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Today's Rundown

Featured Story

Numab raises $111M to challenge Genmab, BioNTech for emerging PD-L1 opportunity

Numab Therapeutics has raised CHF 100 million ($111 million) to expand clinical development of its lead PD-L1x4-1BB drug candidate into multiple cancer indications. Novo Ventures and HBM Partners co-lead the series C round with assists from investors on both sides of the Atlantic.

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Top Stories

Iovance CEO Fardis makes a stealthy exit following FDA setback for lead drug lifileucel

Iovance Biotherapeutics CEO Maria Fardis will exit the company after the company said on Tuesday that the FDA requested more potency assay data for lifileucel, its lead candidate.

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ASCO: Bristol Myers, leading the LAG-3 pack, posts phase 3 melanoma data for Opdivo-boosting relatlimab

Bristol Myers Squibb is no stranger to mixing checkpoint inhibitors—see the many indications in development for the combination of Opdivo and Yervoy. Now, the drugmaker is one step closer to offering a new checkpoint inhibitor cocktail for the treatment of advanced melanoma, with the first phase 3 data for a LAG-3 antibody in tandem with the PD-1 blocker Opdivo. 

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Lilly’s tirzepatide aces fifth phase 3, teeing up approval filings

Eli Lilly has completed a fifth global registration study of tirzepatide, teeing it up to seek approval of the dual GIP/GLP-1 agonist by the end of the year. All three doses of tirzepatide bettered the blood glucose reduction and weight loss seen in the insulin glargine arm of the latest phase 3 trial.

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Bon voyage: Voyager Therapeutics’ CEO, R&D chief exit as beleaguered biotech looks to the future

Battered and bruised by a tough journey, the Voyager 1 space probe is exiting our Solar System into worlds unknown; now, those running its earthly biotech namesake are taking a similar same path.

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Haya Therapeutics shouts 'hiya!' as it emerges from stealth with seed funding

Haya Therapeutics, a Swiss precision medicine biotech, came out of stealth today with nearly $20 million in seed funding for anti-fibrotic therapies targeting emerging field of long non-coding RNAs

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ASCO: Merck's LAG-3 antibody boosts Keytruda in hard-to-treat colon cancer

PD-1 inhibitors work well in about one-fifth of patients with colorectal cancer, but the other 80% are not so lucky. Their tumors are immunologically “cold,” meaning they don’t respond to immunotherapies like Merck’s Keytruda. Enter favezelimab, Merck’s LAG-3-targeting antibody, which helped Keytruda make a dent in metastatic colorectal cancer in very sick patients in a phase 1 study.

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ASCO: Adaptimmune’s cell therapy shrinks 39% of rare sarcomas

CAR-T and other cell therapies have seen success in blood cancers but have shown limited effect in solid tumors. Adaptimmune is taking an engineered T-cell receptor approach to change that and its first phase 2 data, from patients with rare soft-tissue sarcomas, look promising. The MAGE-A4-targeting treatment, afamitresgene autolecel, shrank tumors in 39.3% of the patients.

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Exscientia scores $50M upfront from Bristol Myers—and up to $1.2B total—in AI drug discovery deal

Where there’s smoke there’s fire, and hot on the heels of closing more than a half-billion dollars in venture capital funding, Exscientia announced a drug discovery deal with Bristol Myers Squibb that could pay out up to $1.2 billion or more. The contract starts with $50 million upfront, plus $125 million for near-term successes, before milestones escalate into the 10-figure range.

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Gauging disease risk by studying the gut microbiome's genetic features

Recent research suggests that microorganisms living in the human gut may play a role in diseases ranging from obesity to cancer. A team at Harvard Medical School has gone one step further, linking the microbiome’s genetic features to multiple diseases.

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ASCO: Targeted metabolic inhibitor stabilizes solid tumors in 60% of patients in phase 1

Researchers at the University of Texas MD Anderson Cancer Center led the development of a GLS1 inhibitor that is now showing promise in patients with a variety of solid tumor types. Among the patients who had the longest responses in a phase 1 study were people with ovarian cancer and melanoma that was resistant to checkpoint inhibitors.

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Resources

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

Whitepaper: The Journey to a Global Modular Content Strategy

One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster.

E-Book: 7 Keys to Success in Europe

This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe.

Executive Brief: Seven Secrets to Patient Experience Breakthroughs: Improving the Patient Experience and Study Retention

The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients.

Article: Make the right move at every step of the drug commercialization process

Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Whitepaper: Roche to pick up GenMark Diagnostics in $1.8B infectious disease testing deal

Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously.

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

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