Week In Review: Lee's Pharm Signs $138M Agreement For China Rights To Heart Failure Therapy

seekingalpha01-21

Lee’s Pharm acquired China rights to a heart failure therapy from Windtree Therapeutics.AstraZeneca signed an investment cooperation agreement with the Taizhou National Medical High-tech Development ...

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Lee’s will be responsible for a China Phase III trial of istaroxime for acute heart failure and cardiogenic shock, and it will also have rights to Windtree’s preclinical next-gen dual mechanism SERCA2a activators and rostafuroxin, a Phase II candidate for hypertension associated with specific genotypes. About $100 million of the agreement is for istaroxime. Windtree has already completed a Phase IIb trial of istaroxime in China with positive published results. AstraZeneca (AZN) signed an investment cooperation agreement with the Taizhou National Medical High-tech Development Zone in Jiangsu province to build a new production line in its existing Taizhou manufacturing plant (see story). The agreement calls for the fund to underwrite a new $26.5 million production line for a diabetes therapy that the company launched in China last November. AstraZeneca’s Xigduo XR, a once-daily, fixed dose of dapagliflozin and metformin hydrochloride, is a type-2 diabetes therapy aimed at the large global market for weight loss. AstraZeneca has a large presence in China, which became larger this year after it signed a $1.2 billion deal to acquire China-US CAR-T developer Gracell Biotech (GRCL). Trials and Approvals Suzhou Adagene (ADAG) reported positive early data from a US Phase Ib/II trial of its masked anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in patients with Metastatic Microsatellite-stable ('MSS') Colorectal Cancer ('CRC') (see story). Adagene’s masking technology allows higher, more frequent dosing with better safety, which the company believes will result in a best-in-class candidate. The trial administered ADG126 at a rate of up to 200mg every three weeks in combination with Merck’s anti-PD-1 therapy Keytruda® every three weeks in heavily pretreated patients. The regimen produced a best-in-class safety profile. SineuGene, a Beijing startup that is developing an RNA therapy for ALS, reported that its lead candidate, SNUG01, slowed the progression of ALS to a “plateau stage” in the first person dosed with the therapy. In addition, the patient’s lower limbs responded to electric stimulation, an indication that a nerve has at least partly rejuvenated. SineuGene is led by Yichang Jia, PhD, a Professor at Tsinghua University School of Medicine. The company has not disclosed many details about its research, but its lead candidate stems from his research into RNA metabolism abnormalities that cause ALS. SineuGene believes its technology may also be effective for two other brain maladies, Alzheimer’s and Parkinson’s. Chengdu Chipscreen NewWay Biosciences dosed the first patient in a Phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, in patients with solid tumor cancers. The bsAb targets two targets synergistically, activating the CD40 pathway in a PD-1 dependent manner to reduce the toxicity of CD40 mAbs. The company believes NWY001 is the world's first PD-1/CD40 bispecific antibody to start clinical trials. In 2023, Chipscreen Bio, NewWay’s parent company, acquired rights to NWY001 in a $72 million agreement from a Biocytogen subsidiary, Eucure (Beijing) Biopharma. Beijing InnoCare Pharma (OTCPK:INCPF) was approved to start US clinical trials for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, the company’s fifth innovative candidate to start US trials. ICP-248 is an orally bioavailable BCL2-selective inhibitor that is expected to treat hematologic malignancies as a monotherapy or in combination with other therapies. The abnormal expression of BCL2, a regulatory protein of the apoptosis pathway, is related to the development of several hematologic malignancies. InnoCare has already started a Phase I dose escalation trial of ICP-248 is China, where preliminary results showed good efficacy and safety profiles. Shanghai CARsgen Therapeutics (OTCPK:CRTHF, HK: 2171) was cleared to start a China trial of CT011, an autologous CAR T-cell candidate against Glypican-3 (GPC3) for hepatocellular carcinoma. Patients must have GPC3-positive stage IIIa disease with a high risk of recurrence following surgical resection. CT011 is an autologous GPC3 CAR T-cell product that was originally cleared by China’s NMPA in 2019 to treat patients with GPC3-positive solid tumors, the first China CAR T-cell therapy clearance for a solid tumor indication. CARsgen has completed enrollment of a China Phase I trial for the candidate.  Disclosure: None.  Original Post Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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