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17 August, 2022 |
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Nominations for our fourth annual Women in Biopharma feature will remain open until August 29. Know any deserving candidates? Fill out this form here.
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Max Gelman |
Senior Editor, Endpoints News
@MaxGelman
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Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach |
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by Kyle LaHucik
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Sanofi made clear its AI ambitions were real at the beginning of this year when the Big Pharma took its drug discovery collaboration with Exscientia to the next level, inking a pact that could birth 15 drugs and deliver $5.3 billion to the UK partner. Seven months later, the AI blueprint is far from over at the French Big Pharma, as another of the much-hyped drug discovery startups is coming to the table in a five-drug deal. Sanofi will pay Atomwise $20 million to kick off the hunt for up to five targets, which are aimed at leading to the creation of new small molecules. Another $1 billion is on the line — as are royalties — and the companies kept mum on the specific diseases or broader therapeutic areas of interest. The deal with Exscientia, announced in January, centers on small molecules in immunology and oncology. “Not all AI is created equal and different people are focused on different pieces,” Atomwise CEO and co-founder Abraham Heifets told Endpoints News. He characterized Atomwise’s platform as a “single global model” that can apply to whatever protein the company is working on, as compared to “local models” that other companies have deployed, meaning they need a new model for each area, with EGFR offered as an example. “Our focus has really always been about extrapolation to novel biology to novel chemistry to novel scaffolds, so we can work on proteins where we have no training data , we have no known ligands for that protein, so extrapolations of novel biological space," Heifets said. |
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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images) |
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by Amber Tong, John Carroll
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Sanofi is officially giving up on its oral SERD. The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program. Shares on Nasdaq SNY fell 6% to about $42 in premarket trading — a significant drop for a Big Pharma — as observers ponder what's left in the pipeline. Sanofi has also been seeing turbulence of its stock after analysts drew attention to personal injury litigation related to Zantac. “I’d have to say overall the class has rather underwhelmed in terms of adding something beyond what the standard of care today provides,” Sanofi R&D chief John Reed tells Endpoints Wednesday. “And I think everyone’s data has been mostly in that direction, with possibly the exception of the mutant estrogen receptors where one sees signals of encouragement. That’s obviously more of a niche opportunity, something one sees in late lines of therapy, and might be an opportunity for the class. “We had high hopes for amcenestrant based on the early data and invested broadly, but now with two randomized trials under our belt at least our molecule is not having the robust benefit we had hoped for patients, we decided to pull the plug.” |
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Joel Dudley, new partner at Innovation Endeavors (Tempus Labs) |
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by Tyler Patchen
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Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further. The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs from 2020. In an interview with Endpoints News, Dudley said he has also been working with Innovation Endeavors in some capacity for a little while as a part-time venture partner, but now decided to jump on full-time. Innovation Endeavors has been slowly creeping into biotech investments. While the firm has invested in well-known tech entities such as SoFi and Uber, it made several biotech investments last year. This includes participating in rounds for Geroge Chruch’s spinout GRO Biosciences, the allergy biotech Ukko and BigHat Biosciences. Dudley told Endpoints that bringing him on shows that Innovation Endeavors is taking a harder look into the biotech world, and he feels that the recent developments have made it an attractive landing spot. “You had these trends that were going to happen irrespective of these exponential technologies in molecular profiling, imaging, data science and machine learning, all sort of converging, irrespective of their innovation cycle and hitting these exponential innovation curves,” he said. “But then obviously you have Covid sitting on top of that, which was sort of this World War Two-like cycle of compressed innovation. |
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Kate Haviland, Blueprint Medicines CEO |
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by Lei Lei Wu
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Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered. In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48. Later this year, the Massachusetts biotech plans to file for a supplementary approval for Ayvakit, which was greenlit for the rarer advanced form of SM back in 2021. Despite the apparent positive readout, Blueprint BPMC was trading down by over 20% this morning, dropping from around $68 to $54. For one, analysts noted that the difference between the average symptom scores of the treatment and placebo arms in the Part 2 results was just over 6 points, substantially less than the 16-point difference in the smaller Part 1 study. Not only did the treatment have a smaller effect in Part 2 than in Part 1, in which patients saw a 19-point improvement in their symptom scores, but the placebo plus standard of care fared considerably better than in Part 1 as well, where the control arm saw only a 3-point improvement in symptom scores. When asked about the difference in the control arm, Blueprint COO Christy Rossi told Endpoints News that it was “hard to speculate,” but noted the multi-center, global scale of the second part of the study. |
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Keting Chu, Bluejay Therapeutics CEO |
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by Aayushi Pratap
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Every year, 820,000 people die of chronic hepatitis B infections globally, and 1.5 million get infected, despite the availability of vaccines and treatments, according to the CDC. Current standard-of-care treatments can be effective in stopping virus replication, but they require patients to be on meds for life. Bluejay, which was founded in 2019, is trying to change that, aiming to develop a functional cure for hepatitis B infections by making HBsAg — viral protein-surface antigens — completely undetectable within six months of treatment. And it's got a new round of cash to try making it a reality. The company closed a $41 million Series B round Tuesday led by Arkin Bio Ventures. This round included participation from other new and existing investors, including Synergenics LLC, RiverVest Venture Partners, Yonjin Capital, Octagon Capital and InnoPinnacle International. “Vaccines are available but not everyone has access to it. For instance, the U.K. health system does not even cover it,” said Keting Chu, founder and CEO of Bluejay Therapeutics. “When patients stop taking medicine, the virus rebounds,” Chu added. Even when patients are on meds, their bodies continue to make HBsAg, which causes chronic inflammation that eventually leads to liver cirrhosis and cancer. These HBsAg antigens, when produced in the body, cause "exhaustion" of the immune system, specifically the B cell and T cell, said Chu. Bluejay’s lead asset is BJT-778, an antibody against HBsAg antigens, which the company has licensed from Novartis. “The goal is to restore T cell and B cell functions to get immune control and achieve a functional cure,” Chu said. |
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Pawel Przewiezlikowski, Ryvu Therapeutics CEO |
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by Paul Schloesser
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Many US biotechs have been tightening their pocketbooks in an effort to keep themselves running. But over in Poland, one company is nabbing a debt financing to push itself towards more clinical trials, with the help of one of Europe's largest lenders. Ryvu Therapeutics put out word early Wednesday that the European Investment Bank, the lending arm of the European Union, is providing the biotech with $22.3 million in debt financing — or €22 million. As part of the debt financing, the European Fund for Strategic Investments is backing it with a "first loss guarantee," ensuring that the EIB can at least recoup some of its investment if the company's projects go south, allowing it to invest in projects that could have a higher level of risk. EIB VP Teresa Czerwińska said in a statement that financing projects within R&D are a top priority for the lender, noting, "The EIB’s investment will strengthen Ryvu Therapeutics’ research, development and innovation capacity and competitiveness for the wider social benefit.” Ryvu will use the financing to continue advancing its pipeline of oncology small molecule candidates through the discovery and preclinical phases and into clinical trials, CEO Pawel Przewiezlikowski said in a statement. The biotech is going after such targets as PRMT5 and WRN in synthetic lethality, STING in an antibody-drug conjugate, STING as a standalone and HPK1 in I/O, according to Ryvu's website. |
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by Kyle LaHucik
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The CD47 field ran into another hurdle Tuesday as I-Mab quietly disclosed in an SEC filing that AbbVie is saying goodbye to a Phase I study of the biotech’s drug. Weeks after ending an exploratory trial of I-Mab’s CD47 antibody, AbbVie has now called it quits on another early-stage trial. The Phase I was testing the drug, lemzoparlimab, in combination with azacitidine and venetoclax in patients with acute myeloid leukemia and myelodysplastic syndrome. “This decision was not based on any specific or unexpected safety concerns,” I-Mab disclosed in the paperwork filed with the SEC. The study arose from the pact AbbVie and I-Mab inked in autumn 2020 with $200 million upfront and more than a billion dollars in back-end payments. The partnership will continue with “certain new anti-CD47 antibodies” or “other licensed products,” I-Mab disclosed. I-Mab stands to receive up to $1.295 billion in payments and tiered royalties under the amended deal, the company said. The move comes days after Zai Lab shelved a Phase I program of its CD47 inhibitor ZL-1201 after scoping out the competitive landscape. Multiple setbacks have occurred to the CD47 space since Gilead’s magrolimab, formerly of the biotech Forty Seven and one of the lead programs in the industry, was placed on partial clinical holds last year. All study pauses have since been lifted, and the California biopharma has reiterated its “unwavering” confidence in the program, which aims to block the “don’t eat me” signal loved by some cancer cells. |
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Kate Hermans and Feng Tian |
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by Amber Tong
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When Ambrx Biopharma went public in the summer of 2021 — joining in on the go-go times in biotech — execs celebrated it as the culmination of a winding journey that took them from a failed IPO bid in 2014 to a sale to Chinese investors and pharma companies and, thanks to a new vision and strategy, a $200 million crossover round from marquee VCs before jumping on Nasdaq. But it now appears that another pivot is due. Ambrx, which has been applying its protein engineering tech to make antibody-drug conjugates, is bringing in a new CEO, Kate Hermans, to temporarily replace Feng Tian, who’s been with the biotech for 17 years, previously as CSO. As interim chief, Hermans will oversee a strategic pipeline review “to maximize our commercial opportunities and further extend the cash runway,” the company noted. In the meantime, it will prioritize partnerships such as the one with China’s NovoCodex while searching for a permanent CEO. Ambrx shares AMAM have plunged 85% since it first listed, now trading at $2.56. Currently, Ambrx’s most advanced program is an ADC targeting HER2 called ARX788. While the original plan was to seek accelerated approval at the FDA based on Phase II results, Ambrx admitted in an April SEC filing that it may no longer be viable given the crowded space: |
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Chris Sheldon, AstraZeneca's former VP and head of investor relations |
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by Nicole DeFeudis
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AstraZeneca and GSK are once again wrangling over talent. The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported. Sheldon worked at AstraZeneca for more than 18 years, starting as a research scientist back in 2004 and climbing to global head of business development and licensing for oncology R&D, and eventually, head of IR. He resigned earlier this month, effective immediately, according to Law360. A GSK spokesperson confirmed to Endpoints News on Tuesday that Sheldon’s headed there to become the next senior VP of its commercial portfolio. While the company declined to comment on the AstraZeneca case, the spokesperson added that GSK “committed to leveraging business development as a tool to secure access to external innovation, help shape the portfolio and further strengthen our late-stage pipeline.” Sheldon also declined to comment, though he added: “I deny what is alleged or any wrong doing.” AstraZeneca was not immediately available for an interview. This isn’t the first time AstraZeneca has taken a matter like this to court. Back in 2017, the pharma giant sued former exec Luke Miels, who was poached by GSK earlier that year to head up its global pharmaceuticals business. Miels had worked with AstraZeneca CEO Pascal Soriot for more than a decade at Aventis, Roche and AstraZeneca. He served as an executive VP at AstraZeneca for just over three years before jumping to GSK, where he’s now chief commercial officer. |
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by Beth Snyder Bulik
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The Covid-19 pandemic and rush to vaccines created a stir with a raft of unusual and media-debated names including Moderna’s Spikevax, Pfizer’s Comirnaty and AstraZeneca’s Vaxzevria. Now monkeypox drug names are in the news — although both the leading vaccine Jynneos and the special use treatment Tpoxx have been around for years. Jynneos was approved as protection against smallpox and monkeypox in 2019, while Tpoxx was approved as an antiviral to treat smallpox in 2018. However, unlike the Covid vaccine Big Pharma companies and closely watched developments, the monkeypox drugs aren't close to the market mainstream. Both Jynneos and Tpoxx are national stockpile products and are only supplied and sold to government agencies. Of course, that could change if monkeypox continues to spread in the US and becomes endemic. Siga’s chief scientific officer and longtime pox virologist Dennis Hruby said Tpoxx commercialization is a “future conversation” dependent on whether the outbreak fades or stays in circulation. “We never anticipated monkeypox, of course. With smallpox, the average citizen is not going to go down to the grocery store to get it. Now that’s going to change with monkeypox. And certainly, we’re looking at perhaps launching it through traditional commercial channels, but that will require a bit with approval, probably serialization, etc. So we’ve been too busy really to have those conversations with the FDA, but that could be down the road,” he said. Still, the brand names of both are now cropping up in media mentions, social media channels and casual conversations everywhere. |
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John Carroll
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Editor & Founder
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Arsalan Arif
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Publisher & Founder
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Shehla Shakoor
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Managing Director
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Igor Yavych
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Chief Technical Officer
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Valentin Manov
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Creative Director
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Beth Snyder Bulik
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Senior Editor
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Zachary Brennan
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Senior Editor
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Assistant Editor
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Sales Director
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Sr. Operations Manager
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Operations Manager
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Subscriptions
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News Reporter
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Worldwide made. Thanks for reading.
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