On August 17, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it has filed an amended complaint against Foresight Diagnostics (Press release, Personalis, AUG 17, 2022, View Source [SID1234618465]). The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD).

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The patent, US Patent No. 11,408,033 (the "‘033 patent"), which issued on August 9, 2022, claims priority to one of Personalis’ earliest patent families. It covers personalized MRD panels combining tumor-informed and database-derived content. This combination supports the detection, quantification, and characterization of a tumor over time, by sequencing circulating tumor DNA (ctDNA) of the individual.

On August 2, 2022, Personalis filed a complaint against Foresight for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These three patents are also part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed MRD testing. Personalis continues to seek both injunctive relief and monetary damages based upon Foresight’s infringement.

"The granting of the ‘033 patent provides further recognition of Personalis as a pioneer in the field of leveraging whole genome sequencing for clinical applications," said John West, CEO and co-founder of Personalis. "We stand firm in our resolve to protect our investment and leadership position in the field."

Personalis’ patent portfolio protects its groundbreaking work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with an unprecedented part-per-million sensitivity, which its recently-launched MRD solution, NeXT Personal, is uniquely designed to achieve. See the recent conversation series with John West on the Personalis Blog for more background on Personalis’ ultra-sensitive NeXT Personal assay.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.

On August 17, 2022 Mytide Therapeutics, a company transforming peptide manufacturing with predictive analytics and machine learning, reported that it has partnered with Agilent, a global leader in life science, diagnostic and applied chemical markets (Press release, Mytide Therapeutics, AUG 17, 2022, View Source [SID1234618464]). The two companies will collaborate on robust, scalable and reliable automation solutions for Mytide’s BioFab2 platform, a technology suite that combines chemistry, robotics and machine learning to advance and accelerate peptide and peptide conjugate manufacturing. Under the terms of the agreement, Agilent will supply analytical and preparative chromatography equipment for Mytide’s BioFab2 fleet. The ultimate aim of the partnership is to drive clinical impact by accelerating the development of life-saving therapeutics.

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"It is extremely difficult to maintain data quality within high-throughput pipelines to apply advances in AI due to data reproducibility, quality, and sparsity," said Dale Thomas, Co-Founder, Mytide Therapeutics. "By partnering with Agilent, Mytide’s system will be able to overcome these challenges through deeply integrated hardware and software to enable a true real-time data collection, visualization, and decision-making pipeline."

Together, Mytide and Agilent will leverage their combined technologies and analytical processes to help address known bottlenecks in peptide development and manufacturing by improving process performance and reliability. Mytide’s BioFab2 platform leverages advances in chemistry, robotics and AI to access natural and non-natural peptides faster than typical processes. Leveraging this suite of capabilities, Mytide is continuing to build datasets and technologies to drive access beyond easily accessible biopolymer which includes peptide-drug conjugates, constrained peptides, and short proteins.

"Agilent is very excited by the opportunity to collaborate with the pioneering team at Mytide Therapeutics. Our collaborative endeavor targeting the development of high-purity, customized peptides will contribute to the scientific excellence within the biopharmaceutical community and the scientific field as a whole. Mytide and Agilent are committed to expand on our shared values and mission to deliver trusted answers and advance the quality of life with precision medicines. The journey to partnership with Mytide has been magnificent, assuring an even brighter future. We are thrilled with the prospect of sharing in their vision to redefine the biopharmaceutical industry’s expectations for peptide manufacturing," said Amir Liba, Associate Vice President, CMS East and Canada.

"Mytide and Agilent’s shared interest on leading the revolution on combining analytics and machine learning will accelerate our ability to bring our quick turn manufacturing technology into the broader drug discovery ecosystem to further accelerate the development of new peptide therapeutics," added Thomas.

Mytide prioritizes partnerships with pharmaceutical companies that require salable and time-sensitive manufacturing for both research and clinical programs to support various personalize therapies. Mytide’s BioFab2 platform is designed to be integrated into cGMP manufacturing environments to allow for scalable and decentralized clinical trial manufacturing of a partner’s lead peptide-based therapeutic candidate.

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."

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.

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.