On November 3, 2021 Herantis Pharma Plc ("Herantis"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, reported that Dr. Craig Cook, Chief Executive Officer, will hold 1×1 meetings and have a company presentation at the following investor conferences (Press release, Herantis Pharma, NOV 3, 2021, View Source,c3446216 [SID1234594328]):

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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

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Redeye Life Science Day 2021 – November 11th (Virtual)

Virtual Presentation at 16:10 – 16:30 EET / 15:10 – 15:30 CET

H.C. Wainwright 7th Annual Israel Virtual Conference – November 15, 2021

1×1 meetings and virtual presentation.

8th China HealthCare Summit, November 18 – 19, 2021 (Virtual)

1×1 meetings and virtual presentation.

All presentations will be available via a digital library, which is accessible to event participants only. Please contact the conference organizers, or send an email to [email protected], if you wish to schedule a meeting with Herantis.

On November 3, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that it will host a conference call and live webcast at 4:30 p.m. ET on Wednesday, November 10, 2021 to report its third quarter 2021 financial results and provide a corporate update (Press release, iTeos Therapeutics, NOV 3, 2021, View Source [SID1234594460]).

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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

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To access the live conference call, please dial 833-927-1758 (domestic) or 929-526-1599 (international) and refer to conference access code 861337. A live audio webcast of the event will also be accessible from the News and Events page of the Company’s website at View Source The archived webcast will be available approximately two hours after the completion of the event and for one week following the call.

To pre-register for the event, please use the following link to receive access details via email:
View Source

On November 3, 2021 Race Oncology Limited ("Race") reported that it has entered into a collaborative preclinical research program with The University of Newcastle to develop a companion diagnostic to support the use of Zantrene as a precision oncology treatment, targeting the FTO protein (Press release, Race Oncology, NOV 3, 2021, View Source [SID1234594208]). Eminent genomics researcher, Professor Murray Cairns of the University of Newcastle, will lead the project.

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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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Precision oncology utilises companion diagnostic tests to identify genetic changes in a patient’s cancer that render the cancer sensitive to a particular anti-cancer treatment1. By matching treatment to the cancer’s sensitivities, patients gain better treatment outcomes and avoid unnecessary side effects. Anti-cancer drugs with a companion diagnostic have a significantly increased probability of being approved by regulatory agencies like the US Food and Drug Administration, the European Medicines Agency and Australia’s Therapeutic Goods Administration2.

This project entitled "Genome-wide epitranscriptomic analysis of N6-methyl-adenosine modification at nucleotide resolution using RNA sequencing to identify biomarkers of aberrant tumour RNA methylation" builds on patentable IP developed by Race and will utilise the latest RNA genomics technologies to identify clinically relevant biomarkers of Zantrene sensitivity in human cancer cells and tissue samples.

"Race is extremely pleased to be working with Professor Cairns on this project. He is one of the leading researchers in the RNA genomics field and his background and expertise will maximise our chances of a successful outcome. For companies like Race, having a proprietary companion diagnostic is of increasing importance for our precision oncology clinical programs and will add significant IP protection around Zantrene."

Race Chief Scientific Officer, Dr Daniel Tillett
This work complements the recently announced FTO biomarker collaborative program with the Chaim Sheba Medical Center (ASX announcement: 27 October 2021) by focusing on understanding the m6A methylation status of RNA transcripts at the nucleotide level. This collaboration will provide critical mechanistic data on the effects of FTO inhibition by Zantrene in various cancer types.

"Zantrene’s potency as an FTO inhibitor provides an exciting new opportunity to target cancer by altering its RNA metabolism. I look forward to working with Race to develop a companion diagnostic for the drug’s precision usage in clinical oncology".

Professor Murray Cairns
The work is expected to support current and future clinical trials of Zantrene and provide the scientific basis for developing a clinically validated and Race-proprietary genetic companion diagnostic test for the targeted use of Zantrene in cancer treatment.

This preclinical research program is to start immediately with results to be reported over the coming 12 months.

1. Prasad, V., Fojo, T. & Brada, M. Precision oncology: origins, optimism, and potential. Lancet Oncol 17, e81–e86 (2016).

2. Valla, V. et al. Companion Diagnostics: State of the Art and New Regulations. Biomark Insights 16, (2021).

About Professor Murray Cairns
Professor Cairns is an NHMRC Senior Research Fellow, and Brawn Senior Fellow at the University of Newcastle’s College of Health, Medicine and Wellbeing. He heads the Precision Medicine Laboratory in the school of Biomedical Sciences and Pharmacy, which comprises a team of post-doctoral fellows, research assistants, bioinformaticians and research higher degree students. Professor Cairns has leveraged expertise in bioinformatics and high-throughput sequencing to establish an internationally recognised laboratory specialising in complex trait genomics. He is a leader in genetically informed precision medicine and is developing transformative approaches to address the problem of heterogeneity in the treatment of complex disorders.

Professor Cairns has attracted more than $14 million in funding to support his research programs, which have led to publications in the highest-ranking journals in the field, including Nature, Science, Cell, Nature Biotechnology, Nature Genetics, Nature Reviews Genetics, Nature Neuroscience and Molecular Psychiatry. Collectively, these publications have received more than 14,000 citations. His high-impact collaborative studies highlight an international reputation for research in complex disease genomics, posttranscriptional gene regulation, systems biology, and precision medicine.

On November 3, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecules to treat and improve the lives of patients with genetically defined cancers, reported financial results for the third quarter of 2021 (Press release, Biomea Fusion, NOV 3, 2021, View Source [SID1234594225]).

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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 Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program. BMF-219, our internally discovered and developed small molecule, has shown broad anti-cancer activity pre-clinically and we now have the opportunity to explore this potential in patients in need." said Thomas Butler, Biomea’s CEO and Chairman of the Board. "In September, we received FDA clearance of our IND for BMF-219, and we are now working diligently to initiate a Phase I study for the treatment of relapsed or refractory acute leukemia. We look forward to providing clinical development updates as we deepen our understanding of menin’s role in various cancers and the potential impact of irreversible inhibition for these patient populations. Our vision for this company has always been to develop a suite of novel covalent inhibitors that can act as single agent therapies or in combination, together, to build best-in-class medicine for patients. We have executed on this promise by hiring world-class drug hunters, and developers, and by custom designing and opening a state-of-the-art Research Center. We now have our first molecule ready for the clinic, and a number of exciting programs advancing through pre-clinical development."

Mr. Butler continued, "As we move BMF-219 into the clinic, we intend to also focus on leveraging our novel chemistry across multiple indications. To that end, we anticipate announcing our next pipeline candidate in the first half of 2022."

Business Highlights

FDA clearance of IND for First-in-Human Phase I Clinical Trial of BMF-219. In September 2021, Biomea received FDA clearance of its IND for BMF-219, an irreversible menin inhibitor for the treatment of relapsed or refractory acute leukemias including those with an MLL/KMT2A gene rearrangement or NPM1 mutation.
Preclinical studies underway for DLBCL and multiple myeloma (MM) as potential indications for BMF-219. Biomea is conducting preclinical studies to demonstrate the potential for BMF-219 in genetically defined patient subsets of DLBCL and MM.
Pathway validation studies of irreversible menin inhibition in diabetes. Biomea is continuing preclinical studies to explore the potential of its irreversible menin inhibitor approach for the treatment of type 2 diabetes. The company plans to report findings from these studies in the fourth quarter of 2021.
Launch of Biomea Innovation Center; scale-up of R&D organization. Biomea recently opened the Biomea Innovation Center with laboratory space and a dedicated R&D team focused on leveraging the company’s FUSION platform to generate a broad portfolio of next generation covalent inhibitors.
"Our CEO’s vision for the company is to build a fully sustainable, world-class R&D organization, which mines the deep potential of our FUSION platform and irreversible binding small molecule approach. With our recently opened Biomea Innovation Research Center and our continued scale-up of an extremely talented, forward-and creative-thinking scientific team, we will aggressively interrogate our irreversible binding approach against known and validated biological targets with the goal of rapidly advancing a broad portfolio of therapies designed to deliver enhanced efficacy and safety for patients. Thanks to our successful IPO and considering our current programs’ quarterly expenses, we expect our cash balance to sustain our operations well into 2024," concluded Ramses Erdtmann, Biomea’s COO and President.

Financial Highlights

Third Quarter 2021 Year to Date Financial Results

Biomea reported a net loss attributable to common stockholders of $26.9 million for the first nine months of 2021, compared to a net loss of $1.8 million for the same period in 2020.
Research and development expenses were $16.9 million for the first nine months of 2021, compared to $1.3 million for the same period in 2020. The increase of $15.6 million was primarily due to an increase in personnel-related expenses, as well as an increase in pre-clinical development costs, including manufacturing and external consulting, related to the IND-enabling studies for BMF-219.
General and administrative expenses were $10.0 million for the first nine months of 2021, compared to $0.5 million for the same period in 2020. The increase of $9.5 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s public company status.
As of September 30, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $191.9 million.
About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

About BMF-219

BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KMT2A gene rearrangement or NPM1 mutation.

On November 3, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it will host a key opinion leader roundtable discussion on the ReSPECT-GBM trial on Thursday, November 18, 2021, 4:00 to 5:00 p.m. ET (Press release, Cytori Therapeutics, NOV 3, 2021, View Source [SID1234594249]).

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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 webinar will feature a comprehensive discussion about the ongoing ReSPECT-GBM trial including key safety, tolerability, dosing, feasibility and efficacy data. Speakers will include:

Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principal investigator of the ReSPECT-GBM trial, will provide an update on the trial and provide insight on the trial data.
Toral Patel, M.D., Associate Professor, Department of Neurosurgery, UT Southwestern Medical Center, will provide her prospective on the use of convection enhanced delivery in neurosurgery.
Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, will discuss the technology behind 186RNL as well as an overview of the opportunities for radiotherapeutic development.
The webinar is intended to provide a comprehensive discussion of the trial data and an opportunity for questions from analysts, physicians and advocacy groups.

The ReSPECT-GBM Phase 1 clinical trial is evaluating the Company’s lead investigational asset, Rhenium-186 NanoLiposome (186RNL), in patients with recurrent glioblastoma (GBM). Dr. Brenner will also present ReSPECT-GBM data during a poster session on November 19, 2021, 7:30 – 9:30 p.m. ET, at the 2021 Society for Neuro-Oncology Annual Meeting and Education Day being held in Boston, Massachusetts.

Webcast Details

A live webinar with accompanying slides will be available in the Events page of the Investor Relations section of the Plus Therapeutics website. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 3170796.