Protocols

Redhill spikes — briefly — on positive Crohn’s data; Daiichi inks global licensing deal with Glycotope

→ Shares of Israel’s Redhill BioPharma $RDHL spiked Monday morning — then quickly began to slide back — after the biotech laid out data demonstrating how their drug for Crohn’s disease edged out the placebo arm in their first Phase III study.

The drug is RHB-104, an antibiotic combination that was based on Redhill’s theory that Crohn’s is caused by a bacterial infection. In their Phase III researchers say that 37% of the patients in their drug arm achieved remission at 26 weeks, compared to a hefty 23% in the placebo group. That resulted in a positive p value of 0.013.

Secondary endpoints included early remission at week 16 — 42% versus 29% — and durable remission over weeks 16-52, for an 18% – 9% split between the two arms. Redhill’s shares initially surged 28% on the news, then started to subside. By midmorning the gain was pared down to 1% for the company, which has a tendency to push its luck in promoting results.

→ Daiichi Sankyo and a Berlin-based immuno-oncology company called Glycotope have inked an exclusive worldwide licensing agreement to develop an antibody drug conjugate by combining the Japanese pharma giant’s ADC tech with Glycotope’s investigational tumor-associated TA-MUC1 antibody gatipotuzumab. This builds on a previous 2017 option agreement.

Under the deal, Daiichi has global rights to develop and commercialize gatipotuzumab as an ADC. Glycotope will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide from Daiichi Sankyo. Specific financial terms were not disclosed.

“With the licensing of gatipotuzumab with the intention of developing an ADC, we now have seven novel ADCs in development, which demonstrate our commitment to maximizing the potential of our proprietary ADC payload and linker technology to help address the unmet needs of patients with cancer worldwide,” said Daiichi’s Tom Held, VP and head of the company’s Antibody Drug Conjugate Task Force, Oncology Research and Development.

→ Cambridge, UK-based Kymab has come up with the positive first-in-human data it needed to justify moving its monoclonal antibody into Phase II studies. Having shown that KY1005 has a favorable safety profile and could block T-cell driven inflammation in the skin of healthy volunteers, the clinical team will now move to launch a Phase IIa trial in atopic dermatitis late this year. According to the biotech, that condition — where high levels of the OX40 ligand is found — is exactly the kind of condition their drug is designed to treat. Studies in other immune-related diseases, including graft-versus-host disease, are also in the plans.

→ Antibody drugmaker Immunomedics $IMMU is teaming up with Yale University in a clinical collaboration. Together, they’re testing Immunomedics’ lead drug candidate — sacituzumab govitecan, an antibody drug conjugate — as a single agent in two Phase II studies in endometrial and cervical cancers. On top of the two Phase II trials, Yale will also conduct a preclinical evaluation of sacituzumab govitecan in combination with poly (ADP-ribose) polymerase (PARP) inhibitors in animal in vivo models of gynecologic cancers. Immunomedics has also entered into collaborations with Yale, Memorial Sloan Kettering Cancer Center, and Fred Hutchinson Cancer Research Center to further investigate sacituzumab govitecan and labetuzumab govitecan (IMMU-130) in preclinical cancer models.


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