On March 22, 2021 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibody development, reported the closing of a $120 million Series C financing round (Press release, EpimAb Biotherapeutics, MAR 22, 2021, View Source [SID1234576974]). The round was co-led by China Merchants Bank International (CMBI) and Mirae Asset Financial Group (Mirae), and joined by Hony Capital, Cormorant Asset Management, Yanchuang Capital, Octagon Capital, renowned cultural entrepreneur and investor Adrian Cheng and ShangBay Capital, with strong participation from existing investors such as Decheng Capital, SDIC Fund, Sherpa Healthcare Partners, and Hidragon Capital. Proceeds from the financing will be used to fund the ongoing clinical development of EMB-01, EMB-02 and EMB-06, and to expand the company’s pipeline of novel bispecific antibodies and other biologics. Tony Rong, nominated by CMBI, and Sungwon Song, nominated by Mirae, will also join the EpimAb Board of Directors.

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"The completion of our Series C financing will enable us to accelerate the development of our three clinical assets EMB-01, EMB-02 and EMB-06, and to advance our rich pipeline of preclinical programs into the clinic as we continue to build on our portfolio of novel bispecific antibodies generated based on our proprietary FIT-Ig technology," said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "With three candidates currently progressing through clinical trials and several ongoing high-value development projects in the pipeline poised to move towards the clinic, we are confident in our development strategy and our potential for long-term value generation. We greatly appreciate the support from our new and current investors as we move into this next phase of our company’s development and remain committed to bringing innovative bispecific antibody therapeutics to patients worldwide."

EpimAb is creating a pipeline of novel proprietary bispecific antibody therapeutics with a focus on oncology and other areas of high value to patients. EMB-01, EpimAb’s lead candidate designed to simultaneously target EGFR and cMET on tumor cells, is currently progressing through a Phase I/II clinical study in both China and the U.S. EMB-02, EpimAb’s second clinical candidate, which simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies, recently received FDA clearance to progress into the clinic in the U.S. EMB-06, a T cell engaging bispecific designed to simultaneously target CD3 and BCMA with differentiated properties, has been cleared to initiate clinical trials in Australia.

"EpimAb is among the premier innovative biopharmaceutical companies in China, revolutionizing the bispecific antibody space with a proprietary technology that has global potential," said Tony Rong. "As we continue to expand our global life sciences portfolio, CMBI is committed to support EpimAb’s mission of bringing novel bispecific therapeutics to patients."

"Each of EpimAb’s assets impressed us with enormous potential and a unique approach to treating areas of high unmet medical need. EpimAb’s dedicated pipeline of bispecific antibodies with best-in-class mechanisms makes it one of the driving forces behind Chinese biopharma innovations," said Sungwon Song. "Mirae is excited to be a part of the company’s rapid evolution to become a global leader in its space."

On March 22, 2021 Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, reported that Oxilio Ltd ("Oxilio") has exercised its option to acquire a licence for NXP001 (a proprietary new form of aprepitant) for oncology indications (Press release, Nuformix, MAR 22, 2021, View Source [SID1234621610]).

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· On 23 September 2020, Nuformix granted an exclusive option to Oxilio, a private pharmaceutical development company, to license NXP001 globally for oncology indications. This triggered the first upfront payment and the option period ran until 23 March 2021
· Nuformix and Oxilio will now work together to finalise a global licensing agreement for NXP001. Once this has been agreed, this will trigger a second undisclosed upfront payment, payable to Nuformix. Under this agreement, Nuformix will license its patent estate and know-how on NXP001 in return for development milestone payments and a royalty on any future net sales, capped at £2m per annum

Dr Anne Brindley, CEO of Nuformix, said: "We are very pleased that Oxilio has exercised its option for NXP001, allowing them to continue the development of NXP001 in oncology. We will now look to finalise the licensing agreement with Oxilio that will provide Nuformix with near term revenue and an opportunity to benefit from the upside of the significant global oncology market. This successful outcome endorses the Nuformix strategy of identifying new improved forms of existing drugs for repurposing into new indications with early-stage licensing during the pre-clinical or Phase 1 stages of development."

Dr Simon Yaxley, Co-Founder and Director of Oxilio said: "Exercising our option gives us the opportunity to continue to develop NXP001 in line with our approach to optimise the delivery of our drug for the effective treatment of certain cancers. We look forward to continuing our collaboration with Nuformix to realise the huge potential of this approach."

About NXP001
NXP001 is a proprietary new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting (chemotherapy induced nausea and vomiting). A disadvantage of aprepitant is that its suboptimal properties necessitate a complex formulation. Nuformix discovered new forms of aprepitant (NXP001) with improved properties and it has granted patents on its new forms.

About NXP001 and Oxilio
Oxilio will develop and seek to exploit NXP001 globally for the treatment of cancer. Cancer is one of the world’s primary causes of death. The total worldwide annual economic cost of cancer is substantially in excess of US$1 trillion. Traditional cancer treatments such as surgery, chemotherapy and radiotherapy are expensive and often have debilitating consequences for the patient. Costs of cancer drug treatments are also increasing, in large part due to the expense of taking new drugs through clinical trials where historically there is a very low rate of success. Therefore, there is an urgent need to develop safe, effective, and readily available anticancer agents.

Oxilio is focused on alleviating the current dilemma of a shortage of effective drug candidates that have potential as new cancer therapies, by adopting a drug repurposing strategy (identifying new uses for approved or investigational drugs that are outside the scope of the original medical indication). The major advantage of this approach is that the pharmacokinetics, pharmacodynamics and toxicity profiles of these drugs are already reasonably well established. Thus, drug repurposing is a less risky development route with substantially lower associated development costs. The agreement with Nuformix allows Oxilio to focus on developing rapidly a unique formulation and dosage form with NXP001 and progressing into the clinic.

Oxilio is a privately held pharmaceutical development company focused on repurposing known drugs for the treatment of cancer through a programme of corporate alliances coupled with rapid proof of concept clinical development.

On March 21, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing, and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it will present the preclinical data on the synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit diffuse large B-cell lymphoma (DLBCL) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held in a virtual format on April 10-15 and May 17-21, 2021 (Press release, Antengene, MAR 21, 2021, View Source [SID1234576930]).

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Title: Synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit DLBCL
Permanent Abstract Number: 1380
Abstract Link: View Source!/9325/presentation/2406

Covering the most cutting-edge advances and regarded globally as the very pinnacle of cancer research, the AACR (Free AACR Whitepaper) Annual Meeting is one of the largest and most anticipated scientific events in the cancer research field globally. The abstract entitled "Synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit DLBCL" now available on the AACR (Free AACR Whitepaper)’s website, is the first publication from the preclinical study investigating ATG-010 (XPO1 inhibitor) and ATG-008 (mTORC1/2 inhibitor).

ATG-010, also known as selinexor, is the world’s first approved selective inhibitor of the nuclear export protein XPO1. ATG-010 induces the apoptosis of cancer cells in vitro and in vivo through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins without affecting normal cells.

ATG-008, also known as onatasertib, is a next-generation dual mTORC1/2 inhibitor. mTORC1 and mTORC2 are critical mediators of the PI3K-AKT pathway, which is commonly mutated in many cancers, thus leading to the hyperactivation of mTOR signaling. ATG-008 could reduce the proliferation and promote the apoptosis of tumor cells through the dual-inhibition of mTORC1 and mTORC2.

ATG-010 (selinexor) is approved in the U.S. and Israel for the treatment of multiple myeloma (MM) and DLBCL, and has been included in five treatment regimens by the National Comprehensive Cancer Network (NCCN) Guidelines. Multiple clinical studies have shown that the special mechanism of action (MoA) of ATG-010 allows the drug candidate the therapeutic utility in combination with a variety of antitumor drugs, such as anti-PD-L1 antibodies, for improved efficacy and reduction in treatment-related adverse events. Other studies carried out by Antengene also showed that the dual-inhibition of XPO1 and mTOR has the effect of bolstering antitumor activities.

At present, Antengene is conducting several trials of ATG-010 in China for the treatment of MM, DLBCL, non-small cell lung cancer (NSCLC), endometrial cancer, peripheral T-cell lymphoma and NK/T cells lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for ATG-010 in multiple APAC markets including China, Australia, Singapore and South Korea. Meanwhile, Antengene has also initiated several clinical trials of ATG-008 in China and other APAC markets for the treatment of advanced hepatocellular carcinoma (HCC), advanced NSCLC, advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations, and in combination with an anti-PD-1 antibody in advanced solid tumors including HCC.

On March 21, 2021, Aeglea BioTherapeutics, Inc. (the "Company") reported that it entered into a license and supply agreement (the "License Agreement") with Immedica Pharma AB ("Immedica"), pursuant to which Immedica licensed the product rights for commercialization of pegzilarginase in the European Economic Area, United Kingdom, Switzerland, Andorra, Monaco, San Marino, Vatican City, Turkey, Saudi Arabia, United Arab Emirates, Qatar, Kuwait, Bahrain, and Oman. Upon signing, the Company is entitled to an upfront payment of $21.5 million from Immedica (Filing, 8-K, Aeglea BioTherapeutics, MAR 21, 2021, View Source [SID1234576942]). Under the terms of the License Agreement, the Company is eligible to receive aggregate regulatory and commercial milestone payments of up to approximately $130.0 million. Additionally, the Company is entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that may result from the License Agreement. The Company will continue to be responsible for certain clinical development activities and the manufacturing of pegzilarginase and will retain commercialization rights in the U.S. and rest of the world.

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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.