Despite all the excitement over the possibility of T cell therapies to crack the code against solid tumors, early safety data have limited the burgeoning field’s promise. A clutch of players hope to solve that problem by “masking” their drugs, and now one of those outfits has snared fresh investor cash to take its shot in the clinic.
Amunix closed a $117 million Series B to guide AMX-818, a masked protease-activated T cell engager for HER2 expressing tumors, to the clinic as well as shepherding its bustling pipeline of tumor hunters through the preclinical stage, the company said Thursday.
A 15-year-old firm that only recently pivoted its drug half-life extending platform into next-gen oncology development, Amunix is one of a suite of companies using masking antibodies to sneak therapies directly into the tumor microenvironment without the serious safety risks common to other immunotherapies.
What separates Amunix from the pack? For one, the biotech is using a “universal mask” for its immunotherapy drugs, CEO Angie You told Endpoints News, which allows the team to “plug and play” against different targets where other companies are forced to design custom cloaks for each target.
“The target universe is huge, and our strategy is ‘look, we’re not limited by good targets,'” You said.
The biotech’s lead candidate, for instance, targets HER2 — a highly validated and commonly targeted growth factor protein — but Amunix is also testing four additional candidates “in parallel” to target TROP2, PSMA and EGFR, You said. Those programs are less developed, but Amunix still plans to nominate a second candidate for human testing by the end of the year, she added.
The first immediate milestone for You’s team is taking AMX-818 into the clinic. Amunix will initially launch its first human trial in Spain and is scoping a CTA submission with the EMA by the end of the year to enable patient enrollment by early 2022, You said.
Going after HER2 is a bit of a double-edged sword: It’s a highly validated target but one with a ton of established competition. But You argued all of those drugs target tumors with high expression of HER2, leaving an untapped market in patients with low- or mid-HER2 expression that are “overexpressed” or amplified.
“Some people have a knee jerk reaction like ‘it’s so crowded,'” You said. “What’s emerging is a lot of institutions are screening their patients for HER2 because it seems to be a mechanism of reaction. We think there’s a lot of opportunity there.”
In mouse data presented in December, AMX-818 spurred complete responses even for tumors with low HER2 expression. That could offer a clue that AMX-818’s high potency will offer a clinical benefit across the HER2 spectrum, You said.
But it’s not just T cell engagers on Amunix’s docket. The biotech is also chasing a program for masked, protease-activated cytokines that avoid T cells altogether. That program is still “really early,” You said, but could offer a novel path to cutting down tumors.
With so much in the works, Amunix will look to greatly expand its team of 50 based in South San Francisco, You said. The biotech is also working on partnered drugs with Sanofi and 9 Meters, including a Factor VIII clotting drug with the French drugmaker that is currently in Phase III.
Thursday’s round was led by Viking Global Capital and joined by new investors in Bain Capital Life Sciences, BlackRock, Franklin Templeton, Janus Henderson Investors, ArrowMarkPartners, Avidity Partners, Clough Capital, and CaaS Capital Management. Existing investors that jumped on board the new round included Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital and Polaris Partners.
The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.
Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.
Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.
Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.
You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.
Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.
The jury’s still out on whether the first wave of AI companies can significantly change drug development, but investors are increasingly buying into the hype.
Exscientia, the decade-old UK machine learning outfit, announced Thursday that they’ve expanded their Series C, first announced in May, from $60 million to $100 million. The expansion most notably includes BlackRock, the private equity firm that has been wading deeper and deeper into biotech. They now join Novo Holdings, Bristol Myers Squibb and others among the company’s most recent backers.
Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.
Let’s start with the latest data from Lilly.
The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.
Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.
It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.
The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.
Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.
Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.
Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.
Roughly three and a half months since its last fundraising round, the Peter Thiel-backed ATAI Life Sciences has pulled in its latest venture haul.
The company closed a $157 million Series D round early Wednesday as it presses the gas on its psychedelics-based strategy. Though the short time between the two raises will likely fuel speculation about a potential jump to Nasdaq, ATAI isn’t ready to talk about that just yet, preemptively declining comment on all IPO-related questions.
哪一个部门给阿穆尼克斯的评分？首席执行官Ang-ie You告诉End-Points News说，首先，生物技术是我们为其多种药物提供了一个“单一的面具”，这使得团队能够“即插即用”地对抗各种不同的焦油，在这种情况下，其他公司被迫为每种焦油提供一种“单一的面具”。
周四的活动由维京环球资本公司牵头，贝恩资本生命科学公司、黑岩公司、富兰克林资本公司、Janus Hender-Son资本公司、Arrow Mark资本公司、Avid资本公司、Clough资本公司和CaaS资本公司加入。加入新一轮的前几家公司包括红英里集团、Ven'rock、CAS'din Cap'i'tal、Omega Funds、Fra'zier Health Care Part.Ners、Lon'gi'tude Cap'i'tal和Po'laris Part.Ners。
拥有十年历史的英国机器学习公司Exscientia周四宣布，他们将5月首次宣布的C系列产品的规模从6000万美元扩大到1亿美元。最引人注目的扩张包括私人股本公司贝莱德，该公司在生物技术领域越陷越深。他们现在加入了Novo Holdings,Bristol Myers Squibb和其他公司的最新支持者行列。
据《旧金山纪事报》报道，多达一半的职位将转移到Research Triangle Park，该公司正在那里建立一个新的商业服务和信息技术中心。确切的数字将取决于有多少员工选择搬迁。