Conditionally active antibody specialist Cytomx Therapeutics Inc. has agreed to work with Regeneron Pharmaceuticals Inc. to discover and develop new bispecifics antibodies with what the partners said is the potential to "widen the therapeutic window and help minimize off-target effects." Regeneron will pay Cytomx $30 million up front for the project, which will leverage Cytomx's Probody therapeutic platform and Regeneron’s Veloci-bi bispecific antibody development platform. Regeneron could also pay Cytomx target nomination payments and preclinical, clinical and commercial milestones of up to $2 billion, plus tiered royalties on sales. Cytomx shares (NASDAQ:CTMX) share leapt about 29% to $1.56 by midday, though remain depressed from a 52-week high of $7.46.

With surprise adcom support, Ardelyx surges in CKD

With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease. With that vote, the committee affirmed the benefits outweigh the drug’s risks for the control of serum phosphorus when administered as a monotherapy. Also on Nov. 16, it voted 10-2, with an abstention, that the treatment’s benefits combined with a phosphate binder treatment, also outweigh its risks. Ardelyx stock (NADAQ:ARDX) rise was robust at midday as shares were trading 52% higher at $1.85 each.

Editas shares drop on weak efficacy of CRISPR/Cas9 therapy in inherited blindness study

A lackluster efficacy signal has prompted Editas Medicine Inc. to pause enrollment in a phase I/II trial of its CRISPR/Cas9-based gene editing therapy, EDIT-101, which is in development for patients with a particular form of Leber congenital amaurosis type 10 (LCA 10). An interim data analysis revealed that just three of 14 patients who received the therapy met the study’s definition of a response, which required sustained improvements on the primary endpoint, best corrected visual acuity, and on at least two of three secondary endpoints. “The good news is that we have a proof of concept determined by a very rigorous set of selection criteria,” Gilmore O’Neill, CEO of Cambridge, Mass.-based Editas, told an investor call audience. Shares (NASDAQ:EDIT) were down 13% at midday.

Astellas’ Claudin 18 inhibitor meets primary endpoint in phase III gastric cancer trial

Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival (PFS) in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to top-line data. The Spotlight trial enrolled 566 patients at 220 study locations across the U.S., the U.K., Australia, Europe, South America and Asia. Results showed statistical significance in PFS for patients treated with zolbetuximab plus chemotherapy regimen mFOLFOX6 (oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The study also met the secondary endpoint of overall survival, showing statistical significance for patients treated with zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6.

Fundamental discovery for halting neurodegeneration draws €10M seed round

Fundamental Pharma GmbH has raised €10 million (US$10.3 million) in a seed round to develop a new class of glutamate inhibitors, after uncovering a route to maintaining the protective effects of the neurotransmitter in the synapses while preventing neurotoxicity when it is released elsewhere. The approach rests on the discovery of a previously unknown mechanism by which glutamate N-methyl-D-aspartate receptors (NMDARs) trigger excitotoxicity, leading to excessive glutamate release and neuronal damage. The mechanism involves NMDARs interacting with the transient receptor potential channel TRPM4. Blocking this interaction prevents excessive glutamate release, but does not interfere with its essential role in synaptic plasticity and cognitive function.

Strong clinical data bumps biopharma stocks to a high point

An uptick in positive clinical data reported in recent months has helped nudge the BioWorld Biopharmaceutical Index (BBI) to its highest point this year. BBI is up by 15.58%, significantly higher than the 1.36% increase recorded at the end of August, just as statistically significant clinical results began to roll in from a number of biopharma companies. While the index is moving in the same direction as the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, both of those remain underwater this year, down by 9.56% and 7.56%, respectively.

Simcere gets China rights for Idorsia’s daridorexant in $50M deal

Simcere Pharmaceutical Group Ltd. has inked a licensing agreement picking rights to develop Idorsia Ltd.’s insomnia treatment in greater China, in exchange for a $30 million up-front payment. Idorsia also will be eligible to receive an additional milestone payment of $20 million upon regulatory approval by China’s NMPA, as well as commercial milestone payments and low double-digit tiered royalties based upon future sales.

In assessing shared genetic risk, love can look like pleiotropy

Social scientists are well aware of the consequences of what’s called assortative mating, that is, the fact that marriages tend to occur between people who are of similar in things such as interests, social status, education and wealth. Biologists, on the other hand, have tended to ignore it. “When studying the genetic underpinnings of correlated traits, “for mathematical convenience, we’ve assumed basically for forever that mating is random,” Richard Border told BioWorld. “Which it isn’t.” Border’s work has focused on the consequences of that convenience. Earlier in 2022, he and his team published research showing that heritability estimates of many individual traits were inflated by not taking assortative mating into account. In a new study, he and his colleagues have shown that the faulty assumption of random mating has led to systematic bias in in evaluating the shared genetics of traits that frequently co-occur. “If you have multiple generations of assortative mating, you can get things that look like genetic correlations,” Border said.

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