Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease (RSV-LRTD). In February, the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation. Pfizer has said it is the only company pursuing both populations with a single vaccine. Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer of vaccine research and development, called the approval “a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations.” GSK plc took the lead on the RSV market, expected to reach $10 billion in five years, when it received FDA approval of its vaccine Arexvy on May 3, about four weeks before Pfizer’s vaccine was cleared.

Eikon adds to pipeline, banks about $106M in series C  

Eikon Therapeutics Inc. closed three transactions to beef up its pipeline and raised almost $106 million in a series C round. The firm acquired: global rights to develop and commercialize clinical-stage Toll-like receptor 7 and 8 agonist immune modulators from Seven and Eight Biotherapeutics Corp.; a portfolio of PARP1-selective inhibitors invented by Impact Therapeutics Inc.; and a suite of preclinical assets from Cleave Therapeutics Inc. that address targets involved in protein homeostasis, DNA damage repair and chromatin remodeling. Eikon, with a platform called Single Molecule Tracking, leverages advanced optics and machine learning to chart protein behavior.

Immutep to raise AU$80M to advance LAG-3 immunotherapy pipeline 

Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer. The LAG-3 protein controls the signaling between T cells and antigen-presenting cells that are responsible for the adaptive immune reaction. Immutep is applying the LAG-3 protein in chemo-immunotherapy, immuno-immunotherapy and as an adjuvant to cancer vaccines.

Hookipa seeks $50M as it prepares to progress HPV cancer drug to phase III

Hookipa Pharma Inc.. is looking to raise about $50 million in a public offering to further advance its lead immunotherapy candidate, HB-200, into a pivotal phase III trial in combination with Keytruda (pembrolizumab) for the first-line treatment of recurrent or metastatic head and neck cancer associated with human papillomavirus (HPV) 16. The company plans to sell 22.9 million shares of its common stock and 15,268 shares of its non-voting series A-2 convertible preferred stock, at $1.31 per share. The offering is expected to close on June 5, 2023.

Lonza acquires ADC firm Synaffix for $108M up front, $65M in milestones 

Lonza AG has acquired Synaffix BV, the developer of a widely partnered set of tools for generating antibody-drug conjugates (ADCs), for €100 million up front plus up to €60 million more in milestones. The value of the deal may appear low, given the evident level of industry demand for Synaffix’s technologies. The Amsterdam-based firm has entered around a dozen partnering deals with the likes of Amgen, Inc., Genmab A/S, Mersana Therapeutics BV, Macrogenics, Inc. and ADC Therapeutics SA, among others. Billions of biobucks are attached to these. But company CEO Peter van de Sande stressed that Synaffix has always been a technology rather than a drug development play. The valuations are inherently different. “It’s a very attractive exit for the investors,” he told BioWorld. “I think it’s a very fair price for the business. This is cash now and not cash in the future.”

US debt ceiling deal would flat-line NIH, FDA appropriations in fiscal 2024

The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the NIH or the FDA, two programs of intense interest for companies in the life sciences.

SCOTUS: Belief, not interpretation, at heart of FCA violations

With False Claims Act (FCA) whistleblower lawsuits multiplying, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down today. "What matters for an FCA case is whether the defendant knew the claim was false,” Justice Clarence Thomas wrote for the court in U.S. ex rel. Scutte v. Supervalu Inc. In other words, the court explained, liability in an FCA suit depends on whether defendants believed their claims were false – not on whether they had interpreted a law or regulation in an “objectively reasonable" way, even if the regulation may be ambiguous. While Supervalu involves claims pharmacies submitted to Medicare and Medicaid, the ramifications of the court’s opinion could impact biopharma and med-tech, as well.

AZ drops brazikumab for IBD, loses funding from Abbvie

Astrazeneca plc terminated development of its inflammatory bowel disease candidate brazikumab after losing speed in the last few years. While data from its phase IIb/III Intrepid trial in Crohn’s disease and its phase II Expedition trial in ulcerative colitis showed no safety concerns, the decision was made following a review of brazikumab’s development timeline and “the context of a competitive landscape that has continued to evolve,” the company said in a statement. “The timeline was impacted by delays that could not be mitigated following global events.” By stopping development, Astrazeneca loses funding from Abbvie Inc. under their agreement signed in January 2020, just prior to the onset of the COVID-19 pandemic. Brazikumab is a monoclonal antibody that binds to IL-23 and prevents its interaction with its receptor.

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