Sonny Hsiao, Acepodia CEO
Acepodia chairman and co-founder Patrick Yang called cancer ‘the longest war America (has) ever fought.’ So when he met Sonny Hsiao in 2016 and saw his ‘clever, very simple, elegant’ approach to battling tumor cells, he was all in.
Four years and some very early positive results later, Yang and Hsiao have racked up another $109 million from investors to see their ‘antibody-cell conjugates’ through the clinic. And while Yang says this isn’t a crossover round, he admitted that the company is ‘watching the capital climate’ and could possibly file for an IPO next year.
But for now, he says, the team at Acepodia is laser-focused on their pipeline. The Alameda, CA-based biotech’s platform traces back to Hsiao’s research at UC-Berkeley, where he discovered a way to conjugate antibodies with NK cells in a similar fashion to antibody-drug conjugates (ADCs). Hsiao — now CEO — calls this approach ‘antibody-cell conjugation,’ or ACC for short.
While most NK cell therapies are already administered in conjunction with antibodies, they’re usually given separately, making for less potency, Acepodia believes. By conjugating the two, the cancer-targeting antibodies are less likely to diffuse throughout the body, Hsiao told Endpoints News earlier this year.
‘It’s totally different from the CAR-T scientific community,’ Yang said on Tuesday. ‘Some of the immune cells like NK cells, they’re just patrolling in the body with no specific objective, no targets. If we arm it with a GPS guided to the destination, we could radically improve the treatment outcome.’
While autologous CAR-T therapies have shown great promise, they’re expensive to make and they take too long, Yang said. That’s why his company is going for an off-the-shelf approach that doesn’t require genetic engineering.
‘Our mission statement is to bring a more powerful cancer treatment that can be accessible to all patients, not just a small population of patients who can afford it,’ Hsiao said.
The team brought some positive topline data for their lead candidate, ACE1702, to this year’s ESMO, showing the drug was well-tolerated in seven patients with advanced HER2 tumors who received lower doses. One patient even achieved a confirmed partial response — not earth-shattering, but a positive sign. Hsiao expects to read out the full Phase I data sometime in Q2 or Q3 2022. Then they’ll extend the trial before jumping into a pivotal Phase II study.
‘(At) Acepodia, every day is Wednesday,’ Yang joked. ‘We kind of work around the clock.’
The early results were also a positive sign for JW Therapeutics, which plunked down an undisclosed amount last summer to develop and commercialize the candidate in mainland China, Hong Kong and Macau.
In addition to seeing ACE1702 through Phase I, the company is on track to submit an IND for its second lead program this month — a gamma delta (γδ) T cell therapy targeting CD20.
The Series C round — led by Digital Mobile Venture with a hand from other undisclosed investors — will also help Hsiao expand the team from 45 to 70 by the end of next year. Yang also hinted at potential partnerships coming in the next year or so.
‘The technology that we have is a platform technology, and it takes a lot of hard work to translate the science into a product and get it commercialized,’ Yang said. ‘And we could see that we have a roadmap to get there.’
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.
For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.
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Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.
Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.
Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.
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Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.
Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.
An inmate in Georgia has been sentenced to seven additional years in prison for running a $3 million fraud scheme to steal and then resell heavy equipment from behind bars — by posing as an AbbVie employee using a contraband cell phone.
While serving a 20-year sentence for racketeering and assaulting a police officer, Damon Thomas Young was found to have given himself the fake identity of a purchasing officer with AbbVie named Morgan Sylvia and, beginning in 2019, placed orders for more than $2.8 million worth of heavy construction equipment.
John Maraganore (Scott Eisen/Bloomberg via Getty Images)
After almost two decades of primarily being known as Alnylam’s CEO, John Maraganore is getting a new, prominent title.
Maraganore is among a slate of new venture partners at ARCH Venture, joining alongside ex-FDA official Luciana Borio, Jake Bauer (previously at MyoKardia), Axel Bouchon (former head of Leaps by Bayer) and Sabah Oney (of Alector fame).
The move was hardly surprising. Maraganore has made it clear that his retirement, which is scheduled for the end of the year, signaled a shift into a new phase of his career where, instead of hands-on parenting, he wanted to be like a ‘grandfather’ to the next generation of biotech startups, imparting hard-earned wisdom about the treacherous journey from the lab to market — one he personally shepherded Alnylam and its RNAi science through.
When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.
GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.
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Fyodor Urnov (L) and Charlie Gersbach
A little under 20 years ago, Charlie Gersbach decided he needed to try something else.
The young Georgia Tech grad student started out his career hoping to help patients regenerate injured tissues, but he found pretty much nothing worked. None of the chemical or mechanical or even electric interventions then in vogue yielded much success.
So he turned his attention to an emerging approach: changing the epigenome, or the systems of tags and folds on DNA that govern which genes are expressed and how. And he stuck to it, even as many scientists, enticed by CRISPR and other advances, flocked to genome editing.
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On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.
Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.
https://endpts.com/can-the-antibody-drug-conjugate-model-work-for-nk-cells-acepodia-loads-up-with-another-109m-to-find-out/
