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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On October 26, 2021 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, OCT 26, 2021, View Source [SID1234591947]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This quarter, we were pleased to announce positive data from our Phase 1 multiple ascending dose trial of ASLAN004, supporting the potential of this first-in-class antibody as a differentiated, novel treatment for atopic dermatitis," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "This quarter we also made key appointments to strengthen our management team and established a scientific advisory board comprised of global thought-leaders in dermatology and immunology. In addition, we expanded our US operations with a new office in Menlo Park, CA. We are entering the fourth quarter with strengthened operating position and poised to advance ASLAN004 in a 300-patient, Phase 2b trial before year-end, as well as advance our DHODH inhibitor, ASLAN003 into clinical trials early next year."

Third quarter 2021 and recent business highlights

Q3 and recent clinical developments

In September, positive top-line results were announced from the double-blind placebo-controlled MAD trial of ASLAN004. In the Intent to Treat (ITT) population, patients treated with ASLAN004 achieved a statistically significant improvement versus placebo in the primary efficacy endpoint of percent change from baseline in the Eczema Area Severity Index (EASI), and also showed significant improvements in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM).
In October, the Company announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD PhD, to conduct research that will continue throughout ASLAN’s Phase 2b program to identify and characterize the effects of ASLAN004 on disease-associated skin and serum-biomarkers in adults with moderate-to-severe AD. Dr Guttman-Yassky is Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and a world leader on inflammatory skin diseases. Her research has led to significant breakthroughs in the understanding of the immunologic basis of AD, providing the scientific community with greater clarity on the pathophysiology of the disease, which is complex and multifactorial.
In October, ASLAN-hosted the first in a series of Key Opinion Leader (KOL) webinars: the A4 Series: Aspects of Atopic Dermatitis and ASLAN004. For the first webinar, Associate Professor Jonathan Silverberg, MD PhD MPH, was a guest KOL speaker to discuss the heterogeneity in AD. To access a replay of this event, click here or go to the "Events and Presentations" section in ASLAN’s Investor Relations website at View Source A replay will be archived for 3 months immediately after the event.
Corporate updates

In July, ASLAN secured a loan facility with K2 HealthVentures of up to US$45.0 million of secured debt financing. The facility consists of a US$20.0 million initial term loan funded at closing, with the remaining US$25.0 million subject to certain terms and conditions. The proceeds will be used to advance the clinical development of ASLAN003 as well as for general corporate purposes.
In September, Dr Ferda Cevikbas was appointed as Executive Director, Head of Translational Science. Ferda joined ASLAN from Eli Lilly & Co where she was responsible for translational activities for lebrikizumab and other late-stage immunology projects. Prior to that, she was the Translational Scientist Lead for AD therapy, Eucrisa at Anacor / Pfizer, and held several academic positions at University of California, San Francisco. Ferda has a PhD from the University Hospital of Münster in Germany.
In September, a new Scientific Advisory Board (SAB) chaired by Dr Lawrence Eichenfield, MD FAAD, was established. Dr Eric Simpson, MD MCR, Dr Melinda Jennifer Gooderham, MSc MD FRCPC, Dr Jacob Thyssen, MD PhD DmSci, and Associate Professor Peter Foley, BMedSci MBBS MD FACD, were also appointed as members of the SAB.
In October, ASLAN opened a new office in the US in Menlo Park, California.
Anticipated upcoming milestones

First patient enrolment in global Phase 2b trial of ASLAN004 for AD expected in the fourth quarter of 2021.
Initiation of Phase 2 trial of ASLAN003 in inflammatory bowel disease expected in the first half of 2022.
Third quarter 2021 financial highlights

Cash used in operations for the third quarter of 2021 was US$7.6 million compared to US$2.6 million in the same period in 2020.
Research and development expenses were US$5.3 million in the third quarter of 2021 compared to US$2.2 million in the third quarter of 2020. The increase was driven primarily by preparations for the ASLAN004 Phase 2b clinical trial.
General and administrative expenses were US$2.8 million in the third quarter of 2021 compared to US$1.3 million in the third quarter of 2020. The increase was primarily driven by professional costs related to the debt financing activity completed in July, and the expansion of the US team.
Net loss for the third quarter of 2021 was US$8.6 million compared to a net loss of US$3.5 million for the third quarter of 2020.
Cash and cash equivalents totalled US$100.5 million as of September 30, 2021, compared to US$94.1 million as of June 30, 2021, and US$14.3 million as of December 31, 2020. Management believes that ASLAN’s cash and cash equivalents will be sufficient to fund operations through late 2023.
The weighted average number of ADSs outstanding in the computation of basic loss per share for the third quarter of 2021 was 69.7 million (representing 348 million ordinary shares) compared to 38.0 million (representing 190 million ordinary shares) for the third quarter of 2020. One ADS is the equivalent of five ordinary shares.