1stOncology is recognized as a Top 10 Global Pharma Analytic Provider
Continue your journey with 1stOncology by accessing our Free Leading Cancer Conference Whitepapers, signing up for our Free Weekly Newsletter and requesting a Free Demo to see how we can help you be 1st in Oncology!
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.
Schedule your 30 min Free 1stOncology Demo! Discover why more than 1,500 members use 1stOncology™ to excel in:
"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.
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.
Schedule your 30 min Free 1stOncology Demo! Discover why more than 1,500 members use 1stOncology™ to excel in:
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.
The product names listed above are protected by law.
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 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.
Schedule your 30 min Free 1stOncology Demo! Discover why more than 1,500 members use 1stOncology™ to excel in:
On November 24, 2021 Rousselot B.V. and Zerion Pharma ApS reported that they have strengthened their partnership through an extension of an exclusive license agreement entered into in 2019 (Press release, Zerion, NOV 24, 2021, View Source [SID1234598619]). According to the revised license agreement, Rousselot grants Zerion Pharma an exclusive license to exploit the inventions covered by the patent family belonging to international patent application WO 2017/186889. The revision of the license agreement follows the recent grant of a key European Patent No. 17 722 708.9 that is included in the patent family.
Schedule your 30 min Free 1stOncology Demo! Discover why more than 1,500 members use 1stOncology™ to excel in:
The two companies have worked together since 2019 and Rousselot has supported Zerion Pharma in the development of its Dispersome technology platform that enables significant increase in the solubility of otherwise poorly soluble drug compounds for oral administration. Rousselot has explored early variants of the Dispersome technology and has contributed valuable experimental data including results from pharmacokinetic preclinical studies.
The revised license agreement with Rousselot strengthens Zerion Pharma’s position as an innovative and leading supplier of competitive solutions for addressing one of the pharmaceutical industry’s most pressing problems: poor drug solubility.
"The grant of the European Patent marks an important milestone in our efforts to establish a dominating IP position in the field of preparing amorphous drug formulations using proteins as excipients", says Ole Wiborg, CEO of Zerion Pharma. "We have several other patent families protecting the Dispersome technology but the WO 2017/186889 patent family was filed relatively early and covers certain general aspects of the technology that we consider essential to our business", and continues: "We are delighted to extend and strengthen our partnership with Rousselot that has done an impressive job in demonstrating the usefulness of proteins as excipients for increasing drug solubility and bioavailability. We are very pleased not only with the license grant that secures our IP position in the field but also with the documentation that Rousselot has established during recent years, including proof-of-concept and the comparative advantages of the Dispersome technology in-vivo." While Zerion Pharma has been granted a broad exclusive license, Rousselot has retained certain rights to exploit the inventions described in WO 2017/186889 within limited fields. Under the terms of the agreement, Zerion Pharma will pay license fees and royalties to Rousselot. The financial terms are not disclosed.
"We are extremely pleased to have extended our license agreement with Zerion whom we consider an upcoming leader in the field of drug formulation and an optimal partner to further develop our contribution to the Dispersome technology", says Sandor Noordermeer, Vice President Global Marketing & Sales at Rousselot. "Back in 2019, we were impressed to see the promising results Zerion had generated with the use of whey proteins to increase drug solubility. The combination of their strong scientific foundation, innovativeness and Zerion’s fierce efforts to develop the company made the choice easy. I am confident that joining forces through collaboration and this license agreement will ensure successful commercialization of the Dispersome technology as state-of-art in the field of drug formulation".
On November 24, 2021 Nykode Therapeutics (formerly Vaccibody*) (Euronext Growth (Oslo): VACC) reported the execution of a multi-target license and collaboration agreement with Regeneron (Press release, Nykode Therapeutics, NOV 24, 2021, View Source [SID1234596383]).
Schedule your 30 min Free 1stOncology Demo! Discover why more than 1,500 members use 1stOncology™ to excel in:
In accordance with the agreement and as described in the initial announcement, the board of directors of Nykode Therapeutics has today resolved to issue 2,255,034 new shares to Regeneron at a price of NOK 79.07 per share, based on a resolution to increase the share capital granted by the annual general meeting on May 5, 2021.
Following registration of the share capital increase related to the share issue, the share capital of Nykode Therapeutics will be NOK 2,895,027.44, divided into 289,502,744 shares, each with a par value of NOK 0.01. *)
Vaccibody AS, which is changing its company name to Nykode Therapeutics AS, has called for an EGM on November 30, 2021, to vote for the approval of the change of its company name from Vaccibody AS to Nykode Therapeutics AS.