September 13, 2024 Source: drugdu 63
On September 5, Connect (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company headquartered in the United States, announced its financial results for the six months ended June 30, 2024 and announced plans to large-scale attrition.
In addition, as part of Connect's transformation into a U.S.-focused company, the company plans to significantly reduce the scale of its operations in China.
Just a few months ago, Connect was an innovative pharmaceutical company in China.
All these changes are rooted in the clinical setbacks of Connect’s core pipeline product, Rademikibart (CBP-201). This is a fully human monoclonal antibody targeting IL-4Rα, which is a common subunit of IL-4Rα and IL-13 receptors. It directly targets Sanofi’s new autoimmune drug Duprilumab. anti.
In the CBP-201 clinical data previously announced by Connect, although some connotations of long-term efficacy data were seen, the improvement in the 16-week data was weaker than that of dupilumab; in addition, because it was not head-to-head data, compared with According to the 52-week data of dupilumab, CBP-201 does not have very “significant” data to prove that it can win steadily.
Therefore, the me-too or me-worse label of CBP-201 has not been reversed in the eyes of investors in the US market. At the same time, for CBP-201, which only has long-term effective data on the Chinese subgroup, its value in the markets of developed countries such as Europe and the United States has been weakened to the greatest extent.
As part of a strategic move to transform into a core U.S. company, Connect has reduced its China workforce by approximately 15% over the past year and expects further reductions by the end of the year.
This shift in geographic strategy also includes Connect's transition of production of anti-IL-4Ra antibody rademikibart to a contract manufacturer in the United States, a move expected to significantly reduce manufacturing costs in 2024 and 2025.
Additionally, the company returned the rights to an eczema drug, CBP-174, to Pfizer in April.
In 2012, Connect licensed an oral peripherally acting H3R antagonist (CBP-174) from Arena Pharmaceuticals, which Pfizer acquired a decade later for $6.7 billion.
Connect previously considered the small molecule complementary to its anti-IL-4Ra antibody CBP-201 and competing drug Dupixent from Regeneron and Sanofi.
By treating chronic itching associated with skin inflammation, Connect believes CBP-174 can quickly relieve bothersome eczema symptoms, helping patients wait for CBP-201 to take effect. But Conrad abandoned this vision.
Connect will continue to develop CBP-201 (rademikibart) for the treatment of diseases including eczema, but has decided to terminate the license agreement for CBP-174. The move is to "maximize resources and extend cash flow."
Conserving cash flow to weather the storm is a top priority for Connect, which has halted all preclinical and discovery programs.
Even clinical projects are being weighed.
Although Connect recently received positive feedback from the U.S. FDA on a potential Phase III trial of rademikibart in asthma and atopic dermatitis, the company was still weighing whether to move forward with rademikibart in its recent second-quarter earnings report.
Simcere Pharmaceuticals, which obtained the rights to the drug in Greater China last year, showed no hesitation and recently announced the launch of a Phase III trial of rademikibart in asthma and moderate to severe atopic dermatitis.
"After comprehensively reviewing all of the clinical data generated by rademikibart, I remain very excited about this potentially best-in-class competitive product," Connect CEO Barry Quart said on a Sept. 5 earnings call.
"At the same time, we continue to advance the company's transformation into a U.S.-focused company and significantly reduce the size of our operations in China," Quart added. "We are excited about the company's transformation and look forward to unveiling rademikibart's new strategy in the near future."
As of the end of June, Connect held $110.2 million in cash and equivalents. Combined with the company's ongoing efforts to tightly control spending, the biotech company expects the funding to support its operations until at least the first half of 2027.
Connect's other clinical-stage drug candidate is an S1P1 T-cell receptor modulator called icanbelimo.
Source:https://mp.weixin.qq.com/
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