On October 26, 2021 Indivumed, the developer of the world’s leading discovery platform for precision oncology, and Biognosys, a leader in next-generation proteomics solutions for discovery and drug development, reported the extension of their strategic partnership to provide biopharmaceutical customers with immunopeptidomic perspectives in drug discovery in oncology (Press release, Indivumed, OCT 26, 2021, View Source [SID1234591979]).

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The partnership builds on each company’s unique capabilities in omics research, with Biognosys providing proteomic technology and solutions based on mass spectrometry, and Indivumed providing high-quality samples and data, as well as its multi-discovery AI system. -omics, nRavel .

The initial partnership created in December 2019 aimed to enrich IndivuType, Indivumed’s multi-omic cancer database, with proteomic data from thousands of samples analyzed by Biognosys. Since then, Indivumed and Biognosys have successfully collaborated on various clinical research projects and published the results of a large-scale lung cancer study at AACR (Free AACR Whitepaper) 2020 , unveiling new biomarkers for tumor biology. Building on this success, the companies are extending their partnership with immunopeptidomics research.

Immunopeptides play an essential role in the immune system, and can be analyzed to support the development of personalized treatments, in particular for cancers, vaccines, and infectious and autoimmune diseases. Mass spectrometry is currently the only technology to reliably measure and identify immunopeptide profiles from large-scale biological samples.

Biognosys Immunopeptide Stream deploys its patented Hyper Reaction Monitoring (HRM ) mass spectrometry technology for proteome quantification, in conjunction with its proprietary data analysis software Spectronaut and SpectroMine to identify over 10,000 unique immunopeptides from small quantity samples. Highly efficient and scalable, the flux can be used in large-scale clinical studies.

Indivumed can then provide biopharmaceutical customers with further validation and insight on the immunopeptide signatures identified through the Biognosys feed, leveraging IndivuType, the multi-omics cancer database , and the nRavel analytical platform. in order to optimize R&D activities and new discovery programs for individualized therapy.

Biognosys present validate the sensitivity and reproducibility of the workflow during the annual conference of the American Society of Mass Spectrometry (ASMS) on 1 st November Philadelphia. Indivumed will present a clinically relevant multi-omic analysis at the BioData World Congress on November 2 in Basel.

The new immunopeptidomics offer is already being applied successfully to third-party biopharmaceutical companies in order to optimize their drug discovery efforts.

Lukas Reiter, PhD, Chief Technology Officer, Biognosys: " Biognosys HRM technology uniquely addresses key challenges in immunopeptidomics research. Using only small amounts of tissue, our optimized flow provides a comprehensive biological perspective on the immune system. We are delighted to apply this solution to Indivumed’s valuable tissue samples and to support drug discovery in areas of significant unmet need. "

Roald Forsberg, Sales Manager and Head of IndivuType Business Unit at Indivumed: "With our IndivuType database and our nRavel AI system , we have the perfect opportunity to make new discoveries about the role of the immune response in the tumor microenvironment, and to develop novel immunotherapies against cancer.This extended partnership with Biognosys gives us the opportunity to validate and deepen our findings using mass spectrometry technology that will accelerate the transition between these discoveries and the practice of personalized oncology. "

On October 26, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has reached an agreement with the Italian Medicines Agency, AIFA, for the reimbursement of Trogarzo for eligible people aged 18 and older living with multi-drug resistant (MDR) HIV-1 (Press release, Theratechnologies, OCT 26, 2021, View Source [SID1234596237]).

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"This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy," said Conor Walshe, General Manager, Europe. "Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo for all patients in need. We expect to launch Trogarzo in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months."

Trogarzo was first approved by the U.S. Food and Drug Administration (FDA) in March 2018 and was the first long-acting agent approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their current antiretroviral regimen. Trogarzo was approved by the European Medical Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen and is also commercially available in Germany. A number of patients are also being treated with Trogarzo in other European countries through early access programs. Theratechnologies plans to launch Trogarzo on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo and is working to secure pricing and reimbursement.

About Trogarzo1
Trogarzo a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.

Trogarzo blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. Trogarzo is administered every 2 weeks via intravenous infusion.

The most frequently reported adverse reactions were rash (9.2%), diarrhea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).

On October 26, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that it will report financial results for the quarter ended September 30, 2021, and provide a corporate update on Thursday, November 11, 2021, after the close of the market (Press release, Aptose Biosciences, OCT 26, 2021, View Source [SID1234591946]).

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Conference Call & Webcast:

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the year and quarter ended September 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On October 26, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel therapies for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, November 2, 2021 at 5pm ET to discuss its financial results and corporate update for the quarter ended September 30, 2021 (Press release, Ultragenyx Pharmaceutical, OCT 26, 2021, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-third-quarter-2021-financial [SID1234591962]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 1098326. The replay of the call will be available for one year.

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.

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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.