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Connect Biopharma Announces Positive Rademikibart Global Phase 2b Topline Results in Adult Patients with Moderate-to-Severe Persistent Asthma



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The global trial met its primary endpoint showing both doses of rademikibart treatment significantly improved lung function at Week 12
•
The significant improvement in lung function was observed as early as Week 1 and was sustained through Week 24 with both doses of rademikibart
•
Significant improvement in asthma control occurred early and was sustained through Week 24 for both doses of rademikibart
•
Safety results suggest rademikibart was generally well tolerated
•
A conference call and webcast presentation to discuss the data will be held today at 8:30 a.m. ET, details below


SAN DIEGO, CA and TAICANG, China, December 12, 2023 -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, announced today positive topline results from the global Phase 2b trial evaluating rademikibart efficacy and safety in adult patients with moderate-to-severe persistent asthma.



This Phase 2b trial was a global, multicenter, randomized, double-blind, placebo-controlled study conducted in 79 sites in the United States, Poland, Hungary, China and South Korea with 322 patients randomized 1:1:1 to rademikibart 150 mg every two weeks (Q2W) with a loading dose of 600 mg (n=106), rademikibart 300 mg Q2W with a loading dose of 600 mg (n=108) and placebo (n=108). Two-thirds of the randomized patients were treated in the United States.



The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator (BD) forced expiratory volume over one second (FEV1) showing that at Week 12, lung function significantly improved over placebo with both rademikibart doses (see table below). The significant improvements seen compared to placebo with both rademikibart 150 mg and 300 mg started as early as Week 1 (p < 0.001 for both) and were sustained through 24 weeks of treatment (p = 0.001 and p < 0.001, respectively). A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of ≥ 300 cells/µl (see table below).
https://ih.advfn.com/stock-market/NASDAQ/connect-biopharma-CNTB/stock-news/92785453/form-6-k-report-of-foreign-issuer-rules-13a-16

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April 2022 Shelf
EDGAR
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Current Raisable Amount
$300,000,000
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On November 21, 2023, the Company announced that two of its wholly owned subsidiaries, Connect Biopharma HongKong Limited (“Connect HK”) and Suzhou Connect Biopharma Co., Ltd. (“Connect SZ” and, together with Connect HK, the “Licensor”), have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd. (the “Licensee”), a subsidiary of Simcere Pharmaceutical Group Ltd to develop and commercialize Connect Biopharma’s rademikibart in Greater China.

Under the agreement, the Licensor will complete all of rademikibart’s ongoing China clinical trials and related analysis in atopic dermatitis (AD), which is on track for a new drug application submission for AD in China by the end of Q1 2024. The Licensee has been granted exclusive rights to develop, manufacture and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while the Licensor retains rights in all other markets. The Licensee will be responsible for rademikibart’s new drug application for AD in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart in Greater China.

According to the terms of the agreement, the Licensor will receive a ¥150 million RMB (US$21 million) upfront payment, up to ¥875 million RMB (US$120 million) upon achieving certain development and commercial milestones, in addition to royalties up to low double-digit percentages of net sales. The translation from renminbi to U.S. dollars was made at RMB 7.3166 to US$1.00, representing the exchange rate as of October 31, 2023 set forth in the China Foreign Exchange Trade System.

The description of the Exclusive License and Collaboration Agreement is qualified in its entirety by the Exclusive License and Collaboration Agreement, the English translation of which is furnished herewith as Exhibit 99.1, and incorporated herein by reference.

Other Events.

On November 21, 2023, the Company announced positive topline results from the Stage 2 (maintenance period) of its China pivotal trial evaluating rademikibart’s (formerly known as CBP-201) efficacy and safety in patients with moderate-to-severe AD. These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints.

Positive Stage 2 results at Week 52 show the potential of rademikibart as a Q4W treatment for AD

In Stage 2, patients that achieved EASI-50 (responders) regardless of initial treatment in the 16-week Stage 1 were randomized to either dosing every two weeks (“Q2W”) rademikibart (n=113) or dosing every four weeks (“Q4W”) rademikibart (n=112) arms. Patients that did not achieve EASI-50 (non-responders) were assigned to an open label Q2W rademikibart arm (n=86).


An efficacy analysis in patients that achieved Investigator’s Global Assessment scale (“IGA”) 0/1 or Eczema Area and Severity Index (“EASI”)-75 at Week 16, showed that with both Q2W at Q4W dosing regimens, 76%-87% of them maintained their IGA 0/1 and 92% of patients maintained their EASI-75 at Week 52, respectively.


Rademikibart Week 52 Results
In patients that achieved IGA 0/1 or EASI-75 at Week 16
Rademikibart
300 mg Q4W
Rademikibart
300 mg Q2W
IGA 0/1 with
≥2-point reduction
87.2%
(n=40)
76.0%
(n=34)
EASI-75
91.9%
(n=79)
91.7%
(n=76)

Evaluation of all patients that achieved EASI-50 at Week 16 with rademikibart (active drug responders) showed continued improvement from Week 16 to Week 52. 21%-28% more patients achieved IGA 0/1, and 11%-16% more patients achieved EASI-75 at Week 52.


Rademikibart Week 52 Results
In patients that achieved EASI-50 at Week 16
Rademikibart
300 mg Q4W (n=91)
Rademikibart
300 mg Q2W (n=91)

Week 16
Week 52
Week 16
Week 52
IGA 0/1 with
≥2-point reduction
41.8%
62.6%
30.9%
59.1%
EASI-75
73.6%
84.6%
68.5%
84.8%

Additionally, of the patients who achieved a clinically meaningful ≥4-point reduction in peak pruritus numerical rating scale (“PP-NRS”), 95.2% were able to maintain that level with Q4W dosing and 81.6% with Q2W dosing at the end of the study. With respect to quality of life, a ≥5-point reduction on the dermatology life quality index (“DLQI”) is considered clinically important and 93.4% (Q2W) and 90.0% (Q4W) were able to maintain this level at the end of the 52-week study.

Treatment with 300 mg Q2W and Q4W of rademikibart was generally well tolerated, and there were no new safety signals. There was only one patient discontinuation due to an adverse event (pregnancy) in the rademikibart Q2W open label arm.

On November 21, 2023, the Company issued the press release attached hereto as Exhibit 99.2. The furnishing of the attached press releases is not an admission as to the materiality of any information therein. The information contained in the press releases is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing or furnishing of other reports or documents with the SEC or through other public disclosures.


The information in the paragraphs above under “Information Contained in this Report on Form 6-K” in this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File No. 333-264340) and Form S-8 (File Nos. 333-254254 and 333-266006) of the Company, filed with the Securities and Exchange Commission, and to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.

Forward-Looking Statements

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Connect Biopharma Announces Positive Long-Term Data from the Maintenance Period Through Week 48 of CN002 Phase 2 Icanbelimod Trial in Patients with Moderate-to-Severe Ulcerative Colitis
Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period.
Icanbelimod continued to be well-tolerated, consistent with observed induction period safety data.
SAN DIEGO, CA and TAICANG, China, June 01, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced positive data at Week 48 from Phase 2 trial (CN002) for icanbelimod (formerly known as CBP-307), a once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 (S1P1) modulator in development for the treatment of ulcerative colitis (UC).

Trial Design (Maintenance Period)
The maintenance period of CN002 was a 36-week treatment period that followed the 12-week induction period (N=145) where icanbelimod 0.2 mg, administered orally once daily (PO QD), showed statistically significant improvements in clinical remission and clinical response compared to placebo, and a numerical improvement in change from baseline in adapted Mayo score.

The maintenance period included patients who achieved clinical response at the end of the induction period of the trial and continued treatment on icanbelimod 0.2 mg (n=21), 0.1 mg (n=12) or placebo (n=13) PO QD, and an icanbelimod 0.2 mg PO QD open-label arm for all non-responders (n=40) from the induction period.

Icanbelimod 0.2 mg PO QD Efficacy Data Highlights from Maintenance Period

86% (18/21) of patients who received icanbelimod completed the maintenance period.
67% (12/18) of patients who completed the study through Week 48 achieved clinical remission.
80% (8/10) of patients who achieved clinical remission at the end of the induction period sustained it through Week 48.
Overall, 57% (12/21) of patients with clinical response at the end of the induction period achieved clinical remission at the end of the maintenance period.
Safety Data Highlights from Maintenance Period

Icanbelimod was well-tolerated and long-term safety data through Week 48 remained consistent with safety findings observed in the induction period.
Frequencies of treatment emergent adverse events were similar between icanbelimod and placebo groups, and most were mild to moderate in severity with no new safety signals noted.
“Current treatment options for UC have not demonstrated break-through efficacy based on clinical remission, highlighting the need for new and more effective therapies. Based on the icanbelimod 0.2 mg data, the clinical remission efficacy, safety data and absolute lymphocyte count reduction are compelling,” said Brian Feagan, M.D., Professor in the Departments of Medicine, Epidemiology and Biostatistics at the Shulich School of Medicine & Dentistry, University of Western Ontario. “Additionally, because icanbelimod has rapid recovery of lymphocytes upon discontinuation and high potency, there is an opportunity to optimize the dosing strategy in future trials to further enhance the already encouraging efficacy data,” added Dr. Feagan.

“These promising data from the maintenance period of CN002 further support the potential of icanbelimod to be not only a best-in-class S1P1 modulator, but also an important new treatment option among current standard of care therapies, offering patients with UC a much-needed sustainable control of inflammation,” said Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. “We are actively exploring strategic partnerships to advance icanbelimod into a registrational program to realize its therapeutic potential. In addition, we plan to submit the full data from the study to a medical congress later this year.”

About CN002 Trial

CBP-307CN002 is a Phase 2 study evaluating the efficacy and safety of icanbelimod as an induction and maintenance therapy in adult patients with moderate-to-severe UC. The randomized, double-blind, placebo-controlled, multi-center study enrolled a total of 145 patients in two active dose arms (icanbelimod 0.1 mg (n=39); icanbelimod 0.2 mg (n=53)) and a placebo arm (n=53) from over 60 sites in 4 countries.

About Ulcerative Colitis

Ulcerative Colitis (UC) is an idiopathic inflammatory condition of the mucosal and submucosal colon that has a globally increasing prevalence thought to be driven by societal changes. There are approximately 600,000 to 900,000 people in the United States living with ulcerative colitis. When insufficiently controlled, UC leads to progressive organ damage that presents as functional impairment and anatomical changes such as dysplasia, which may ultimately progress to cancer. Despite the availability of new treatments that have advanced the standard of care, a “therapeutic ceiling” exists, meaning that treatment options remain limited and clinical remission is still not achieved in 70–80% patients.

About Icanbelimod (formerly known as CBP-307)

Discovered internally using Connect Biopharma's proprietary Immune Modulation Technology, icanbelimod is an

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Connect Biopharma (NASDAQ:CNTB) was downgraded by analysts at Piper Sandler from an "overweight" rating to a "neutral" rating.The current price is $0.75.

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