On July 12, 2022 GenScript ProBio (Brian Ho-sung Min, CEO), a global CDMO, and ACT Therapeutics (Seogkyoung-Kong, CEO), developing next-generation chimeric antigen receptor (CAR)-T cell therapy platform targeting solid cancer, reported that they had entered into a strategic partnership MOU concerning the development of a new CAR-T cell therapies (Press release, GenScript, JUL 12, 2022, View Source [SID1234616630]). GenScript ProBio and ACT Therapeutics have agreed to strengthen their cooperation in the cell therapy field through this MOU.

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GenScript ProBio and ACT Therapeutics are in the process of signing a contract for plasmid and virus vector development and production for the first pipeline of ACT Therapeutics’ Advanced CAR-T Platform (ACT platform), which will also be commissioned to produce raw materials for ACT Therapeutics’ subsequent pipeline.

With this agreement, GenScript ProBio has become a global partner that can support ACT platforms for ACT therapeutics.

The ACT platform is an immune cell-based next-generation cell and gene therapy technology that uses virus vectors to insert genes designed to target cancer antigens into immune cells. GenScript ProBio has a high-quality virus vector process development and one-stop service platform for GMP production required for cell and gene therapy development.

ACT Therapeutics’ ACT platform, is an advanced CAR-T technology that has a next-generation structure beyond the second-generation CAR-T cell therapy targeting existing blood cancer by overcoming the immune suppression microenvironment of solid cancer and activating surrounding immune cells. And various studies have secured animal experimental data on the efficacy and safety of the ACT platform, and confirmed the therapeutic characteristics while remaining in the immunosuppressive microenvironment of solid cancer and it complements the shortcomings of the existing second-generation CAR-T, which makes it competitive technology for solid cancer.

ACT therapeutics is a Korean bio venture company that has received initial investment through DAYLI Partners, Korea’s leading bio and healthcare venture capital since its establishment in 2020, and has been recognized for its technology such as receiving pre-series A investment in Samho Green Investment. Currently, investment consultations are underway with securities firms and venture capital to attract Series A investment

Brian H. Min, CEO of GenScript ProBio, said, "We are very happy to cooperate with ACT therapeutics in strategic partnership, and we are looking forward to support ACT Therapeutics’ ACT platform as a global partner through our accumulated technology."

Seogkyoung-Kong, CEO of ACT Therapeutics, said, "We have completed preparations for the ACT platform to emerge globally through a strategic partnership with GenScript ProBio. We will accelerate the development of treatments targeting refractory and intractable solid cancers."

On July 12, 2022 BostonGene Corporation reported a master agreement with New York’s Memorial Sloan Kettering Cancer Center (MSK) that includes multiple research initiatives (Press release, BostonGene, JUL 12, 2022, View Source [SID1234616628]). The collaboration will support pre-clinical and clinical research activities at MSK which utilize BostonGene’s CLIA-certified and CAP-accredited high complexity molecular laboratory and advanced computational algorithms that identify and validate novel precision medicine approaches.

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MSK is the world’s oldest and largest private cancer center. Its physicians and scientists work in close collaboration to provide patients with the best cancer care available while discovering more effective strategies to prevent, control, and ultimately cure cancer in the future.

The collaboration builds upon several ongoing research initiatives, including the targeted tumor-sequencing test MSK IMPACT study, in which BostonGene provides advanced analytics of next generation sequencing data to advance the clinical utility of genomic testing. This new master agreement enables further support of clinical trial correlative analysis to discover novel biomarkers and actionable targets. Additionally, BostonGene will perform comprehensive bioinformatics to validate hypothesis-driven research to identify targetable molecular alterations, evaluate gene expression and gene signatures, characterize cellular components in the tumor microenvironment, estimate tumor heterogeneity and predict neoantigens and tumor clonality.

"We share a vision with Memorial Sloan Kettering to develop innovative solutions and advance the adoption of precision medicine," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "With BostonGene’s integration of scientific and clinical knowledge, we are equipped to support MSK in identifying personalized treatment options and improving care for patients."

On July 12, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its second quarter 2022 financial results will be released on Tuesday, August 2, after the market closes (Press release, Gilead Sciences, JUL 12, 2022, View Source [SID1234616627]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s second quarter 2022 financial results and will provide a business update.

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A live webcast will be available on the investor relations section of investors.gilead.com and will be archived there for one year.

On July 12, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that has added another patent family to its molecular residual disease (MRD)-related IP portfolio, with priority to January 2013 (Press release, Personalis, JUL 12, 2022, View Source [SID1234616626]). US Patent No. 11,384,394 describes the detection of MRD and recurrence by using whole genome sequencing of a patient’s tumor to identify variants for a personalized liquid biopsy assay.

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As with recently issued US Patent 11,299,783, the ‘394 patent covers many elements of Personalis’ NeXT Personal platform, including that it describes a highly sensitive measurement of tumor burden with simultaneous tracking of up to thousands of tumor variants, both tumor-informed and prespecified, in a single panel design. Prespecified variants from a database may be used to identify resistance to a tumor therapy, or the emergence of a second, unrelated tumor.

Tumors can be detected by the DNA they shed into a patient’s blood plasma, but the amount of that DNA can be very low. After a tumor has been surgically resected, it may be present at just a few parts per million. At that level, most parts of the tumor genome are not present in a plasma sample. To improve the chances of detecting a signal, data can be combined from several tumor mutation positions in a genome. Since the position of these mutations is not stereotypical in most cancers and appear in different positions across the genome for each patient’s tumor, using an older, tumor-agnostic (fixed panel) approach to cancer sequencing wastes up to 99.9% of sequence reads because they cover parts of the genome where that patient’s tumor does not have a mutation. If, instead, a patient’s tumor is sequenced once to identify where a patient’s mutations are on the genome, a custom assay can then view just those positions whenever a blood sample needs to be analyzed.

By eliminating wasted sequencing, it also becomes practical to sequence deeply enough to identify even minute tumor signals. This is called a tumor-informed approach. To identify the slightest trace of cancer, Personalis’ NeXT Personal looks for the fingerprint of each tumor (its mutations) at almost two thousand places across the genome. Most tumors have that many mutations, but only a few percent are in the coding regions of the genome, where an exome could capture them. To find thousands of mutations, most tumors, particularly those from breast and prostate cancers, which have low mutational burden, whole genome sequencing is needed. Personalis has pioneered this approach, and using it, the NeXT Personal platform can detect tumors in blood plasma down to a few parts per million, or below. In many cases this increase in sensitivity could allow recurrence to be detected much earlier when there may be better therapeutic options.

With the issuance of the ‘394 patent, Personalis now has 21 issued US and foreign patents, spanning 16 distinct families, relating to advanced genomic sequencing and analysis solutions. In addition, the company has over 30 pending US and foreign patent applications that relate to its existing advanced cancer detection platforms and novel research areas, including methods for interpreting genetic data generated by its platforms.

John West, CEO and co-founder of Personalis, and a co-inventor, said, "Personalis was active in whole human genome sequencing very early on. Our first publication, in 2011(1), pioneered methods for whole genome sequence analysis, and by 2012 we had received our first customer order for the sequencing and analysis of over 1,000 human genomes. By 2013, when we filed this patent, we had also pioneered methods for advanced targeted sequencing(2) and realized how powerful it could be to use them together. NeXT Personal is our most recent product leveraging the combination, and we believe that it can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected. The issuance of this newest patent from one of our earliest patent families further validates our early vision to provide our customers, partners, and patients with the best possible information regarding an individual’s tumor."

Since 2012, Personalis has sequenced over 150,000 human genomes. In 2019 the company launched whole genome tumor sequencing as a service, and in 2021 it launched NeXT Personal for the highly sensitive detection of MRD, based on a whole genome tumor-informed approach.

References

(1) "Phased Whole-Genome Genetic Risk in a Family Quartet Using a Major Allele Reference Sequence," PloS Genetics, Sept 15, 2011.

(2) "Personalis seeks edge with ‘Enhanced’ exome and genome sequencing, high quality annotations," J. Karow, GenomeWeb, March 6, 2013.

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 July 12, 2022 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported the publication of a technical review examining the ability of SQZ Antigen Presenting Cells (APCs) to activate CD8 T cells through MHC-I antigen presentation, an approach that may enable a more powerful T cell response and infiltration into solid tumors (Press release, SQZ Biotech, JUL 12, 2022, View Source [SID1234616625]). Published in ESMO (Free ESMO Whitepaper)’s Immuno-Oncology and Technology (IOTECH) journal, the review further explores the advantages of the company’s Cell Squeeze technology in cell engineering and manufacturing as well as potential opportunities to develop additional clinical candidates with enhanced capabilities.

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"In this review, for patients with solid tumors, we discuss the critical need to generate CD8 T cell penetration into the tumor microenvironment," said lead author Jong Chul Park, MD, Medical Oncologist, Massachusetts General Hospital Cancer Center, and SQZ cell therapy trial site investigator. "Activation of CD8 T cells through MHC-I antigen presentation is a promising approach and is being tested in the SQZ-PBMC-HPV-101 clinical trial where we’ve seen increases in CD8 T cell tumor infiltration and clinical benefit in a refractory patient with HPV16-mediated cancer. We look forward to potentially building on these early results through combination with various immunomodulatory drugs, such as checkpoint inhibitors."

SQZ has three ongoing Phase 1/2 clinical trials aiming to drive CD8 T cell responses against HPV16+ solid tumors. Given the broad relevance of CD8 T cell responses across tumors, the authors highlight potential for future expansion of development programs into additional areas such as mutant KRAS, mutant TP53, EBV, and other patient-specific antigens.

Review Highlights:

Comparison of Intracellular Delivery Approaches: The Cell Squeeze engineering method has compelling features compared to viral or electroporation approaches across a number of categories, including cell perturbation, scalability, cell types, cargo types, targeting, dosage control, and cost per dose
Enabling MHC-I Presentation and Multi-Dimensional Immune Engineering: SQZ’s approach has demonstrated preclinically dramatic improvements in potential CD8 T cell activation as well as synergy with next generation immuno-oncology drugs such as PD-1 IL2v
Manufacturing and Patient Dose Timing: SQZ clinical candidates experienced an average vein-to-vein time of roughly one week, faster than most other therapeutic approaches for delivering sterile cell therapy
About SQZ-PBMC-HPV
SQZ-PBMC-HPV is the company’s Antigen Presenting Cell (APC) autologous cell therapy clinical candidate and is derived from peripheral blood mononuclear cells (PBMCs), primarily composed of monocytes, T cells, B cells, and NK cells, and engineered with tumor specific E6 and E7 peptide antigens. It received FDA fast track designation in April 2022. In December 2021, the company presented clinical data at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress that included a checkpoint refractory head-and-neck cancer patient who demonstrated a radiographic, symptomatic, and immune response in the monotherapy cohort of the Phase 1/2 clinical trial.

SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination phases of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.