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.

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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.

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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.

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.

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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."

On January 19, 2022 Engitix reported that With the close of its Series A round at €48M ($54M), the tissue models company has shifted its business from providing drug discovery services to developing its own treatment pipeline for liver diseases (Press release, Engitix, JAN 19, 2022, View Source [SID1234610299]).

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When Engitix was spun out of University College London in 2016, the startup primarily aimed to provide tissue models to pharmaceutical companies for speeding up drug discovery in liver disease. As the company closes a €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici this week, Engitix is reinforcing its plans to become a drug developer in its own right.

Drug candidates are typically tested in the lab using cell cultures, which are easy to grow and screened in large numbers. However, they don’t well resemble the structures of human organs, which are made up of cells and the extracellular matrix between them.

Engitix is developing drug testing models that are a closer imitation of real organs than cell cultures. The company sources extracellular matrix scaffolds from diseased and healthy organs from biobanks and grows cells on the scaffold to simulate a real organ.

Many companies are working on ways to screen drug candidates using more informative methods than cell cultures. Earlier this week, the Swiss startup EraCal deployed a high-throughput drug screening model based on zebrafish in a drug discovery collaboration with Novo Nordisk. There are also many firms that bioprint organs using polymer gels and cells.

By using human tissue scaffolds, Engitix’s models can shed light on local conditions influencing the behavior of tumor cells, such as blood vessels and immune cells, known as the microenvironment.