Category Archives: Topics

New Ph1 Trial for Novartis’s BCMA CAR-T PHE885 Using a New Manufacturing Method

A new Novartis-sponsored Ph1 trial has been detected for the BCMA CAR-T, PHE885, in ≥3L relapsed and refractory multiple myeloma (RRMM). Of note, the trial uses a new CAR-T manufacturing method. Below, FENIX provides insights on this new trial and how a potentially improved manufacturing process could enhance Novartis’s position compared to the BCMA CAR-T leaders, BMS and Janssen.

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Roche Q1 ’20 Earnings Update; SENS Secures $20M from a New Credit Facility

Two diabetes-related news items have been observed: Roche hosted its Q1 ’20 earnings call and provided updates to its diabetes business, and Senseonics secured a $20M new credit facility with certain funds managed by Highbridge Capital Management, LLC. Below, FENIX provides highlights from the call and thoughts on Senseonics’ current financial position.

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Thoughts on Lilly’s “Tempo Pen” for Connected Care

In November 2019, the product labels for Lilly’s Basaglar and Humalog were updated to include administration via a new disposable connected pen called the “Tempo Pen.” Ahead of Lilly’s Q1 ’20 earnings call on Thursday, April 23, FENIX provides thoughts on the Tempo Pen since Lilly has not made any public announcements as of yet.

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Janssen and Fate Collaborate to Develop iPSC-derived CAR-T and NK Therapies

On Thursday, April 2, Fate Therapeutics announced a multi-year collaboration with Janssen to develop and commercialize new off-the-shelf CAR-NK and CAR-T cell products derived from induced pluripotent stem cells (iPSCs). As part of the agreement, Fate will apply its iPSC product platform and Janssen will contribute proprietary antigen-binding domains for up to four tumor-associated antigen targets. Below, FENIX provides highlights from the deal and analysis of how Janssen’s ability to develop off-the-shelf cell therapies, potentially also targeting solid tumors, could strengthen the company’s position in the cell therapy field.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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J&J Q1 2020 Earnings Update

On Tuesday, April 14, J&J held their Q1 ‘20 earnings call (press release / slides). While the call focused predominantly on J&J’s response to the COVID-19 crisis, the company stated that filing of JNJ-4528 (BCMA CAR-T) continues to be projected for H2 2020. J&J also emphasized their determination to reduce the impact of the pandemic on their ongoing clinical trials. Below, FENIX provides highlights and analysis from the call, including how JNJ-4528’s upcoming filing may impact BMS’s ide-cel, the current BCMA CAR-T frontrunner.

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Afrezza Promotional Update; MannKind Receives $4.9M Forgivable Loan

MannKind recently updated the Afrezza patient website with new promotional messaging, which aligns with the recent corporate rebranding. Additionally, MannKind announced the company has received a forgivable loan under the Paycheck Protection Program of the CARES Act. Below, FENIX provides an analysis of the updated Afrezza messaging as well as brief thoughts on the impact of COVID-19 to MannKind and the Afrezza brand.

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Novo Offers Free Insulin in COVID-19 Response

Novo Nordisk announced plans to give away 90-day supplies of insulin for people who have lost their health insurance due to the COVID-19 pandemic. Below, FENIX provides thoughts on Novo’s response as well as insight into how Novo could be using the program for lead generation and to neutralize biosimilar insulin competition.

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J&J Q1 ’20 Earnings Update

Johnson & Johnson hosted their Q1 ’20 earnings call and briefly touched on the Invokana franchise. Unsurprisingly, much of the call was focused on the impact of COVID-19, which led J&J to lower its 2020 guidance. Below, FENIX provides diabetes-related highlights and insight from the call.

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Thoughts on i2O, the Harvard Oral Peptide Delivery Spinout

A new Harvard spinout called i2O Therapeutics has raised $4M in seed funding from Sanofi Ventures and JDRF T1D Fund. Of note, the company was created with the intention of commercializing a novel oral peptide delivery technology initially directed toward diabetes. Below, FENIX provides insight into why i2O may be using oral insulin development as a stepping stone to other molecules and thoughts on how Sanofi may be leveraging its diabetes expertise without committing to R&D.

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