HOOKIPA Pharma to Report Third Quarter 2021 Financial Results on Wednesday, November 10, 2021

On November 3, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it will release third quarter 2021 financial results before the market opens on Wednesday, November 10, 2021 (Press release, Hookipa Biotech, NOV 3, 2021, View Source [SID1234594264]).

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The Company will not be conducting a conference call in conjunction with this earnings release.

TransThera Receives Fast Track Designation from FDA for its Core Product TT-00420 to Treat Cholangiocarcinoma

On November 3, 2021 TransThera Sciences (Nanjing) Inc., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule drug therapies for oncology, inflammatory and cardiovascular diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its phase II stage product TT-00420 for the treatment of patients with Cholangiocarcinoma (CCA) who have no standard treatment options (Press release, TransThera Biosciences, NOV 3, 2021, View Source [SID1234594281]).

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TT-00420 is a spectrum selective kinase inhibitor that is found to show high potency to a variety of clinically identified FGFR2 mutations in preclinical experiments. The unique combination of TT-00420’s target profile and mechanism of action also allow it to effectively treat patients with heterogeneous tumors, such as CCA patients without clear biomarkers.

The grant of Fast Track Designation is primarily based upon the clinical results of TT-00420 in its completed phase I study, in which nine CCA patients were enrolled and treated with TT-00420 at different dose levels. Seven patients had at least one post treatment efficacy assessment. Two achieved PR and five achieved SD. Among these evaluable patients, (i) Five harbored FGFR2 fusion or rearrangement and developed acquired resistance to prior treatment of FGFR inhibitors. One patient achieved PR with PFS about ten months. The other four patients achieved SD. (ii) One patient with primary resistance achieved PR with PFS about eight months. (iii) One patient without FGFR alterations achieved SD with shrinkage of target lesion. The clinical evidence supports the continuing exploration of TT-00420 in treating CCA patients with no standard treatment options.

"Receiving Fast Track Designation is an important milestone for the development of TT-00420." commented excitedly by Dr. Frank Wu, CEO of TransThera, "We have been and will continue to actively work with FDA, expediting the clinical development of TT-00420 in CCA field."

In November 2019, TT-00420 was already granted Orphan Drug Designation by FDA to treat Cholangiocarcinoma.

About TT-00420

TT-00420 is a highly innovative clinical-stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. A large number of preclinical studies have found that TT-00420 has promising inhibitory effect on triple-negative breast cancer, cholangiocarcinoma and other malignant tumors. In September 2018, TT-00420 was approved by the US FDA for the first human clinical trial; in February 2019, it was approved by China’s NMPA for human clinical trials; and in November of the same year, TT-00420 was granted the "Orphan Drug Designation" status (ODD) by FDA for the treatment of cholangiocarcinoma. In November 2020, it was again approved by the US FDA targeting the clinical trial of new indications for cholangiocarcinoma.

Herantis Pharma to Participate in the Upcoming Investor Conferences

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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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.

iTeos to Report Third Quarter 2021 Financial Results on November 10, 2021

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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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:
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Race Initiates University of Newcastle Collaboration to Develop a Genomics-based Companion Diagnostic for Zantrene

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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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.