EXUMA Biotech to Present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

On September 22, 2021 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies and delivery solutions for liquid and solid tumors, reported that Chairman and Chief Executive Officer, Gregory Frost, Ph.D., will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29th, 2021, from 2:40-3:10 p.m. ET (Press release, EXUMA Biotechnology, SEP 22, 2021, View Source [SID1234590125]).

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Investors and the general public are invited to listen to a live webcast of the session at View Source

An archived edition of the session will be available at exumabio.com for at least 30 days following the event.

Paige Receives First Ever FDA Approval for AI Product in Digital Pathology

On September 22, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported that the U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Paige Prostate, a clinical-grade AI solution for prostate cancer detection (Press release, Paige AI, SEP 22, 2021, View Source [SID1234590124]). As a novel technology, Paige Prostate is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic (IVD) use via Paige’s FDA-cleared FullFocus digital pathology viewer.

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With a projected 60 percent increase in the number of cancer cases globally in the next two decades and a decrease in the number of pathologists relative to this diagnostic demand, there is a significant need to provide new technologies for the practice of pathology. Paige Prostate is a cancer detection solution that identifies foci suspicious for cancer and provides this information to the pathologist. Paige Prostate is designed to assist pathologists in finding small foci of cancer and enable pathologists to work efficiently and confidently in their diagnostic process.

"This landmark approval of Paige Prostate by the FDA marks the beginning of a new era in the use of computer-assisted diagnostics for pathology. The approval reflects the rigor with which Paige Prostate has been validated, as the first clinical-grade AI technology to assist pathologists in the interpretation of routinely stained slides. This innovation paves the way for the introduction of numerous future tools to help standardize pathology diagnosis, expedite the diagnostic process, and provide pathologists and patients greater comfort from the added scrutiny of their pathology slides," said David Klimstra, M.D., Co-Founder and Chief Medical Officer at Paige. "FDA approval allows pathology laboratories to introduce this diagnostic tool into their clinical workflow to help make pathologists more accurate, more reproducible, and more efficient, which will allow them to focus their attention on the most critical aspects of establishing the diagnosis."

"This achievement is the culmination of more than a decade of work and a testament to the dedication of Paige and our collaborators in developing clinical-grade AI that will transform the practice of pathology," said Thomas J. Fuchs, Dr.Sc., Co-Founder and Chief Scientist at Paige, and Dean of Artificial Intelligence and Human Health at Mount Sinai.

In the clinical study submitted to the FDA, pathologists using Paige Prostate were shown to increase over 7 percentage points in sensitivity in correctly diagnosing cancer (from 89.5% to 96.8%). Pathologists using Paige Prostate had a 70% reduction in false negative diagnoses and a 24% reduction in false positive diagnoses. This improvement was independent of diagnostic sub-specialization or years of experience of the pathologists and whether the analysis was done remotely or on-site. Furthermore, the study showed that non-specialist pathologists using Paige Prostate were as accurate as prostate specialists who were not using the software. The dataset included slides from over 150 institutions to ensure the system generalized to cases from different hospitals and different geographies. This dataset represented a broad range of natural variations encountered in day-to-day clinical practice and Paige Prostate was used across this entire dataset without modification or the need for calibration. The company plans to submit the full data for publication in a peer-reviewed journal.

"The approval is a landmark achievement in the field of digital pathology and demonstrates how robust our technology is when faced with the broad range of natural variations in tissue slides encountered in day-to-day clinical practice," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "We are grateful for everyone at Paige and our clinical partners who have brought this new generation of computational pathology products to reality."

Paige Prostate is now available for diagnostic use in the U.S. For more information about Paige Prostate, visit View Source or contact [email protected].

Outside of the U.S., Paige Prostate is CE-marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.

Viewpoint Molecular Targeting® Announces Publication of Preclinical Data of VMT01 in Peer-Reviewed Journal, “Cancers”

On September 22, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the publication of VMT01 preclinical data in an article titled, Targeted Alpha-Particle Radiotherapy and Immune Checkpoint Inhibitors Induces Cooperative Inhibition on Tumor Growth of Malignant Melanoma1 in the peer-reviewed journal Cancers (Press release, Viewpoint Molecular Targeting, SEP 22, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-announces-publication-of-preclinical-data-of-vmt01-in-peer-reviewed-journal-cancers/ [SID1234590123]).

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VMT01 is Viewpoint’s specialized peptide designed to target the melanocortin 1 receptor (MC1R) on tumor cells. The results from preclinical studies indicate that MC1R-targeted therapies, such as peptide receptor radionuclide therapies (PRRT), are a promising alternative to current therapies for metastatic melanoma. In the published preclinical data, the 212 Pb radiolabeled peptide [212 Pb]VMT01 targeting MC1R was used to deliver α-particle radiation to melanoma cells. Robust anti-tumor specific cooperation between [212 Pb]VMT01 and systemic immune checkpoint inhibitor (ICI) immunotherapy was observed in preclinical melanoma models. This cooperation relies on the combination of the intact adaptive immunity and the immunogenicity caused by [212 Pb]VMT01.

"We are very pleased with the results of this preclinical study and are honored with the acceptance of this manuscript for publication in Cancers. We continue to be encouraged by the potential of VMT01 to significantly enhance responses to currently available immunotherapies for the treatment of metastatic melanoma," commented Michael K. Schultz, PhD, Chief Science Officer of Viewpoint. "Our data suggest that our targeted alpha-particle therapies have the potential to significantly enhance responses to currently available immunotherapies for the treatment of metastatic melanoma. We look forward to providing updates on our imaging study of VMT01 and the rest of our pipeline leveraging our proprietary 212 Pb alpha-particle radiotherapies and complementary 203 Pb diagnostic imaging agents."

Key findings of the publication are summarized below:

The combination of [212 Pb]VMT01 and immune checkpoint inhibitor therapy resulted in 43% complete and durable response rate in the syngeneic mouse model.
Further in vivo assays and rechallenge studies (in which naïve tumor cells were reintroduced to treated mice after a complete response) suggested a tumor specific T-cell mediated immune response.
Mice who demonstrated complete response to the combination of VMT01 and immune checkpoint inhibitors demonstrated resistance to the reintroduction of tumor cells, with either no growth or much slower tumor growth observed in these animals compared with control cohorts.
The results of this study suggest that targeted radionuclide therapy (TRT) such as [212 Pb]VMT01 is emerging as an effective approach to systemically deliver α-particle radiation that can induce anti-tumor immunity and enhance the efficacy of immunotherapies in a cooperative, potentially synergistic manner.
Data demonstrated that [212 Pb]VMT01 induced immunogenic cell death, tumor infiltrating lymphocytes, and sensitized immunotolerant melanoma tumors to ICI treatments (i.e., tumors were unresponsive to ICI therapy alone).
Viewpoint’s VMT01 program is intended to address an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma. This image-guided approach is often referred to as "theranostics." Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 ligand is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues. VMT01 represents a unique way to treat metastatic melanoma that has been vetted as scientifically sound by rigorous peer review and has the potential to be transformative for melanoma patients.

VMT01 is currently being evaluated in a Phase 1 imaging study being conducted at the Mayo Clinic. Provisional results for the VMT01 imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.

Alligator to Participate in Upcoming Investor Conferences

On September 22, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that Søren Bregenholt, Chief Executive Officer, will participate and host one-on-one investor meetings at the following upcoming investor conferences (Press release, Alligator Bioscience, SEP 22, 2021, View Source [SID1234590121]):

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Redeye Online Investor Forum
Location: Virtual
Date: Thursday, September 23, 2021
Time: 15:00-16:40 (CET)

Redeye Malmö Investor Forum
Location: Malmö, Sweden
Date: Thursday, September 30, 2021
Time: 18:00-20:00 (CET)

21st Annual Biotech in Europe Forum
Location: Virtual IO Advanced Therapeutics Panel
Dates: Thursday, October 7 – Friday, October 8, 2021
Time: 13:30 – 14:30pm (CET)

Vator Securities Healthcare Innovation Summit
Location: Stockholm
Date: Thursday, October 7, 2021
Time: 11:40 – 12:00 CEST

BioStock Life Science Summit
Location: Virtual
Date: Wednesday, October 20, 2021
Time: TBD

All presentations will be available via a digital library, which is accessible to event participants only. Please contact the organizers at Redeye, Vator Securities, and/or BioStock if you wish to attend and/or schedule a meeting with Alligator.

Hexagon Bio Closes $47 Million in Series A Financing to Advance Novel Oncology and Infectious Disease Therapies

On September 22, 2021 Hexagon Bio, Inc. ("Hexagon"), a biotechnology company turning nature’s genomes into medicines, reported that it has closed $47 million in Series A financing (Press release, Hexagon Bio, SEP 22, 2021, View Source [SID1234590120]). The round was led by The Column Group, with participation from 8VC and Two Sigma Ventures. Tod Smeal, formerly of Eli Lilly, Pfizer and SUGEN, will join as Chief Scientific Officer as the company adds drug discovery capabilities to complement its interdisciplinary platform for molecule identification.

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Hexagon’s molecule discovery platform uses data science, genomics, and synthetic biology to discover potent, evolutionarily refined secondary metabolites and their protein targets from fungal genomes. Secondary metabolites, which are small molecules produced by bacteria, fungi, and plants (also known as "natural products"), comprise many of the world’s most efficacious therapeutics including the antibiotic penicillin and the cholesterol-lowering drug lovastatin. Among FDA-approved drugs, 49% of all small molecule cancer drugs and 73% of all antibiotics originated from secondary metabolites. While secondary metabolites have proven to be rich sources of potent drugs, their translation has been hindered by the lack of mechanistic understanding of their intended target. Hexagon’s proprietary algorithms identify novel secondary metabolites, along with their cognate proteins (therapeutic targets), from genomic data, allowing Hexagon to bypass traditional screening methods.

"Hexagon has shown that we can build small molecules targeting key proteins in human disease, using our database of microbial genomes. Now it’s time to scale up, and Hexagon is exceptionally well poised to do so using automation and large-scale DNA sequencing of microbes, starting with fungi," said Hexagon CEO, Maureen Hillenmeyer.

Only a few thousand fungal genomes have been studied, but it is estimated that there are five million fungi on earth. Large-scale sequencing of those genomes could yield novel treatments for a vast array of human diseases. Hexagon will use the Series A funding to develop a proprietary genomics database of new secondary metabolites, and to build a drug discovery team to develop these compounds. Hexagon’s initial therapeutic focus areas are oncology and infectious disease. The platform is extendable to other therapeutic areas including immunology, cardiovascular, neurological, and metabolic disorders.

Tod Smeal, PhD, will join Hexagon as Chief Scientific Officer to lead drug discovery efforts. Dr. Smeal brings 22 years of research and development experience in the biotechnology and pharmaceutical industries, most recently as Chief Scientific Officer of Cancer Biology, Oncology Drug Discovery at Lilly Research Labs. "Tod Smeal’s track record at delivering clinical candidates, combined with his leadership experience in building drug discovery teams, will enable the company to enter its next phase: developing new targeted therapies identified by Hexagon’s platform," said Maureen Hillenmeyer.

"I am excited by Hexagon’s vision of genomics-driven discovery of secondary metabolites that target disease-driving proteins. The molecules that result from Hexagon’s platform have evolved to target specific proteins and are cell-permeable, making them excellent starting points for drug discovery," said David Goeddel, Chairman of the Board of Directors.

The company is led by CEO and founder Maureen Hillenmeyer. Other Hexagon founders are Brian Naughton, Head of Data and formerly founding scientist at 23andme, Colin Harvey, Head of Platform and Yi Tang, Professor of Chemical and Biomolecular Engineering at UCLA.

In conjunction with the Series A financing, David Goeddel, PhD, Managing Partner at The Column Group will join as chairman of Hexagon’s Board of Directors. Dr. Goeddel’s pioneering work at Genentech in the fields of gene cloning and expression of human proteins was the basis for five marketed therapeutics including human insulin, human growth hormone, interferon-alpha, interferon-gamma and tissue plasminogen activator. Juan Jaen, PhD, co-founder, President and Head of Research at Arcus Biosciences, and formerly co-founder and head of R&D at Flexus Biosciences will join Hexagon’s Board as an independent director.

"Drug resistance in human fungal and bacterial infections is a growing threat with the potential to severely limit treatment options for patients," said Dusan Perovic, Principal at Two Sigma Ventures. "We are proud to support the world-class engineers and data scientists at Hexagon as they work to leverage software and automation to build the next wave of targeted therapies and expand treatment options for infectious diseases."

Hexagon Bio is headquartered in Menlo Park, CA.

Hexagon Bio’s founders are:

Maureen Hillenmeyer, PhD, CEO
Brian Naughton, PhD, Head of Data
Colin Harvey, PhD, Head of Platform
Yi Tang, PhD, Professor, Department of Chemical and Biomolecular Engineering, UCLA
Hexagon Bio’s board members are:

Maureen Hillenmeyer, PhD (Co-Founder & CEO, Hexagon Bio)
Brian Naughton, PhD (Co-Founder & Head of Data, Hexagon Bio)
David Goeddel, PhD (Managing Partner, The Column Group)
Millie Ray, PhD (Principal, The Column Group)
Alex Kolicich (Founding Partner, 8VC)
Juan Jaen, PhD (Co-Founder & President, Arcus Biosciences)