DUBLIN – Roche Holding AG is taking a second shot on the NLRP3 inflammasome by acquiring Dublin-based Inflazome Ltd. for €380 million (US$447.8 million) up front plus undisclosed milestones linked to the progress of its two clinical-stage candidates, inzomelid and somalix. In terms of cash on the table, the deal is the largest yet for a portfolio of drug candidates that acts on the NLRP3 inflammasome, and it represents a profitable exit for Inflazome’s investors, who put €55 million into the company over two funding rounds, in 2016 and in 2018.

ESMO 2020: With new Trodelvy data, Immunomedics looks like an even better acquisition

Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of data released at the European Society for Medical Oncology over the weekend. The confirmatory phase III Ascent study showed Trodelvy (sacituzumab govitecan-hziy) significantly extended overall survival and improved overall response rate and clinical benefit rate compared to standard single-agent chemotherapy in brain metastases-negative patients with metastatic triple-negative breast cancer. On Sept. 14, in Gilead’s largest-ever acquisition and potentially the fifth biggest biotech M&A ever, the company said it would buy Immunomedics for $21 billion. The purchase brings Trodelvy into the Gilead fold, strengthening the company’s growing oncology portfolio. Morris Plains, N.J.-based Immunomedics’ stock (NASDAQ:IMMU) barely budged in midday trading, with shares down less than one percentage point.

ESMO 2020: Verzenio a maybe, Ibrance a no for early stage breast cancer

CDK 4/6 inhibitor Verzenio (abemaciclib Eli Lilly and Co.) reduced the risk of recurrence in women with high-risk hormone receptor driven and Her2-negative breast cancer when added to endocrine therapy in the monarchE phase III trial. Stephen Johnston, Royal Marsden Hospital NHS Foundation Trust professor of breast cancer medicine and head of the breast unit at the Royal Marsden Hospital NHS Foundation Trust, reported at initial data based on a planned interim analysis at Sunday’s Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

ESMO 2020: Opdivo/Cabometyx is new advanced RCC option

One of the highlights of the first presidential program at this year’s European Society for Medical Oncology 2020 Virtual Congress were results from the Checkmate 9ER study by Toni Choueiri, who is the director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute. Checkmate 9ER tested the use of a combination of checkpoint blocker Opdivo (nivolumab, Bristol Myers Squibb Co.) and receptor tyrosine kinase inhibitor Cabometyx (cabozantinib, Exelixis Inc.) as first-line treatment for advanced renal cell carcinoma (RCC). BMS and Exelixis had announced in April of 2020 that the trial had met its primary endpoint of progression-free survival (PFS), as well as its secondary endpoints of improving overall survival (OS) and overall response rate (ORR) when compared to treatment with Sutent (sunitinib, Pfizer Inc.). In the trial, the Opdivo/Cabometyx combination reduced the risk of death by 40%, and doubled PFS from 8.3 to 16.6 months and ORR from 27 to 56%.

ESMO 2020: Checkpoint blockers move up the line for gastric tumors

Advanced gastroesophageal tumors can benefit from first-line treatment with PD-1 checkpoint blockers in addition to chemotherapy, staving off progression and death by a few months. Checkmate-649 investigators reported overall survival (OS) at a prespecified interim analysis and progression-free survival (PFS) at final analysis from the Opdivo (nivolumab, Bristol Myers Squibb Co.) plus chemotherapy vs. chemotherapy alone arms. Keynote-590 data, meanwhile, showed improved OS and PFS in patients with Keytruda (pembrolizumab, Merck & Co. Inc.) plus chemotherapy, compared to chemotherapy alone.

Scenic nabs Genentech as first partner for genetic modifier efforts

LONDON - Scenic Biotech BV has signed up Genentech as first partner for its high-throughput platform for identifying genetic modifiers that can suppress or even completely block the effect of a disease-causing mutated gene, as starting points for drug discovery and development. Under the terms of the agreement, Scenic will identify modifiers in undisclosed therapeutic areas, with Genentech, part of the Roche Group, having an option to take multiple targets into development. Amsterdam, the Netherlands-based Scenic will receive an up-front payment, target selection fees, development milestones and royalties on any marketed products. The total value could exceed $375 million.

Immune Regulation readies for phase II trials with £40.6M series B round

Immune Regulation Ltd., a U.S.-U.K. venture advancing peptide-based therapies for rheumatoid arthritis and allergic diseases, has closed a £40.6 million (US$53.4 million) series B financing intended to support its preparation for multiple phase II studies, as well as an evaluation of one candidate in COVID-19-related acute respiratory distress syndrome. Morningside Ventures led the round, along with existing shareholders, including London-based 24Haymarket. The company was formerly known as Peptinnovate Ltd.

STING: A hot target in immunology research and drug discovery

The importance of the stimulator of interferon genes (STING) pathway in orchestrating the body’s innate response to pathogenic, tumor, or self-DNA in the cytoplasm has made it a hot target in immunology research and drug discovery and several biopharma companies have started programs dedicated to this area spanning infectious and inflammatory diseases as well as cancer. The second part of this feature examines the products undergoing preclinical development as well as the ones that are now in clinical testing.

Illumina snaps up liquid biopsy-focused Grail for $8B

Following days of speculation, Illumina Inc. said today it will acquire liquid biopsy startup Grail Inc. for $8 billion in cash and stock, bringing back into the fold a company it spun out in 2016. The deal gives Illumina a major stake in the race to develop a less-invasive way to diagnose cancer. Since spinning out, Grail has raised nearly $2 billion from big-name investors with promises of a blood test for early cancer detection and is hoping to introduce its liquid biopsy as a laboratory-developed test (LTD) as early as next year. Under the definitive agreement, Grail stockholders will receive $3.5 billion in cash and $4.5 billion in shares of Illumina common stock, subject to a collar. Illumina presently owns 14.5% of outstanding shares of Grail and about 12% on a fully diluted basis. In addition, Grail stockholders will receive future payments based on a tiered single digit percentage of unspecified Grail-related revenues.

Regulatory Front: CDER lays out public speech rules for staff

The FDA’s Center for Drug Evaluation and Research (CDER) encourages its employees to speak at conferences and publish articles in professional journals or lay publications on topics related to their work or their areas of expertise – so long as it’s approved by their supervisors. A new CDER Manual of Policies and Procedures released today spells out how those articles and speeches are to be reviewed and cleared. It also draws the line between employees’ work-related speech and their personal speech. Also today, the Department of Health and Human Services (HHS) disclosed a Sept. 15 memo clarifying that all rules coming out of the department and any of its agencies must be signed by the HHS secretary.

Also in the news

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