Astellas Pharma Inc. and 4D Molecular Therapeutics Inc. (4DMT) inked a deal worth up to $942 million under which Astellas will license 4DMT's intravitreal R100 gene therapy vector for rare ophthalmic targets. Under the deal, Astellas gains rights to use the intravitreal retinotopic R100 vector invented by 4DMT for one genetic target implicated in rare monogenic ophthalmic diseases, with options to add up to two additional targets in rare monogenic ophthalmic diseases after paying additional option exercise fees. 4DMT will provide its R100 vector technology to deliver Astellas’ genetic payloads, while Astellas will conduct all subsequent research, development, manufacturing and commercialization activities.

Seven deaths and five adverse events cause ADC to halt enrollment in phase II cancer study

Seven deaths and five respiratory-related, treatment-emergent adverse events in a frail or unfit group of 40 patients rang alarm bells for ADC Therapeutics SA. With that in mind, the company has voluntarily paused enrollment in its phase II Lotis-9 study of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) for treating previously untreated diffuse large B-cell lymphoma. ADC said 11 of the 12 events, including six of the fatalities, were individually assessed by investigators as being unlikely or unrelated to the study drug. The cause is now being investigated, ADC added. The stock had been knocked sideways at midday, with shares plunging 20% to $1.87 each.

Crossbow targets cancer with T-Bolt molecules and $80M series A

Crossbow Therapeutics Inc. has launched with $80 million in funds through a series A round to advance novel therapies that mimic T-cell receptors (TCR) and target peptide-loaded major histocompatibility complexes on cancer cells. Once the company has identified, validated and prioritized promising cancer-specific targets, it develops its TCR-mimetic antibodies and incorporates them into T-cell engagers and other immunotherapies, forming tumor-bolt (T-Bolt) molecules designed to optimize manufacturing processes and potency, while minimizing tumor resistance. The round was led by MPM Bioimpact and Pfizer Ventures, with participation from Polaris Partners, BVF Partners, Eli Lilly and Co., Mirae Asset Venture Investment and Mirae Asset Capital.

Kelun Biotech raises $174M in Hong Kong IPO to race in ADC market

Kelun-Biotech Biopharmaceutical Co. Ltd. raised HK$1.36 billion (US$174 million) in an IPO in Hong Kong to support its push into the increasingly competitive antibody-drug conjugate (ADC) market in China. Shares opened at HK$60.6, jumped over 6% in the middle of the day, and closed at HK$62.5 on the first trading day. Kelun Biotech plans to use 45% of the proceeds from the IPO for the development and commercialization of its two core ADC assets, SKB-264 and A-166.

Thyroid-eye prospect encouraging for Viridian in phase I/II data

Viridian Therapeutics Inc. popped the lid off positive preliminary data from the ongoing phase I/II trial with infused VRDN-001, a full antagonist antibody to the insulin-like growth factor 1 receptor, in patients with chronic thyroid eye disease (TED). The drug yielded reductions in proptosis as measured by Hertel exophthalmometer as well as magnetic resonance imaging. Wall Street seemed less than enthusiastic, and shares of the firm (NASDAQ:VRDN) were trading midday at $21.07, down $3.45, or 14%. A subcutaneous version of the VRDN-001 for TED is in the works, too.

Sanders using HELP position to advance Rx pricing agenda

The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices. At the same time, Sanders is overriding what otherwise would be bipartisan, must-pass legislation with his personal pricing platform. It’s not the first time the senator and former presidential candidate has held up Democratic presidential nominations over drug prices. But in this go-round, he’s wielding the gavel of the Senate Health, Education, Labor and Pensions (HELP) Committee, which means it's up to him to schedule confirmation hearings and set the committee’s agenda.

Nodthera’s says oral NLRP3 inhibitor reduces inflammation in the brain

Nodthera Ltd. claims to be first to demonstrate it is possible to modulate the NLRP3 inflammasome in the brain, after showing there were reductions in inflammatory and disease-specific biomarkers in blood and cerebrospinal fluid after seven days of daily administration of its lead product, NT-0796, an oral NLRP3 inhibitor. The data, relating to four elderly, healthy volunteers, who each acted as their own controls, have set the scene for the next phase of the Ib/IIa trial of NT-0796, which is recruiting patients with midstage Parkinson’s disease.

Building CDMO reach, Lotte Biologics partners with Kanaph for ADC-tech platform

Lotte Biologics Co. Ltd. said it partnered with domestic bioventure Kanaph Therapeutics Inc. to develop an antibody-drug conjugate (ADC) technology platform in hopes of rounding out a full, in-house ADC value-chain. The latest news underscores fierce competition among major players in contract development and manufacturing organization services — including Samsung Biologics Co. Ltd. — that are vying for a bigger piece of the domestic biomanufacturing pie.

Also in the news

Acerus, Aim Immunotech, Akari, Apie, Arbutus, Armata, Beigene, Biodexa, Biontech, Biophytis, Biorestorative, Bristol Myers Squibb, Centessa, Clearmind, Clearside, Doer, Eterna, Evotec, Exscientia, Genelux, Geovax, Hansoh, Hemogenyx, Hillstream, Hutchmed, Immunity, Infinity, Iovance, Longeveron, Maia, Mallia, Marker, Mediwound, Mendus, Monopar, Myopax, Neuraxpharm, Nexcella, NK:IO, Novartis, Panbela, Pluri, Recce, Sensorion, Septerna, Sequana, Silence, Spinogenix, Sumitomo, Sybleu, Tango, Tonix, Tracon, Verastem, Verismo, Versameb