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Trading and Funding
Structure Therapeutics (GPCRThe San Francisco and Shanghai-based clinical-stage company had a busy week, announcing positive clinical results for its obesity treatment and then raising $476 million through the issuance of ADSs. StoryStructure is a company developing small molecule versions of AI/Structure-based biopharmaceuticals and peptide drugs. In 2021, it will acquire Schrödinger (Sustainable Development), a New York-based AI company that became a strategic partner in the company formerly known as ShouTi, is now trading at $54 per ADS, up 65%, from $32 per ADS before the court filings.
Suzhou Alfamab Oncology is a wholly owned subsidiary of Arivent BioPharma Inc.AVBPThe Philadelphia-area biotechnology company signed an agreement to discover antibody-drug conjugates for ArriVent using its linker-payload (alfa-tecan) and glycan-conjugation platform. StoryAlfamab is The company will receive an unspecified upfront payment, as well as milestone payments of up to $615.5 million, and royalties. Jiangsu Alphamab BioPharma, a subsidiary of Alphamab Oncology, will hold the Greater China rights to the ADC products. Founded in 2008, Alphamab is currently pursuing more than 30 projects, including biosimilars, novel mAbs, and engineered versions of mAbs and proteins.
Summit Therapeutics (SMMT) is Akeso’s (OTCPK:AKESF) Ibonecimab adds Latin American and Middle Eastern/African countries (see: StorySummit signed a $70 million deal for expanded rights. Last week, Akeso said ibonecimab, a bispecific PD-1/VEGF antibody, showed superior results to Keytruda in a Phase 3 trial enrolling NSCLC patients. As part of today’s announcement, Summit also announced it had raised $200 million in a private placement. Summit acquired US/EU/Japan rights to ibonecimab for $500 million upfront and $4.5 billion in milestone payments in 2023.
Company News
GenScript Biotechnology may be the next target as part of the US Congress’ ongoing investigation into China-linked biopharmaceuticals. Founded in New Jersey in 2002, GenScript offers a wide range of early biological services to biopharmaceutical companies and researchers. All three founders of the company are from China, and the company has a presence in China. Two members of the US House of Representatives China Committee have asked US intelligence agencies to determine whether the Chinese Communist Party is influencing GenScript’s operations. The letter to the FBI included a strong assertion that “GenScript is working to establish a Communist Party-controlled bottleneck in a key area of biotechnology where the US currently leads.”
Testing and Approval
Suzhou Ascent Pharma (OTCPK:ASPHF(http://www.clinicaltrials.gov/clinical_trials/clinical_trials_2019022222) reported that an objective response rate of 90.9% was achieved in an international Phase Ib/II study of the combination of the Bcl-2 inhibitor Lisaftoclax and the Janssen-AbbVie BTK inhibitor Ibruvica in patients with Waldenström’s macroglobulinemia (“WM”). The combination was more than twice as effective as other treatments. Lisaftoclax was administered as monotherapy or in combination with other agents to treatment-naive study enrollees. Lisaftoclax is the first pivotal-stage Bcl-2 inhibitor in China. The data were presented at the American Society of Clinical Oncology Annual Meeting.
Nanjing Leeds Biolabs has announced clinical data from a Phase I/II study of LBL-024, a bispecific antibody consisting of anti-PD-L1 and anti-4-1BB (CD137) antibodies. The candidate showed efficacy as a monotherapy for patients with advanced malignancies, particularly for patients with extrapulmonary neuroendocrine carcinoma (EP-NEC) who have failed at least one form of chemotherapy. EP-NEC is a rare disease that typically occurs in the stomach, intestine, and pancreas. Diagnosis is usually made at a late stage of the disease, so the cancer has already metastasized and the prognosis is poor. There are no approved treatments for EP-NEC.
Yantai RemeGen (OTCPK:REGMF(Headquarters: China) reported positive data from the first Phase I/II clinical trial in China of RC88, an ADC targeting mesothelin (MSLN) and delivering a monomethylauristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors, but its expression in normal tissues is limited. The trial enrolled 170 patients with ovarian cancer, non-small cell lung cancer, and cervical cancer who had previously failed other therapies. Currently, chemotherapy is the standard treatment for ovarian cancer, with an overall response rate of 12%, but RC88 recorded an ORR of 42% in the trial.
SCG Cell Therapy Pte, Singapore, announced positive data for its first-in-class autologous Hepatitis B virus-specific T cell receptor modified T cell therapy. In six patients with advanced HBV-HCC, SCG101 resulted in a 33% objective response rate. SCG is developing novel immunotherapies against infections and their associated cancers targeting the most common cancer-causing infections: Helicobacter pylori, HPV, HBV and EBV. It is also developing TCR-based cellular immunotherapy products for 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 in Milan, Italy.
AbelZeta Pharma, a Maryland and Shanghai-based CAR-T company, reported positive results from a Chinese investigator-initiated trial of C-CAR031 in patients with heavily treated advanced hepatocellular carcinoma (“HCC”). In the trial, patients saw early signs of efficacy with a manageable safety profile. C-CAR031 is an autologous GPC3-targeted CAR-T therapy being developed in China, but is being developed by AstraZeneca (Azun), which is based on AstraZeneca’s novel GPC3-targeted CAR-T platform. It is manufactured by AbelZeta in China and is being co-developed by AbelZeta and AstraZeneca.
I love youImabBristol-Myers Squibb, which is now a U.S. company after selling its Chinese assets earlier this year, is also a wholly owned subsidiary of the company.Be Me) combines I-Mab’s Claudin 18.2 x 4-1BB bispecific antibody, givastomig, with BMS’ PD-1, nivolumab. The Phase I trial will investigate the combination as a first-line treatment for advanced Claudin 18.2-positive gastric and esophageal cancer. Patients will also receive chemotherapy (FOLFOX or CAPOX). BMW will provide nivolumab to study participants. I-Mab is developing givastomig in collaboration with ABL Bio of South Korea.
Disclosure: none.
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