On March 21, 2021 Harbour BioMed (HBM) (HKEX: 02142) reported the dosing of the first patient in its open Phase I clinical study of HBM4003 for Chinese patients suffering from advanced melanoma and other solid tumors (study No. 4003.2) (Press release, Harbor BioSciences, MAR 21, 2021, View Source [SID1234576929]). This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with teriprizumab (PD-1 antibody) in the treatment of solid tumors. Prior to this, the China National Medical Products Administration (NMPA) has approved this combined study of HBM4003 and PD-1 antibody/chemotherapy for patients with NSCLC and other solid tumors.

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Professor Jun Guo, Deputy Dean of Beijing Cancer Hospital, Deputy Director of Beijing Institute for Cancer Research and Director of Melanoma Department, said: "Due to the special subtype of melanoma in China, treatment for this disease is especially challenging, resulting from poor prognosis, low survival rate, and the limited efficacy of current PD-1 monotherapy of around 16 percent. Innovative solutions that can improve the treatment efficacy and patients’ overall survival is urgently needed. As this study by Harbour BioMed unfolds, we look forward to providing more effective and safer treatment options to Chinese patients with melanoma and other solid tumors in a near future."

"HBM4003 is a new generation of anti-CTLA-4 antibody. Based on its unique mechanism, it has shown great safety and strong anti-tumor activity in pre-clinical studies." Dr. Wang Jingsong, Founder, Chairman and CEO of Harbour BioMed said. "Each year, there are about 4 million newly diagnosed cancer patients in China and there is an urgent need for innovative drugs and therapeutic solutions for cancer treatment. We will continue to accelerate the global development of HBM4003 for multiple cancers, so that we can help cancer patients around the world to live better and longer lives."

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

On March 19, 2021 Optieum Biotechnologies reported that the company has entered into a research collaboration with Daiichi Sankyo Company (Press release, Optieum Biotechnologies, MAR 19, 2021, https://optieumbio.com/wp-content/uploads/2021/03/20210319_Announcement-of-Research-Collaboration-with-Daiichi-Sankyo.pdf [SID1234639139]). Optieum Biotechnologies intends to use its Eumbody System technology to identify a new functional single chain fragment variables (scFvs) that can be utilized for CAR-T cell against the target of interest selected by Daiichi Sankyo.

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Eumbody System is a single-chain antibody generation system yielding CAR-T cells with superior antitumor function developed by Dr. Toshiki Ochi, co-founder of Optieum Biotechnologies, which exclusive license is granted to Optieum Biotechnologies.

Under the terms of the agreement, Optieum Biotechnologies will receive an undisclosed upfront payment, and is eligible for payments associated with the achievement of certain development milestones.

On March 19, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that it will be added to the Russell 2000 Index as part of the planned first quarter IPO additions scheduled to join the Russell US Indexes after US equity markets close on March 19, 2021 (Press release, Kinnate Biopharma, MAR 19, 2021, View Source [SID1234579512]).

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"Kinnate’s inclusion in the Russell 2000 Index marks an exciting milestone following our successful IPO in December 2020 and is a testament to the incredible progress we have made in building a pipeline of targeted therapy candidates for underserved cancer populations," said Nima Farzan, Chief Executive Officer of Kinnate Biopharma. "We are pleased to be part of the Russell Indexes and look forward to telling our story to a broader audience of investors and other key stakeholders."

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. The Russell 2000 Index measures the performance of the small-cap segment of the U.S. equity market. The index is a subset of the Russell 3000 Index and represents approximately 10 percent of the total market capitalization of that index. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a leading global index provider.

On March 19, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported a share capital increase arising from subscription right exercises (Press release, Galapagos, MAR 19, 2021, View Source [SID1234577411]).

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Galapagos issued 99,814 new ordinary shares on 19 March 2021, for a total capital increase (including issuance premium) of €2,258,042.82.

Pursuant to the subscription right exercise program of Galapagos’ management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights and in total he exercised 41,874 subscription rights. These 41,874 subscription rights were due to expire in May 2021 and this exercise window was his last possibility to exercise. Two other management board members exercised an aggregate number of 10,000 subscription rights.

In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,359,437.71, the total number of securities conferring voting rights amounts to 65,511,581, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 6,792,843 subscription rights under several outstanding employee subscription right plans, which equals 6,792,843 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

On March 19, 2021 The Institute of Cancer Research, London (ICR) reported that its ‘resistance-busting’ drug EP0042 has entered a Phase I clinical trial in patients with cancers including acute myeloid leukaemia (AML) (Press release, AstraZeneca, MAR 19, 2021, View Source [SID1234576925]).

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The dual-inhibitor drug blocks the activity of two cancer-driving proteins from the Aurora and FLT3 families.

The discovery and initial development of EP0042 was conducted by scientists in ICR’s Cancer Research UK Cancer Therapeutics Unit, funded largely by Cancer Research UK with additional support from Breast Cancer Now.

According to ICR, EP0042 has shown promise as a potential treatment for patients with AML, by targeting FLT3-mutated cancer that become resistant to FLT3-selective inhibitor drugs.

It has also demonstrated potential as a treatment for additional cancer types, such as the childhood cancer neuroblastoma.

The development of EP0042 was advanced by Ellipses Pharma following successful negotiations between ICR and the company.

Under the terms of the deal between ICR and Ellipses, the company retains full responsibility for the EP0042 development programme, including pre-clinical studies and reformulation of the drug product to obtain clinical trial authorisation.

Ellipses will also be responsible for the progression of EP0042 into the clinic for the first-in-human trial, as well as any subsequent clinical studies.

The Phase I trial will be conducted at study centres planned in the UK, the Netherlands and Australia. If successful, EP0042 could progress into larger trials and become a new potential treatment for AML and neuroblastoma, ICR said in a statement.

"EP0042 is an innovative drug, targeting both Aurora and Flt3, and could ultimately counteract drug resistance in cancers including acute myeloid leukaemia and neuroblastoma," said Olivia Rossanese, head of cancer therapeutics at the ICR.

"It’s always a real pleasure to see one of our drugs enter Phase I trials – it’s the culmination of our work to translate our scientific understanding of how cancer grows into new therapies to treat patients. And it’s a reminder of the power of effective collaborations, with industry and our partners at The Royal Marsden, to develop and deliver new medicines to patients," she added.