Hello Avatar! Another week of biotech news is in the history books. We are proud to bring you the latest edition of Sweat Equity, our weekly biotech news fix. The content is designed to be consumed as a quick scroll to bring readers up to speed on key events from the week. For those of you interested to read a bit more, we provide links to the source articles.
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BIOTECH NEWS UPDATES FOR THE WEEK 4/22
The Challenges Biopharma Companies Face in Hiring Candidates Who Need Visas
According to two recruitment experts, some biopharma companies are hesitant to hire professionals who require visas due to their unfamiliarity with the visa process. Smaller or newer companies are less likely to hire these candidates, while larger employers like Pfizer, Johnson & Johnson, and Amgen are more likely to understand and navigate the visa process effectively. The cost of visa sponsorship, although a potential concern, is not the primary reason for reluctance, as the time and anxiety associated with the approval process often outweigh cost considerations. Another factor is the preference for local candidates, as hiring individuals who are already in the country allows for quicker onboarding. However, by avoiding candidates who need visas, companies miss out on a wider pool of talent, greater workforce diversity, and committed employees who are grateful for sponsorship opportunities.
Moderna Revolutionizes Employee Workflow with AI Chatbots in Partnership with OpenAI
Moderna has announced an expanded partnership with OpenAI to provide custom-built AI chatbots to its employees. The biotechnology company hopes that these tailored versions of OpenAI's ChatGPT tool will boost productivity as it works to develop 15 new vaccine and drug products over the next five years. Already, Moderna employees have created over 750 "GPTs" (Generative Pre-trained Transformers) to assist with various tasks, such as selecting vaccine doses for testing and scanning contracts. The new agreement allows employees to build their own GPTs for specific purposes. For instance, a pilot tool called Dose ID is designed to verify vaccine doses selected by Moderna's clinical study team. Moderna aims to have all of its employees using GPTs in their regular work processes. The partnership with OpenAI follows a broader trend of biotech companies using AI tools like large language models to enhance their operations.
Biogen's Zurzuvae Surpasses Sales Expectations, Shows 'Encouraging' Trends for Postpartum Depression Drug
Biogen has reported "encouraging early trends" for its postpartum depression pill Zurzuvae, with sales reaching $12 million in the first quarter of 2024, surpassing analyst estimates. The drug, discovered by Biogen's partner Sage Therapeutics and approved by the FDA last August, is the only pill specifically meant to treat postpartum depression. However, the number of prescriptions filled for Zurzuvae was not disclosed, making it difficult to track demand. Despite this uncertainty, the launch of Zurzuvae has shown promising signs, as more prescribers are recommending it and women are able to access and get insurance coverage for the drug more quickly. Zurzuvae is a pill that can be shipped to a person's home and is taken daily for two weeks, making it more convenient than the infused drug Zulresso. While some analysts remain skeptical, the market potential for postpartum depression drugs is estimated to be around $500 million, and sales could continue to grow if positive trends persist.
Insurers Drop Humira Coverage, Leading to Surge in Biosimilar Sales | BioSpace
According to a recent article on BioSpace, biosimilar sales have been increasing as insurers start to drop coverage for AbbVie's flagship drug, Humira. Here are some highlights from the article:
• AbbVie has maintained its majority market share among biologics for rheumatoid arthritis, despite the loss of exclusivity for Humira.
• Insurers have started changing their coverage policies, resulting in a surge in prescriptions for Humira biosimilars, especially Sandoz's Hyrimoz.
• Hyrimoz is seen as one of the main competitors to Humira and has seen significant growth due to formulary changes by CVS Caremark.
• AbbVie has only lost 4% of the market to biosimilars so far, but analysts predict that estimates will be lowered as existing Humira biosimilars capture more market share.
• AbbVie has made strategic acquisitions to offset the impact of Humira's loss of exclusivity, including the acquisition of ImmunoGen and Cerevel Therapeutics.
• Analysts are waiting to see how the addition of other biosimilars impacts sales, but expect estimates to be lowered in late 2024 and into 2025.
• The article also discusses the factors that could affect the success of biosimilar drugs and which ones may rise to the top.
Biogen Foregoes Large Acquisitions, Shifts Focus to Collaborations and Early-Stage Assets
Biogen, a biotechnology company, has indicated that it does not plan on making any large acquisitions this year. CEO Chris Viehbacher stated that while the company is eager to diversify beyond neuroscience, any dealmaking in the near-term would likely focus on collaborations and early-stage assets. Some key points from the article include:
• Biogen had close to $1.1 billion in cash and cash equivalents and records around $3 billion in income before taxes, interest, and depreciation as of March 31.
• The company is more focused on collaborations, licensing agreements, or deals for early-stage drugs, rather than full company acquisitions.
• Biogen's CEO, Chris Viehbacher, has emphasized the need for the company to expand its research efforts beyond the brain and nervous system drugs that make up most of its pipeline.
• Biogen sees rare diseases and immune system disorders as areas worthy of investment and recently made its largest deal in dollar terms, acquiring Reata Pharmaceuticals for $7.3 billion.
• The company sold a regulatory fast pass asset for $103 million and intends to put the proceeds toward business development.
Overall, Biogen is looking to grow through collaborations and partnerships rather than large acquisitions, as it seeks to diversify its pipeline beyond neuroscience.
BMS-Cellares Collaboration Spotlights Rising U.S.-China Biopharma Tensions in the Industry
The recent collaboration between Bristol Myers Squibb (BMS) and Cellares to secure capacity for producing CAR T cell therapies is not only about securing supply chain diversification but also reflects the geopolitical tensions between the U.S. and China in the biopharmaceutical industry. The $380 million agreement will have Cellares dedicating its manufacturing platform, Cell Shuttle, to facilities in the U.S., Japan, and the European Union exclusively for BMS's use. This move towards diversification is likely in response to the proposed BIOSECURE Act, which aims to distance U.S. biomedical R&D from Chinese companies that pose a national security risk. Cellares CEO Fabian Gerlinghaus believes the company's U.S.-based status is a strength in the current geopolitical climate. However, both BMS and Cellares have not explicitly commented on China's involvement in this collaboration. Overall, tensions between the U.S. and China in the biopharmaceutical industry have been building, and companies are now faced with the need to navigate these geopolitical risks.
Pharmas Partner to Revitalize Japanese Drug Research and Innovation
Three large Japanese firms, Takeda Pharmaceutical, Astellas Pharma, and Sumitomo Mitsui Banking, have formed a joint venture to boost drug research in Japan and address the decline in the development of innovative medicines in the country. The joint venture will incubate early drug discovery programs primarily from Japan and turn them into new therapies. Takeda and Astellas will each own 33.4% of the shares, while Sumitomo will hold the remaining 33.2%. The venture will be led by Toshio Fujimoto, a pharmaceutical veteran, and will be located at Shohan Health Innovation Park. The joint venture aims to advance academic research in Japan and help support the formation of startup companies around it. Japan has struggled in recent years to produce new drugs and startup companies, with a decline in clinical trial starts and new medicines launched.
Boehringer Ingelheim Signs $1.3B Collaboration Deal with Ochre Bio to Fight MASH Disease
Boehringer Ingelheim, a German drugmaker, has signed a $1.3 billion deal with British biotech Ochre Bio to collaborate on the development of treatments for metabolic-associated steatohepatitis (MASH), also known as nonalcoholic steatohepatitis (NASH). Boehringer will pay Ochre $35 million upfront, as well as milestone payments, royalties, and commercial milestones, if any of the targets prove successful. Ochre is focused on developing RNA therapies that enhance the regenerative capabilities of the liver to treat chronic liver diseases. Boehringer has previously made similar bets on RNA therapies, including partnerships with other biotechs and partnerships to target disease-causing genes in the liver. Boehringer's partnership with Ochre Bio is aimed at accelerating the development of new treatments for chronic liver diseases. Boehringer has already seen success in the MASH space this year with a phase 2 trial of its glucagon/GLP-1 agonist survodutide in February.
AstraZeneca's Cancer Drugs Drive Surprising Earnings Growth, Impressing Investors
AstraZeneca's revenue and profits exceeded Wall Street expectations in the first quarter of the year, driven by the success of its cancer drugs. The company reported a 17% increase in total revenue to $12.7 billion and a 22% jump in operating profit to $3.1 billion compared to the same period last year. The revenue and profit figures surpassed consensus forecasts by 7%. The strong earnings indicate a recovery from the previous quarter when AstraZeneca missed profit estimates. The company's oncology division, led by lung cancer drug Tagrisso and immunotherapy Imfinzi, accounted for $5.1 billion in sales, an increase of 23% year over year. AstraZeneca's focus on oncology and rare diseases, as well as strategic acquisitions, has contributed to its growth. Investors are now looking to the company's pipeline to determine future growth potential. AstraZeneca will host a research and development event on May 21 to showcase its pipeline.
Bristol Myers to Implement Workforce Reduction and Streamline Drug Pipeline to Ensure Long-Term Growth
Bristol Myers Squibb has announced plans to cut 6% of its workforce, impacting around 2,200 employees, as part of a restructuring effort to save $1.5 billion by the end of next year. The company also plans to trim its drug pipeline and consolidate its offices and laboratories. The restructuring is aimed at strengthening the company's long-term growth profile, according to CEO Christopher Boerner. Bristol Myers is facing patent expirations for its top-selling products, Eliquis and Opdivo, which will impact its near-term growth. The company has been acquiring other companies, such as Karuna Therapeutics, RayzeBio, and Mirati Therapeutics, to bolster its business in preparation for these losses. The restructure will prioritize products with the highest potential, and two-thirds of the cost savings will come from reducing research and development spending. Bristol Myers' shares fell by almost 8% following the announcement.
Mastering Emotional Intelligence: How to Handle Difficult Bosses and Thrive in the Workplace
This webpage discusses the different types of difficult bosses and provides strategies for dealing with them. The author, Travis Bradberry, an emotional intelligence expert, emphasizes the importance of using emotional intelligence to manage relationships with difficult bosses.
• Bradberry identifies seven types of difficult bosses: the tyrant, the micromanager, the inappropriate buddy, the incompetent, the robot, the seagull, and the visionary.
• To deal with a tyrant, present ideas in a way that allows them to take partial credit and choose battles wisely.
• To neutralize a micromanager, be flexible, competent, and disciplined while staying in constant communication.
• To set boundaries with an inappropriate buddy, refuse invitations to socialize outside of work while remaining friendly during work hours.
• To deal with an incompetent boss, share your experience and knowledge without being condescending to become their ally and confidant.
• To interact with a robot boss, speak their language by using data to support ideas and performance.
• A group approach is effective in addressing a seagull boss, where the entire team provides constructive feedback on their problem-solving style.
• To neutralize a visionary boss, ask specific questions to help them realistically implement their ideas.
Bradberry advises that understanding the type of boss you have can shift your perspective and change your behavior in a way that is less stressful and more effective.
Regeneron Pharmaceuticals and Mammoth Biosciences Join Forces in $100M Gene Editing Deal
Regeneron Pharmaceuticals has signed a major gene editing deal with Mammoth Biosciences. The partnership will focus on in vivo CRISPR-based gene editing therapies, with an upfront payment of $100 million and potential milestone payments of $370 million per target. Regeneron will contribute its adeno-associated viral vectors (AAVs) for delivering genetic medicine payloads, while Mammoth will provide its ultracompact nucleases and gene editing systems. The upfront payment will include $95 million in equity. Under the agreement, Mammoth will also receive royalties and milestone payments, and will have the option to co-fund and share profits on the collaboration's programs. Regeneron will gain access to Mammoth's editing technology, with the possibility of extending the deal for another two years. This is Regeneron's second major gene editing deal, alongside its collaboration with Intellia Therapeutics.
Xaira Therapeutics Secures $1 Billion Funding to Revolutionize Drug Discovery with AI Technology
Xaira Therapeutics, an AI-driven drug discovery biotech, has secured $1 billion in funding from investors including Arch Venture Partners, Foresite Labs, F-Prime, NEA, Sequoia Capital, Lux Capital, and Lightspeed Venture Partners. The company, founded by David Baker at the University of Washington School of Medicine, aims to combine machine learning, data generation, and therapeutic product development to build a platform for drug discovery. Xaira will develop new ways to connect biological targets and engineered molecules to human diseases using protein and antibody design models developed by Baker's lab. The company will also incorporate technologies and personnel from Illumina's functional genomics R&D effort and a proteomics group from Interline Therapeutics. Former Genentech chief scientific officer Marc Tessier-Lavigne will serve as the CEO of Xaira. The board of the company will include industry veterans such as former FDA Commissioner Scott Gottlieb and Nobel laureate Carolyn Bertozzi.
Day One's Ojemda Receives FDA Accelerated Approval for Pediatric Brain Tumor Treatment
Day One Biopharmaceuticals has received accelerated approval from the FDA for its drug, Ojemda, for the treatment of relapsed or refractory pediatric low-grade glioma. Ojemda is an oral kinase inhibitor that is indicated for patients with confirmed BRAF fusion or rearrangement alterations, or a BRAF V600 mutation. The drug is available in tablet and oral suspension formulations and should be dosed once a week. The continued approval of Ojemda depends on the verification of its clinical benefit in a confirmatory study. To fulfill this requirement, Day One is running the Phase III FIREFLY-2/LOGGIC trial, a randomized study comparing Ojemda versus chemotherapy for pediatric low-grade glioma. Ojemda is the first FDA-approved medicine for children with BRAF fusions or rearrangements and is the only systemic treatment option for pediatric low-grade glioma that allows for a once-weekly treatment schedule. The drug works by disrupting tumor cells' growth and proliferation.
• Day One Biopharmaceuticals receives FDA accelerated approval for Ojemda for pediatric low-grade glioma
• Ojemda is indicated for patients with confirmed BRAF fusion or rearrangement alterations, or BRAF V600 mutation
• Ojemda is a once-weekly treatment option for pediatric low-grade glioma
• Continued approval of Ojemda depends on verification of clinical benefit in a confirmatory study
• Ojemda disrupts tumor cells' growth and proliferation by binding to a key player in the MAPK signaling cascade
ImmunityBio Secures FDA Approval for Groundbreaking IL-15 Superagonist to Treat NMIBC
ImmunityBio has received FDA approval for the IL-15 superagonist nogapendekin alfa, which will be marketed under the brand name Anktiva, for the treatment of non-muscle invasive bladder cancer (NMIBC). The approval allows for the use of Anktiva with Bacillus Calmette-Guérin (BCG) in BCG-unresponsive patients with carcinoma in situ. Anktiva can be used in NMIBC patients with or without papillary tumors, as approximately 80% of new bladder cancer diagnoses are NMIBC. ImmunityBio plans to make Anktiva available in the US by mid-May 2024. The approval was based on data from the Phase II/III QUILT-3.032 study, which showed a 62% complete response rate in patients receiving Anktiva and BCG, with a duration of response exceeding 47 months. Anktiva is a therapeutic fusion protein that stimulates the immune system and activates various types of cells to target bladder cancer cells.
Bristol Myers Partners with Startup to Enhance Cell Therapy Manufacturing for Cancer Treatments
Pharmaceutical company Bristol Myers Squibb has announced a partnership with startup Cellares to enhance the manufacturing of CAR-T cell therapies for cancer. The deal, worth up to $380 million, will involve Cellares transferring the technology for certain Bristol Myers cell therapies to its automated manufacturing platform called the Cell Shuttle. The partnership aims to increase the scale and speed of production for CAR-T therapies to meet growing demand. CAR-T therapies are personalized treatments made from a patient's own immune cells and are currently time-consuming and costly to produce. Cellares' Cell Shuttle platform is designed to automate and streamline the manufacturing process, reducing failure rates and production costs. As part of the agreement, Cellares will dedicate multiple Cell Shuttles to Bristol Myers and house them in facilities in the US, Europe, and Japan.
Neurocrine's Depression Drug Achieves Surprising Success in Clinical Trial
Neurocrine Biosciences has seen a surprise win with its experimental depression drug, causing its stock to rise by 5%. The drug hit the main goal and key secondary endpoints in a mid-stage study focused on major depressive disorder. The company's chief medical officer, Eiry Roberts, commented that the data is "very encouraging" and reflective of the drug's potential to alleviate symptoms of depression. The study showed that patients given the drug experienced significant changes in depression symptom scores compared to those on a placebo. Neurocrine plans to meet with the FDA to discuss the next steps for late-stage testing. Some highlights from the article include:
• The drug hit the Phase 2 trial's main goal and key secondary endpoints
• Patients on the drug experienced a significant decrease in depression symptom scores compared to the placebo arm
• The drug is designed to amplify a protein involved in the transmission of glutamate, a chemical found at lower levels in people with depression
• Neurocrine's stock rose by approximately 5% following the positive results from the study
UW Researchers Harness AI to Revolutionize Drug Discovery with Novel Drug-Like Peptides
Researchers at the University of Washington's Institute for Protein Design have developed AI algorithms that can create new drug-like peptides. Peptides are chains of amino acids that are smaller than proteins but can still have potent effects on the human body. The researchers used their AI programs to construct ring-shaped peptides known as macrocycles, which have the potential to disrupt pain signals, interfere with viral infections, and inhibit tumor growth. The AI algorithms were able to systematically generate and manufacture small macrocycles with four or fewer amino acids. These macrocycles were able to cross cell membranes and survive degradation processes in preclinical experiments. The researchers believe that their work demonstrates the potential for using computational design to explore new classes of chemicals for drug discovery. The study was published in the journal Science and the technology has been licensed by a UW spinout company called Vilya Therapeutics.
Endeavor Biomedicines Raises $132.5M in Series C Funding for Fibrosis Drug Development
Endeavor BioMedicines, a clinical-stage biotech company focusing on fibrosis, has raised $132.5 million in a series C funding round. The funding will extend the company's cash runway through 2026 as it advances its two-asset pipeline, with a specific focus on developing a midstage drug for idiopathic pulmonary fibrosis (IPF). The round included new investors such as AyurMaya, Fidelity, and Invus, among others. Endeavor had initially aimed to raise between $75 million and $100 million but demand was high and up to $250 million was on the table. The raised funds will also support the clinical testing of Endeavor's second asset, an HER-3-targeting antibody-drug conjugate acquired from Hummingbird Bioscience. The company plans to launch a phase 2b trial for ENV-101, their lead asset, and a phase 1/2 trial for the HER-3 ADC in the near future. Endeavor is also open to adding additional assets to its pipeline if they have a significant impact on fibrosis treatment.
CONCLUSION
There you have it, another week of SWEAT EQUITY - Your Weekly Biotech News Fix. We hope you enjoyed it, please drop a comment with any feedback you may have.
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