On May 31, 2022 M2GEN reported that continues to partner with our Oncology Research Information Exchange Network (ORIEN) members to enable breakthrough scientific research that advances patient care (Press release, M2Gen, MAY 31, 2022, View Source [SID1234615263]). ORIEN researchers are showcasing several projects at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that utilize M2GEN’s rich longitudinal clinico-genomic Avatar data, and feature collaborations with scientists across ORIEN and M2GEN. These projects highlight research discoveries across four key areas: gastrointestinal cancers, developmental therapeutics, immunotherapy, and gynecologic cancers.

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Learn more about how ORIEN investigators are collaborating with fellow Network members and M2GEN to leverage the expansive clinical and molecular Avatar database, for the research being featured at ASCO (Free ASCO Whitepaper) 2022:

On Saturday, June 4, during ASCO (Free ASCO Whitepaper)’s Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary poster session:

Gudbjorg Jonsdottir, M.D., of the University of Iowa Holden Comprehensive Cancer Center will present a poster entitled "The impact of HRD in patients with pancreatic adenocarcinoma who undergo surgical resection: an updated analysis" (Abstract: 4132, Poster: 118, Full Text).
Summary: Utilizing data from 311 pancreatic cancer patients in the ORIEN Avatar database, Dr. Jonsdottir determined that patients with one of 18 genetic mutations in the homologous recombination repair (HRR) pathway, which is involved with repairing DNA, had improved survival if treated with platinum-based chemotherapy compared to those who were not.
On Sunday, June 5, during ASCO (Free ASCO Whitepaper)’s Developmental Therapeutics—Immunotherapy poster session:

Ahmad Tarhini, M.D., Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Predictors of immunotherapeutic benefits in patients with advanced malignancies treated with immune checkpoint inhibitors utilizing "real-world" data" (Abstract: 2618, Poster: 273, Full Text)
Summary: Of 1,214 patients with 27 cancer types in the ORIEN Avatar database treated with immune checkpoint inhibitor (ICI) therapies, Dr. Tarhini found that there was a significant increase in overall survival if the ICI was given as the first treatment. Furthermore, for patients with melanoma, Dr. Tarhini identified six patterns of gene expression that correlated significantly with improved survival on ICIs.

Payman Ghasemi Saghand, Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "A deep learning approach utilizing clinical and molecular data for identifying prognostic biomarkers in patients treated with immune checkpoint inhibitors: An ORIEN pan-cancer study" (Abstract: 2619, Poster: 274, Full Text)
Summary: Utilizing ORIEN Avatar data for 522 cancer patients treated with immune checkpoint inhibitor (ICI) therapy, Dr. Saghand developed a machine learning algorithm correlating survival outcomes to specific gene expression patterns. The algorithm aims to predict the genes that are associated with resistance to ICI therapy; future work will determine the mechanism behind this genetic resistance.

Kevin Chua, M.D., of the Rutgers Cancer Institute of New Jersey will present a poster entitled "Comparing Rate of Immunotherapy Treatment Change Due to Toxicity by Gender" (Abstract: 2656, Poster: 310, Full Text)
Summary: Utilizing clinico-genomic data from 447 patients treated with immunotherapies in the ORIEN Avatar database, Dr. Chua analyzed differences between treatment courses in female and male patients. He found that female patients were on immunotherapies for a shorter overall period, but there was no difference in treatment discontinuation rates due to adverse side effects.
On Sunday, June 5, during ASCO (Free ASCO Whitepaper)’s Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session:

Daniel Spakowicz, Ph.D., of The Ohio State University will present a poster entitled "Pan-cancer analysis of exogenous (Microbial) sequences in tumor transcriptome data from the ORIEN consortium and their association with cancer and tumor microenvironment" (Abstract: 3113, Poster: 105, Full Text)
Summary: Utilizing RNA-sequencing data, Dr. Spakowicz analyzed the microbiomes of 2,892 tumors collected from patients in the ORIEN Avatar database and 2,720 patient samples in The Cancer Genome Atlas. The tumor microbiome was found to correlate better with the type of cancer than the level of oxygen in the tumor microenvironment, suggesting that the tumor microbiome is dependent on location.

Emily Hoskins of The Ohio State University will present a poster entitled "Pan-cancer landscape of PD-L1 and PD-L2 structural variations" (Abstract: 3133, Poster: 125, Full Text)
Summary: PD-L1 and PD-L2 are proteins that are involved in suppressing the creation of new immune cells; cancer cells often produce increased amounts of these proteins to evade the immune system’s attack. Utilizing large datasets, including ORIEN Avatar whole-exome data, Emily Hoskins curated 514 cancer cases with structural variations in PD-L1 and PD-L2 that increased expression of these genes. Patients with these gene rearrangements may potentially respond better to therapies that block PD-L1 or PD-L2 activity.
Additionally, in the Gynecologic Cancer section of the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a supplement to the Journal of Clinical Oncology:

McKayla Riggs, M.D., of the University of Kansas Markey Cancer Center will publish an abstract entitled "DACH1 mutation frequency in endometrial cancer is associated with high tumor mutation burden in a nationwide cohort" (Abstract: e17634, Full Text)
Summary: From 691 endometrial cancer patients in the ORIEN Avatar database, Dr. Riggs found that those with mutations in DACH1 had overall tumor mutation burden and co-occurred with other genome destabilizing mutations. The researchers also found that DACH1 mutations were more prevalent in the local Appalachian region than elsewhere in the country. Their findings suggest DACH1 may be a candidate biomarker for future immunotherapy trials, particularly for endometrial cancers.
To inquire about partnering with M2GEN and the Oncology Research Information Exchange Network (ORIEN), or our rich longitudinal clinico-genomic ORIEN Avatar dataset, contact [email protected].

On May 31, 2022 InveniAI LLC, a global leader in applying Artificial Intelligence (AI) and Machine Learning (ML) to transform drug and target discovery and development, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported the achievement of the first milestone in disease model systems that triggered a milestone payment that has been received by InveniAI under the research collaboration between the companies (Press release, Kyowa Hakko Kirin, MAY 31, 2022, View Source [SID1234615262]).

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Yoshifumi Torii, Ph.D., Executive Officer, Vice President, and Head of R&D Division of Kyowa Kirin, added, "We are excited to achieve a successful outcome by leveraging InveniAI’s platform AlphaMeld that detected very early signals of association between targets/mechanism of action and clinical utility based on the platform’s analytics. We have since validated this program which, as predicted, has shown signals of efficacy in preclinical proof-of-concept studies for the treatment of a disease indication where current therapeutic options lack efficacy and have adverse effects. We are eager to test this very promising candidate for further studies. We also look forward to the selection of additional novel programs identified by InveniAI’s truly game-changing platform and believe that our collaboration will contribute to addressing enduring unmet medical needs."

"We are delighted with the progress of our synergistic collaboration with Kyowa Kirin and the advancement of an AI-identified target and associated clinical utility at unprecedented speed," said InveniAI’s President and Chief Executive Officer, Krishnan Nandabalan, Ph.D., "Our AI-powered drug and target discovery platform, AlphaMeld, has repeatedly demonstrated the ability to generate concepts that have been validated by our partners from preclinical to late-stage clinical success. The ability to translate data into meaningful efficacy, safety, and clinical endpoints is pushing the current probability of clinical success from 1 in 10 to 3 in 10 – a significant impact in today’s drug discovery and development paradigm," he added.

InveniAI and Kyowa Kirin have been collaborating since 2018 and have expanded the framework of their collaboration twice so far (2020 and 2021)*. This milestone achievement is the result of the first joint research to maximize the portfolio value that began in 2018. In addition to the above-mentioned projects, there are ongoing projects aimed at discovering new drug candidates in several disease areas.

About AlphaMeld
AlphaMeld is an Artificial Intelligence (AI) and Machine Learning (ML) powered platform that accelerates innovation for the discovery of targets, drugs, and healthcare products and technologies. The platform generates testable hypotheses by taking into account the ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations.

On May 31, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, to treat advanced solid tumors (Press release, Gritstone Oncology, MAY 31, 2022, View Source [SID1234615261]). Additionally, the company announced it is presenting a "Trial in Progress" poster summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study for first-line maintenance treatment of metastatic, microsatellite stable colorectal cancer) at the 2022 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"The updated OS data from our Phase 1/2 study continue to demonstrate a correlation between molecular response and overall survival, and points to the potentially significant impact GRANITE is having on lives of patients with advanced stage cancer," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "The median overall survival observed in multiple trials of various therapies in the third-line MSS-CRC setting has been around 6-7 months, which is consistent with what we observed in our study in patients who did not have molecular response (median overall survival of 7.8 months). The very different outcome observed in the molecular responder subset, with median overall survival of over 18 months, is all the more striking given how rarely long-term survival is observed in MSS-CRC patients who have been treated with and progressed on two prior therapies. These maturing data, demonstrating long-term clinical benefit, further support moving GRANITE upstream in the treatment of patients with this grim cancer in the ongoing randomized Phase 2/3 study, which has registrational intent."

The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, Opdivo (nivolumab) and subcutaneous anti-CTLA-4 antibody, Yervoy (ipilimumab) in advanced solid tumors. This study enrolled and treated 26 patients as of ESMO (Free ESMO Whitepaper) 2021 presentation with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. As presented at ESMO (Free ESMO Whitepaper) 2021, of 9 patients with MSS-CRC who were treated and evaluable for molecular response, 4 experienced a molecular response (as evidenced by a reduction in circulating tumor DNA [ctDNA]) and continue to have an OS advantage compared to those patients who did not have a molecular response.

Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

Updated overall survival data from GRANITE Phase 1/2:

4 of 9 treated patients with MSS-CRC had a molecular response (as reported during the ESMO (Free ESMO Whitepaper) 2021 data presentation) and the observed median overall survival in this group will now exceed 18 months (median OS not yet reached versus 7.8 months in those who did not have a molecular response).
All patients with MSS-CRC assessed for molecular response and alive at the time of the ESMO (Free ESMO Whitepaper) 2021 data presentation remain alive after an additional 35 weeks of follow-up.
ASCO presentation details are as follows:

Abstract TPS3635: Phase 2/3, randomized, open-label study of an individualized neoantigen vaccine (self-amplifying mRNA and adenoviral vectors) plus immune checkpoint blockade as maintenance for patients with newly diagnosed metastatic colorectal cancer (GRANITE)
Date/Time: Saturday 04 June 2022, 8:00am CST
Session: Gastrointestinal Cancer – Colorectal and Anal
Location: Poster 425b

On May 31, 2022 Fresenius reported that PEMEtrexed for injection, a drug used to treat adult patients with lung cancer and malignant pleural mesothelioma, is now available from Fresenius Kabi in the United States (Press release, Fresenius, MAY 31, 2022, View Source [SID1234615260]). This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 31, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that members of the company’s management team will participate in fireside chats at the following investor conferences in June (Press release, Exelixis, MAY 31, 2022, View Source [SID1234615258]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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William Blair 42nd Annual Growth Stock Conference: Exelixis is scheduled to present at 11:00 a.m. ET / 10:00 a.m. CT / 8:00 a.m. PT on Tuesday, June 7, 2022, in Chicago.
2022 Jefferies Healthcare Conference: Exelixis is scheduled to present at 1:30 p.m. ET / 10:30 a.m. PT on Wednesday, June 8, 2022, in New York.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.