Sparks flew both ways today as some senators pushed for Robert Kennedy to resign as secretary of the U.S. Department of Health and Human Services. The calls for him to step down came as Kennedy engaged in heated exchanges with the Senate Finance Committee just a week after the CDC lost several senior leaders, including Susan Monarez, the newly confirmed director, over vaccine disagreements. “The U.S. is in the midst of a health care calamity,” Ranking Member Ron Wyden, D-Ore., said in his opening remarks, which were littered with personal attacks. His comments set the tone of the hearing, especially when he asked that Kennedy be sworn in, given what Wyden considered the secretary’s lying to Congress during his confirmation process. When Chair Mike Crapo, R-Idaho, refused to break with the usual practice of not swearing in witnesses, Wyden called it a “grave mistake” that signals it’s OK to lie to the committee.

Radiance signs $1B-plus pact for Novatim’s c-met/EGFR inhibitor

About two years since it first emerged, new company Radiance Biopharma Inc. signed a deal in which it could pay up to $1.165 billion to Novatim Immune Therapeutics Co. Ltd. for global rights outside of certain Asian countries to a bispecific nano-antibody antibody-drug conjugate (ADC) that targets c-MET and EGFR to treat solid tumors. Most of the money is on the back end, with $1 billion tied to potential commercial milestone payments. The candidate, which Radiance is now calling RB-601 (previously KY-0301) is in a phase I trial in China and has gained IND clearance for a U.S. trial. The deal also brings Novatim a $15 million up-front payment and up to $150 million in potential development and regulatory milestone payments, plus tiered royalties on annual net sales. Novatim, an Anji, Zhejiang, China-based company founded in 2018 that also goes by the name Keyi Pharmaceutical Technology Co. Ltd., is retaining rights in mainland China, Hong Kong, Macao and Taiwan.

Immunovant rolls out positive phase II batoclimab data in Graves

Roivant Sciences Ltd.’s Immunovant Inc. unit touted an abstract that details positive, six-month off-treatment data from a single-arm phase II study in uncontrolled Graves’ disease (GD) patients treated with FcRn-targeting monoclonal antibody batoclimab for 24 weeks. The findings will be presented in a week at the annual meeting of the American Thyroid Association in Scottsdale, Ariz. Of 21 patients who entered the follow-up period, about 80% (17/21) turned up a response, resulting in normal thyroid function (T3 and T4 hormones less than the upper limit of normal) at the end of the six-month follow-up period. GD is an autoimmune disorder that causes the thyroid gland to become overactive.

Sanofi hits phase III endpoints in AD but stock drops

Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back. The study of adolescents and adults who received dosages every four or 12 weeks saw statistically significant and clinically meaningful efficacy in skin clearance and disease severity at week 24. However, the treatment efficacy was seen by the market as inferior to that of blockbuster Dupixent (dupilumab). Sanofi’s stock (NASDAQ:SNY) had dropped 8.4% at midday, with shares going for $45.68 each.

MRM raises $64M for ‘high performance teams of bacteria' in IBD

The funding is in place for a phase IIb trial of its lead gut microbiome live biotherapeutic, after MRM Health NV closed a €55 million (US$64 million) series B round. The product, MH-002, a rationally designed mix of six different commensal bacteria sourced in the healthy gut microbiome, will now be advanced into a 210-patient study in mild to moderate ulcerative colitis. MRM in the company’s name stands for Microbial Resource Management. This is intended to signify that just as organizations require cohesive teams to function well, the gut needs a well-managed community of beneficial bacteria.

The ‘molecular revolution’ driving R&D of new cancer therapeutics

“New explosions in biotechnology are allowing us to interrogate cancers at a very sophisticated level compared to before,” Dennis Slamon told audience members at the Global Bio Conference in Seoul South Korea Sept. 3. Slamon, chief of the division of hematology/oncology and director for the division of clinical/translation research at UCLA’s Jonsson Comprehensive Cancer Center, noted that treatment has been based on a ”one-size-fits-all approach.” While the progress made in oncology is being celebrated, research is still ongoing, he said, noting that one of the major breakthroughs has been finally grasping the “molecular diversity in human cancers” that carries profound biologic and therapeutic implications.

Propanc to acquire $100M of Ethereum to accelerate pipeline

Propanc Biopharma, Inc. plans to acquire $100 million of Ethereum cryptocurrency over the next 12 months to accelerate its pipeline. The company is advancing its lead candidate, PRP, to enter a phase Ib trial in 30 to 40 advanced cancer patients with malignant solid tumors.

Synthetic carbohydrate receptors as broad-spectrum antivirals

Viral pandemics threaten public health and the economy at a global level, such as the recent COVID-19 pandemic caused by the SARS-CoV-2 virus. To date, despite advances in modern medicine, vaccines and therapeutics to rapidly prevent the spread of deadly emerging viral outbreaks are insufficient. Three antivirals have been approved for the treatment of SARS-CoV-2 infection: remdesivir, Paxlovid and molnupiravir. Developing broad-spectrum antivirals (BSAs) is challenging due to the high variability in the sequence of viral proteins.

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