On February 9, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that anti-CD20/CD3 bispecific antibody mosunetuzumab achieved the primary endpoint of complete response rate (CRR) in an expansion cohort of the Japanese Phase I study evaluating the efficacy and safety in patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior systemic therapies (Press release, Chugai, FEB 9, 2024, View Source;category= [SID1234639948]). The safety profile was consistent with previous overseas studies.

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"R/R FL is a disease that repeatedly recurs and is difficult to cure, and new treatment strategies are required. We are very pleased that bispecific antibody mosunetuzumab achieved CRR and showed promising results for remission. We will continue efforts to apply for the approval of mosunetuzumab in Japan to deliver this drug as a new treatment option for patients as quickly as possible," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai will file a new drug application in Japan based on these study results and the overseas Phase I/II clinical studies conducted by Roche in the same patient population.

About Japanese Phase I study for mosunetuzumab
This study is a Japanese phase I clinical study to evaluate the efficacy and safety of mosunetuzumab in a dose-escalation cohort and in an expansion cohort for patients with R/R FL who have previously received two or more systemic therapies. 19 patients were enrolled in the expansion cohort. The primary endpoint was CRR. Key secondary endpoints included overall response rate, progression-free survival, and duration of response.

About mosunetuzumab
Mosunetuzumab is a CD20xCD3 T cell-engaging bispecific antibody designed to target CD20 on B cells and CD3 on T cells. Mosunetuzumab is expected to activate the immune system through cytotoxic T cells and have antitumor effects on CD20 expressed tumor cells. Mosunetuzumab is currently being developed with intravenous and subcutaneous formulations for the treatment of R/R FL and R/R aggressive B-cell non-Hodgkin lymphoma.

About follicular lymphoma
FL is a type of lymphoma that occurs when B lymphocytes, a type of white blood cell, become cancerous. At diagnosis, 70-85% of patients reach an advanced stage1. Generally, the progression is slow, and chemotherapy is initially effective, but recurrences occur repeatedly in many cases. Repeated recurrences can make it difficult for existing treatments to be effective, and new highly effective treatments are expected. In Japan, approximately 5,000 people reportedly become afflicted with FL each year.

On February 28, 2024 Disruptive Pharma reported the company’s Board of Directors has, subject to approval at an extraordinary general meeting on April 2, 2024 has, subject to approval at an extraordinary general meeting on April 2, 2024, resolved to conduct a new share issue with preferential rights for the Company’s existing shareholders, which, if fully subscribed, will provide the Company with approximately SEK 35 million before issue costs (the "Rights Issue") (Press release, Disruptive Pharma, FEB 8, 2024, View Source [SID1234649945]). The purpose of the Rights Issue is primarily to finance development activities related to the Company’s first product candidate, DPH001.

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On February 8, 2024 Attovia Therapeutics, a biotech company pioneering spatially optimized biparatopic biologics, reported the closing of the $30 million second tranche of its previously reported $60 million Series A financing (Press release, Attovia Therapeutics, FEB 8, 2024, View Source [SID1234647442]). Attovia also announced the nomination of the first development candidate generated from its Attobody biologics platform, ATTO-1310, a potential first-in-class, long half-life anti-IL31 Attobody. Proceeds from the second tranche will be used to advance ATTO-1310 through early clinical trials, move the Company’s second program, ATTO-002, a bispecific IL31 x IL13 ligand trap, toward IND-enabling studies, and to further develop the Attobody platform and early discovery pipeline.

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"The novel advantages of the biparatopic binding mode of the Attobody technology include potential for higher efficacy and the ability to expand the universe of druggable epitopes," said Tao Fu, CEO of Attovia. "Our first set of programs validate the Attobody platform and illustrate Attovia’s core capabilities to discover and develop small format biologics with first- or best-in-class potential at industry-leading speed. In just eight months, the Attovia team has successfully closed both tranches of the $60 million Series A financing, built a pipeline of five novel programs, and rapidly advanced our lead programs towards the clinic. I am thrilled to partner with our investors, executive team, and advisors to develop our highly innovative product portfolio."

Pipeline Update

Attovia’s lead programs focus on immune-mediated disease. The Company’s first program, ATTO-1310, is currently in IND enabling studies and is intended for the treatment of atopic dermatitis and other pruritic diseases. Through biparatopic binding and ligand- rather than receptor-targeting, ATTO-1310 has the potential to achieve faster and deeper responses than other IL31-pathway targeting molecules. ATTO-1310 utilizes clinically validated half-life extension technology designed to lengthen its dosing interval to potentially once every three months, compared to bi-weekly or monthly dosing with marketed biologics for these indications. ATTO-1310 is currently on track to enter the clinic around year-end 2024.

The Company’s second program, ATTO-002, is a small format, bispecific ligand trap targeting IL31 and IL13. ATTO-002 seeks to establish a new standard of care in the treatment of atopic dermatitis by simultaneously inhibiting two non-overlapping pathways involved in disease pathology with potentially best-in-class potency, and by avoiding receptor-mediated drug removal. Attovia expects to nominate a development candidate and advance the candidate to IND enabling studies in the second half of 2024. Given the modularity of the platform, the existing IL13 binder from ATTO-002 can be combined with new additional arms such as anti-TSLP, -OX40L, -IL33, and others, to build Attobody-based bispecifics targeting respiratory and fibrotic diseases such as asthma, idiopathic pulmonary fibrosis (IPF), or chronic obstructive pulmonary disease (COPD).

Attovia has initiated three additional discovery programs in immune mediated disease and oncology:

ATTO-004, targeting a novel G-protein-coupled receptor (GPCR);
ATTO-005, targeting a first-in-class bispecific combination in inflammatory bowel disease (IBD);
ATTO-003, an anti-B7H4 drug conjugate program exploring the possibility of using Attobody as the ideal binder for payload delivery to improve therapeutic index in select solid tumors.

On February 8, 2024 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its report for the fourth quarter 2023 (Press release, Swedish Orphan Biovitrum, FEB 8, 2024, View Source [SID1234642334]).

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On February 8, 2024 AstraZeneca reported its full year and fourth quarter 2023 financial results (Press release, AstraZeneca, FEB 8, 2024, View Source [SID1234639964]).

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