On October 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its third quarter 2021 financial results before the market opens on Thursday, November 4, 2021 (Press release, Personalis, OCT 21, 2021, View Source [SID1234591713]). In conjunction with the release, the company will host a conference call and webcast that day at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 7896264. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On October 21, 2021 Mablink Bioscience S.A.S. a biotechnology company developing a pipeline of ADC based on its proprietary PSARlink drug-linker technology and Emergence Therapeutics AG, a European biopharmaceutical company developing novel antibody drug conjugate (ADC) immuno-therapeutics to treat cancers with high unmet needs reported that they entered into a Licensing Agreement (Press release, Mablink Bioscience, OCT 21, 2021, View Source [SID1234591752]). Under the terms of the agreement, Emergence Therapeutics will use a PSARlink drug-linker developed by Mablink to develop an ADC targeting Nectin-4, a protein overexpressed in several severe cancers.

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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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Jack Elands, CEO of Emergence Therapeutics said: "Mablink Bioscience’s technology, PSARlink, which is based on a hydrophilic linker using a polysarcosine arm, enabled us to design a Nectin-4 ADC loaded with the cytotoxic agent of our choice, whilst retaining the antibody’s pharmacological properties. This technology has the potential to widen the therapeutic index of an ADC and to make our Nectin-4 ADC a best-in-class. The preclinical data we obtained so far are very encouraging in this regard." Jean-Guillaume Lafay, CEO of Mablink Bioscience added: "We have developed a unique technology that we believe solves the core issue that impaired so many ADC developments. Grafting cytotoxic molecules to an Antibody usually creates a rather hydrophobic ADC, which is correlated with poor pharmacological properties (low drug-exposure and general toxicity issues). While Mablink Bioscience develops its own drug candidates targeting several difficult-to-treat cancers, we are delighted to be joined by Emergence Therapeutics in our effort to develop the 3rd generation of ADCs and to bring new, more efficient, therapeutic options to cancer patients."

Pursuant to the agreement, Mablink Bioscience is entitled to receive milestone and royalty payments, based on the development of the Nectin-4 ADC.

About PSARlink

PSARlink drug-linkers are a chemical physical link that can be placed between an antibody and a chosen cytotoxic molecule to be delivered into tumor cells. PSARlink’s unique structure "masks" the cytotoxic molecules, especially hydrophobic compounds, and provides a "stealthy" property to such antibody drug conjugates, enabling them to stay longer in the body, giving them more time to destroy tumor cells. At the same time, making ADC stealth avoids most of the damage typically caused by such molecules to healthy cells: PSARlink-based ADC are better tolerated. These improvements translate into a 10-fold increase of the therapeutic index observed in animal models, a potentially game changing factor for future clinical success.

On October 21, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different mechanisms of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), reported that it has scheduled its third quarter 2021 financial results and corporate update for Thursday, November 4, 2021 (Press release, Arbutus Biopharma, OCT 21, 2021, View Source [SID1234591673]). The schedule for the press release and conference call/webcast are as follows:

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•Q3/2021 Press Release: Thursday, November 4, 2021 at 7:30 a.m. ET
•Q3/2021 Conference Call/Webcast: Thursday, November 4, 2021 at 8:45 a.m. ET
•Domestic Dial-In Number: (866) 393-1607
•International Dial-In Number: (914) 495-8556
•Conference ID Number: 5035306
A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 5035306.

On October 21, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported dosing of the first patient in the Phase 2 expansion of an ongoing open-label Phase 1/2 study investigating eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790) (Press release, Karyopharm, OCT 21, 2021, View Source [SID1234591692]). The Phase 2 expansion is designed to evaluate eltanexor monotherapy in patients with hypomethylating agents (HMA) refractory, intermediate or high-risk myelodysplastic syndrome (MDS). The primary endpoint for this Phase 2 expansion is overall response rate (ORR) with the secondary endpoints of determining progression-free and overall survival.

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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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Initiation of the Phase 2 expansion follows encouraging results from the Phase 1 portion of the study where single-agent eltanexor showed activity in patients with high-risk, relapsed MDS that was refractory to HMAs. In that study (Sangmin, et al. EHA (Free EHA Whitepaper) 2021), eltanexor demonstrated a 53% ORR and a median overall survival of 9.9 months, comparing favorably to historical controls. At the recommended Phase 2 dose of 10 mg, eltanexor monotherapy was well tolerated with low incidence and grade of gastrointestinal events. Exacerbation of cytopenias occurred in 20-40% of patients. Based on these promising signals, the study has been expanded to include an additional 83 patients with the first patient recently dosed.

"MDS is a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function, leading to a high risk of transformation into acute leukemia. HMAs are the current standard of care for patients with newly diagnosed, higher-risk MDS, however only 40-60% patients respond, with these responses typically lasting less than two years. As such, prognosis in HMA refractory disease is poor, with a median overall survival of four to six months. With no agents currently approved for primary HMA refractory MDS, the need for novel, efficacious agents is critical. Based on the promising signal observed in the prior Phase 1 study, we are pleased to initiate dosing in the Phase 2 expansion and look forward to updating you on the progress of this important study in the future," said Sharon Shacham, PhD, MBA, Co-Founder and Chief Scientific Officer of Karyopharm.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that, like selinexor, functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure at higher levels than is possible with selinexor. As a result, we believe that eltanexor represents another novel SINE compound and we are evaluating its safety, tolerability and efficacy in ongoing clinical studies.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration, Health Canada, the European Medicines Agency, or any other regulatory agency.

On October 21, 2021 Biognosys, a leading inventor and developer of mass spectrometry-based proteomics solutions, reported they will be presenting major scientific and technological advances on their proprietary proteomics research services, software, and kits at the American Society for Mass Spectrometry (ASMS) Annual Conference from October 31st to November 4th in Philadelphia (USA) (Press release, Biognosys, OCT 21, 2021, View Source [SID1234591715]).

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Biognosys will present a record number of 3 oral presentations, 10 scientific posters, 2 poster collaborations, 1 workshop panel, and 2 Spectronaut breakfast seminars. In addition, their team of scientific experts will be present at booth #224 to answer questions and demo software. Further demo sessions will be offered at the Bruker Daltonics booth #719.

Collectively, this presence demonstrates Biognosys’ significant contributions to transforming life science and clinical research with next-generation proteomics, particularly in the areas of plasma proteomics, immunopeptidomics, and proteomics data analysis.

Lukas Reiter, PhD, Chief Technology Officer of Biognosys:
"Our major contribution to the ASMS scientific program is a testimony of Biognosys’ relentless commitment to innovation in mass spectrometry-based proteomics and progress in life science and clinical research."

Discovering biomarkers in cancer with next-generation plasma proteomics

The plasma proteome is an underexplored source of insights on the health state of an individual. Biognosys will present results from a deep human plasma profiling study on a cohort of 180 lung, breast, colorectal, pancreatic, and prostate cancer patients, using an early version of their next-generation Plasma Biomarker Discovery workflow, launching in November. The workflow is optimized for use on Thermo Fisher Scientific Exploris 480 and FAIMS Pro instruments. Out of the entire plasma proteome, they quantified over 2,700 proteins and identified a protein panel with a significant positive predictive value for individual cancer stages.

Andreas Huhmer, Senior Director Life Sciences Research OMICS Marketing at Thermo Fisher Scientific:
"Biognosys has a proven track record for maximizing all innovative features of the Thermo Scientific Orbitrap mass spectrometers in state-of-the-art proteome analysis. Their new Plasma Biomarker Discovery workflow is a good example of this. The unprecedented depth and quantitative precision they can achieve, coupled with the inherently unbiased nature of mass spectrometry-based analysis, has the potential to take plasma biomarker discovery to the next level."

Gaining insights on the immune system to support personalized drug development

Immunopeptides play an essential role in the immune system and can be analyzed to support the development of personalized treatments. Mass spectrometry is currently the only technology that can reliably measure and identify immunopeptide profiles of biological samples on a large scale. Biognosys will present their immunopeptidomics workflow, optimized to provide deep and comprehensive biological insights on the immune system in large-scale clinical studies.

Turning data to insights with Spectronaut, SpectroMine, and SpectroDive

Biognosys provides leading software products for proteomics data analysis. In a series of talks, their team will detail how they leverage the latest developments in Machine Learning and Deep Learning to allow deeper insights into the proteome. Biognosys is also excited to host two breakfast seminars with three guest speakers sharing their latest results from using Spectronaut in their research projects. In addition, a sneak-peak into the next planned release will be disclosed.

Gary Kruppa, Vice President, Proteomics at Bruker Daltonics:
"Biognosys’ software tools are among the top solutions for the analysis of proteomics data generated with Bruker instruments. Particularly the latest Spectronaut version yields spectacular performance improvements for dia-PASEF data. We invite all Bruker users to experience Spectronaut’s capabilities and enjoy the exceptional support Biognosys provides."

Visit biognosys.com/asms2021 for a complete overview of Biognosys’ presence at ASMS.