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Nektar to Announce Financial Results for the Third Quarter 2021 on Thursday, November 4, 2021, After Close of U.S.-Based Financial Markets

On October 26, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter 2021 on Thursday, November 4, 2021, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, OCT 26, 2021, View Source [SID1234591984]). Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 6, 2021.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S); (970) 315-0453 (international)
Conference ID: 8264398 (Nektar Therapeutics is the host)

Personalis Announces Issuance of US Patents Related to the Exome-Wide NeXT Liquid Biopsy Platform

On October 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the issuance of two key US Patents related to its high-performance, exome-wide liquid biopsy platform, NeXT Liquid Biopsy (Press release, Personalis, OCT 26, 2021, View Source [SID1234591983]).

The first patent, US Patent No. 11,142,802, entitled "Methods for Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin", issued on October 12, 2021. The ‘802 patent claims novel methods for identifying cancer mutations by comparing the sequence of cell-free nucleic acids found in the plasma to the individual’s "normal" genome, obtained from leukocytes or PBMCs, also isolated from the blood sample.

For later stage cancer patients with substantial tumor DNA in their plasma, this comparison helps discriminate true somatic variants from those of their germline genome. For earlier stage patients, with much less tumor DNA in their plasma, this method can help discriminate tumor variants from mosaicism elsewhere in the body, often referred to as CHIP.

The second patent, US Patent No. 11,155,867, entitled "Methods and Systems for Genetic Analysis", issued on October 26, 2021. The ‘867 patent claims a novel method for the deep sequencing of a clinically-relevant exome from a cell-free nucleic acid sample. The sequencing is accomplished using capture probe techniques that target one or more genomic features, which might be missed if using just a standard exome. This technology may reveal more of the cancer biology of a patient, enabling new drug development insights or better treatment options. As the liquid biopsy field moves on from first generation small panels to next generation exome scale, and drives towards higher sensitivity, these methods will become increasingly important.

Both the ‘867 and ‘802 patents are members of broader patent families that relate to Personalis’ early work relating to exome-wide analysis and the cell-free detection of disease. These families claim priority to applications filed in 2013 and 2014, respectively.

"We are pleased that the USPTO has recognized Personalis’ continued innovation for the exome-scale, cell-free detection of nucleic acids for the detection of disease," said Dr. Leslie Grab, VP of Intellectual Property at Personalis. "The issuance of these patents further strengthens the company’s significant intellectual property estate in the field of advanced cancer detection and analysis." To date, Personalis has been granted 18 US and foreign patents relating to advanced genomic sequencing and analysis solutions. In addition, the company has over 25 pending US and foreign patent applications that relate to its existing advanced cancer detection platforms as well as novel research areas, including methods for interpreting genetic data generated by its platforms.

"For over ten years, Personalis has been focused on innovation," said John West, Personalis’ Chief Executive Officer. "Our IP portfolio now spans 16 families, which cover important areas including liquid biopsy methods, personalized genetic testing, advanced biomarkers based on neoantigen characterization and HLA-loss, and more."

Personalis Publishes New Data Demonstrating Performance and Utility of SHERPA for High-Accuracy Neoantigen Prediction and Cancer Diagnostic Biomarker Development

On October 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the publication of its study "Precision neoantigen discovery using large-scale immunopeptidomes and composite modeling of MHC peptide presentation," in the Immunopeptidomics Special Issue of the journal Molecular & Cellular Proteomics (Press release, Personalis, OCT 26, 2021, View Source [SID1234591982]).

The Personalis authors created Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), a novel pan-allelic machine learning algorithm for predicting MHC-peptide binding and presentation that demonstrates significantly improved performance compared to currently available prediction tools. To improve performance and generalizability, SHERPA was trained with immunopeptidomics data from newly engineered cell lines mono-allelic for HLA combined with other publicly available datasets. In addition, SHERPA was designed to more comprehensively capture epitope binding and presentation features to further enhance the predictive power of the algorithm. Using a composite model constructed with gradient boosting decision trees, multi-allelic deconvolution, and 2.15 million peptides encompassing 167 unique human HLA alleles, SHERPA achieved a 1.44-fold improvement of positive predictive value compared to existing tools when evaluated on independent mono-allelic datasets. Since publication, Personalis has further expanded the in-house generated immunopeptidomics training data set to a total of ~70 mono-allelic cell lines, resulting in a new version of SHERPA with further enhanced performance.

"Integrating data from diverse cell lines and tissue types improved the generalizability of our models compared to other in silico methods, a critically important aspect when applying our models to patient samples. With a high degree of accuracy, SHERPA has the potential to enable higher accuracy neoantigen binding prediction for many clinical applications," said Richard Chen, MD, Personalis’ CMO and SVP of R&D. "With this advancement, SHERPA is expected to facilitate the discovery of more predictive biomarkers for cancer therapy as well as empower the development of neoantigen-targeting, personalized cancer therapies. Our recently published NEOPS biomarker is one example of a SHERPA-derived composite biomarker that has shown promise in predicting immunotherapy response in cancer patients."

First Patient Dosed in CANbridge Pharmaceuticals CAN008 Phase 2 Trial for Treatment of Glioblastoma Multiforme (GBM) in China

On October 26, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, reported that it has dosed the first patient in the CAN008 Phase 2 clinical trial to treat glioblastoma multiforme (GBM) in Mainland China (Press release, CANbridge Life Sciences, OCT 26, 2021, View Source [SID1234591981]).

The multi-center, randomized, double-blind, placebo-controlled Phase 2 trial will compare standard-of-care (tumor removal, followed by radiation therapy plus temozolomide (TMZ)) with placebo, to standard-of-care with CAN008. The trial will investigate efficacy, as well as explore how select biomarkers correlate to outcome, to provide potential benefits to GBM patients.

The compound has been recognized by regulatory bodies in key international markets as potentially promising in the treatment of glioblastoma. It was granted orphan drug designation by the United States Food and Drug Administration (FDA) and received an orphan medicinal product designation by the European Medicines Agency (EMA) for the treatment of glioblastoma multiforme. In addition, it also was accepted into the EMA’s PRIME (Priority Medicines) program, which provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. CANbridge completed the Phase 1 clinical trial of CAN008 plus temozolomide (TMZ), during and after radiation therapy, in patients with newly diagnosed glioblastoma multiforme (GBM). The results demonstrate that CAN008 has excellent safety and tolerability in patients with GBM and could potentially improve the quality life and the survival time of the patients

"Glioblastoma multiforme is the most common primary intracranial malignant tumor," said Professional Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University. "Under the current standard treatment, the media survival time of patients is only 14.6 months, and the two-year survival rate is only 27%. The incidence in China has been increasing in recent years. The preliminary clinical trial results of CAN008 show that it has a good treatment effect trend, as well as very good safety and tolerability. We are pleased to participate in the domestic clinical study of CAN008 to provide a potential new treatment option for patients with glioblastoma."

"CAN008 is our first clinical product approved to commence clinical trials that has received a Class 1 new drug designation by China Food’s National Medical Products Administration," said James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc. "The dosing of the first patient in CAN008 Phase 2 trial for the treatment of GBM in China represents a major milestone for CANbridge. We look forward to advancing this truly novel, fusion protein treatment for glioblastoma along the clinical pathway in China, where it might provide new options for patients."

About Glioblastoma (GBM)

Glioblastoma (GBM) is the most common malignant tumor of the central nervous system, accounting for 35.26% – 60.9% of intracranial tumors. It is classified by the World Health Organization (WHO) as a stage-IV cancer, according to the latest classification standard of intracranial tumors. GBM is highly infiltrative and aggressive and is not surgically curable, which leads to a high recurrence rate. Although the treatment of GBM, through resection radiotherapy and chemotherapy, has continuously improved, prognosis has not been substantially improved. The median survival time is still only 14.6 months.

According to the American Association of Neurological Surgeons AANS Statistics, the number of patients with GBM in western countries is 2-3/100,000 every year, accounting for 52% of intracranial tumors. The two-year and five-year survival rates are about 30% and 4-5%, respectively.

According to Frost & Sullivan, GBM patients in China accounted for 46.6 % of intracranial tumors, totaling 54,700 patients in 2020. With the aging population and aggravated levels of air pollution and ionizing radiation exposure, the number of patients with newly diagnosed glioblastoma in China is expected to reach 59,800 in 2025, and 64,400 in 2030.

About CAN008

CAN008 is a CD95 Fc fusion protein that blocks the interaction between CD95 receptor, and its cognate ligand CD95L, through binding to CD95L. CAN008 has a unique dual mechanism of action, which can not only inhibit the invasive growth and migration of tumor cells, but could also reduce the apoptosis of T cells induced by Caspase, and enhance immune recognition. Previous clinical trial data show that CAN008 has good safety, can effectively improve the quality-of-life of GBM patients, and can greatly prolong the survival time of patients. Based on this, European Medicines Agency (EMA) included CAN008 in the Priority Medicines (PRIME) program.

Note: The European Medicines Agency (EMA) officially launched the "PRIority MEdicines (PRIME)" plan on March 7, 2016, to accelerate the review process of drugs that could address medically underserved conditions.

SimBioSys Raises $15 Million Series A to Develop the Future of Precision Cancer Care

On October 26, 2021 SimBioSys reported it raised $15 million in Series A funding to accelerate the development and commercialization of its TumorScope software platform (Press release, Northpond Ventures, OCT 26, 2021, View Source [SID1234591980]). The company’s novel, simulation-based, precision medicine platform enables individualized treatment planning for cancer patients. This Series A was co-led by Genoa Ventures and Northpond Ventures, with participation from AV8 Ventures, Heritage Medical Group, and Mayo Clinic. Existing investors and founders also participated in this financing round, bringing the company’s total capital raised to $21 million.

In the first half of 2021, SimBioSys tripled its headcount, bringing in expert clinicians, scientists, and executives from the life sciences industry. SimBioSys is also working in collaboration with 20 leading cancer institutions across the country to run clinical validation studies and recently published results from independent validation performed by prestigious cancer centers, demonstrating over 90 percent accuracy in predicting response to therapy in its first indication of early breast cancer.

"We are honored to have the support of such prestigious and thoughtful investors, validating the novelty and promise of our science and its potential to improve outcomes for millions of patients in the future," said Tushar Pandey, CEO of SimBioSys.

Despite the crowded landscape of precision medicine, treatment decisions continue to be made based on trial and error, and the resulting uncertainty among clinicians leads to sub-optimal outcomes for patients. SimBioSys aims to individualize care and eliminate uncertainty by assessing response to therapy at the time of treatment planning.

"The rate of innovation in oncology is truly inspiring, but it doesn’t always translate to benefit for most patients," said Tushar. "SimBioSys firmly believes we can do more with what is currently available while accounting for the rapidly evolving standard of care to ensure all patients have access to precision medicine."

SimBioSys’ early validation data and approach with standard-of-care data alone provides a glimpse into the future of oncology and drug development. With this new funding, the company now has the resources to move one step closer to delivering on its mission.

"Since meeting Tushar and the SimBioSys team, Genoa Ventures has been excited about the enormous potential for the TumorScope platform to democratize insights for precision medicine in cancer care," said Vikram Chaudhery, Principal at Genoa Ventures. "For the first time, any hospital, clinic or cancer center can make truly informed decisions in choosing the best treatment protocols for patients, based on the standard pre-existing patient data available, eliminating the need for additional, expensive wet-lab testing."

Unlike current approaches, SimBioSys’ first-of-its-kind application combines artificial intelligence with biophysical simulations to model the impact of phenomena such as drug delivery, metabolism, and spatial heterogeneity in a comprehensive model using standard-of-care data alone. The results are generated within minutes, enabling physicians to make a well-informed decision while improving patient experience and shared decision-making. In addition, the technology can support the drug development process across pre-clinical and clinical trial settings.

"Robust clinical and patient-reported data is critical to assess and prescribe the best options of cancer care for patients," said Andrea Jackson, Director at Northpond Ventures. "The SimBioSys TumorScope virtualizes cancer to simulate – in minutes – a patient’s tumor response to therapies. Simulating response before prescribing treatment is a significant stride in personalized treatment planning. Northpond is grateful to partner with Tushar and the SimBioSys team on this important work."

The company’s name, SimBioSys, and logo capture its core scientific approach – Simulating Biological Systems. SimBioSys’ TumorScope virtualizes cancer in 3D and can accurately simulate how a patient’s tumor will respond to a variety of therapies following diagnosis. The new funding will allow SimBioSys to expand its state-of-the-art technology into other solid tumors beyond its current focus on breast cancer. Additionally, the new capital will drive commercialization efforts to bring the technology to patients and the biopharma industry. Andrea Jackson at Northpond Ventures and Vikram Chaudhery at Genoa Ventures will join the SimBioSys Board of Directors.