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Deals and Financings

Structure Therapeutics (GPCR), a San Francisco-Shanghai clinical stage company, had a busy week, announcing positive clinical results for its obesity drug and then raising $476 million via an offering of its ADSs (see story).

Structure is an AI/Structure-based company that develops small molecule versions of biologic and peptides drugs. It was co-founded in 2021 by Schrödinger, an AI company based in New York that became a strategic partner of the company previously known an ShouTi. Structure's stock price jumped from $32 per ADS before the trial news and now sits at around $53 per ADS, a 65% increase. 

Suzhou Alphamab Oncology announced a deal with ArriVent BioPharma (AVBP), a Philadelphia area biotech, to use its linker-payload (Alphatecan) and glycan-conjugation platforms to discover antibody drug conjugates for ArriVent (see story). Alphamab will receive an unspecified upfront payment and potential milestones of up to $615.5 million, plus royalties.

Jiangsu Alphamab BioPharma, an Alphamab Oncology subsidiary, will retain Greater China rights to the ADC products. Founded in 2008, Alphamab is currently advancing more than 30 active projects, including biosimilars, novel mAbs, and engineered version of mAbs and proteins. 

Summit Therapeutics (SMMT) of Miami expanded its rights to Akeso’s (AKESF) ivonescimab, adding the countries in Central and South America plus the Middle East and Africa (see story). Summit signed a $70 million agreement for the expanded rights.

Last week, Akeso said ivonescimab, a bispecific PD-1/VEGF antibody, showed better results than Keytruda in a Phase III trial that enrolled patients with NSCLC. As part of the announcement, Summit also reported it raised an unsolicited $200 million in a private placement. In 2023, Summit acquired US/EU/Japan rights to ivonescimab for $500 million upfront and $4.5 billion in milestones. 

Company News

GenScript Biotechnology (GNNSF) may be the next target of the US Congress, as part of its ongoing examination into biopharmas with links to China (see story). Founded in 2002 in New Jersey, GenScript offers a broad array of early biologic services to biopharmas and researchers. Its three founders are all from China, and the company has expanded into China.

Two members of the US House of Representatives Committee on China asked the US intelligence community to determine if China’s Chinese Communist Party  influences GenScript's operations. The letter to the FBI included a strong allegation: “GenScript is working to establish CCP-controlled chokepoints in critical areas of biotechnology in which the US currently leads,” it said. 

Trials and Approvals

Suzhou Ascentage Pharma (ASPHF) reported an objective response rate of 90.9% in a global Phase Ib/II trial of its Bcl-2 inhibitor, lisaftoclax, in Waldenström macroglobulinemia (WM) patients who received a combination of lisaftoclax and Imbruvica, a Janssen-AbbVie BTK inhibitor (see story). The combination was more than twice as effective than other regimens.

Lisaftoclax was administered either as a monotherapy or in combination with other drugs in the trial’s treatment-naïve enrollees. Lisaftoclax is the first pivotal-stage Bcl-2 inhibitor in China. The data was presented at the American Society of Clinical Oncology Annual Meeting.

Nanjing Leads Biolabs presented clinical data from a Phase I/II trial of LBL-024, a bispecific antibody composed of an anti- PD-L1 and an anti-4-1BB (CD137) antibody (see story). The candidate showed efficacy as a monotherapy for patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinoma (EP-NEC) patients who had failed at least one line of chemotherapy.

EP-NEC is a rare disease that usually occurs in the stomach, intestines, and pancreas. Because the diagnosis is usually made at a late stage of the disease, the cancer has already metastasized, and the prognosis is poor. There is no approved therapy for EP-NEC. 

Yantai RemeGen reported positive data from a first-in-human China Phase I/II trial of RC88, an ADC that targets mesothelin (MSLN) and delivers a monomethyl auristatin E (MMAE) payload (see story). MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues.

The trial enrolled 170 patients with ovarian, non-small cell lung, and cervical cancers who had previously failed other therapies. Currently, chemotherapy is the standard of care for ovarian cancer with an overall response rate of 12%, while RC88 recorded a 42% ORR in the trial. 

Singapore’s SCG Cell Therapy Pte announced positive data from a first-in-class autologous hepatitis B virus-specific T-cell receptor-engineered T Cell therapy (see story).

In six patients with advanced HBV-HCC, SCG101 produced an objective response rate of 33%. SCG develops novel immunotherapies for infections and their associated cancers, targeting the most common cancer-causing infections: helicobacter pylori, HPV, HBV, and EBV. It also develops TCR-based cellular immunotherapy products against infection- associated cancers.

The trial data was included in the recent Best of EASL Congress Wrap-Up summary at the European Association for the Study of the Liver Congress in Milan, Italy. 

AbelZeta Pharma, a Maryland-Shanghai CAR-T company, reported positive results from a China Investigator-Initiated Trial of C-CAR031 in patients with heavily pretreated advanced hepatocellular carcinoma (HCC) (see story). The study showed early signs of efficacy in the patients and a manageable safety profile.

C-CAR031 is an autologous, armored GPC3-targeting CAR-T therapy being developed in China, though it belongs to AstraZeneca (AZN) and is based on Astra-Zeneca’s novel GPC3-targeting CAR-T platform. It is manufactured by AbelZeta in China, where it being co-developed by AbelZeta and AstraZeneca. 

I-Mab (IMAB), now a US company since selling off its China assets earlier this year, announced plans to form a clinical trial collaboration with Bristol Myers Squibb (BMY) that will combine I-Mab’s givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, with Bristol Myers' PD-1, nivolumab (see story).

The Phase I trial will examine the combination as a first-line therapy for advanced Claudin 18.2-positive gastric and esophageal cancers. Patients will also receive chemotherapy (FOLFOX or CAPOX). Bristol Myers will supply nivolumab to participants in the trial. I-Mab is jointly developing givastomig with ABL Bio of Korea.

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