW," respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

NuCana Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 17, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the second quarter ended June 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 17, 2022, View Source [SID1234618456]).

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As of June 30, 2022, NuCana had cash and cash equivalents of £46.5 million compared to £52.6 million as of March 31, 2022 and £60.3 million at December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £3.9 million for the quarter ended June 30, 2022, as compared to a net loss of £9.1 million for the quarter ended June 30, 2021. Basic and diluted loss per share was £0.07 for the quarter ended June 30, 2022, as compared to £0.17 per share for the quarter ended June 30, 2021.

"During the first half of the year, we have remained focused on the rapid and efficient implementation of our development plans," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "In the past few months, we initiated two studies: NuTide:323, a randomized Phase 2 trial of NUC-3373 in combination with other agents for the treatment of second-line patients with colorectal cancer; and NuTide:303, a Phase 1b/2 study of NUC-3373 in combination with other agents including the PD-1 inhibitor pembrolizumab, for the treatment of patients with solid tumors. We also continue to enroll patients in the Phase 1b/2 NuTide:302 study of NUC-3373 in patients with colorectal cancer and the Phase 2 monotherapy part of the NuTide:701 study of NUC-7738 in patients with solid tumors, which will expand to include combination with pembrolizumab."

Mr. Griffith continued: "From a corporate perspective, we recently announced that the Regional Court of Dusseldorf issued a judgement that Gilead’s sofosbuvir infringes our European composition-of-matter patent. We will continue to defend our patent rights and the foundational work of our late Chief Scientific Officer, Professor Chris McGuigan. Additionally, we regained compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market."

Mr. Griffith concluded: "We have provided multiple data updates for both NUC-3373 and NUC-7738 that demonstrate the potential of our ProTides to offer more effective and safer treatment options for patients with cancer. These data have highlighted the compelling anti-cancer activity and favorable safety profiles and pharmacokinetic properties of our product candidates. With an anticipated cash runway into 2025 and through numerous key milestones for both NUC-3373 and NUC-7738, we remain on track to provide a number of data updates over the coming year as we continue to advance our pipeline."

Anticipated Milestones: H2 2022 and H1 2023

• NUC-3373 (a ProTide transformation of 5-FU)

In the second half of 2022, NuCana expects to:

Commence enrollment in the randomized, controlled Phase 2 (NuTide:323) study of NUC-3373 in combination with other agents for the second-line treatment of patients with colorectal cancer;
Commence enrollment in the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents, including the PD-1 inhibitor pembrolizumab, in patients with solid tumors to identify additional indications for development;
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab in second-line patients with colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
In the first half of 2023, NuCana expects to:

Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
• NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In the second half of 2022, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors;
Commence enrollment in the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with the PD-1 inhibitor pembrolizumab, in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.

In the first half of 2023, NuCana expects to:
Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.