What Makes It Different

Unlike traditional probiotics, CLB101™ produces butyrate directly in the lower intestine. This beneficial compound strengthens the intestinal barrier, supports immune function, and promotes a diverse microbiome—all critical for gut health.

The strain, isolated from healthy humans, underwent rigorous safety testing including genomic characterization and multiple toxicology studies before receiving expert panel approval.

Market Launch

ClostraBio plans to launch CLB101™ as a supplement this fall through direct sales and partnerships, including a collaboration with a leading healthcare practitioner-focused brand.

“This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health,” said CEO Ritu Shah.

Spun out from the University of Chicago, ClostraBio’s first-to-market advantage with Anaerostipes caccae positions it well as consumers increasingly seek targeted, research-backed gut health solutions.

“Helping our members access non-dilutive funding is a core priority for iBIO,” says John Conrad, President & CEO of iBIO. “Through our partnership with G2G Consulting, we’re providing members with expert guidance and real-time intelligence on federal funding opportunities that can accelerate their innovations while preserving equity.”

Notable opportunities include DARPA’s HyBRIDS program exploring biohybrid platforms, ARPA-H’s EHI Initiative supporting early career investigators, and multiple NIH grants focused on cancer research. The report highlights substantial funding in AI/ML applications for psychiatric drug development and FDA’s PrecisionFDA GenAI Community Challenge.

Key focus areas receiving significant attention include:

• Cancer research (48 opportunities)
• Mental health initiatives (13 opportunities)
• Biomedical research (12 opportunities)
• AI & Machine Learning (10 opportunities)

Members can access detailed information through an upcoming webinar on January 16, 2025, featuring both open and premium sessions. Additionally, G2G will host a special webinar on January 22 focusing on the Military Health System Research Symposium, with abstract submissions due February 16.

The report also includes valuable recurring opportunities from major agencies including ARPA-H, BARDA, DARPA, and various military branches, offering diverse pathways for life sciences ventures to secure government funding while maintaining equity positions.​​​​​​​​​​​​​​​​

Download the January Report

The December 11, 2024 agreement marks a rare bright spot in the challenging landscape of antibiotic development. Since 2013, while the FDA has approved nine antibiotics from small companies, all but one of those developers have faced financial collapse, highlighting the stark reality of antimicrobial drug development.

“The licensing of XENLETA® bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance,” said Tom Shea, Meitheal’s CEO. XENLETA®, a first-in-class pleuromutilin antibiotic, offers new hope for treating community-acquired bacterial pneumonia (CABP), which affects five million Americans annually.

“Antimicrobial resistance represents one of the most serious public health threats of our time,” says John Conrad, President and CEO of iBIO. “We’re fortunate to have leading companies like Meitheal Pharmaceuticals in Illinois, taking bold steps to address this crisis through the development and commercialization of innovative antibiotics. Their work is not just crucial for public health—it’s vital for maintaining Illinois’ position as a hub for biotechnology innovation.”

The stakes couldn’t be higher. Without effective antibiotics, routine medical procedures—from C-sections to joint replacements—could become dangerously risky. Common infections could once again become life-threatening. This reality has sparked legislative action in the form of the bipartisan PASTEUR Act, which proposes a subscription-based model for antimicrobial medicines to incentivize new drug development.

For Illinois, successful antibiotic development could generate hundreds of jobs and strengthen the local economy. Meitheal’s acquisition of XENLETA® through Hong Kong King-Friend Industrial Co., Ltd. (HKF) demonstrates one approach to bringing new antibiotics to market, complementing their recent CONTEPO™ acquisition.

The World Health Organization estimates that only one in 30 antibiotics in development reaches patients. While the PASTEUR Act, supported by over 65 members of Congress including an Illinois’ Congressman Mike Quigley, could help reverse this trend, time is of the essence. Meitheal’s commitment to commercializing novel antibiotics like XENLETA® represents a crucial step forward in the fight against antimicrobial resistance, offering hope in an increasingly challenging healthcare landscape.​​​​​​​​​​​​​​​​

Unlike traditional AI drug discovery companies, Pathos AI focuses on identifying existing Phase 1 cancer drugs that could succeed with more targeted patient populations. The company uses artificial intelligence to determine which patients are most likely to respond to specific treatments.

“By leveraging AI to understand why some patients respond and others do not, we believe we can materially increase the probability of successful trials,” said Ryan Fukushima, Interim CEO of Pathos AI, who also serves as chief operating officer of Tempus.

The three-year-old company, founded by Tempus executives including CEO Eric Lefkofsky, has already acquired three clinical-stage drugs through deals with Prelude Therapeutics, Rain Oncology, and Novo Nordisk. Pathos AI plans to launch new clinical trials for these medicines in 2025.

The funding will support the expansion of the company’s scientific team and further development of its PathOS™ Platform, which uses AI to improve patient selection strategies and clinical trial design.

Aliada’s lead compound, ALIA-1758, is an antibody therapy currently in Phase 1 clinical trials. The drug targets pyroglutamate amyloid beta, a component of the brain plaques characteristic of Alzheimer’s disease. What makes ALIA-1758 particularly notable is its use of Aliada’s proprietary MODEL™ platform, which helps therapeutic compounds cross the blood-brain barrier more effectively.

“Many promising CNS-targeted therapies fail to reach late-stage trials due to their inability to cross the blood-brain barrier,” explained Dr. Michael Ryan, Aliada’s chief medical officer. “Our MODEL™ platform addresses this challenge directly.”

The technology works by targeting specific receptors (transferrin and CD98) that are abundant in brain blood vessel cells, potentially offering a more efficient way to deliver various types of drugs to the brain, including antibodies and genetic medicines.

Dr. Roopal Thakkar, AbbVie’s chief scientific officer, emphasized that neuroscience is a key growth area for the company. “This acquisition immediately positions us to advance ALIA-1758, a potentially best-in-class disease-modifying therapy for Alzheimer’s disease,” he said.

Aliada, founded in 2021 through investments from Johnson & Johnson, RA Capital Management, and other venture capital firms, has developed its technology based on research originally conducted at Johnson & Johnson.

The transaction is expected to close in the fourth quarter of 2024, subject to regulatory approvals and standard closing conditions.

“The introduction of novel products, like ORLYNVAH, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. The company anticipates a commercial launch around mid-2025.

The FDA’s decision was supported by data from two pivotal Phase 3 clinical trials – SURE 1 and REASSURE. The SURE 1 trial demonstrated superiority to ciprofloxacin in treating fluoroquinolone-resistant infections, while REASSURE showed both non-inferiority and statistical superiority to Augmentin™ in susceptible populations.

UTIs represent a significant health burden, affecting up to 60% of women during their lifetime, with 40% experiencing recurrent infections. Approximately 40 million uUTI prescriptions are generated annually in the United States, with an estimated 1% of these infections caused by pathogens resistant to commonly available oral antibiotics.

The approval comes despite concerns raised during an FDA advisory committee meeting last month regarding potential off-label use and antimicrobial resistance risks. The committee specifically discussed the implications of making a carbapenem-class antibiotic available in an outpatient setting for the first time.

With the FDA approval secured, Iterum plans to pursue strategic partnerships for commercialization. The company has indicated it is actively seeking to sell or license the rights to the treatment, with CEO Fishman noting that mid-size to large pharmaceutical companies with existing prescriber relationships would be ideal partners.

The development marks an important addition to the limited arsenal of treatments for antibiotic-resistant UTIs, following the April 2024 approval of Utility Therapeutics’ Pivya (pivmecillinam), which ended a two-decade drought in new uUTI treatments.

Dr. Marjorie Golden, Site Chief of Infectious Disease at St. Raphael Campus Yale New Haven Hospital, welcomed the approval, stating, “ORLYNVAH has the potential to be an important treatment alternative for use in the community.”

The company will host a conference call on Monday, October 28, 2024, to discuss its commercialization strategy and next steps for bringing this novel antibiotic to market.

Press release from Iterum Therapeutics

The Illinois expansion includes:

• A massive 545,000-square-foot addition to PCI’s existing Rockford facility
• 345,000 square feet dedicated to advanced injectable packaging
• 130,000 square feet of new warehouse space
• Over 20 customer suites for various development phases
• Cutting-edge technology for assembling and packaging vials, prefilled syringes, and autoinjectors
• An additional 70,000 square feet for “patient-centric” drug-device combinations, including on-body injectors

PCI plans to bring the Rockford expansion online in two phases, with initial operations slated to begin in the third quarter of 2025. This substantial investment in Illinois underscores the state’s growing importance in the pharmaceutical manufacturing landscape.

The company cited recent new business as the driving force behind this expansion, positioning Rockford to capitalize on growth opportunities in the injectable drug delivery market. PCI’s focus on advanced drug-device combination products aligns with industry trends toward more sophisticated and patient-friendly delivery systems.

While the Illinois project takes center stage, PCI is also expanding its footprint internationally:

• Upgrading drug delivery technology at its Philadelphia headquarters
• Acquiring a packaging and device assembly plant near Dublin, Ireland
• Breaking ground on a new facility at its CityNorth Dublin campus

These global investments complement the Rockford expansion, strengthening PCI’s position as a leading CDMO with a significant presence in the American Midwest.

The Rockford project follows a $50 million expansion at the same site announced last spring, highlighting PCI’s continued commitment to growing its Illinois operations. As the pharmaceutical industry evolves, Rockford is poised to become a key hub for advanced drug delivery manufacturing, bringing potential economic benefits and job opportunities to the region.

Chicago Becomes U.S. Base for Global Rare Disease Company

On September 9th, Immedica revealed plans to establish its U.S. headquarters in Chicago. The new entity, Immedica Pharma US Inc., will spearhead the company’s efforts to introduce innovative therapies for rare and severe diseases in North America.

CEO Anders Edvell emphasized the strategic importance of this move, stating, “This expansion into the U.S. is a pivotal moment for Immedica as we continue our mission to deliver life-changing therapies to people living with rare diseases.”

Joe Whalen Joins Immedica’s Business Development Team

In a further boost to its U.S. operations, Immedica announced today (September 24, 2024) that Joe Whalen, formerly of Horizon Therapeutics, has joined its business development team.

Whalen brings over a decade of experience from Horizon, where he played a crucial role in the company’s growth from a 20-employee startup to a pharmaceutical giant with $3.6 billion in net sales. Most recently, he served as Senior Vice President of Alliances & Business Development at Amgen, overseeing Horizon’s integration following its $28 billion acquisition in 2023.

At Immedica, Whalen will focus on business development initiatives primarily in the U.S., working part-time under a consultancy agreement from the Chicago area. He will report directly to Immedica’s Head of Business Development.

Anders Edvell expressed enthusiasm about the new addition, saying, “Joe’s vast industry knowledge and successful track record in strategic deal-making will be key as we continue to drive growth and expand Immedica’s footprint in the rare disease and specialty care sectors.”

These developments underscore Immedica’s commitment to becoming a global leader in the rare disease sector and signal an exciting new chapter for the company’s U.S. operations.

Read the press release

Syntax Bio’s technology mimics human developmental processes at the epigenetic level, using a modified CRISPR system to regulate gene expression. This innovative method aims to streamline cell differentiation, potentially reducing costs and increasing accessibility of cell therapies.

Co-founded by Dr. Ryan Clarke and Professor Brad Merrill from the University of Illinois at Chicago, Syntax Bio’s platform has attracted attention for its potential to overcome longstanding challenges in stem-cell-derived therapies. The company’s approach significantly accelerates the generation of high-value cell types, a crucial factor in advancing cell therapy treatments.

Industry leaders have expressed enthusiasm for Syntax Bio’s potential. William Watt, President of Astellas Venture Management LLC, highlighted the technology’s promise in addressing manufacturing challenges, while Ron Mazumder of Illumina Ventures praised its potential to democratize the cell therapy industry.

As Syntax Bio moves forward in the preclinical stage, the biotechnology community will be watching closely to see how this innovative platform could reshape the future of cell therapy.

Read the press release on Business Wire

Addressing the Chronic Disease Challenge

Despite advancements in medical research and care, chronic diseases continue to pose a significant challenge to public health. While modern medicine has successfully extended human lifespan, it has not necessarily improved health-span. This disparity is partly attributed to a focus on treating illness rather than emphasizing preventive health. Moreover, scientists have identified modern dietary habits and widespread antibiotic use as factors disrupting the gut microbiome, an often overlooked yet crucial component of overall health.

The Gut Microbiome: The Sixth Vital Organ

The gut microbiome is increasingly recognized as a vital component of human health, sometimes referred to as the “sixth vital organ.” Dysbiosis, or disruption of this intricate system, can lead to systemic inflammation, increased infection risk, and a range of chronic diseases. Despite its importance, there are currently no universally standardized measures for assessing the functional health of the gut microbiome.

32 Biosciences’ Innovative Platform

To address this critical need, 32 Biosciences has developed a suite of gut microbiome platform technologies. Key among these is GB-0001, an advanced diagnostic management tool designed to provide a standardized measure of functional gut microbiome health. If approved, GB-0001 could have a direct impact on clinical decision-making, enabling healthcare professionals to monitor gut health while modifying medication and nutrition regimens to restore microbiome health.

In addition to GB-0001, the company is developing CS-0003, a lead therapeutic asset intended to target virulent gene expression while promoting the growth of beneficial bacteria. 32 Biosciences also plans to introduce science-based nutritional products aimed at restoring and maintaining functional gut microbiome health.

A New Approach to Medicine

Peter Farmakis, CEO of 32 Biosciences, emphasized the company’s innovative approach: “We are pioneering a new approach to medicine by leveraging our advanced microbiome scientific research to create clinically validated physician management tools for diagnosing and addressing dysbiosis—an important factor in the development of many diseases.”

The company’s strategy is twofold: to better serve patients who currently have limited FDA-approved options and to create significant financial value by addressing high unmet needs in large economic markets.

Scientific Foundations and Partnerships

32 Biosciences’ approach is built on research by scientific co-founders John Alverdy, MD, and Eugene Chang, MD, from The University of Chicago, and Joseph Pierre, PhD, from the University of Wisconsin-Madison. Their innovative microbiome research and development have been supported by an impressive $119 million in National Institutes of Health (NIH) grants.

The company has also forged strategic partnerships, collaborating with The University of Chicago Duchossois Family Institute to produce GB-0001 and The University of Chicago Pritzker School of Molecular Engineering to develop CS-0003 technologies.

Looking Ahead

As 32 Biosciences steps into the spotlight, it brings with it the promise of a new era in gut microbiome medicine. By focusing on the critical role of the gut microbiome in overall well-being, the company aims to enhance health-span and revolutionize our approach to chronic disease prevention and treatment.

With its innovative technologies and strong scientific foundation, 32 Biosciences is poised to make a significant impact on the healthcare landscape, potentially offering new hope to millions of patients worldwide.

Read the press release