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:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On November 29, 2021 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-class allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the close of its oversubscribed $100 million Series C financing, bringing its total funding to $190 million (Press release, HotSpot Therapeutics, NOV 24, 2021, View Source [SID1234596182]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Led by Pivotal bioVenture Partners, with significant participation by LSP and B Capital Group, the round includes new investors Monashee Investment Management, LLC, CaaS Capital Management, Revelation Partners and Pavilion Capital, as well as participation from previous investors, Atlas Venture, Sofinnova Partners, SR One Capital Management, funds managed by Tekla Capital Management, LLC, and MRL Ventures Fund. Ash Khanna, PhD, of Pivotal bioVenture Partners, and Fouad Azzam, PhD, of LSP, will join the HotSpot Board of Directors.

The new financing will be used to continue advancing HotSpot’s Smart AllosteryTM platform, with a focus on undrugged and poorly druggable targets, as well as the company’s existing pipeline.

"With the support of top-tier healthcare and technology investors, we will expand on the significant productivity of the Smart Allostery platform to enable a treasure trove of sought-after disease targets and thereby develop medicines that broadly benefit patients," said Jonathan Montagu, Co-founder and Chief Executive Officer of HotSpot Therapeutics. "We have diligently established a deep pipeline of product opportunities in cancer and autoimmune disease, each offering a clear path to clinical value through precision and patient-targeted trial design."

HotSpot’s Smart AllosteryTM platform unlocks a vast range of disease-relevant proteins for the first time through the identification of protein pockets called "natural hotspots." Natural hotspots are pockets that are decisive in protein function yet previously unexploited using conventional allostery approaches. The Smart Allostery platform encompasses a broad suite of AI-enabled technologies and the industry’s largest and most diverse chemical library tailored to hotspots. The company is leveraging the Smart Allostery platform to uncover, capture, and drug natural hotspots across a wide array of disease-causing proteins.

"Within 36 months, HotSpot has established a new paradigm for allostery drug discovery that is reproducibly delivering small molecules across multiple target classes, including transcription factors and E3 ligases," said Ash Khanna, PhD, Venture Partner at Pivotal bioVenture Partners. "We are thrilled to be partnering with HotSpot as they advance their pipeline to the clinic and realize the promise of delivering potentially lifesaving therapeutics to patients."

Earlier this month, HotSpot announced new data validating its Smart AllosteryTM platform in the elucidation and preclinical evaluation of a novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy. The data show successful targeting with the first and only selective small molecule inhibitors of CBL-B. Identified via the company’s Smart AllosteryTM platform, these small molecules promote T cell responses in vitro and in mice. Through allosteric inhibition of this negative regulator of immune cells, HotSpot’s small molecule CBL-B inhibitors offer the potential for increased immunotherapy efficacy for cancer patient populations that have historically exhibited poor treatment responses.