Fierce Pharma Asia—Takeda's narcolepsy trial problem, gene therapy pact; human error in Moderna's COVID vaccine

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Takeda's TAK-994 safety signal and Selecta Biosciences gene therapy deal, plus Moderna's COVID-19 vaccine contaminations in Japan, make our news this week. (Google)

Takeda's pipeline has taken a hit as the company reported a safety signal from a midstage narcolepsy program. The Japanese pharma doubled down on gene therapy with a licensing deal with Selecta Biosciences to work on lysosomal storage disorders. Takeda and Moderna have pinpointed how contaminants landed in three lots of COVID-19 vaccines in Japan. And more.

1. Takeda slams brakes on narcolepsy program, stopping 2 studies early in response to safety signal

Takeda halted two phase 2 trials of its narcolepsy candidate, TAK-994, as “an immediate precautionary measure” in response to a safety signal. The two trials were supposed to recruit altogether 300 patients, with completion dates in January and April 2022. The drug is an oral orexin agonist designed to increase wakefulness.

2. Takeda taps Selecta for $1.1B gene therapy research pact

Takeda penned a deal to tap Selecta Biosciences’ ImmTOR platform to develop targeted gene therapies for two indications within the field of lysosomal storage disorders. The Japanese pharma is paying an undisclosed upfront payment and up to $1.12 billion in milestones. Selecta’s technology is designed to induce antigen-specific immune tolerance, and Takeda hopes it could help overcome immunogenicity barriers to current adeno-associated virus-based gene therapy.

3. Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant

Japan recently suspended three lots of Moderna’s COVID-19 vaccine after noticing contamination. Now, an investigation by the company and its Japanese distributor Takeda has concluded the impurities were caused by friction between two pieces of metal that were incorrectly installed in the production line at a plant in Spain by contract manufacturer Rovi.

4. Is the cancer immunotherapy market up for disruption as AstraZeneca, Regeneron-Sanofi, cheaper Chinese offerings line up?

Several Chinese PD-1/L1 players and their Western partners have indicated that they aim to compete in the U.S. market with lower prices. But SVB Leerink analyst Daina Graybosch, Ph.D., suggests pricing discounts alone won’t be enough to shake up the market now led by Merck & Co.’s Keytruda because of a common drug contracting practice known as the “rebate wall.”

5. Celltrion makes case for Remicade biobetter with subcut switch data

Celltrion posted some post hoc analysis of its EU-approved Remsima SC, a subcutaneous formulation of Remicade. In inflammatory bowel disease patients who switched from intravenous infusions to the under-the-skin product, the proportion of individuals who exceeded the target exposure went up from 20% to 88%, Celltrion reported.

6. Roche, Takeda and Pfizer notch top scores among rare disease patient advocacy groups

A recent PatientView survey of 230 rare disease patient advocacy groups showed 50% of the groups described pharma’s corporate reputation as “excellent” or “good.” Among 29 pharma companies, Takeda ranked second for its corporate reputation and patient support during COVID-19.

7. Samsung Biologics signs up to supply Enzolytics with COVID-19, HIV drugs

Samsung Biologics has signed a deal with Texas-based Enzolytics to make the latter’s antibody candidates for COVID-19 and HIV. The Korean CDMO will make a stable cell line from facilities in San Francisco and make clinical trial materials at its site in Incheon, South Korea.

8. AffyImmune attracts $30M with its CAR-T strategy for beleaguered solid tumor cancers

Hong Kong venture capital shop ORI Capital has poured $30 million into AffyImmune Therapeutics. The biotech is working on CAR-T therapy for solid tumors. It’s trying to solve problems that have plagued similar cell therapy efforts, including T-cell exhaustion and unwanted toxicities, with a “tune and track” approach.