Sacituzumab govitecan-hziy

Gilead Sciences is extending its dealmaking streak with an agreement to acquire its German partner Tubulis for $3.15 billion upfront, marking its third major takeout in a little over a month. Through the latest deal, which could reach $5 billion with milestones, Gilead adds an early-stage antibody-drug conjugate (ADC) pipeline and a platform it believes will bolster its offering of targeted cancer therapies beyond the TROP-2 targeting ADC Trodelvy (sacituzumab govitecan), which is already approved for certain patients with breast cancer and urothelial cancer. The company spent $21 billion to acquire Immunomedics and Trodelvy in 2020, though it booked an impairment charge of $4.2 billion a few years later tied to assets from that deal."Today's agreement follows a two-year collaboration with Tubulis, which has given us strong conviction in their programmes and research capabilities," Gilead CEO Daniel O'Day said Tuesday.Promising early dataThe centrepiece of the acquisition is TUB-040, an NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase Ib/II testing for platinum-resistant ovarian cancer and non–small-cell lung cancer. The drug uses Tubulis' proprietary P5 conjugation, a cysteine-selective chemistry that the company says generates ADCs with highly stable linkers and enhanced biophysical properties.Data from the Phase I/IIa NAPISTAR1-01 study shared at last year's European Society for Medical Oncology (ESMO) congress showed a confirmed overall response rate of 50% in heavily pre-treated patients with platinum-resistant ovarian cancer, including one complete response. The Munich-based biotech raised €308 million ($356 million) via a series C round in the days leading up to that presentation.Gilead will also acquire TUB-030, a 5T4-targeted ADC that has shown "promising" early data in multiple solid tumour types.'Sound bolt-on'RBC Capital Markets analyst Brian Abrahams said the Tubulis takeout represents a strategically sound bolt-on that addresses Gilead's oncology pipeline growth needs, while securing differentiated next-gen ADC platform capabilities.Once the transaction is finalised, expected this quarter, Tubulis will operate as a dedicated ADC research unit within Gilead, with the Munich site serving as a hub for ADC innovation.The deal continues a recent trend that has seen pharma companies such as Eli Lilly and Biogen snapping up small- and mid-sized biotechs in order to bolster their pipelines, and Gilead has been particularly busy (see – Vital Signs: The biggest spenders of the first quarter).In late February, it agreed to acquire cell therapy developer Arcellx for $7.8 billion to secure full control of a BCMA-directed CAR-T, and more recently struck a separate agreement to buy Ouro Medicines for up to $2.2 billion to bolster its immunology pipeline.

Dive Brief:Gilead Sciences will acquire German biotechnology startup Tubulis in a potentially $5 billion deal that expands the companys growing pipeline of cancer drugs.Per terms of a deal announced Tuesday, Gilead will pay $3.15 billion upfront for Tubulis and could shell out another $1.85 billion if certain unspecified milestones are met. The deal hands Gilead a technology for making next-generation antibody-drug conjugates along with two products, TUB-040 and TUB-030, in clinical testing against different tumor types.The acquisition is the latest in a series of company buyouts Gilead, historically known for its HIV drugs, has struck to build up its cancer portfolio. Its also the third M&A deal the company has made since late February, following purchases of Arcellxand Ouro Medicines.Dive Insight:Tubulis is making ADCs, a type of targeted medicine thats become a staple of cancer treatment over the past decade. These therapies pair a targeting molecule with a cancer-killing toxin, an approach thats meant to more precisely kill cancer cells.Many ADCs are now on the market or in development.Launched as a spinout from two research institutes in Germany in 2019, Tubulisis among the companies aiming to take the technology a step further.Using a special type of chemical linker, the company has been hoping to prove it can overcome some of the toxicity issues associated with earlier ADC technology and access tough-to-reach drug targets. Its also been trying to predict what cancer patients might need in the future as ADCs become more popular.At some point, there will also be a lot of patients that have built up resistances against this mode of action, and we need to have an answer for these patients as well, Dominik Schumacher, Tubulis CEO, told BioPharma Dive last year.Tubulis approach had already drawn the interest of venture investors, which have poured some $600 million in private fundinginto the company. It also attracted partnerships with Gileadand Bristol Myers Squibb.Todays agreement follows a two-year collaboration with Tubulis, which has given us strong conviction in their programs and research capabilities, Daniel ODay, Gileads CEO, said in a statement. Bringing this potential into Gilead would further expand what is already the strongest and most diverse pipeline in our companys history.Tubulis will remain a dedicated ADC research organization within Gilead and retain its facilities in Munich for R&D and manufacturing, the company said.Gilead has spent billions of dollars trying to build a cancer drug business over the last decade. An acquisition of Kite Pharma yielded a cell therapy business that now brings in more than $1 billion annually. A $21 billion buyout of Immunomedics marked its first big foray into ADCs, handing the company a now-marketed drug known as Trodelvy that hasnt yet become the kind of seller Gilead once envisioned.Tubulis prospects and technology have broad potential across multiple tumor types, complementing Gileads existing cancer drug work, the company said. The startups lead program,TUB-040, demonstrated promising efficacy in early testing in ovarian cancer, wrote RBC Capital Markets analyst Brian Abrahams in a Tuesday note to clients.The acquisition represents a strategically sound bolt-on that addresses [Gileads] oncology pipeline growth needs while securing differentiated next-gen ADC platform capabilities, Abrahams added. '