On March 11, 2023 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the Phase II clinical trial of ImmuneOnco Biopharmaceuticals bispecific antibody-receptor recombinant protein drug (Project No. IMM0306), which targets both CD47 and CD20, was completed on 3rd April (Press release, ImmuneOnco Biopharma, MAR 11, 2023, View Source [SID1234655683]). This is another milestone achievement in the rapid development of ImmuneOnco Biopharmaceuticals.

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Previously, IMM0306 had obtained clinical trial approvals from China NMPA and US FDA, as well as patent authorizations from China, US, and Japan, solidifying ImmuneOnco Biopharmaceuticals’ leading position in the development of CD47 targeted drugs and bispecific antibodies research. On March 16th, following unanimous agreement from project research experts, IMM0306 selected a safe and effective single-agent dose of 2mg/kg to enter into the IIa phase of clinical trials, targeting further clinical development in indications for indolent lymphomas such as third-line and above follicular lymphoma (FL) and marginal zone lymphoma (MZL). At the same time, the Ib/IIa phase of clinical trials for IMM0306 in combination with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma (FL) is also underway.

The preliminary data from the Phase I clinical trial has demonstrated encouraging efficacy and favorable safety profile of IMM0306. IMM0306 was safe and well tolerated up to 2.0 mg/kg. Among the evaluable patients across four cohorts dosed from 0.8 mg/kg to 2.0 mg/kg, who had relapsed or progressed after receiving rituximab previously, three CRs and four PRs were observed. Also, no significant cytokine storm toxicity was observed in all patients.

Dr. Wenzhi Tian, founder and chairman of ImmuneOnco Biopharmaceuticals, said:

"We are very pleased to see the first subject enrolled in our Phase II clinical trial of IMM0306, a recombinant antibody-receptor protein (mAb-Trap) targeting both CD47 and CD20 and is the first CD47 and CD20 dual-targeting bispecific to enter into clinical stage globally. IMM0306 does not bind to human erythrocytes in vitro and has been shown to be significantly more effective than rituximab at the same dose in preclinical in vivo efficacy trials. data from phase I clinical studies have demonstrated a favorable safety and clinical efficacy response as a single agent, with encouraging tumor efficacy observed particularly in patients with relapsed refractory FL and MZL and DLBCL. We will continue to advance the IMM0306 program and strive to bring early benefits to the majority of cancer patients."

On March 11, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that neither ImmixBio, nor any of its subsidiaries, have any exposure to Silicon Valley Bank ("SVB") or Silvergate Bank (Press release, Immix Biopharma, MAR 11, 2023, View Source [SID1234628546]).

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On March 11, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported an update about its capital resources (Press release, Mersana Therapeutics, MAR 11, 2023, View Source [SID1234628544]). A de minimis amount of Mersana’s capital is currently held in a checking account at Silicon Valley Bank (SVB). The balance of the company’s capital resources is held in a custodial account managed by another institution and in money market funds of institutions other than SVB.

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Mersana has a loan and security agreement with Oxford Finance LLC and SVB. As previously disclosed, to date the company has borrowed $25 million under the loan agreement, and $15 million is available to be borrowed at the company’s option under the terms of the loan agreement. The recent closure of SVB and the appointment of the Federal Deposit Insurance Corporation as receiver is not a repayment trigger pursuant to the terms of the loan agreement.

On March 11, 2023 Veracyte, Inc. (Nasdaq: VCYT) outlined the company’s cash, reported its cash equivalents and short-term investment status in light of the events surrounding Silicon Valley Bank (SVB) (Press release, Veracyte, MAR 11, 2023, View Source [SID1234628542]).

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As of December 31, 2022, the company had $178.9 million in cash, cash equivalents and short-term investments. The majority of these assets are not restricted by the Federal Deposit Insurance Corporation’s (FDIC) action to take control of SVB. The company believes its currently accessible cash, cash equivalents and short-term investments will be sufficient to satisfy its operations and obligation

On March 10, 2023 Huihe Biotechnology (CytoCares) reported that its CC312 was approved for clinical trial license by the NMPA (Acceptance number: CXSL2200621), the indication is relapsed/refractory CD19-positive B-cell malignant hematological tumors (Press release, CytoCares, MAR 10, 2023, View Source [SID1234635271]). CC312 is TriTE independently developed by Huihe Biotech. The first product of the platform is also the first trispecific antibody based on CD28 costimulatory signal to be clinically approved in China and the third in the world. This is another milestone after CC312 obtained FDA clinical implicit approval on May 14, 2022, marking the product entering the clinical research stage in China and the United States.

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CC312 is Huihe Biotechnology’s first TriTE-basedTM(Tri-specific T-cell Engager) technology platform independently developed project with independent intellectual property rights. Full activation of T cells requires the synergistic effect of two stimulatory signals, including the first stimulatory signal acting on the CD3/TCR complex, and the costimulatory signal acting on receptors such as CD28 or 4-1BB. Among them, the loss of any signal may lead to incomplete activation of T cells or incompetence or apoptosis after activation. TriTETMThe platform is based on the "dual signal" activation mechanism of T cells and uses co-stimulation signals as the "amplifier" of the first stimulation signal to achieve sustained and sufficient activation of T cells.

CC312 is composed of three single-chain variable region fragments (scFv) targeting CD19, CD3 and CD28 antigens . The three functional domains are connected by a flexible fragment and an IgD hinge region fragment. The T T receptor mediated by the antibody molecule of this structure The immune synapse formed between cells and target cells is closest to the immune synapse mediated by TCR and MHC complexes under natural conditions. By targeting the CD19 functional domain, T cells are precisely directed to tumor cells, and then T cells are fully activated through CD3xCD28 dual stimulation activation signals. Activating T cells with a "dual signal" regulatory mechanism has a longer-lasting activation effect on effector cells and can induce T cells to differentiate into memory T cells. CC312 also has strong tumor suppressive activity at low dosing frequency, thereby Can improve clinical dosing patterns.

Amgen’s blinatumomab (trade name Blincyto) targets CD3xCD19, which is not only expensive, but also requires continuous intravenous infusion for 4 weeks. The administration mode is very inconvenient. CC312 (CD19xCD3xCD28) has shown good pharmacological properties, bioavailability, and safety in preclinical studies for hematomas. As well as effectiveness and longer half-life , it is an upgraded version of the CD19xCD3 dual antibody and has clinical substitution. As an antibody-based version of CAR-T, CC312 has unique advantages in terms of patient compliance and accessibility. It combines the advantages of CAR-T, monoclonal antibodies, and dual antibodies, and has great potential to replace CAR-T therapy.

Dr. Zhu Huaxing, founder and chairman of Huihe Biotechnology, said "The CC312 project has obtained clinical trial research approval from NMPA, which is a major milestone for Huihe Biologics. As China’s first triple-antibody drug based on a dual-signal activation mechanism to obtain IND approval from China and the United States, it has broken the boundaries of foreign new drug development. We are very proud of our monopoly position. We will fully promote the phase I clinical research of CC312 and benefit more subjects as soon as possible. Huihe will also continue to uphold the principle of "continuous innovation, benefiting the people, working together with one heart, and embracing all rivers." The concept of providing more, better and more affordable new drugs for clinical practice and patients."