On January 25, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on January 22, 2021 for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the tropomyosin receptor kinase (TRK) inhibitor, larotrectinib developed for the treatment of patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, also known as TRK fusion cancer (Press release, Chugai, JAN 25, 2021, View Source [SID1234574246]).

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"Chugai aims to advance personalized healthcare and it is an important step for us that FoundationOne CDx Cancer Genome Profile received approval as a companion diagnostic for larotrectinib, which was developed for the treatment of cancer patients with an NTRK gene fusion, a rare genomic alteration," said Dr. Osamu Okuda, Chugai’s President and COO. "We are committed to broaden the adaptation of this genomic profiling so that as many patients as possible can receive the appropriate treatment for the disease."

This approval expands the use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic to identify patients with TRK fusion cancer who could benefit from treatment with larotrectinib. The efficacy and safety of larotrectinib were investigated in the multiple clinical trials conducted by Bayer; a phase I trial in adult patients, the phase II NAVIGATE trial in adult and adolescent patients, and the phase I/II pediatric SCOUT trial. Bayer Yakuhin, Ltd. submitted an application for marketing authorization of larotrectinib for the treatment of patients with solid tumors harboring an NTRK gene fusion to the MHLW on May 22, 2020.

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

Approval information The underlined part has been 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)
NTRK1/2/3 fusion gene Solid tumors entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro 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 program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About larotrectinib
Larotrectinib, an oral selective TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. Larotrectinib was granted Orphan Drug Designation by the Ministry of Health, Labour and Welfare for the expected indication of "Locally advanced or metastatic solid tumor harboring an NTRK gene fusion."

On January 23, 2021 Scandion Oncology A/S ("Scandion" or the "Company") reported it has completed the first 12 patient cohort in the ongoing dose-range finding part of the clinical phase II study with SCO-101 in combination with chemotherapy (FOLFIRI) in patients with drug resistant metastatic colorectal cancer (Press release, Scandion Oncology, JAN 23, 2021, View Source,c3272887 [SID1234574546]). The Company has now received green light from the Data Safety Monitoring Board to move forward with the next treatment cohorts.

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In this first cohort from the CORIST study, all patients received combination treatment with SCO-101 and the chemotherapy regime FOLFIRI. The cohort was utilized to stepwise adjust the dose of chemotherapy when given together with a fixed dose of SCO-101.

First cohort has added significant understanding

CMO Peter Michael Vestlev: "The CORIST study is our first clinical study where SCO-101 is combined with chemotherapy in drug resistant cancer patients who have no further treatment options. The data has added significant understanding of how to proceed with the SCO-101 treatment. I am looking forward to the next cohorts and to perform the second part of this phase II clinical study."

Timeline maintained, readout expected in Q2, 2021

CEO Bo Rode Hansen: "Our clinical team together with the clinical investigators have done a great job in recruiting this many patients within a short time frame despite the COVID-19 situation. We maintain our expectation of a readout in Q2, 2021 from this first part of the CORIST study."

This information is information that Scandion Oncology A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on 23 January 2021.

On January 22 , 2021 PharmCAD, an artificial intelligence ( AI )-based new drug development company, reported that it signed a joint development agreement with Kainogen to develop and commercialize a new anticancer drug (Press release, PharmCADD, JAN 22, 2021, View Source [SID1234644206]).

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With this contract, PharmCAD plans to use the new drug development platform ‘Pharmulator’ to discover anticancer drug candidates optimized for Kainogen’s target proteins within 20 weeks and provide them to Kainogen. Kainogen will synthesize substances and conduct clinical trials.

Pharmulator is a new drug development platform that combines AI , physics, chemistry, and bioinformatics. It consists of modules for protein 3D structure prediction, molecular dynamics simulation, quantum calculation, toxicity prediction, and new drug creation. Through the combination of these modules, candidate substances with a high probability of success as a new drug can be derived.

Kainogen is a company developing a next-generation anti-cancer technology platform based on immunosynapse and immunometabolism technologies that strengthen the bond between cancer cells and immune cells.

Kainogen CEO Moon Ji-young said, "Through the joint development agreement, we will be able to further accelerate the speed of research and development of not only the immune anti-cancer drug pipeline that we are pursuing, but also the metabolic anti-cancer drug pipeline."

Taehyung Kwon, CEO of PharmCAD, said, "Through the joint development agreement with Kainogen, which is focusing on developing next-generation anticancer technology, we will be able to further strengthen the technological scalability and reliability of PharmCAD’s new drug development platform ‘Pamulator.’"

On January 22, 2021 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and Representative Director: Gyo Sagara; "ONO") and Helsinn Group (Lugano, Switzerland; CEO: Riccardo Braglia, "Helsinn") reported that ONO received the manufacturing and marketing approval of Adlumiz (generic name: anamorelin hydrochloride) Tablet 50mg ("Adlumiz"), a ghrelin receptor agonist, for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer in Japan (Press release, Ono, JAN 22, 2021, View Source [SID1234605556]).

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　This approval is mainly based on the results from the following two clinical studies conducted in Japan in patients with cancer cachexia:

Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study in cancer cachexia patients with non-small cell lung cancer (ONO-7643-04)

Phase III multi-center, open-label, uncontrolled study in cancer cachexia patients with gastric, pancreatic or colorectal cancer (ONO-7643-05)

　Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body weight (especially decreased muscle mass) and anorexia associated with cancer. It has been well documented that cancer cachexia causes a significant impact on patients’ quality of life and prognosis. To date, an effective treatment method for cancer cachexia has not yet been established.

　Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.

　Kiyoaki Idemitsu, Corporate Executive Officer and Executive Director, Clinical Development of ONO commented: "We are extremely pleased that Adlumiz has been approved for the indication of cancer cachexia in Japan. We believe that today’s approval can provide a promising new treatment option for the patients suffering from cancer cachexia for which there previously were no other approved treatment methods".

　Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: "We are delighted that Ono’s application has been successful for the treatment of cancer cachexia in Japan. This is an important milestone towards the improvement of the quality of life for all cancer cachexia patients, a condition that is still largely untreatable."

Overview of Adlumiz Tablet 50 mg
Product Name Adlumiz Tablet 50mg
Generic name (JAN) Anamorelin hydrochloride
Indication Cancer cachexia in the following malignant tumors:
Non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer
Dosage and administration Usually, for adults, administer 100 mg of anamorelin hydrochloride at fasting state orally once a day.
Manufacturer/distributor Ono Pharmaceutical Co., Ltd.
Approval date January 22, 2021
Conditions for approval
Risk Management Plan should be designed and appropriately implemented.
A post-marketing use-results survey covering all cases should be performed until data on a certain number of patients have been accumulated after the launch of the product in order to collect safety and efficacy data as early as possible and take measures necessary for the proper use of the product.

On January 22, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the 12th Annual RNA Therapeutics Virtual Conference, a UK based online event taking place February 10-11, 2021 (Press release, PCI Biotech, JAN 22, 2021, View Source [SID1234585156]). The 2021 conference is set to explore the latest developments in RNA delivery agents and RNA-based therapeutics with the latest case studies on advanced mRNA technologies, oligonucleotide delivery, therapeutic applications and future trends and innovations. PCI Biotech is also a sponsor of the event.

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On Wednesday, February 10, 2021 at 13:10pm (CET), Dr. Anders Høgset, CSO, will present an overview of PCI Biotech’s proprietary platform technology, focusing on the delivery of RNA molecules, including the most recent data on the use of the fimaNAc delivery technology in the exciting field of RNA based therapies. The presentation slides will be made available through a separate press release around the timing of the presentation and the full presentation will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Scientific publications & presentations" after the event.