On November 16, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 15, 2021, for FoundationOne CDx Cancer Genomic Profile to be used to identify advanced/recurrent tumor mutation burden-high (TMB-High; ≥10 mutations/megabase (mut/Mb)) solid tumors (Press release, Chugai, NOV 16, 2021, View Source [SID1234595672]). An application for a humanized anti-human PD-1 monoclonal antibody, pembrolizumab (genetical recombination) [Product name: Keytruda] in TMB-High solid tumors that have progressed following prior chemotherapy was submitted by MSD K.K. on March 11, 2021 and is currently under review with the MHLW.

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"The approval may enable physicians to make treatment suggestions based on TMB measurement. TMB is the third tumor-agnostic biomarker following NTRK fusion and high microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "We will continue to encourage the proper use of this test to support treatment decision-making, and therefore enable better access to targeted therapies by evaluating many potential gene alterations at one time."

With this approval, FoundationOne CDx Cancer Genomic Profile will help identify patients with TMB-High advanced/recurrent solid tumors.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care, and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information (underlined indicates newly added)

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden-high pembrolizumab (genetical recombination)*
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
* Application under review and not yet approved for the drug indication as of November, 2021

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro companion diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The device is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About tumor mutational burden
Tumor mutational burden (TMB) is a measure of the number of somatic mutations per coding region within a tumor’s genome. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome, and with a status of 10 mutations per megabase or more defined as TMB-High by the FoundationOne CDx Cancer Genomic Profile. More neoantigen is induced in TMB-High tumors, and such tumors may respond better to immune-checkpoint inhibitors. TMB-High tumors are reported to be relatively common in malignant melanoma, non-small cell lung cancer, colorectal cancer, and endometrial cancer1).

Trademarks used or mentioned in this release are protected by laws.

On November 16, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported its results for the third quarter of 2021 (Press release, BerGenBio, NOV 16, 2021, View Source [SID1234595671]).

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A presentation and live webcast by BerGenBio’s senior management will take place at 10am CET today, please see below for details.

Operational Highlights – third quarter of 2021 (including post-period end)

Martin Olin appointed Chief Executive Officer, bringing 20 years of executive experience in the pharmaceutical and biotechnology industry. Previous roles include CEO of Symphogen
Post-period end, NSCLC data presented at SITC (Free SITC Whitepaper), highlighting bemcentinib’s potential in NSCLC patients harbouring STK11 mutations
AML data presented at EHA (Free EHA Whitepaper) indicate bemcentinib/LDAC combination is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy
COVID-19 data in a late-breaking abstract presentation at ECCMID demonstrate encouraging evidence for the effect of bemcentinib in hospitalised patients receiving steroids ± remdesivir
Financial Highlights – third quarter of 2021

Revenue amounted to NOK 0.0 million (Q3 2020: NOK 0.0 million)
Total operating expenses were NOK 71.4 million (Q3 2020: NOK 68.3 million)
Q3 operating loss of NOK 70.5 million, decreased compared to previous quarters, (Q3 2020: NOK 67.3 million)
A strong cash position of NOK 509.4 million at end of Q3 2021
Martin Olin, Chief Executive Officer of BerGenBio, commented: "It is my great pleasure to provide an update on BerGenBio’s progress over the last quarter, my first since joining the Company as CEO in September 2021. Having completed a strategic review of operations following my appointment, we have reiterated our focus on pursuing a rigorous data driven approach of connecting a consistent scientific rationale, pre-clinical and clinical data to high unmet medical needs will enable us to define the best possible path to registration as well as unlocking significant market potential.

"Our focus will be the clinical development of bemcentinib as a second line treatment in relapsed AML, building on the promising data accumulated so far with the planned initiation of a confirmatory randomized placebo-controlled trial in H2 2022. The clinical development of the NSCLC program continues, and a Phase 1b trial investigating bemcentinib in patients with STK11 mutations in 1L NSCLC is also scheduled to be initiated in H1 2022.

"We will also look to validate our COVID-19 clinical data through a confirmatory randomized placebo-controlled trial supported by a major, multinational collaboration that provides access to a large number of sites across Europe and established infrastructure at significantly reduced cost to BerGenBio. We anticipate this study to commence in H1 2022.

"The Company is well-funded with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders. I look forward to providing further updates on our progress in due course."

Presentation and Webcast Details

An in-person briefing will take place at 10:00 am CET at: Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo where BerGenBio’s senior management team will provide an update on the Company followed by a Q&A session.

The presentation will also be webcast live, details below.

The Q3 2021 report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On November 16, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the 4th Annual Evercore ISI HealthCONx Conference on Tuesday, Nov. 30 at 8:25 a.m. ET (Press release, PTC Therapeutics, NOV 16, 2021, View Source [SID1234595669]).

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The presentation will be webcast live on the Events and Presentations page on the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On November 16, 2021 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company will present two abstracts at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will be held virtually and in-person in Atlanta, Ga. December 11-14, 2021 (Press release, Aptevo Therapeutics, NOV 16, 2021, View Source [SID1234595633]).

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Details of the presentations are as follows:

Title: "Tolerability and Single Agent Anti-Neoplastic Activity of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory AML or MDS"
Lead Author: Justin M. Watts, M.D., Sylvester Comprehensive Cancer Center and University of Miami Health System, Miami, Florida
Date/Time: Monday, December 13, 2021, 6:00 PM-8:00 PM
Online Access: View Source

Title: "Risk and Severity of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436"
Lead Author: Tara L. Lin, M.D., University of Kansas Cancer Center, Westwood, Kansas
Date/Time: Monday, December 13, 2021, 6:00 PM-8:00 PM
Online Access: View Source

About APVO436
Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo’s lead proprietary drug candidate, APVO436 is a bispecific ADAPTIR that targets CD123 x CD3 and is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger a rapid and complete destruction of leukemia cells. APVO436 has been engineered using Aptevo’s proprietary and enabling bioengineering methods and is designed to reduce the likelihood and severity of an unintended and potentially harmful activation of the immune system. APVO436 has been engineered to stay in the blood circulation long enough to locate, bind with and destroy target leukemia cells. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.

On November 15, 2021 Gate2Brain reported the company seeks capital to advance its first therapy (Press release, Gate2Brain, NOV 15, 2021, View Source [SID1234641091]). The Spanish biotechnology company has opened a bridge financing round of one million euros to carry out the "key trials" of its cancer therapy, which are prior to the clinical phase.

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In 2022, the company plans to open another round of five million more euros , with which all regulatory and non-regulatory preclinical trials will be carried out, according to Meritxell Teixidó, CEO of the company, to PlantaDoce. Gate2Brain expects the human clinical trial to take place in 2024.

The Spanish biotechnology company develops a patented technology based on peptides with the aim of improving the effectiveness of therapies against childhood tumors. The most important characteristic of the start-up is that it is focused on overcoming the physiological obstacles inherent to the human body , such as the blood-brain barrier.

Gate2Brain plans that its technology will allow pharmaceutical companies to recover drugs that do not end up reaching the market

The first therapy of its technological platform, named G2B-002, is aimed at the treatment of rare pediatric solid tumors . This treatment "acts as a shuttle and facilitates the arrival of the drug to the tumor areas," explains Teixidó. The company’s approach combines expertise in oncology, rare diseases and pediatrics.

The Barcelona start-up also plans that its technology will allow pharmaceutical companies to recover medications that do not end up reaching the market due to the impossibility of reaching the brain. In this sense, the company’s CEO states that "98% of drug candidates are discarded because they do not pass the blood-brain barrier." The company is in contact with some pharmaceutical companies.

At the beginning of the year, Gate2Brain was looking for up to three million euros to reach the clinical trial and planned to open a financing round. The objective of this round was already to find the capital necessary to reach the clinical trial, although the company’s plans have been adapted to the new planning, which increases the economic volume, but lengthens the deadlines and divides the round into two stages .

The founders control the majority of the company’s shareholders

Gate2Brain has received support from the Mind The Gap Program, from the Botín Foundation, which has invested half a million euros in the project. The start-up also obtained support from the CaixaImpulse program, from the La Caixa Foundation, funding from the Agency for Management and University Research Grants (Agaur) and from Banc Sabadell. In total, the company has raised 600,000 euros so far .

The founders control the majority of the company’s shareholders. Gate2Brain has been created by researchers from IRB Barcelona, ​​the University of Barcelona and the Sant Joan de Déu Research Institute. The company has its headquarters in the Barcelona Science Park .