U.S. Steel said in a statement on Saturday that the Biden administration will hold off enforcing a requirement laid out in an executive order this month that Nippon Steel abandon its $14.9 billion bid for U.S. Steel.
The parties previously had 30 days to unwind their transaction.
The delay will give the courts time to review a legal challenge brought by the parties earlier this month against President Joe Biden's order.
Capping off a flurry of mega-round launches this week, Kardigan debuted Friday with an all-star cast and an ambitious mission: to unseat cardiovascular disease as the leading cause of death worldwide.
The San Francisco and New Jersey–based company announced the closing of a $300 million Series A round led by Perceptive Advisors, ARCH Venture Partners and Sequoia Heritage.
Helmed by former MyoKardia CEO Tassos Gianakakos, Kardigan is taking a targeted approach to cardiovascular disease. The biotech’s platform “leverages a proprietary set of cardiac-specific tools that enable a deep understanding of the mechanisms across its therapeutic candidates as well as patients’ individualized responses to treatment,” according to its Friday press release.
“For decades, our team has observed significant treatment gaps across cardiovascular disease - from clinical care to investment in new medicines,” Gianakakos said in the statement. “While current standards of care play an important role, collectively, they fail to address the global health emergency in front of us.”
Kardigan is the latest play from Gianakakos and fellow MyoKardia alumni Jay Edelberg (chief medical officer at Kardigan) and Bob McDowell (the new company’s chief scientific officer). The execs led the development of mavacamten, which in 2022 became the first FDA-approved cardiac myosin inhibitor specifically targeting the source of obstructive hypertrophic cardiomyopathy. The approval was granted to Bristol Myers Squibb, which acquired MyoKardia for $13.1 billion in October 2020.
The team’s initial focus at Kardigan will be on disease opportunities and patient segments that are resistant or poorly managed on current therapies, including primary and secondary cardiomyopathies leading to heart failure, according to the press release.
The cardiovascular space—and cardiomyopathies specifically—are experiencing a renaissance of late with the November 2024 FDA approval of Attruby for transthyretin amyloid cardiomyopathy (ATTR-CM). The greenlight set up a head-to-head competition with Pfizer’s Vyndaqel and Vyndamax (tafamidis) in an increasingly crowded space that could soon see the addition of Alnylam’s Amvuttra (vutrisiran).
In a recent interview with BioSpace, Tenaya Therapeutics CEO Faraz Ali said it is currently a “golden era for cardiomyopathies,” noting the advent of multiple modalities, including gene therapies. Tenaya itself is developing an investigational gene therapy for hypertrophic cardiomyopathy targeting mutations in the MYBPC3 gene.
As biopharma gets set for the J.P. Morgan Healthcare Conference next week, several new companies have burst onto the scene. Also on Friday, GSK-based Ouro Medicines announced that it had raised $115 million to advance a pipeline of T cell engagers. In the obesity space, Verdiva Bio broke cover Thursday with $411 million in Series A funds to develop a potentially first-in-class oral GLP-1 receptor agonist and other next-gen therapies. And on Wednesday, Tenvie Therapeutics launched with $200 million and assets from Denali Therapeutics to go after neurological diseases. Rounding out the group was Denmark’s oral medicine–focused Orbis Medicines, which raised a $93.2 million Series A and added Eli Lilly to its stable of investors.
https://www.biospace.com/business/myokardia-alumni-launch-kardigan-with-300m-to-tackle-heart-disease
Eli Lilly is teaming up with venture capital firm Andreessen Horowitz (a16z) to form a new $500 million biotech fund aimed at fueling potentially disruptive science and ambitious leaders in the industry. Lilly and a16z did not specifically say what disease areas the fund will focus on beyond saying it will look for “therapeutic platforms and cutting-edge technology companies.”
The Biotech Ecosystem Venture Fund will combine the sourcing capabilities of a16z with Lilly’s expertise in R&D—and its money, according to a Friday release. Lilly is providing all the capital for the new fund, plus access to its Catalyze360 program that offers early-stage biotechs support via Lilly Ventures, Lilly Gateway Labs and Lilly ExplorR&D.
“Catalyze360 was created to accelerate the success of emerging biotech startups by providing access to people, tools, capabilities, and expertise that is traditionally hard for early-stage companies to reach,” Nisha Nanda, group vice president of Catalyze360, said in the statement. “With the Biotech Ecosystem Fund, we can further scale our work to empower entrepreneurs as they work to bring transformative therapies to patients faster.”
Catalyze360 was revealed by Lilly CEO David Ricks a year ago. The program is being used in a partnership with Shanghai-based Laekna to develop a next-generation obesity treatment. Lilly Ventures, meanwhile, started off the year participating in Orbis Medicines’ $93 million series A.
Meanwhile, a16z has been around since 2009 and has $44 billion in committed capital across multiple funds. Notable investments include Big Hat Biosciences, Cartography Biosciences and CAMP4 Therapeutics.
“Combining our strengths as organizations will empower founders with not only the venture backing needed to advance groundbreaking technologies, but also the resources needed to strategically select the most promising application areas for these platforms,” Vineeta Agarwala, general partner at the life sciences–focused branch of a16z, a16z Bio + Health, said in the announcement.
https://www.biospace.com/business/lilly-partners-with-a16z-on-500m-vc-fund-for-early-stage-biotechs
Antiobesity drugs are amazing people by how fast they melt off pounds. But it's no surprise to Richard DiMarchi.
DiMarchi, a chemical biotechnology and drug discovery pioneer, helped create life-altering drugs for patients impacted by diabetes and other endocrine diseases. But he also laid the foundation for drugs like Ozempic and Mounjaro that control type 2 diabetes without insulin, while lowering body weight. This trait of these compounds kicked off the boom in antiobesity drugs.
DiMarchi is a distinguished professor of chemistry and Gill Chair in Biomolecular Sciences at Indiana University. He's also a former group vice president at Eli Lilly (LLY) and later a vice president at Novo Nordisk (NOV).
In a career spanning decades, DiMarchi developed breakthrough drugs that revolutionized diabetes treatment. All the while, he muted skeptics, who said it couldn't be done.
DiMarchi says the accomplishments built "the foundation for this new class of drugs based on gut hormones that have ability to control type 2 diabetes without insulin, while reducing body weight." Take glucagon-like peptide-1 receptor agonists (GLP-1s).
"Such drugs mimic the actions of the natural hormone GLP-1 released after eating, and constitute a part of the more powerful peptides where such pharmacology is complemented by additional hormonal mechanisms of action," he said.
DiMarchi's academic research has broadened the understanding of glucagon physiology and the discovery of a single drug, not a mixture, has multiple modes of action for the treatment of diabetes and obesity.
But DiMarchi's role in developing the popular antiobesity drugs is just one in a list of achievements as a groundbreaking researcher and innovator.
He contributed to the discovery and development of recombinant DNA (rDNA)-derived Humalog, rGlucagon and Forteo. Humalog, an injectable, fast-acting insulin to treat diabetes, became the first rDNA-derived molecule chemically optimized for human use.
What has been his formula for success in leading drug development?
"I don't believe there is a single formula, but a central element is focus on doing something that is different from what everyone else is doing," said DiMarchi, 72. "I pride myself on being a person aiming to do something different, something seemingly impossible or at least improbable."
DiMarchi says "a breakthrough requires inventive creativity. It is not an iterative improvement. What others are doing is not to be repeated, it is reason to do something else."
DiMarchi's path to success began early in his career. A native of Brooklyn, he left New York's Rockefeller University, where he did his postdoctoral fellowship, for Eli Lilly in Indianapolis. He started as a bench scientist in 1981 working on the biosynthesis of human insulin, which became Humulin.
"The reason I came to Lilly was less to make this one molecule than it was to learn the technology in how to synthesize these molecules in microorganisms," said DiMarchi.
In 1982, Eli Lilly launched Humulin, the first mass-produced biosynthetic insulin. "It was a launching point for the biotech industry," DiMarchi said. "The venture capital community saw they could profitably invest and reinvest significantly in drugs made with this technology."
DiMarchi saw potential in further developing and commercializing this biotechnology. "Once we had validated this technology, we had a commercial method to make virtually any peptide or protein on a commercial scale, at a suitable cost," he said. "My vision was that these natural sourced peptides and proteins could be chemically optimized for medicinal purposes."
His approach evolves century-old medicinal methods that used synthetic chemistry to "optimize" natural products such as antibiotics to discover breakthrough medicines.
"What I envisioned in biotechnology was an analogous optimization of peptides and proteins which nature has optimized for physiological purposes, now being enhanced for pharmacological use," he said.
DiMarchi smashed the prevailing view that changing natural human sequence was a "risky proposition more likely to increase toxicity than pharmaceutical performance," he said.
As research director of biotechnology at Eli Lilly, DiMarchi and his colleagues changed the structure of insulin to make it work better around mealtime for insulin-dependent diabetics.
That drug, Humalog, an injectable fast-acting insulin to treat diabetes, became the first rDNA-derived drug FDA approved as a substance that had been "purposefully optimized to superior performance that exceeded the natural form of the hormone."
In 1996, the FDA-approved this "synthetic macromolecule" as a lifesaving, daily therapy for millions of patients. It proved to be a blockbuster drug for Eli Lilly.
The National Inventors Hall of Fame inducted DiMarchi in 2014 for the "molecular design" of Humalog. Significantly, "it established a precedent for optimizing proteins to create superior drugs than found in nature," said the NIHF.
DiMarchi didn't stop with Humalog.
"In extending our first commercial success, our chemistry evolved to more adventurous objectives," he said. "What would happen if we were to integrate multiple complementary hormones into a single medicine; could greater efficacy and safety be achieved?"
And DiMarchi was right on the money with the formula for yet another breakthrough.
Eli Lilly's blockbuster drug Mounjaro is a "first in class medicine" that works through two hormonal mechanisms, DiMarchi says. Those hormones are GLP-1 and GIP (glucose-dependent insulinotropic polypeptide). Mounjaro is the first medication in its class to simultaneously activate both the GLP-1 and GIP receptors. The drug is a huge winner for Eli Lilly.
DiMarchi didn't just toil in obscurity. DiMarchi won the 2023 Mani L. Bhaumik Breakthrough of The Year Award from the American Association for the Advancement of Science, which recognizes the GLP-1 drug class as "transforming the management of obesity and related chronic diseases."
"DiMarchi transformed thinking about the hormones this class of therapies should mimic as a critical part of their efficacy," said the AAAS in the April 2024 statement announcing the award, which also honored co-recipient Lotte Bjerre Knudsen, chief scientific advisor at Novo Nordisk
The ability to overcome the setbacks in pursuing his research drives DiMarchi's success as a discovery scientist and pioneering biotechnologist. DiMarchi knows how to prove naysayers wrong.
"I am an iconoclastic person, someone who is willing to challenge long held views to explore whether they are or are not correct," he said.
DiMarchi's leadership style drove his success as a groundbreaking researcher and innovator.
"My style is one of servant leadership, rolling up your sleeves," he said. "I'm very much involved in the nitty-gritty details of work. I view it important that I recruit those individuals who are similarly prepared, capable and motivated."
Keeping with his leadership style, DiMarchi says he decreased the scope of his role. That way "I could maintain my proficiency and the intimacy of association with the technical details and the scientists who are collaborating with me on the technical aspects of the work. I am more interested in achieving one discovery than I am in supervising large groups of people," he said.
DiMarchi also surrounds himself with people who "have the same pioneering spirit as mine. It takes people who have enormous conviction and self confidence that eventually we will succeed, as you spend more time proverbially in the valley of death than on the summit of success."
DiMarchi knows how to guide his team to achieve success.
"One key aspect of DiMarchi's leadership is his ability to identify the important goals and be focused on achieving them," said Diego Perez-Tilve, research associate professor, Department of Pharmacology, Physiology and Neurobiology at University of Cincinnati-College of Medicine.
Perez-Tilve collaborated with DiMarchi for 15 years. "He (DiMarchi) has a laser focus on the long-term achievement of a goal. He has the ability to see the forest beyond the trees. That's what gives people working with him confidence."
DiMarchi is also an entrepreneur and scholar. He co-earned more than 100 U.S. patents and coauthored more than 250 peer-reviewed scientific publications. DiMarchi cofounded eight successful biotech companies. One of those companies, MBX BioSciences (MBX), went public last year.
Students ask DiMarchi what they should do with their careers. His answer? "Be surrounded by people filled with optimism and have huge outrageous expectations for what is possible. If you can maintain this mission and follow a compass to true north with self-confidence, it's doable," he said.
Investor interest in companies with obesity candidates in their pipeline clearly remains high, given that a brand new Anglo-US start-up – Verdiva Bio – has just decloaked with a whopping $411 million in first-round financing.
The London and San Francisco-based company has emerged with a portfolio of oral and injectable treatments for obesity, cardiometabolic disorders, and related complications, headed by once-weekly oral GLP-1 and oral amylin therapies for weight loss and maintenance.
In the new biotech's sights are the current duopoly of Novo Nordisk and Eli Lilly, whose GLP-1 agonist-based therapies for obesity and diabetes are already raking in billions of dollars in sales, while dozens of other companies are hoping to capture a slice of a market that, according to IQVIA predictions, could reach a value of up to $131 billion by 2028.
Khurem Farooq, formerly chief executive of Aiolos Bio and Gyroscope Therapeutics prior to their respective acquisitions by GSK and Novartis, has been named as the CEO of Verdiva. He said its lead asset VRB-101, an oral GLP-1 peptide, "has the potential to be a first-in-class, once-weekly oral treatment for obesity and weight loss maintenance that could dramatically improve patient access and affordability."
VRB-101 – which has been licensed from Chinese biotech Sciwind – has already cleared a phase 1 trial that supported the viability of once-weekly dosing with the drug, as well as its ability to achieve weight loss, according to Verdiva.
The company's pipeline also includes two other candidates licensed from Sciwind, namely VRB-103, a once-weekly oral amylin agonist, and VRB-102, a long-acting, subcutaneous amylin agonist. Those candidates are in preclinical development and Verdiva plans to test them as monotherapies and in combination with oral and injectable GLP-1 drugs.
"People living with obesity and its complications deserve better options at each stage of their treatment journey," said Farooq, adding that those include "oral therapies with less frequent dosing regimens, the potential for improved efficacy and tolerability, and innovative combination therapies in pursuit of healthier weight loss and, equally importantly, maintenance of metabolically healthy weight."
Verdiva's senior management also includes chief scientific officer Jane Hughes, who worked with Farooq at Aioilos and Gyroscope and previously worked at GSK and Medimmune, and chief medical officer Mohamed Eid who joins Verdiva from Boehringer Ingelheim.
The Series A was co-led by Forbion and General Atlantic, with participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital.
https://pharmaphorum.com/news/verdiva-bio-raises-411m-obesity-pipeline
A new biotech start-up – Ouro Medicines – launched today with $120 million in funding from a Series A and a plan to develop bispecific antibody-based T-cell engager (TCE) therapies for autoimmune diseases.
Founded by Monograph Capital and GSK, the San Francisco–based company has entered the stage with one clinical-stage programme – a BCMA-directed, bispecific TCE licensed from China's Keymed Biosciences codenamed OM336 – and a following pipeline of drugs for chronic immune-mediated diseases.
OM336 is already in a phase 2 trial in China as a potential treatment for blood cancer multiple myeloma, relying on the use of the drug to attack malignant cells that express BCMA.
Starting later this year, Ouro intends to start a phase 1 clinical trial of its own, eyeing the development of the drug for immune diseases like systemic lupus erythematosus, scleroderma, rheumatoid arthritis, Sj̦gren's, and myositis Рwhich are driven by BCMA-expressing B-cells that can be depleted using the bispecific antibody.
The company said it has supportive proof of concept data from off-label use of BCMA-directed TCEs in these indications.
That approach – described by Ouro as an "immune reset" – could result in durable remissions in these autoimmune conditions without the need for ongoing immunosuppression using drugs that can have significant side effects, according to the company.
The company is led by Jaideep Dudani, a portfolio principal at Monograph who was also involved in the creation of Hi-Bio, another immune-focused biotech that was acquired by Biogen last year for $1.8 billion, $1.15 billion of that upfront.
TCEs have become a major focus of R&D in the biopharma sector because of their potential as cancer immunotherapies, revving up the immune system to fight tumours, but Ouro has joined a smaller but growing group seeking to harness them in the opposite direction.
"We see a tremendous opportunity to define the future of treatment for people with immune-mediated diseases because the standard of care today leaves a lot to be desired," said Dudani.
He is joined in an Ouro C-suite by chief medical officer Neely Mozaffarian – formerly of GentiBio and Atomwise, as well as pharma groups Johnson & Johnson, Gilead, Eli Lilly, and AbbVie – and chief development officer Kevin Baker, who previously held the same role at Pionyr Immunotherapeutics. Christina Carlson – another Hi-Bio veteran – has joined the start-up as chief administrative officer.
The Series A was co-led by TPG and Norwest Venture Partners, with participation from Monograph, GSK, UPMC Enterprises, Boyu/Zoo Capital, LongRiver Investments, and other unnamed investors.
https://pharmaphorum.com/news/ouro-makes-debut-120m-autoimmune-disease-tces
The 2024 presidential campaign that resulted in the re-election of Donald Trump was unique in many ways. One thing it demonstrated is the increased power that individual voices, first and foremost on social media, have in comparison to the actual “fourth power”, the news media.
And it’s not just mega influencers like Elon Musk or Joe Rogan, people with tens of millions of followers on social media, who shape the political views of many, especially young people these days, but also thousands of smaller-scale news influencers.
These are people with large social media followings, who regularly post about politics and current events but are, more often than not, unaffiliated with an actual news organization. As trust in news organization has eroded in recent years, news influencers have become more popular for those seeking independent voices outside the often-maligned “mainstream media”.
As Statista's Felix Richter shows in the chart below, according to a Pew Research Center report commissioned by the Pew-Knight Initiative, 21 percent of U.S. adults regularly get news from news influencers, with young adults significantly more likely to do so than older ones.
37 percent of 18 to 29- year-olds regularly get news from influencers versus just 15 percent of 50 to 64-year-olds and 7 percent of those aged 65 and above. While it would be easy to assume that people mostly seek out news influencers who’s views closely align with their own, that doesn’t necessarily appear to be the case. According to Pew’s findings, 61 percent of those wo regularly get opinions from news influencers say that they see opinions they agree and disagree with about equally. 30 percent see mostly opinions they agree with, while very few (2 percent) mostly see opinions from influencers they disagree with.
So why do people lean on news influencers to get informed? According to Pew, 65 percent of news influencer followers said that they helped them better understand current events and civic issues. More than 70 percent said that news influencers offered news that are extremely/very different (23 percent) or somewhat different (48 percent) from the news they get elsewhere.
And one final aspect is likely trust: while the news media has lost trust in recent years, influencers have it in abundance, often built through years of social media “relationships” with their followers. What they often lack compared to traditional news outlets is an actual journalistic background, meaning that the trust they enjoy from their followers may not always be backed up by their actual understanding of often complex matters.
As Statista's chart shows, X (formerly Twitter) is the most popular platform among news influencers, with 85 percent of the 500 sampled influencers active on the platform acquired by Elon Musk in 2022. Instagram, YouTube and Facebook are also very commonly used, while TikTok is surprisingly far down the list with only 27 percent of the sampled influencers active on the platform.
https://www.zerohedge.com/political/rise-news-influencers-and-where-they-can-be-found
