Bit.bio CEO Mark Kotter says the last major revolution in biopharma occurred around the 1980s, when antibodies — or, as some called them, anticancer ‘magic bullets’ — opened up the door for new therapies.
Now cell therapy is having a very similar moment, he told Endpoints News, and some blue-chip investors are giving his cell coding company $103 million to get behind it.
Kotter unveiled the high-dollar Series B round on Friday, with participation from Arch Ventures, Charles River Laboratories, Foresite Capital, National Resilience, Metaplanet, Puhua Capital and Tencent. The new cash builds on a $41.5 million Series A round that attracted some interesting investors last June, including National Cancer Institute ex-chief Rick Klausner, Arch’s Bob Nelsen and Foresite Capital CEO Jim Tananbaum. The latest round brings a few more notable names onto bit.bio’s board of directors, including monoclonal antibody pioneer and Nobel laureate Greg Winter, Amadeus Capital Partners co-founder Hermann Hauser, and Alan Roemer, the entrepreneur behind both Pharmasset and Roivant.
Bit.bio’s roots trace back to the University of Cambridge’s Stem Cell Institute, where Kotter worked on a platform approach to coding for cells at an industrial scale, making it possible to relatively quickly generate batches of specific cells that come out with enhanced features.
First-generation cell therapies are made with a mix of cells that are often ‘not in very good shape,’ Kotter said, adding that scientists will start with cells taken from patients who are already battling cancer.
‘There’s a lot of variability with the cells, and you have very little control,’ he added. Bit.bio is one of the many companies pursuing an off-the-shelf approach, starting with engineered pluripotent stem cells. It’s a group that includes other new entrants like Garuda Therapeutics which launched last year, and Clade Therapeutics, which emerged from stealth earlier this week.
What will set the Cambridge, England company apart from the pack? Scalability, Kotter says.
‘Other companies in that space have made incredible progress,’ he said. ‘We now have a few stem cell products being tested in the market, but they’re still having issues with scale and with reproducibility.’
Kotter says bit.bio’s biology is more permissive, adding that the company is already at industrial scale in terms of cell production. He compared the company’s ‘opti-ox’ platform to a hack into the software of the cell. By activating specific transcription factors, scientists can essentially change the program or identity of the cell. Now all the team needs is to get into the clinic — though Kotter didn’t provide a timeline for that.
‘I’m not going to say this is going to be easy,’ he said. ‘It’s going to be super hard, but our advantage is that we’re not fighting a biology that is resisting, you know, scale up and consistency.’
The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Every part of ‘normal’ day-to-day life has been disrupted. Clinical trials and the traditional way of conducting them has been no different. Flexibility became an immediate need for sponsors, CROs, clinical sites, and patients. Quick adjustments had to be made, along with finding new ways to make sure that patients had the appropriate care, oversight of the clinical sites continued to be managed, and drug supply and accountability were maintained. Many clinical sites found themselves acting as a shipping department, trying to make sure all of their patients received their drug safely and on time. CRAs performed remote oversight visits, virtual site tours, and virtual accountability audits. Sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.
For the past 20 years, Novartis and Roche were more than cross-town rivals reigning over towering pharmaceutical dynasties. Novartis also holds a sizable chunk of Roche’s shares — amounting to a nearly one-third voting stake.
Now, Roche is buying that stake back for $20.7 billion.
‘After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,’ Novartis CEO Vas Narasimhan said in a statement, adding that the cash will go toward purposes in line with current capital allocation.
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After a fiasco surrounding the contamination of Covid-19 vaccine doses in its facilties — during a time in which vaccinating residents was dire to America’s return to normalcy — Emergent BioSolutions’ $600 million manufacturing deal with the US government has come to an end.
CEO Bob Kramer said that the two parties ‘mutually agreed’ to terminate the contract in an earnings call with investors Thursday, evaporating about $180 million in deal value.
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House Democrats are on the cusp of passing two major pieces of Biden’s agenda Friday, but Medicare drug price negotiations — once the centerpiece of the Build Back Better Act’s revenue stream — has been relegated to only about $100 billion in savings over the next decade. That number fell lower yesterday.
Overall, the compromise ended up winning over both Democrat senators receiving PhRMA cash, like Kyrsten Sinema and Bob Menendez, and more liberal senators, like Elizabeth Warren. But on the House side, the battle continued up until yesterday evening.
DeepMind CEO Demis Hassabis
Last summer marked a major breakthrough in drug discovery when DeepMind, a predictive modeling startup from Google parent company Alphabet, offered the most accurate picture yet of the ‘protein folding’ problem. The Alphabet team is now propping up a unit focused solely on drug discovery, and it will look to leverage lessons learned from DeepMind’s example.
Alphabet has launched Isomorphic Labs, a London-based drug discovery startup leveraging the company’s AI and machine learning work, and lessons from DeepMind’s AlphaFold breakthroughs, CEO Demis Hassabis said in a blog post Thursday.
Despite a very late line approval for its TKI drug last year, Deciphera has had its eyes set on cracking into earlier patients with GI tumors — a possibility investors cheered. But that door has now been slammed shut, and Deciphera’s cheerleaders are fleeing in droves.
Deciphera’s Qinlock (ripretinib) failed a head-to-head matchup against standard-of-care sunitinib in second-line patients with gastrointestinal stromal tumors (GIST) who had previously been treated with TKI inhibitor imatinib, the biotech admitted Friday.
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Say hello to yet two more biotechs that jumped on a 2021 IPO this week.
German firm Evotec SE debuted a downsized IPO in the US yesterday — pricing at $21.75 per ADS share and $43.50 for a share on Nasdaq under the ticker $EVO.
The biotech announced last week that it planned to raise more than half a billion dollars by offering 22 million shares at $26.16 each — representing 11 million shares, according to an amended F-1 filed with the SEC.
Site of bluebird’s new headquarters at 455 Grand Union Blvd, Assembly Row (Photo credit: Aram Boghosian)
Recouping from a series of setbacks for its gene therapy business, bluebird bio successfully bisected itself earlier this week as part of a big rebrand around genetic disease. Now, with its future still in the wind, bluebird has found a new nest.
Bluebird has signed a lease for a new 61,000 square-foot headquarters at Assembly Row in Somerville, MA, that the newly stripped-down biotech envisions as its hybrid home base of the future after spinning off its oncology business earlier this week.
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The US government’s $1.8 billion investment into Novavax’s Covid-19 vaccine may soon pay off as the company floated some positive comments around the issues surrounding the manufacturing of its recombinant protein vaccine, which could be added early next year to the world’s arsenal of shots.
The company has struggled with its vaccine candidate’s potency and purity, pushing back the timing of submitting its application to the FDA all summer, and in June the US government had to steer Novavax, instructing the company to prioritize alignment with the FDA on its analytic methods before conducting additional US manufacturing, and ‘further indicated that the US government will not fund additional US manufacturing until such agreement has been made,’ the company said.
https://endpts.com/cell-therapy-startup-bit-bio-adds-100m-to-its-coffers-and-some-impressive-names-to-its-board-of-directors/
