On June 22, 2023 Kanvas Biosciences, the leader in microbiome mapping technology, reported a $12M Pre-Series A funding round (Press release, Kanvas Bioscience, JUN 22, 2023, View Source [SID1234644493]). The investment will be used to further advance the company’s proprietary platform technology, which promises to revolutionize drug development for microbiome-associated diseases. The round was led by DCVC with participation from Lions Capital LLC, Cooke LLC, Uncommon Denominator, and Triple Impact Capital. As part of the investment round, Jason Pontin, partner at DCVC, will join the company’s board of directors.

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The interactions between the microbiome and its host are critical to human health. The current gold standard for analyzing these interactions is to extract a sample, blend it, and sequence the genetic material in the sample. This strategy enables broad inferences about the composition of the sample, but little more, as information regarding biospatial localization and cellular function is lost in the process.To overcome this challenge, Kanvas has developed a revolutionary technology platform that enables highly multiplexed spatial profiling of microbial species. The platform not only determines the identity and function of these microbes, but also maps the host’s corresponding local response – all executed within a single, comprehensive assay.

With Kanvas’ proprietary technology, based on research first published in Nature by the company’s founders, researchers can profile both the microbiome and the host cells with sub-cellular resolution to provide critical context and unparalleled insight into complex host-microbe interactions. This platform can be applied to the discovery and development of novel, live biotherapeutic products, the identification of disease-associated microbes for diagnostics, and leveraging the microbiome to improve therapeutic responses.

"Our technology takes the gastrointestinal tract and the microbiome from black box to transparent and measurable terrain," says Kanvas Biosciences co-founder and CEO Matthew Cheng, MD. "We are thrilled to drive forward the development of life-saving treatments for some of the world’s most common conditions." While the microbiome has long been associated with inflammatory bowel disease and colon cancer, emerging data indicate its intimate connection to a range of conditions beyond the gastrointestinal tract, including cardiovascular disease, metabolic disorders, and response to cancer immunotherapy treatments.

The raised capital will be used towards expanding Kanvas’ proprietary single-cell spatial transcriptomics platform and launching biological and R&D discovery platforms. To this end, Kanvas has already established partnerships with leading biotechnology and pharmaceutical companies.

"This breakthrough technology empowers researchers to explore microbial communities in unprecedented ways, with profound implications for the health and biomedical industries. It fundamentally transforms our understanding of the human microbiome, allowing us to consider it as a distinct and druggable organ, opening uncharted territories in medicine," said Jason Pontin of DCVC.

On June 22, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma (GBM) (Press release, Erasca, JUN 22, 2023, View Source [SID1234639353]). ERAS-801 is an orally bioavailable, small molecule EGFR inhibitor that exhibited substantial central nervous system (CNS) penetration in preclinical animal studies.

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Per FDA regulations, ODD is granted by the FDA to investigational therapies addressing rare medical diseases or conditions affecting less than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.

"GBM is an aggressive malignancy afflicting approximately 37,000 patients annually in the United States and Europe. Currently approved EGFR inhibitors are limited by insufficient CNS penetration to treat GBM and minimal activity against GBM-specific EGFR amplifications, mutations, and other molecular alterations, which contribute to high rates of relapse and a five-year survival rate below 10%," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Receiving ODD recognizes both the importance of innovation for patients with GBM and the therapeutic potential of ERAS-801 to provide a targeted treatment option for these patients, who have a poor prognosis. This ODD follows the earlier Fast Track Designation granted to ERAS-801 by the FDA and underscores the urgency of finding new treatments for this patient population. The broad activity against both oncogenic and wildtype EGFR, high CNS penetration, and demonstrated ability to improve outcomes in over 90% of diverse EGFR-driven patient-derived glioma models support the potential for ERAS-801 to overcome current challenges with existing therapies. We anticipate reporting initial monotherapy data for ERAS-801 from the Phase 1 THUNDERBBOLT-1 trial in patients with recurrent GBM in the second half of 2023."

ERAS-801 was designed and developed by a renowned team of cancer researchers—Michael Jung, Ph.D., Timothy Cloughesy, M.D., and David Nathanson, Ph.D.

About ERAS-801
ERAS-801 is a highly potent, selective, reversible, and orally bioavailable small molecule EGFR inhibitor with significantly enhanced CNS penetration. In animal models, ERAS-801 had a brain-to-plasma partition coefficient, Kp, of 3.7 and a corresponding unbound partition coefficient, Kp,uu, of 1.2, which was up to four times higher than approved EGFR inhibitors, suggesting that approximately 100% of the free drug in plasma is able to cross the blood-brain barrier (BBB). At clinically relevant exposures across 30 patient-derived GBM models that were intended to represent the heterogeneity of GBM, ERAS-801 demonstrated a survival benefit in 13 out of 14 (93%) EGFR mutant and/or amplified models and had statistically significantly higher brain penetrance and prolonged survival compared to approved EGFR tyrosine kinase inhibitors, including osimertinib, lapatinib, and erlotinib. ERAS-801 is currently being evaluated as a monotherapy in THUNDERBBOLT-1, an ongoing Phase 1 trial in patients with recurrent GBM (rGBM). In April 2023, the FDA granted Fast Track Designation (FTD) to ERAS-801 for the treatment of adult patients with GBM with EGFR gene alterations. In June 2023, the FDA granted ODD to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma.

About THUNDERBBOLT-1
THUNDERBBOLT-1 is evaluating the safety, tolerability, and preliminary efficacy of ERAS-801 as a monotherapy in patients with rGBM. The dose escalation portion will determine the recommended dose, which will then be used during the dose expansion portion to further evaluate the efficacy and safety of ERAS-801. Future sub-studies of THUNDERBBOLT-1 may potentially explore ERAS-801 in combination with other agents and in broader patient types. Initial Phase 1 data from THUNDERBBOLT-1 are anticipated in the second half of 2023.

On June 22, 2022 Boost Immune, which researches and develops immuno-oncology for new targets, reported the company has closed Series A worth 17 billion won (Press release, Boostimmune, JUN 22, 2023, View Source [SID1234634473]). It has been 10 months since the 2 billion won pre-A round in August last year.

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Boost Immune CEO Lee Kwang-hee said, "This follow-up investment fund will be used for the pre-clinical entry of the leading BIO-101 project and production of samples for clinical trials." It plans to apply for a clinical trial application (IND) to the US FDA by the end of 2023.

Boost Immune attracted pre-A funding from Mirae Asset Financial Group, Ajou IB Investment, Company K Partners, and Smilegate Investment in August of last year. In this series A round, all four existing investors made follow-up investments, and SV Investment, Premier Partners, We Ventures, and Timefolio Asset Management joined as new investors.As a result, BoostImmune has raised venture capital investments for a period of about a year since its establishment

. Boost Immune was co-founded in

February 2021 by CEO Kwang-Hee Lee and Professor Tadatsugu Taniguchi of the University of Tokyo. ‘, a new ADC (antibody drug polymer) project ‘BIO-103’, and has a number of pipelines.

CEO Lee Kwang-hee received a bachelor’s/master’s degree in molecular biology from Seoul National University and a doctorate from Washington University School of Medicine in the United States, then pursued a postdoctoral program at Genentech in San Francisco, USA. Since then, he has served as the director of Sanofi Korea Research Center and vice president of translational research at Bridge Biotherapeutics.

Professor Taniguchi is a world-renowned immunologist who first discovered interleukin 2, interferon beta, and HMGB1. He has been awarded the Robert Koch Prize in Germany, the Keio Medical Science Prize in Japan, and the Pezcoller Foundation-AACR International Award in Italy-USA. He has been a member of the National Academy of Sciences since 2003 and a member of the National Academy of Medicine since 2016.

On June 22, 2023 EpiAxis Therapeutics reported the nomination of epiresatide as its lead candidate for IND advancement (Press release, EpiAxis Therapeutics, JUN 22, 2023, View Source;utm_medium=rss&utm_campaign=epiaxis-nominates-ep-132-0-as-lead-candidate-for-ind-advancement [SID1234633038]).

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Epiresatide is a generation 2.1 stapled peptide specifically targeting nuclear LSD1, which offers a novel mode of action.

Designed to address the challenge of treatment resistance and prevention of cancer recurrence in numerous haematological and solid tumours, epiresatide has demonstrated superior biological performance in modulating LSD1 demethylase activities, coupled with an excellent pre-clinical safety and tolerability profile.

EpiAxis CEO Dr Jeremy Chrisp said the company is planning to move forward with the clinical development of its lead candidate, epiresatide, marking a significant milestone in its progress,

"This is a pivotal valuation inflection point for shareholders and provides momentum for EpiAxis’ fundraising and partnering activities," Dr Chrisp said.

"Currently, EpiAxis is actively seeking collaborations and investment opportunities to accelerate the development and commercialisation of epiresatide, cementing its position at the forefront of the biotechnology industry."

EpiAxis remains dedicated to transforming the lives of cancer patients and meeting the urgent need for more effective treatments. Future updates will be provided on the progress of epiresatide as the company progresses this ground-breaking therapeutic.

On June 22, 2023 Parthenon Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that the Journal for ImmunoTherapy of Cancer (JITC) has published results from a collaboration between Parthenon Therapeutics, The University of Texas Health Center at Houston (UTHealth Houston) and George Washington University, demonstrating that PRTH-101 potently inhibits the adhesion of collagen receptor discoid in domain receptor-1 (DDR1)-expressing cancer cells to collagen substrates and DDR1 autophosphorylation induced by collagen (Press release, Parthenon Therapeutics, JUN 22, 2023, View Source [SID1234632864]).

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The article entitled, "A highly selective humanized DDR1 mAb reverses immune exclusion by disrupting collagen fiber alignment in breast cancer," describes the humanization of PRTH-101 and the mechanism by which the drug candidate binds to its target to inhibit DDR1. The publication is now available online on the JITC website.

Key Publication Highlights

Structural studies, including a PRTH-101/DDR1 co-crystal structure, identified the PRTH-101 epitope on DDR1
Culturing DDR1-expressing human cancer cells with PRTH-101 inhibited DDR1 autophosphorylation induced by collagen and the shedding of DDR1 fragments from the cell surface
PRTH-101 demonstrated the ability to potently inhibit the adhesion of DDR1-expressing cancer cells to collagen substrates, disrupting the physical barrier formed by aligned collagen fibers in tumors
The ability of PRTH-101 to inhibit functions of the extracellular component of DDR1 differentiates PRTH-101 from DDR1 kinase inhibitors
"Our collaboration with UTHealth Houston and George Washington University has yielded great insight into the capabilities of PRTH-101 as well as demonstrated the role of DDR1 in promoting immune exclusion in cancers," said J. Paul Eder, MD, Chief Medical Officer of Parthenon Therapeutics. "This study reinforces the development of PRTH-101 as a cancer therapeutic, and also sheds light on a new therapeutic strategy to modulate collagen alignment in the tumor ECM for enhancing antitumor immunity."

Parthenon recently initiated a Phase 1 first-in-human clinical trial for its lead candidate PRTH-101 in patients with advanced solid tumors (NCT05753722).

About PRTH-101

PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a minimally permeable physical barrier blocking immune cells from interacting with and attacking tumor cells. Thus, these "immune cell-excluded" solid tumors are resistant to attack by the immune system (as well as other existing therapies). By disabling DDR1, the collagen fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T cells to enter and attack the tumor. The creation of DDR1-directed collagen alignment does not appear to have a normal physiological surrogate and may therefore be unique to pathologies such as neoplasia, potentially allowing for relatively safe interventions. Thus, blockade of DDR1 represents a unique and "orthogonal" approach to stimulating the immune-based antitumor activity, and such blockade shows both single agent anti-tumor activity as well as marked augmentation of immunity enhanced by PD-1 blockade.

Tumor types which show particularly high levels of DDR1-associated collagen barriers include colorectal, ovarian, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1.