Chief Executive Officer Lee Sang-hoon of ABL Bio said, "We are continuing to discuss a technology transfer with Novabridge for the gastric cancer treatment candidate 'Zivastomig (ABL111),' and we are also keeping open the option of technology transfer or in-house development after further clinical trials to enhance its value."
At a press briefing held on the 7th at the Conrad Seoul in Yeouido, Lee said, "We could do a technology transfer now, or it could be possible six months later or even while a global phase 3 trial is underway."
Zivastomig is a bispecific antibody treatment candidate being co-developed by ABL Bio and U.S.-based Novabridge Biosciences. It simultaneously targets "claudin 18.2," a protein overexpressed in gastric and pancreatic cancers, and the immune T-cell activation receptor "4-1BB."
The agent received priority review (fast track) designation from the U.S. Food and Drug Administration (FDA), will skip phase 2, and is set to begin a global phase 3 trial in November this year for approval. ABL Bio will also present phase 1 results at the upcoming European Society for Medical Oncology (ESMO).
Development is also on track for 'Tovestimig (ABL001),' which is being developed as a treatment for cholangiocarcinoma. U.S. partner Compass Therapeutics plans to file a biologics license application (BLA) with the FDA as a second-line therapy for cholangiocarcinoma at the end of this year or early next year.
Lee also stressed that the 'Grabody-B' blood-brain barrier (BBB) shuttle platform project, which was licensed out last year to GSK plc and Eli Lilly and Company, is progressing faster than expected.
He said, "Joint research is proceeding smoothly to the extent that Lilly asked us to move up the development timeline for follow-up candidates that are scheduled to be disclosed at the end of this year," adding, "Recently, 10 ABL Bio researchers visited Lilly's Boston lab to hold a Joint Research Committee (JRC) meeting, and in November–December this year, Lilly researchers will visit Korea to continue follow-up discussions." He added, "We are also continuing online meetings with GSK."
He also highlighted results from 'BIO USA' held last month in San Diego, California.
Lee said, "At BIO USA, we continued follow-up talks with 10 big pharma companies with which we had been discussing technology transfer or joint development," adding, "We also held new meetings with a global pharmaceutical company we had not contacted once in the past 10 years."
He added, "This company previously ventured into the central nervous system (CNS) field without success, but it is recently strengthening its CNS business again," noting, "I think this shift could lead to new collaboration opportunities."
ABL Bio is also expanding the scope of application of its core platform, the BBB shuttle 'Grabody-B.'
Lee said, "We are extending the BBB shuttle beyond antibodies to various modalities, such as small interfering RNA (siRNA) and nucleotides, and we are also developing next-generation BBB shuttles," adding, "An EGFR-based program is also at the preclinical stage."
He continued, "We have secured data showing that bispecific antibodies employing the BBB shuttle effectively cross the blood–cerebrospinal fluid (Blood-CSF) barrier, and we are preparing a related paper," adding, "The bispecific antibody project targeting tau is aiming to enter toxicity studies next year."
ABL Bio also plans to continue pursuing technology transfer for the immuno-oncology platform 'Grabody-T,' which has not yet achieved an out-licensing result. Lee said, "There has been no technology transfer result over the past 10 years, but we are confident in our technical data," adding, "The question is when it will bear fruit."
Regarding 'ABL301,' a BBB platform-based Parkinson's disease treatment candidate that recently raised market concerns, the company dismissed the possibility of halting development.
ABL301 is a bispecific antibody candidate targeting alpha-synuclein, for which France's Sanofi holds global development and commercialization rights. When Sanofi mentioned ABL301 as a reprioritization target in its fourth-quarter results last year, the market raised the possibility of discontinuation or rights being returned.
On this, Lee said, "Reprioritization does not mean the end of the clinical trial," adding, "The change of clinical trial sponsor has been completed, and as soon as biomarker preparation is finished, my understanding is that follow-up clinical trials will begin." He added, "It was an excessive market reaction for the share price to fall by nearly 30% when the program was not even terminated."
He also outlined the development strategy for antibody-drug conjugates (ADC), which are being fostered as a next-generation growth engine.
Lee said, "For ADCs, the competitiveness of the payload is ultimately the most important," adding, "We are developing next-generation platforms, including bispecific ADCs and dual-payload ADCs."
He explained, "ABL503 maintained efficacy comparable to existing candidates while reducing liver toxicity, and after we present phase 1 results for solid tumors at ESMO, we plan to expand to combination therapy trials," adding, "ABL103 is in phase 1b/2 combination trials with MSD's immunotherapy Keytruda."
He said, "Chinese corporations have become much faster in clinical development, but in the BBB shuttle field, ABL Bio has been conducting research more than 10 years ahead, securing competitiveness," adding, "In the long term, our goal is to grow into a company that consistently closes global out-licensing deals like China's Innovent."