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On November 26, 2021Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it was awarded of the 2021 Innovation Award in the "Life Sciences" category at the 31st ADRIQ Innovation Awards Gala held on November 25, 2021 (Press release, Theratechnologies, NOV 26, 2021, View Source [SID1234596239]).
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Every year, the ADRIQ (Association pour le développement de la recherche et de l’innovation du Québec) gala rewards Quebec-based companies for leadership in innovation in their respective field.
At the beginning of 2021, Theratechnologies received the United States Food and Drug Administration’s "Fast-track" designation for TH1902 as a single agent for the treatment of patients with advanced and recurrent solid tumors expressing the sortilin receptor and refractory to standard treatments. TH1902 is the lead peptide-drug conjugate derived from the SORT1+ Technology in oncology.
"It is quite rare to obtain the "fast-track" designation this early in the drug development process and this was achieved through spectacular preclinical data. We are very proud of this achievement and look forward to the future with great hope for patients," said Mr. Paul Lévesque, President and Chief Executive Officer of Theratechnologies.
About TH1902 TH1902 combines Theratechnologies’ proprietary peptide to docetaxel. This peptide-drug conjugate is the lead candidate stemming from Theratechnologies’ SORT1+ Technology in oncology.
The Canadian Cancer Society and the Government of Quebec, through the Consortium Québécois sur la découverte du médicament (CQDM), contributes a total of 1.4 million dollars towards some of the research currently being conducted for the development of Theratechnologies’ targeted oncology platform.
On November 26, 2021 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at Aktiespararna’s Stora Aktiedagen Stockholm on December 2, 2021 (Press release, Oasmia, NOV 26, 2021, View Source [SID1234596108]). The presentation starts at 9:30 CET and will be broadcast live as a webcast at: www.aktiespararna.se/tv/live.
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The presentation will be available online the following day on www.aktiespararna.se/tv/evenemang and on Oasmia Pharmaceutical’s website www.oasmia.com.
On November 25, 2021 ImmunoPrecise (IPA) reported that it will be attending The BioTech Pharma Summit November 29-30, 2021 being held in Porto, Portugal and virtually (Press release, ImmunoPrecise Antibodies, NOV 25, 2021, View Source [SID1234596033]). BioTech Pharma Summit brings together a large number of pharma industry buyers and sellers all under one roof.
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On November 25, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibody Herceptin Injection 60 and 150 [generic name: trastuzumab] for the additional indication of advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection (Press release, Chugai, NOV 25, 2021, View Source [SID1234596079]). Orphan drug designation had been granted by the MHLW on March 11, 2021 for this indication.
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Salivary gland cancer, a type of head and neck cancer, is a rare cancer with less than 1,000 patients newly diagnosed annually in Japan1. The standard therapy is primarily surgery, and there is no established chemotherapy for this cancer. Unlike other head and neck cancers, salivary gland cancer includes many histological types, associated with diversity in genomic alterations and prognosis. Less than 15% of all salivary cancers in Japan are estimated to be HER2-positive, relatively more common in salivary duct carcinomas.
"We are very pleased that Herceptin has become a new treatment option as the first personalized medicine for salivary gland cancer, for which no standard chemotherapy has been established so far. I’d like to thank everyone who strongly supported us toward the approval based on evidence from Japan, particularly those involved in the investigator-initiated clinical trial that formed the basis for approval," said Chugai’s President and CEO, Dr. Osamu Okuda. "Herceptin has been used as a standard treatment for breast and gastric cancer for many years. We are committed to promoting appropriate use of Herceptin so that it can contribute to the treatment of salivary gland cancer, a cancer with high unmet needs."
The approval is based on a Japanese investigator-initiated phase II clinical study (HUON-003-01 study) with 16 patients with HER2-positive advanced or recurrent salivary gland cancer. The study investigated the efficacy and safety of Herceptin in combination with docetaxel. The primary endpoint was the response rate. 60% of 15 patients in the efficacy analysis population showed response (95%Cl: 32.3 – 83.7). Major adverse events included neutropenia, leukopenia, alopecia, anemia, stomatitis, and hypoalbuminemia.
HER2 protein overexpression and gene amplification should be determined with the pathological testing kit VENTANA ultraView Pathway HER2 (4B5) and VENTANA DISH HER2, both provided by Roche Diagnostics K.K. obtained regulatory approval for the two tests on November 11, 2021 as companion diagnostics for Herceptin to identify advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection.
[Approval Information] *Changes are underlined.
Indications
Breast cancer overexpressing HER2 Advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection Dosage and administration
Use either Regimen A or Regimen B for breast cancer overexpressing HER2. Use Regimen B for advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection, in combination with other antineoplastic agents. Use Regimen B in combination with docetaxel formulation for advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection. Regimen A: The usual adult dosage is a loading dose of 4 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 2 mg/kg once a week, each administered by intravenous infusion over at least 90 minutes.
Regimen B: The usual adult dosage is a loading dose of 8 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 6 mg/kg every 3 weeks, each administered by intravenous infusion over at least 90 minutes.
If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.
About Herceptin Herceptin is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Herceptin was launched in 2001 for metastatic breast cancer overexpressing HER2. In 2011, it was approved for the treatment of patients with advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection.
About Salivary Gland Cancer Salivary gland cancer is a type of head and neck cancer2,3 and develops in the cells that form salivary gland tissues. It is characterized by a variety of histological patterns as classified into 21 types4, making pathological diagnosis difficult5. Recently, gene expression and abnormalities that define features of each histological type have become increasingly clear6. About 80% of salivary gland tumors are in the parotid gland, of which about 20% are malignant2. Standard therapy includes surgery, radiation therapy, and pharmacological treatment, and no standard chemotherapy has been established for advanced or recurrent salivary gland cancer7.
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Japan Society for Head and Neck Cancer Registry Committee, Report of Head and Neck Cancer Registry of Japan Clinical Statistics of Registered Patients, 2018 View Source Accessed November 2021 Institute of Medical Information Science, ed. Diseases in View vol.13 Otorhinolaryngology, 1st edition, Medic Media, 2020. Japan Society for Head and Neck Cancer, ed. Manual of Head and Neck Cancer, 6th revised edition, Kanehara Shuppan, 2019 WHO Classification of Head and Neck Tumors. Fourth edition, 2017 Toshitaka Nagao. Ear and nose. 59(Supplement 1): S32-37, 2013 Japan Salivary Gland Society, ed. Thorough Lecture on Saliva and Salivary Glands, Kanehara Shuppan, 2016 Japan Society for Head and Neck Cancer, ed. Guidelines for the Treatment of Head and Neck Cancer 2018 Edition, Kanehara Shuppan, 2017
On November 25, 2021 Priothera Limited, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported the appointment of Elisabeth Kueenburg, M.D., as Chief Medical Officer (Press release, Priothera, NOV 25, 2021, View Source [SID1234596081]). Dr. Kueenburg will lead the advancement of mocravimod into Phase 2b/3 clinical trials as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving hematopoietic stem cell transplantation (HSCT), and expansion of Priothera’s pipeline.
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"The breadth of knowledge Elisabeth has gained working at Celgene, alongside her extensive clinical experience, makes her a crucial addition to our team," said Florent Gros, Co-Founder and CEO of Priothera. "We are delighted to welcome Elisabeth during this exciting time as we look to progress mocravimod, into a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia receiving hematopoietic stem cell transplantation. The study is expected to begin in 2022."
"I am pleased to join Priothera at such an important stage of its development," said Dr. Kueenburg. "Mocravimod has the potential to address the significant unmet need of AML patients undergoing HSCT. I look forward to guiding mocravimod and future programs into the clinic and making an important contribution to Priothera’s future success."
Dr. Kueenburg brings significant drug development and medical affairs experience from her years at Celgene where she most recently served as Clinical Development Lead. At Celgene she developed deep clinical development and medical affairs expertise, providing strategic insight and overseeing the coordination of multiple clinical trials, in the area of hematology and specifically in multiple myeloma. Furthermore, Dr. Kueenburg has supported the successful global launch of Celgene’s Revlimid.
Prior to her numerous roles at Celgene, Dr. Kueenburg spent more than 15 years in clinical practice and academic research specializing in oncology and hematology.
Dr. Kueenburg gained her Doctor of Medicine from the University of Vienna in Austria.