On February 22, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that National Medical Products Administration (NMPA) approved Phase Ib/II clinical trial application of the first domestic SIRPα-Fc fusion protein drug candidate targeting human CD47 (IMM01) combined with PD-1 antibody for the treatment of relapsed/ refractory malignant tumors (Press release, ImmuneOnco Biopharma, FEB 22, 2022, View Source [SID1234655638]). So far, 6 clinical trial applications related to IMM01 have been approved, which further establishes leading position of the company in the field of drug R&D targeting CD47.

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The preliminary data from IMM01 phase I clinical trial is encouraging. At the low dose levels, it has benefited some advanced lymphoma patients with a good safety profile. These clinical manifestations are based on the differentiated molecular design of IMM01. IMM01 is designed and screened not binding to human erythrocytes so as to avoid the "antigen sink effect". The molecule itself has low immunogenicity so that there is no ADA after administration in human. IMM01 has only half of the regular IgG molecular weight so has good tissue permeability and bioavailability. What is more, in preclinical in vivo efficacy tests, when IMM01 was used in combination with targeting drugs and immunotherapy drugs, it demonstrated strong tumor-inhibiting activity and synergistic effect against solid tumors.

PD-1 antibody has also been shown to have superior curative effect on a variety of tumors, but limited by the content of T cells in tumor tissue (such as "cold tumor"), most patients do not have a good response to PD-1 antibody therapy.

It is well proven that strong synergistic effects happen when PD1 antibody combined with CD47/SIRPa inhibitors. Macrophages are innate immune cells and antigen-presenting cells. After activation, they can improve the efficacy of PD-1 antibody and maintain the durability of the efficacy through the following ways:

1) By directly phagocytosing tumor cells, macrophages can present the processed tumor antigens to T cells to induce tumor antigen-specific T cell responses.

2) Macrophages release chemokines (such as CXCL9/CXCL10) to induce T cells to the tumor tissue, thereby transforming "cold tumors" into "hot tumors".

Dr. Tian Wenzhi, Founder, Chairman and CEO of ImmuneOnco, said: "I am very pleased to see that clinical trial application of our IMM01 combined with PD-1 antibody for the treatment of relapsed and refractory malignant tumors approved by the National Medical Products Administration (NMPA). Preclinical studies have shown that IMM01 combined with PD-1 antibody has a strong synergistic effect. We are optimistic and confident that synergistic use of IMM01 with PD-1 antibody will have superior clinical performance and will bring good news to the cancer patients."

ON February 22, 2022 Huahui Health reported successful completion of first patient dosing of Phase I trial of HH-101, an Fc-enhanced anti-TIGIT antibody (Press release, Huahui Health, FEB 22, 2022, View Source [SID1234642184]).

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HH-101 has demonstrated superior anti-tumor effects and a good safety profile in pre-clinical studies. The Phase I study aims to evaluate the safety, tolerability, PK and efficacy of HH-101 in patients with late-stage solid tumors.

The Leading PI, Prof. SHEN Lin at Beijing Cancer Hospital, commented on the Phase I study, "Compared with many other anti-TIGIT antibodies, HH-101 is with enhanced Fc region, which may potentially lead to more effective Treg depletion and consequently improved anti-tumor effects. Hopefully the superior pre-clinical efficacy data can be translated into improved patient outcomes through human studies. We wish to have a successful clinical development of HH-101, providing Chinese cancer patients with more therapeutic options."

"HH-101 is the first oncology pipeline asset of Huahui Health that has received IND approval and entered clinical development stage. This is a milestone for the company’s rapid growth, and a recognition of Huahui’s R&D capabilities in oncology," says Dr. Bin Chen, the CEO of Huahui Health. "We strive to innovate breakthrough therapies to transform patient lives across the globe, through our continued commitment and efforts in understanding the disease biology and translating science into medicine and improved clinical benefits."

On February 22, 2022 Hovione, the leader in spray drying and particle engineering, reported a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement technology platform (Press release, Zerion, FEB 22, 2022, View Source [SID1234609347]).

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Zerion´s innovative Dispersome technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome technology with Hovione’s unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility.

"We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients.", comments Jean-Luc Herbeaux, Hovione´s Chief Operating Officer. "Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome".

Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg.

The announcement of this partnership follows Hovione’s communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company’s commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing.

On February 22, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported it will host a conference call and webcast on Monday, February 28, 2022 at 4:30 p.m. ET to discuss its fourth quarter and full year 2021 financial results and corporate highlights (Press release, Celldex Therapeutics, FEB 22, 2022, View Source [SID1234608895]).

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To access a live or recorded webcast of the call, please visit the "Events & Presentations"(opens in a new tab) page under the "Investors & Media"(opens in a new tab) section of the Celldex Therapeutics website at www.celldex.com(opens in a new tab). The call can also be accessed by dialing (866) 743-9666 (United States) or (760) 298-5103 (international). The conference call passcode is 2177774.

On February 22, 2022 LUMICKS, a leading life science tools company advancing science and improving human health by unlocking the measurement of forces and interactions in biology, reported that it is introducing a new innovative C-Trap to its portfolio at the 66th Annual Biophysical Society Meeting in San Francisco, California (Press release, LUMICKS, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=lumicks-unveils-new-c-trap-product [SID1234608855]).

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The technological advances embodied in LUMICKS’ C-Trap technology have been lauded by researchers worldwide for their transformational role in advancing scientific discoveries and led to approximately 100 peer-reviewed papers in leading scientific journals over the past 5 years. The C-Trap portfolio is now complemented by the new C‑Trap ‘Edge’, which is dedicated to support important surface related applications, such as cytoskeletal structure & transport and mechanobiology where current tools are not sufficient to manipulate, observe and measure the mechanism of action in real-time.

Jos Maas, General Manager of LUMICKS’ Dynamic Single Molecule (DSM) business unit, states "We are delighted to expand our portfolio with the introduction of the C-Trap ‘Edge’. Its new functionality will help us address the growing needs of our academic research customers around the world. It brings our powerful optical tweezers and microfluidics technology ‘to the surface’ with TIRF imaging, label-free IRM and a dedicated workflow for force measurements and manipulation at the surface. For even more flexibility, the C-Trap ‘Edge’ can be equipped with a widefield imaging mode to unlock solution assays, which makes it a versatile multi-user tool."

LUMICKS also announced that it will rebrand its existing flagship C-Trap product line into C‑Trap ‘Dymo’. The C-Trap ‘Dymo’ combines state-of-the-art optical tweezers with microfluidics and confocal or STED microscopy. The C-Trap ‘Dymo’ is a proven solution for impactful science in important application areas such as DNA-binding proteins, protein folding, and biomolecular condensates.