Product Development

Sept. 20 Quick Takes: Seagen, Genmab prepping launch of ADC for cervical cancer

With FDA’s accelerated approval Monday of Tivdak tisotumab vedotin-tftv to treat cervical cancer, the product will be the first for which Genmab A/S (CSE:GMAB; NASDAQ:GMAB) will take on commercial responsibilities, the result of a strategic...

ESMO, Jeito & the latest from Washington: a BioCentury podcast

On the latest BioCentury This Week podcast, BioCentury’s editors discuss highlights from the European Society for Clinical Oncology (ESMO) Congress, including standout breast cancer data on Enhertu fam-trastuzumab deruxtecan-nxki from AstraZeneca plc (LSE:AZN; NYSE:AZN) and...

The non-cancer bispecific pipeline: Data Byte

Use of bispecific technologies is creeping beyond cancer, where the approach now underpins 130-plus clinical programs. Collectively, companies have advanced 19 bispecific candidates into human trials across the four disease areas, hematology, ophthalmology, autoimmune and infectious...

AZ’s Enhertu data highlight value of continued HER2 innovation

It’s no surprise that AstraZeneca’s Enhertu outperformed Kadcyla in a head-to-head second-line breast cancer trial, but the magnitude of the progression-free survival advantage went well beyond expectations and represents the kind of meaningful advance that...

Mirati data underscore KRAS opportunity in colorectal cancer

Colorectal cancer is the new battleground for the most advanced KRAS inhibitors, and Mirati’s latest data from ESMO leave the company in a very competitive position going into registrational studies.  During a poster session at...

Booster meeting outcome: FDA, manufacturers no longer aligned on COVID

An FDA advisory committee’s decision to dial-back Pfizer’s request that it recommend approval of a booster dose for everyone who has received its Comirnaty COVID-19 vaccine flowed from the advisers’ rejection of the company’s contention...

Sept. 17 ESMO Quick Takes: EQRx and CStone report more positive PD-1 data

Meeting the primary endpoint for sugemalimab in a non-small cell lung cancer (NSCLC) population not yet served by PD-1 inhibitors, EQRx Inc. and partner CStone Pharmaceuticals Co. Ltd. (HKEX:2616) have hit another milestone on their...

Questions about big benefit seen at ESMO with AZ’s CD73, NKG2A mAbs

Data from the Phase II COAST trial showed mAbs against two immuno-oncology targets — CD73 and NKG2A — led to big PFS benefits in NSCLC when combined with PD-L1 inhibitor Imfinzi durvalumab. But Imfinzi...

Sept. 16 Quick Takes: Moderna data support COVID booster shots as Spikevax gains first full approval

Moderna Inc. (NASDAQ:MRNA) reported preliminary Phase IIa data Wednesday suggesting three different types of booster shots were able to increase neutralizing antibody responses to a panel of COVID variants...

ESMO Quick Takes: MacroGenics’ early proof of concept for B7-H3 ADC

Investors were disappointed by Phase II/III durability for anti-HER2 mAb Margenza margetuximab-cmkb from MacroGenics Inc. (NASDAQ:MGNX) in gastric cancer, which showed comparable efficacy to first-generation mAb Herceptin trastuzumab. The Fc-engineered anti-HER2 mAb plus anti-PD-1 mAb...

Amgen identifies promising KRAS combination for colorectal cancer

Data emerging from ESMO suggest Amgen may have hit on an effective pairing for its first-in-class KRAS inhibitor in a new indication, colorectal cancer, on its first attempt.  In an abstract presented at the European...

Quick Takes: FDA approves Takeda’s Exkivity for NSCLC with specific mutation

Almost six weeks ahead of the therapy’s PDUFA date, FDA granted accelerated approval to Exkivity mobocertinib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) to treat non-small cell lung cancer with an EGFR exon 20 insertion...

What the latest patient death means for gene therapy development

The fourth death of a patient in Astellas’ gene therapy trial for X-linked myotubular myopathy is not likely to have the same broad derailing effect across gene therapies as earlier setbacks....

Newly public Candel looks to two years of value inflection points

Less than a year after announcing a new leadership team, Candel believes it has the funding it needs to get to a pivotal readout for its lead viral immunotherapy, as well as advance its early...

Sept. 9 Quick Takes: Obsidian readies for IPO with $115M crossover round

Cell and gene therapy play Obsidian Therapeutics Inc. looks set to seek a public listing after raising $115 million in a series B round led by The Column Group Crossover Fund. Other new investors included...