On September 25, 2019 ImaginAb Inc., a clinical-stage immuno-oncology imaging company, reported it has enrolled its first patient for the Phase II clinical trial of its lead product CD8 tracer, 89Zr-Df-IAB22M2C, at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) (Press release, ImaginAb, SEP 25, 2019, View Source [SID1234539761]). This study is a collaboration between UAB’s Division of Hematology and Oncology and Division of Molecular Imaging and Therapeutics, reflecting UAB’s commitment to world-class research and clinical care.

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89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, enabling treatment to be tailored quickly and specifically to the needs of that patient.

UAB is one of ImaginAb’s active clinical sites conducting Phase II baseline/on-treatment clinical trials investigating the utility of ImaginAb’s CD8 tracer, 89Zr-Df-IAB22M2C, to image CD8 T cells before (baseline) and after (on-treatment) cancer patients receive immunotherapy-based treatment.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to predict, inform, monitor and enable the treatment of cancer more effectively. We are delighted to have enrolled and imaged our first patient in this ongoing clinical study at UAB, a world-renowned research center in Nuclear Medicine and Molecular Imaging."

The trial will enroll advanced and metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8+ T cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

The ImaginAb team will be at the European Society for Medical Oncology ESMO (Free ESMO Whitepaper) Congress 2019 at Fira Gran Via, Barcelona from September 27 to October 1, 2019. Dr. Anna Wu, Chief Scientific Advisor, and Board member and Dr. Toni Ribas, Ph.D., ImaginAb Science Advisory Board Member and President-Elect for The American Association for Cancer Research (AACR) (Free AACR Whitepaper), will be attending and hosting meetings. In addition, ImaginAb’s commercial team led by Ivan Plavec, Chief Business Officer (CBO), will be hosting meetings and available at the ImaginAb Booth #477.

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144

On September 25, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained the approval of expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for anti-tumor agent/PARP inhibitor Lynparza (generic name: olaparib) for the maintenance treatment after 1st line chemotherapy in patients with BRCA-mutated advanced ovarian cancer from the Ministry of Health, Labour and Welfare (MHLW) (Press release, Chugai, SEP 25, 2019, View Source [SID1234539760]). With this approval, Foundation One CDx Cancer Genomic Profile will be available in Japan as a companion diagnostic for 15 therapies.

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The approval allows physicians to identify patients with BRCA-mutated advanced ovarian cancer who could benefit from Lynparza as a maintenance treatment after 1st line chemotherapy by detecting BRCA1/2 gene mutations. In Japan, AstraZeneca (LSE/STO/NYSE: AZN) has obtained approval for an additional indication of maintenance treatment after 1st line chemotherapy in patients with BRCA-mutated ovarian cancer for Lynparza from the MHLW on June 19, 2019.1) Under the global strategic oncology collaboration between AstraZeneca and MSD (NYSE: MRK), the two company has jointly commercialized Lynparza in Japan.

"We are pleased that FoundationOne CDx Cancer Genomic Profile has been approved as a companion diagnostic for Lynparza in certain patients with advanced ovarian cancer," said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. "The program is the first MHLW-approved companion diagnostic which can detect BRCA alterations including both germline and somatic mutations in Japan.* We are committed to improve patient access for optimal treatment through the program."

"The approval of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Lynparza (olaparib) in women with ovarian cancer represents significant progress in delivering precision medicine to more Japanese patients via our strong collaboration with Foundation Medicine Inc. and Chugai Foundation Medicine Unit.," said Ruth March, Ph.D., Senior Vice President and Head of Precision Medicine, Oncology R&D, AstraZeneca.

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 molecular-targeted drugs approved in Japan.

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

* FoundationOne CDx Cancer Genome Profile detects BRCA mutation including both germline (inherited) and somatic (acquired) mutations, but its report does not provide information on the origin of mutation.

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
EGFR exon 19 deletions and EGFR exon 21 L858R 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
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
BRCA1/2 alterations Ovarian cancer olaparib
Trademarks used or mentioned in this release are protected by laws.

[Reference]

Lynparza approved in Japan for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer. Press release issued by AstraZeneca on June 19, 2019. View Source (Accessed on September, 2019)

On September 25, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported that the management team is scheduled to conduct one-on-one meetings at the Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies, and to present and conduct one-on-one meetings at the 2019 Cantor Global Healthcare Conference (Press release, X4 Pharmaceuticals, SEP 25, 2019, View Source [SID1234539587]).

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Details related to the team’s participation are as follows:

Conference:
Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies

Location:

New York, NY

Date:

September 23rd

Conference:

2019 Cantor Global Healthcare Conference

Location:

New York, NY

Presentation Date & Time:

October 2nd at 4:10 pm EDT

On September 24, 2019 The Ivy Brain Tumor Center at Barrow Neurological Institute, reported a new collaboration with QED Therapeutics, Inc., a subsidiary of BridgeBio Pharma, Inc., (Nasdaq:BBIO) to investigate the FGFR1-3 tyrosine kinase inhibitor, infigratinib, for the treatment of glioblastoma (GBM) (Press release, The Ivy Brain Tumor Center, SEP 24, 2019, View Source [SID1234576263]). With the goal of addressing unmet medical needs for those affected by malignant brain cancer, this collaboration will focus on targeting FGFR (fibroblast growth factor receptor) genetic alterations that have been shown to spur growth in malignant tumors.

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"Five to seven percent of glioblastoma patients’ tumors are driven by FGFR signaling," said Dr. Nader Sanai, director of the Ivy Brain Tumor Center. "We believe our collaboration with QED Therapeutics will enable us to test how FGFR-driven GBM tumors respond to infigratinib. If proven effective, we then intend to move forward new combined drug strategies incorporating this target."

In the preclinical studies, the Ivy Center will employ orthotopically implanted, well-characterized FGFR3 fusion patient-derived xenograft models. This is intended to allow the team to further explore the extent to which the drug crosses the blood-brain barrier and what activity it has in the brain.

"We believe the work we are undertaking with the Ivy Center will provide critical insight to shape our clinical development strategy for this disease," said Susan Moran, M.D., M.S.C.E., chief medical officer of QED Therapeutics. "Our hope is that infigratinib will become the backbone of new combination therapies to treat patients with glioblastoma."

Infigratinib is an orally administered, FGFR1-3 selective tyrosine kinase inhibitor. QED Therapeutics has observed activity that appears to be meaningful in clinical trials for cancers that are driven by errors in the FGFR genes. These include chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genetic alterations.

"The intricacies of the brain have posed significant challenges for brain cancer research and the development of therapies," said Gary Li, head of translational medicine at QED Therapeutics. "We believe collaborating with the Ivy Brain Tumor Center will enable us to move swiftly and further translational research that we hope will unlock the doors to effective treatment options."

On Spetember 24, 2019 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research in immuno-oncology announced today that it has signed a licensing agreement with Hanmi Pharmaceutical Co., LTD (Hanmi), a well-known global player in the biopharmaceutical field, for the development of bi- and/or multi-specific antibodies for immuno-oncology applications (Press release, Hanmi, SEP 24, 2019, View Source;board_id=INFORMATION_ENGLISH_NEWS [SID1234573788]). Under the terms of the agreement, Hanmi will evaluate and license antibody sequences against an undisclosed target from Phanes and use them in multiple projects under the Pentambody platform, a proprietary bispecific antibody technology developed by Hanmi’s subsidiary in Beijing.

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Under the terms of the agreement, Hanmi will be responsible for the discovery, development, manufacturing and commercialization of the bi- and/or multi-specific antibodies and has exclusive worldwide commercial rights to the molecules for any cancer indications. Phanes will receive upfront and milestone payments plus royalty fees. The details of the financial terms were not disclosed.

"Phanes is an emerging leader in innovative discovery research in the immuno-oncology area and we have demonstrated significant differentiations that we believe will be clinically meaningful in multiple internal programs. We are extremely excited about partnering with Hanmi in the bi- and multi-specific antibodies area with the ultimate goal of providing cancer patients with new treatment options. We have clearly demonstrated the differentiation between our lead mAb and competitor molecules with respect to its mechanism of action. It has great potential to resolve the issues we are facing in the clinic," said Dr. Ming Wang, PhD, MBA, CEO of Phanes Therapeutics, "At Phanes, our mission is to become a source of innovation in the biopharma industry and we are fully committed to delivering robust therapeutic molecules to patients. But we can’t do it alone; we will continue to leverage partnerships with companies that have capabilities complementary to ours."

"Through the collaboration with Phanes, we are planning to expand the potential of the Pentambody platform in innovative immuno-oncology field and generate new treatment options for patients suffering from cancers." said Sechang Kwon, President and CEO of Hanmi pharmaceuticals.