IGI, Abbvie team up to advance myeloma treatment ISB 2001
$700M deal inked for therapy using antibody engineering technology
Ichnos Glenmark Innovation (IGI) is partnering with Abbvie to advance the development of ISB 2001, a multiple myeloma treatment candidate that’s now in early clinical testing.
Under the agreement, Abbvie will receive exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China. In return, IGI will receive an upfront payment of $700 million, with eligibility to receive as much as $1.225 billion in future milestones as well as royalties on sales if ISB 2001 is ultimately approved and brought to market.
“This partnership with IGI reflects our unwavering commitment to advancing novel therapies for patients with multiple myeloma, a disease where significant unmet need remains despite recent progress,” Roopal Thakkar, MD, executive vice-president of research and development and chief scientific officer at Abbvie, said in a press release issued by the two companies.
ISB 2001 is a trispecific antibody therapy designed to simultaneously bind to three different proteins: BCMA and CD38, both of which are proteins expressed by myeloma cells, and CD3, which is expressed by cancer-killing immune cells called T-cells. By binding all three at the same time, the therapy essentially aims to trigger T-cells to attack and destroy cancer cells.
“Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously,” Thakkar said.
The experimental therapy was developed using IGI’s proprietary platform BEAT, an advanced antibody engineering technology.
According to Cyril Konto, MD, president and CEO of IGI, the new agreement with Abbvie “accelerates ISB 2001’s path to patients and sharpens our focus on advancing the next generation of BEAT-enabled assets in oncology.”
Treatment now being tested in myeloma patients in Phase 1 trial
An ongoing Phase 1 clinical trial (NCT05862012) is testing ISB 2001 in people with multiple myeloma that is relapsed or refractory — meaning the disease has failed to respond to prior treatments or has come back after initially responding to earlier therapy.
The Phase 1 part of the study tested a range of different doses of the therapy; three dosages are now being further tested in the trial’s Phase 2 part. As of June, the trial was still recruiting participants at sites in the U.S., Australia, and India.
The study’s main goal is to evaluate the safety of ISB 2001. Recent data from 35 participants indicated an overall favorable safety profile. Approximately half of the participants had severe low blood cell counts related to ISB 2001 treatment. Other common side effects included injection site reactions, infections, and an inflammatory reaction called cytokine release syndrome.
“ISB 2001 exemplifies the potential of our BEAT protein platform to generate effective multispecifics that may overcome resistance and improve outcomes in hard-to-treat cancers.
Preliminary efficacy data from the first patients have been positive. At active doses, about three-quarters (79%) of the patients responded to treatment, meaning their cancer burden was decreased. Among them, nearly a third (30%) showed a complete response, meaning their cancer was brought into remission, when treated with a high dose of the medication. These rates were broadly consistent in different subgroups of patients, including individuals whose cancer had failed to respond to various previous types of myeloma treatment.
“ISB 2001 exemplifies the potential of our BEAT protein platform to generate effective multispecifics that may overcome resistance and improve outcomes in hard-to-treat cancers,” Konto said.
The U.S. Food and Drug Administration has granted both fast track and orphan drug statuses to ISB 2001. These designations aim to incentivize and speed the development of certain experimental therapies.
The Phase 1 trial is expected to run through 2027.
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