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PreGene Closes $21 Million Financing for Fusion/Nano-Antibody Drugs

On November 24, 2020 PreGene, a Shenzhen biotech, reported that it closed a $21 million B financing as it looks forward to an IPO on the Hong Kong exchange. The funding was led by Haier Biomedical (Press release, PreGene, NOV 24, 2020, View Source [SID1234571741]). PreGene claims to have the world’s only fusion drug and nano-antibody drug biotechnology R&D platform. Founded in 2012, PreGene is also developing TCR-T, CAR-T and stem cell candidates. Its BCMA CAR-T candidate is approved to start clinical trials in China.

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Alvotech, Alvotech & CCHT Biopharmaceutical and Yangtze River Pharmaceutical Agree on an Exclusive Biosimilar Partnership in China

On November 24, 2020 Biopharmaceutical company Alvotech hf. and Alvotech & CCHT Biopharmaceutical Co., Ltd., which is the China joint venture company of Alvotech hf. and Changchun High & New Technology Industries (Group) Inc., reported that have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China (Press release, Alvotech, NOV 24, 2020, View Source [SID1234571699]). The initial pipeline contains biosimilar candidates for treatment in the fields of autoimmunity, ophthalmology, and oncology, as well for treating severe immune and inflammatory conditions.

Robert Wessman, founder and chairman of Alvotech, commented, "As our progression continues, we are excited to announce this new partnership with Yangtze River Pharmaceutical Group, one of the largest pharmaceutical companies in China. Through this commercial relationship, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd are gaining an extremely valuable access to Yangtze River Pharmaceutical’s strong brand reputation and market experience in China. This will give patients in China better access to high quality biosimilar medicines and creates a powerhouse in the introduction and adoption of biosimilars in the region."

Under this distribution and marketing agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd will be jointly responsible for the development, registration, and supply of their biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialize the biosimilar candidates. China is the world’s second largest pharmaceutical market, and this new collaboration follows Alvotech’s recent global partnerships including: Teva Pharmaceuticals in the U.S. market, Stada for key European markets and several others.

Mr. Xu, Jingren, founder and Chairman of Yangtze River Pharmaceutical Group, said, "The commercial partnership with Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd. is an attempt on international collaboration of biosimilar medicines. Develop, Manufacture and introduce high quality biosimilars is also Yangtze River’s vision. We aim to make full use of our brand advantage and market experience to deliver the biosimilars with extensive clinical needs to the broad China market. This will help us fulfil our purpose of ‘Committed for the better and Dedicated to caring for all.’"

Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd.’s leading innovative capability and technology allow us to have confidence to provide Chinese patients with safe, effective and affordable biosimilar medicines which improves the lives of patients. We sincerely hope that this partnership will be constructive, complementary and have positive outcomes for all involved," Mr. Xu Jingren concluded.

The manufacturing of these biosimilar candidates for the Chinese market will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT Biopharmaceutical Co., Ltd partnership1. The manufacturing site will include the latest best in class technology, including disposable single use bioreactors. The first Phase of the facility is expected to be completed in 2021.

Mr. Ma, Ji, chairman of CCHT, and chairman of Alvotech & CCHT Biopharmaceutical Co., Ltd, added, "Innovation and sharing are the core value of CCHT, establishing Changchun Alvotech & CCHT Biopharmaceutical Co., Ltd with Alvotech is aiming to build a global standard antibody drug producing and manufacturing platform. The cooperation with Yangtze River Pharmaceutical Group, a leading company in the industry, is strategic, constructive, and complementary; both parties could give full play to their advantages in exploring China’s biosimilar drug market, so as to improve the availability and accessibility of the drugs and ameliorate people’s life. We will further discuss cooperation with YZR on more levels in the future."

1 Footnote: Alvotech & CCHT Biopharmaceutical Co., Ltd is a Chinese limited liability Sino-foreign equity joint venture company owned jointly by Alvotech hf and Changchun High & New Technology Industries (Group) Inc.

Targovax demonstrates encouraging survival data for ONCOS-102 in mesothelioma

On November 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, NOV 24, 2020, View Source [SID1234571697]).

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line).

At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021.

In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS-102 drives the observed clinical benefit.

The powerful immune activation generated by ONCOS-102 builds a strong rationale for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination could provide further clinical benefits in this indication. Targovax and Merck (known as MSD outside of the USA) are currently reviewing next steps for combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.

Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased that overall survival in first-line patients, is tracking well in the ONCOS-102 treated group. We have already established in the current study that ONCOS-102 drives favorable remodeling of the tumor microenvironment, and we are now starting to see this immune activation translating into the encouraging improved survival outcomes in these 18-month results. This is exactly what we had hoped to see and prepares the way for combining ONCOS-102 with checkpoint inhibition. The immune data suggest to us that survival outcomes in combination with Keytruda may be further improved from the results reported today."

The first results from the trial were announced in January 2020 (see press release here), while immunological data and 12-month survival rate were reported in June 2020 (see press release here) and presented at the SITC (Free SITC Whitepaper) annual meeting in November 2020 (see poster here).

Jubilant Therapeutics Announces Upcoming Presentation at 2020 ASH Virtual Annual Meeting

On November 24, 2020 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, reported that an abstract related to its dual LSD1 and HDAC6 inhibitor, JBI-802, has been accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Annual Meeting taking place Dec. 5-8, 2020 (Press release, Jubilant Therapeutics, NOV 24, 2020, View Source [SID1234571696]).

"We look forward to discussing our novel potent and selective dual inhibitor of LSD1-HDAC6 for the treatment of cancer at the 2020 ASH (Free ASH Whitepaper) Virtual Annual Meeting," said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics. "Our work to progress JBI-802 into the clinic as a potential, differentiated therapeutic for the treatment of select hematological and solid tumors with specific gene signatures is on track and we expect to initiate first-in-human studies in the second half of next year."

The abstract, currently available on the ASH (Free ASH Whitepaper) conference website, is as follows:

Title: Novel Dual Inhibitor of LSD1-HDAC6/8 for Treatment of Cancer

Date: Monday, December 7, 2020

Session: 802. Chemical Biology and Experimental Therapeutics: Poster III

Abstract: 3378

Presenter: Dhanalakshmi Sivanandhan, Ph.D., Associate Vice President & Head of Biology, Jubilant Therapeutics Inc.

Immunic, Inc. to Participate in Investor Conferences in December

On November 24, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported management’s participation in the following investor conferences in December (Press release, Immunic, NOV 24, 2020, View Source [SID1234571695]):

November 30 – December 3: Piper Sandler 32nd Virtual Healthcare Conference. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will participate in a fireside chat. Beginning November 23, the fireside chat will be available for viewing anytime through December 3 by accessing the recording library on the Piper Sandler conference site. An archived replay of the presentation will be available on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations for a period of 90 days after the conference.
December 1-3: Evercore ISI 3rd Annual HEALTHCONx Conference. Dr. Vitt will participate in a fireside chat on Thursday, December 3, at 12:10 pm ET. A live audio webcast of the presentation will be available on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of one year after the conference.