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HUTCHMED Initiates a Phase I Trial of HMPL-653 in Patients with Advanced Malignant Solid Tumors and TGCT in China

On January 20, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it has initiated a Phase I trial in China of HMPL-653, an investigational novel, highly selective, and potent colony-stimulating factor 1 receptor ("CSF-1R") inhibitor (Press release, Hutchison China MediTech, JAN 20, 2022, View Source [SID1234605577]). The first patient received their first dose on January 18, 2022.

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The Phase I trial is a multicenter, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-653 in the treatment of patients with advanced or metastatic solid tumors and tenosynovial giant cell tumors ("TGCT"). Approximately 110 patients are expected to be enrolled in the dose escalation and expansion phase of this study. The primary endpoints are dose limiting toxicity, safety, tolerability, recommended phase II dose and maximum tolerated dose. The secondary endpoints include pharmacokinetics, objective response rate, progression free survival, disease control rate, and overall survival. The lead principal investigator is Dr Cheng Ying of the Jilin Cancer Hospital, which is the lead institution for this study.

About HMPL-653
HMPL-653 is an investigational novel, highly selective, and potent CSF-1R inhibitor designed to target malignant driven tumors as a monotherapy or in combination with other drugs.

CSF-1R is usually expressed on the surface of macrophages and can promote growth and differentiation of macrophages after binding with its ligand, CSF-1. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate the tumor microenvironment, relieve tumor immunosuppression, and synergize with other anti-cancer therapies such as immune checkpoint inhibitors to achieve tumor inhibition. It has been demonstrated in several clinical studies that other CSF-1R inhibitors, by inhibiting CSF-1R activity, could be used to treat TGCT, and to treat a variety of malignancies through combination with immuno-oncology and/or other therapeutic agents. Currently no CSF-1R inhibitor has been approved in China.

HUTCHMED currently retains all rights to HMPL-653 worldwide.

About TGCT
TGCT is a very rare type of soft tissue tumor caused by abnormal proliferation and inflammation of giant cells, monocytes and inflammatory cells. These tumors are mainly characterized by the expression of CSF-1. Targeting CSF-1R has become an effective therapeutic strategy for TGCT. The incidence of TGCT is approximately between 1.8 and 50 per 1 million people.[1] Surgery is the standard treatment for TGCT patients. However, among patients with diffuse or recurrent/refractory TGCT, tumors are wrapped in peripheral organs such as bone, tendon, ligament and joint, which makes removal by surgery difficult. The recurrence rate of diffuse-type cases is estimated to be 21% to 50%.[2] There is a high unmet need for effective and safe treatment for these patients.

Duality Biologics and Harbour BioMed reached a strategic collaboration agreement

On January 19, 2022 Duality Biologics reported a strategic cooperation agreement with Harbour BioMed (Press release, DualityBio, JAN 19, 2022, View Source [SID1234649926]). According to the agreement, Harbour BioMed will grant the self-developed preferred monoclonal antibody for specific tumor targets to Duality Biologics for the exclusive development of ADC medicines in the world. Based on the DITAC (Duality Immune Toxin Antibody Conjugate) technology platform with its independent intellectual property rights, Duality Biologics will rapidly develop the world’s first-in-class ADC medicines to benefit patients all over the world. And Harbour BioMed will receive the down payment, milestone payments and sales-based royalties paid by Duality Biologics.

Harbour BioMed and Duality Biologics always maintain a strategic win-win cooperative relationship. After signing the agreement, both parties will continue to uphold the common goal of rapid research and development of high-quality ADC: Duality Biologics will be responsible for the preclinical research, clinical development, clinical registration, production and commercialization of the ADC candidate molecule; Harbour BioMed will continue to pay close attention to the relevant follow-up research of this molecule and provide necessary support.

"Previously, fully human antibodies developed from Harbour Mice have been used in multiple company’s ADCs development projects, demonstrating the advantages of our fully human antibodies in ADC development. With Duality Biologics’ strong R&D advantages in ADC development, this strategic collaboration will further strengthen our overall strategy in the field of ADC, maximize the value of Harbour Mice, develop more high-quality and differentiated new ADC drugs to meet global patients’ needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

"I’m very pleased to achieve strategic collaboration with Harbour BioMed, and we are both very excited and confident about this new target of ADC drug. The combination of our proprietary ADC platform in next-generation and tumor-specific antibody will optimize the value of our DITAC platform, a leading 3rd generation toxin ADC platform with significantly improved therapeutic window, and rapidly enrich our pipeline to generate original innovative products. The signing of this agreement is the beginning of our platform-based strategic win-win cooperation. In the future, Duality Biologics hopes to maintain the close cooperation with Harbour BioMed and continue to propel more product development, jointly bringing better therapeutics to patients." said Dr. John Zhu, founder and CEO of Duality Biologics.

Dompé Farmaceutici S.P.A Announces Strategic Investment and Collaboration with Engitix Positioned Around Use of Dompé’s Exscalate Drug Discovery Platform

FINAL RESULT OF OASMIA’S RIGHTS ISSUE

On 19 January 2022, Oasmia Pharmaceutical AB ("Oasmia" or the "Company") reported that the Board of Directors had resolved to carry out a fully secured rights issue (the "Rights Issue") (Press release, Vivesto, JAN 19, 2022, View Source [SID1234611842]). The Board of Directors’ resolution of the Rights Issue was approved by the Extraordinary General Meeting held on 21 February 2022. Oasmia announces that the final result of the Rights Issue shows that 48,367,120 shares, corresponding to approximately 53.9 percent of the shares offered, were subscribed for by the exercise of subscription rights. 1,519,430 shares, corresponding to approximately 1.7 percent of the shares offered, have been allotted to persons who have subscribed for shares without the use of subscription rights. The remaining 39,787,359 shares offered, corresponding to approximately 44.4 percent, have been allotted to guarantors. Oasmia will receive approximately SEK 151 million through the Rights Issue before issue costs.

Through the Rights Issue, Oasmia’s share capital will increase by SEK 8,967,390.9, from SEK 44,836,954.6 to SEK 53,804,345.5 by issue of 89,673,909 new shares. After the Rights Issue, the number of shares in Oasmia will amount to 538,043,455 shares.

Those who have subscribed for shares without subscription rights will be allotted shares according to the principles in the prospectus published by Oasmia on 3 March 2022. As confirmation of allotment of shares subscribed for without subscription rights, a contract note will be sent on or about 25 March 2022. Subscribed and allotted shares must be paid in cash in accordance with the instructions in the contract note. Nominee-registered shareholders will receive notice of allotment in accordance with the procedures of the nominee. Only those who have been allotted shares will be notified.

The last day of trading in the interim shares ("BTA") will be on 4 April 2022. Trading of the new shares is expected to begin on Nasdaq Stockholm on 8 April 2022.

Advisers

In connection with the Rights Issue, Oasmia has appointed Danske Bank A/S, Danmark, Sverige Filial as financial adviser and Sole Bookrunner. Törngren Magnell & Partners Advokatfirma KB acts as legal adviser to the Company and Schjødt acts as legal adviser to Danske Bank.

Pierian and Biodesix Partner to Advance Lung Cancer Diagnostics

On January 19, 2022 Pierian, the global leader in clinical genomics knowledge, reported that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC) (Press release, PierianDx, JAN 19, 2022, View Source [SID1234611225]). Biodesix (Nasdaq: BDSX) will use the Pierian platform to provide clear, up-to-date clinical interpretations for mutations detected by the GeneStrat NGS test as part of patient test results used by physicians to help inform a personalized treatment strategy and facilitate monitoring in lung cancer.

The GeneStrat NGS test is a key part o f the IQLung testing strategy, designed to measure tumor-specific mutations and patient immune profiles with results in an unprecedented 72 hours so that physicians can assess overall prognosis and personalize treatment plans. The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test data will be analyzed and interpreted using the most current therapy approvals and oncology guideline recommendations and delivered in a physician-ready report. The technology is backed by a comprehensive clinical knowledgebase and adaptive learning algorithms that take disparate inputs and translate them into concise interpretations with supporting evidence. As a result, characteristics of patient variants, even though rare or novel, are leveraged to present the most optimal treatment possibilities.

"We are helping to meet an unmet need in the continuum of care for lung cancer," said Scott Hutton, CEO of Biodesix. "Partnering with Pierian not only helps to deliver rapid results to physicians, but it also gives them information that can be easily interpreted and actioned, supporting them in providing precision care for their patients."

"We are thrilled to provide our interpretation technology to support the outstanding testing solution from Biodesix to treat patients with lung cancer," states Mark McDonough, CEO of Pierian. "We are committed to democratizing clinical genomics globally and this partnership with Biodesix supports our vision to broaden access to genomic testing and provide precision care to patients everywhere."