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 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Janux Therapeutics, MAY 31, 2022, View Source [SID1234615280]). JANX007 is the Company’s lead novel T cell engager (TCE) therapeutic from its TRACTr platform. Janux plans to initiate a Phase 1 clinical trial for JANX007 in the second half of 2022.

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"We are proud to announce today the clearance of Janux’s first IND – a critical milestone for our TRACTr platform and for the Company as we advance a broad pipeline of next generation immunotherapies to address unmet needs and improve the treatment of cancer," said David Campbell, Ph.D., President and CEO of Janux. "JANX007 is uniquely designed to overcome the clinical limitations of existing TCE approaches, potentially providing mCRPC patients a safer therapeutic option, while also generating potent anti-tumor activity by enabling the delivery of a higher concentration of active drug. With this IND acceptance, we are on track to advance JANX007 into the clinic in the second half of this year."

Unlike existing TCE approaches to prostate cancer that have been limited to-date by dose-limiting toxicities, poor pharmacokinetic (PK) profiles and attenuated efficacy, JANX007 is designed as a safer, highly potent anti-tumor approach to mCRPC. In preclinical studies, JANX007 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic.

On May 31, 2022 QureBio Ltd., a clinical-stage biopharmaceutical company focusing on bi-specific antibodies and other engineered bio-therapeutics for the treatment of cancer, inflammation, and other serious disorders, reported that its Q-1802 clinical program was selected for presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings on June 3–7, 2022, and the abstract of relevant results for this study has been published on ASCO (Free ASCO Whitepaper) website (View Source) (Press release, QureBio, MAY 31, 2022, View Source [SID1234615298]).

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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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The presentation will showcase the preliminary results of a first-in-human Phase 1a/1b, multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity Q-1802, a Claudin18.2/PD-L1 bi-specific therapeutic in patients with relapsed or refractory solid tumors after standard therapies. Professor Lin Shen from Peking University Cancer Hospital and Institute leads this study. The key data from the mono-therapy of Q-1802 in both dose-escalation and dose-expansion studies demonstrate excellent safety, tolerability, and preliminary anti-tumor activities of Q-1802 at the dose up to 10 mpk.

The abstract for the study is found in 2022-ASCO-Annual –Meeting Abstracts (#2568), and the poster session information is listed below. First Author, Dr. Jifang Gong from the Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute will present the relevant results on Sunday, June 5, 2022.

About Q-1802

Q-1802, a humanized bi-specific antibody, is the first FDA-approved Claudin18.2/PD-L1 bi-specific therapeutic to enter clinical trial. In animal model studies, Q-1802 demonstrates both superior anti-tumor activities and excellent safety profiles. It recruits multiple immune mechanisms to kill tumor cells, offering a novel therapeutic opportunity for Claudin18.2 positive solid tumors. Q-1802 also exhibits robust physicochemical properties and superb productivity with titers exceeding 4 grams per liter.

On May 31, 2022, GlycoMimetics, Inc. (the "Company") reported that it received a notice from The Nasdaq Stock Market ("Nasdaq") that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days (Filing, 8-K, GlycoMimetics, MAY 31, 2022, View Source [SID1234615506]). The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Global Market.

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The Company has 180 calendar days, or until November 28, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by November 28, 2022, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. The Company’s failure to regain compliance during this period could result in delisting.

The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq listing criteria.

On May 31, 2022 GSK plc (LSE/NYSE: GSK) reported that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones (Press release, GlaxoSmithKline, MAY 31, 2022, View Source [SID1234615247]). Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.

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Pneumococcal disease includes pneumonia, meningitis, bloodstream infections, and milder diseases such as sinusitis and otitis media and remains a significant unmet medical need despite the availability of current pneumococcal vaccines. There are many different pneumococcal serotypes. The number of serotypes in current vaccines is limited due to the degree of immunological interference observed when using existing conjugation technologies.

Affinivax has developed the Multiple Antigen Presenting System (MAPS), a novel technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines. Affinivax’s most advanced vaccine candidate (AFX3772) includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "The proposed acquisition further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens GSK’s existing scientific footprint in the Boston area. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need."

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above. Phase III is expected to start in the short term. Phase I/II clinical trials to assess the use of the vaccine in paediatrics are planned to begin later this year.

"Affinivax grew out of our founders’ scientific and personal vision to drive vaccine innovation to make a meaningful impact on people’s lives, in both developed and developing countries," said Steven Brugger, CEO of Affinivax, Inc. "Over the past eight years, we have taken that vision from the initial development of our MAPS vaccine platform at Boston Children’s Hospital to a pipeline of novel vaccines with our lead vaccine candidate in late-stage clinical studies. We are proud that GSK has recognized our team’s accomplishments and are confident that GSK is an ideal new home for our MAPS platform and the team behind its success. GSK’s significant capabilities will enable continued advances with MAPS to improve existing vaccines – as is the case with our lead Streptococcus pneumoniae MAPS vaccine program – and develop vaccines that combat novel and resistant infectious diseases for which there are no effective immunization strategies available today."

Financial considerations

Under the terms of the agreement, GSK will acquire 100% of the outstanding shares of Affinivax. The consideration for the acquisition comprises an upfront payment of $2.1 billion to be paid upon closing and two potential milestone payments of $0.6 billion to be paid upon the achievement of certain paediatric clinical development milestones. The transaction is subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott- Rodino Anti-Trust Improvements Act of 1976. The transaction is expected to close in the third quarter of 2022.

GSK will account for the transaction as a business combination.

New GSK reaffirms its full-year 2022 guidance and the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**.

* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange Rate

Pneumococcal disease

The bacterium Streptococcus pneumoniae causes pneumococcal disease. There are multiple types of pneumococcal disease, including bloodstream infections (sepsis), pneumonia, meningitis, and other milder diseases such as sinusitis and otitis media. A significant unmet medical need remains despite the availability of current vaccines. Pneumococcal pneumonia causes an estimated 150,000 hospitalisations each year in the United States; pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019[i].

MAPSTM technology platform

Multiple Antigen Presenting System (MAPS) is a novel and highly efficient vaccine technology platform that enables the precise, high-affinity binding of disease-relevant polysaccharides to disease-relevant protein antigens in a single vaccine. Immunisation with the resulting polysaccharide-protein complexes induces a broad and potentially protective B-cell (antibody) response to the polysaccharides and a separate B-cell and T-cell immune response to the proteins. The distinctive plug-and-play nature of MAPS enables the targeting of a broad range of infectious diseases.

The initial use of the technology has been directed primarily toward preventing pneumococcal disease. Applicability of the technology has also been demonstrated for additional infectious disease pathogens, including those that cause hospital-acquired infections.