During a busy day of dealmaking, Cour Pharmaceuticals entered a pact with Roche Holding AG’s Genentech unit to advance tolerogenic nanoparticle treatments for an autoimmune disease indication, garnering $40 million in up-front and near-term milestone payments, and becoming eligible for more than $900 million in other milestone payments. The company, which was founded by Northwestern University and University of Sydney scientists in 2012, completed a $105 million series A round in January 2024. It previously signed deals with Takeda Pharmaceutical Co. Ltd. in December 2015 to develop immune-modulating therapies for celiac disease, and with Ironwood Pharmaceuticals Inc. in November 2021 for CNP-104 to treat primary biliary cholangitis. Cour’s partnership with Genentech, though, is its biggest to date, and the largest deal announced by a biopharma company on Dec. 3. A total of seven deals that day amounted to a combined single-day deal value of $3.67 billion.

Phase Ia interim data in prostate cancer boost Janux stock

Janux Therapeutics Inc. shares (NASDAQ:JANX) were trading at $64.91, up $24.73, or 61%, after the firm disclosed positive updated phase Ia interim data for its JANX-007 program in advanced or metastatic prostate cancer. Outcomes were provided from 16 late-line patients who’d undergone a median of four prior lines of therapy, with starting step-doses of ≥0.2 mg and target doses ≥2 mg weekly. The update “beats high expectations,” Leerink analyst Jeffrey La Rosa said in a report. JANX-007 emerged from the firm’s Tumor Activated T Cell Engager platform.

Tubulis inks $465M ADC collaboration with Gilead

Tubulis GmbH has sealed a potential $465 million option and licensing deal under which it will apply proprietary technologies to discover an antibody-drug conjugate (ADC) against a solid tumor target for Gilead Sciences Inc. Tubulis receives an up-front payment of $20 million to get the project rolling, to be followed by a further $30 million if Gilead takes up the option to license the ADC. The remainder of the headline value is based on development and commercialization milestones. For any product that makes it to market, Tubulis is in line for royalties on sales in the mid-single to low double-digit range.

PYC advances PYC-003 to clinic for polycystic kidney disease

After raising AU$40 million (US$25.9 million) earlier this year to advance lead candidate VP-001 for treating retinitis pigmentosa type 11, PYC Therapeutics is now advancing PYC-003 to the clinic for polycystic kidney disease. PYC-003 is designed to address the underlying cause of autosomal dominant polycystic kidney disease (PKD), which affects roughly one in 1,000 people and for which there is no effective treatment available. The disease is characterized by large numbers of cysts forming in the kidneys that increase in size over time and ultimately destroy kidney tissue, resulting in renal failure. Most patients with PKD will require a kidney transplant.

Celltrion to expand CRDMO business, hit ₩10T sales in 2027

South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena. “Historically, we started as a CDMO … but what I really wanted to do was develop biosimilars,” Seo said while addressing the audience at a Hong Kong-based investors conference on Nov. 27. As Asia’s first CMO founded in 2002, Celltrion is known as a “biosimilar pioneer,” Seo said, with plans to launch an additional 11 biosimilars by 2025, expected to grow to 22 drugs by 2030.

Kiromic’s nondisclosure of clinical hold leads to SEC settlement

Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million. Citing the company’s self-reporting and cooperation, the SEC said the settlement with the Houston-based Kiromic involves no civil penalties, but the former CEO, Maurizio Chiriva-Internati, and former chief financial officer, Tony Tontat, will pay penalties of $125,000 and $20,000, respectively. Chiriva also will be barred for three years from serving as an officer or director of a public company, according to a settlement subject to court approval.

US lawmakers call out PBM role in opioid epidemic

The congressional finger-pointing at pharmacy benefit managers (PBMs) continues. The latest singling out is in a bipartisan letter from four House members calling on the U.S. Department of Justice to investigate the role PBMs played in the nationwide opioid crisis. The letter, led by Reps. Buddy Carter, R-Ga., and Raha Krishnamoorthi, D-Ill., noted that in 2017 alone, the three largest PBMs – CVS Caremark, Express Scripts and Optum Rx – together received about $400 million in rebates and fees from Purdue Pharma LP, the maker of Oxycontin (oxycodone). The PBM rebate system “contributed to a culture of excessive prescribing and dispensing of Oxycontin,” according to the letter.

Also in the news

Aavantgarde, Alligator, Altrubio, Applied, Autolus, Beigene, Biocon, Bluebird, China Medical System, Cytokinetics, Eton, Everest Medicines, Galderma, Gilead, Healx, Hemostemix, Hepion, Hua Medicine, Johnson & Johnson, Maplight, MBX, Medexus, Merus, Mind Medicine, Neurosense, Nouscom, Novartis, OSE, Partner, Pharma Two B, PTC, Pulmokine, Rakovina, Renalys, Revolution Medicines, Rigel, Sana, Senti, Sernova, Soligenix, Stallergenes, Teva, Theratechnologies, Tonix, Xoma