On September 16, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, reported preclinical data demonstrating that the Company’s novel microbiome-derived peptide, SG-3-00802, can reverse resistance to anti-programmed death protein-1 (PD-1) therapy, illustrating that the microbiome directly interacts with the immune system to impact antitumor immunity (Press release, Second Genome, SEP 16, 2021, View Source [SID1234587855]). The data (E-Poster #1023P) were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, held virtually September 16-21.

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"Despite the clinical success of immune checkpoint inhibitors (ICI) in many cancers, there is still significant unmet need in ICI-resistant patients, but there is encouraging promise for microbiome-derived approaches to turn anti-PD-1 non-responders into responders and ultimately provide innovative new therapies for people living with cancer," said Helena Kiefel, Ph.D., Head of Immuno-Oncology at Second Genome. "We were pleased to share preclinical data at ESMO (Free ESMO Whitepaper) demonstrating that the combination of SG-3-00802 with anti-PD-1 antibody was able to achieve complete tumor regression and significant prolongation of survival in an ICI-resistant model. We believe SG-3-00802 has potential to improve responses in immune checkpoint inhibitor-resistant cancer patients. Importantly, based on the mechanism of action, SG-3-00802 has potential for broad clinical development in combination with immunogenic chemotherapies and radiation in earlier lines of therapy. We look forward to advancing SG-3-00802 into the clinic, with an IND submission on track for 2022."

Using Second Genome’s proprietary algorithms, an ICI responder-specific microbial signature was identified, and biologically active molecules were derived from the ICI-responder microbiome. SG-3-00802’s unique pathway and its use to treat tumors markedly increased CXCL10 and CD8 T cell levels and reduced tumor volumes, increasing overall survival in mouse models. Furthermore, treatment in combination with anti-PD-1 significantly improved overall survival in anti-PD-1-insensitive RENCA mouse model, with many mice showing complete tumor regression, versus anti-PD-1 antibody alone. Surviving mice with fully regressed tumors also rejected newly implanted tumors when rechallenged with RENCA cells, demonstrating long-lasting antitumor memory responses generated by the combination of SG-3-00802 plus anti-PD-1.

The mechanism of action by which SG-3-00802 exerted its anti-tumor effects demonstrated to be CXCR3 dependent. Receptor activation and immune cell recruitment assays demonstrated that SG-3-00802 enhanced the activity of CXCR3 in the presence of its endogenous ligands, resulting in increased lymphocyte migration, validating CXCR3 as the functional target. These observations were confirmed in vivo, as CXCR3 inhibition decreased the anti-tumor activity of SG-3-00802 alone and in combination with anti-PD1.

The poster presentation will be available for on-demand viewing on the ESMO (Free ESMO Whitepaper) website and will also be made available on the Company’s website at View Source

On September 16, 2021 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported that it has completed a $25 million Seed Funding to finalize its ongoing IND-enabling activities for its lead program, BTM-3566, and consummate preparations for first in human clinical trials (Press release, Bantam Pharmaceutical, SEP 16, 2021, View Source [SID1234587854]). The funding was co-led by Bantam’s current investors.

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Bantam plans to submit its Investigational New Drug application in February 2022 and start Phase 1 clinical studies in patients with B-cell hematological malignancies in the second quarter of 2022. In addition, Bantam has established its operations in the Alexandria cluster based in Research Triangle Park, an area rich in clinical development resources and capabilities.

"This funding enables Bantam Pharmaceutical to be fully prepared to enter the clinic for first in human studies in early 2022, representing a major milestone. We are excited about moving to the next stage of development," said Lionel Goldfrank, Co-founding investor and board member.

BTM-3566 is a novel selective modulator of mitochondrial dynamics, targeting a pathway involved in mitochondrial homeostasis that specifically drives cancer cell apoptosis in a number of tumor types with high unmet need. The company has leveraged a protein translational phenotypic screen to discover its clinical candidate and related compounds.

"This Fall we will raise our Series A round to drive clinical development studies and expand our discovery platform to accelerate our novel drug programs and address the ongoing unmet needs of many different cancers, beginning with B-cell hematological malignancies," said Michael Stocum, President and Chief Executive Officer of Bantam. "Our team remains focused on progressing our fundamental scientific insights along the clinical pathway to transform the treatment of patients with cancer."

About BTM-3566
BTM-3566 is a novel selective modulator of mitochondrial dynamics, targeting a pathway involved in mitochondrial homeostasis that specifically drives cancer cell apoptosis. Bantam has leveraged a protein translational phenotypic drug discovery and precision medicine-based platform approach to identify the pathway and related biomarkers, enabling enrichment of patient populations most likely to respond to BTM-3566. Initial clinical proof of concept will focus on areas of unmet clinical need with initial phase I/II clinical trials planned in relapsed/refractory B-cell hematological malignancies, including Diffuse Large B-cell Lymphoma.

On September 16, 2021 Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, a first-in-class anti-resistance oncology therapeutic, reported that it has demonstrated potent anti-tumor activity in combination with a PD-1 checkpoint inhibitor in a validated I/O in vivo model of colorectal cancer (Press release, Bold Therapeutics, SEP 16, 2021, View Source [SID1234587853]). Cancer immunotherapies that blockade the PD-1/PD-L1 checkpoint, such as Merck’s Keytruda (pembrolizumab), BMS’ Opdivo (nivolumab) and more recently Jiansu Hengrui’s AiRuiKa (camrelizumab), have been shown to create durable therapeutic responses not typically seen with traditional anti-cancer therapies, improving patient outcomes in an increasingly wide range of indications and generating more than $23B in annual revenues worldwide. However, these therapies remain ineffective in a significant percentage of patients who are inherently resistant, and some patients who initially respond acquire resistance to these therapies over time. As the mechanisms underlying both inherent and acquired resistance to PD-1/PD-L1 are further elucidated, proactive anti-resistance therapeutic strategies could potentially result in both more frequent and improved patient outcomes.

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In the experiment shown, BOLD-100 was tested by an independent CRO in an MC-38 mouse model of colorectal cancer. BOLD-100 not only demonstrated potent monotherapy activity, as it has in other models, but also significantly improved outcomes when combined with a PD-1 inhibitor. Adding to an increasing wealth of literature, this data strongly supports BOLD-100’s potential to synergize with checkpoint inhibitors to reduce inherent and acquired resistance and improve patient outcomes. Further experiments are planned to explore and optimize BOLD-100’s utility in combination with checkpoint inhibitors in various established preclinical models with the goal of quickly advancing into a combination clinical study. BOLD-100 has already been shown to be generally safe and well-tolerated in a 46-patient monotherapy Phase 1 study, and Bold Therapeutics anticipates initiating numerous Phase 2 studies in 2022 and beyond.

"These results in combination with a PD-1 checkpoint inhibitor adds to extensive preclinical and clinical evidence supporting BOLD-100’s broad utility," stated E. Russell McAllister, CEO of Bold Therapeutics. "We have already demonstrated synergy between BOLD-100 and the therapies used in the majority of cancer care settings, ranging from traditional chemotherapies (e.g. cisplatin, gemcitabine) to targeted therapies (e.g. proteasome inhibitors, PARP inhibitors, receptor tyrosine kinase inhibitors – and now checkpoint inhibitors) to novel therapies (e.g. apoptosis and DNA damage pathway inhibitors). Drug resistance remains a significant unaddressed challenge in oncology, and Bold Therapeutics and our collaborators worldwide continue to demonstrate BOLD-100’s ability to address this unmet need by defeating both inherent and acquired resistance in a wide range of both solid and liquid tumor indications. Meanwhile, our ongoing seamless adaptive Phase 1b/2a clinical study is exploring the safety and efficacy of BOLD-100 in combination with FOLFOX in the treatment of advanced GI cancers – and we continue to expect to present results from the Phase 1b portion of the study at a conference in early 2022."

On September 16, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported its participation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress, from September 16-21, 2021 (Press release, Berg, SEP 16, 2021, View Source [SID1234587852]). At the event, the company will unveil its most recent medical and clinical research developments for pancreatic ductal adenocarcinoma (PDAC) as part of its Project Survival longitudinal prospective clinical trial with Beth Israel Deaconess Medical Center (BIDMC), a research and teaching affiliate of Harvard Medical School (HMS).

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The presentation entitled "Identification of Novel Protein Biomarkers for FOLFIRINOX- Based Chemotherapy Response in Advanced Pancreatic Adenocarcinoma Using Patient Omics and Bayesian AI" is a coordinated effort based on BERG’s prospective pancreatic cancer biomarker and precision medicine program, as well as its Phase 2 Pancreatic cancer therapeutic program involving BPM 31510. As part of the research, BERG’s Interrogative Biology platform was used to identify relationships between patients receiving FOLFIRINOX chemotherapy treatment as well as additional therapies to identify biomarkers indicating overall survival.

"This multidisciplinary collaboration is an important step on the road to personalized treatment for pancreatic cancer," said Dr. A. James Moser, Co-Director of the Pancreas and Liver Institute at BIDMC, and Professor of Surgery at HMS. "This protein biomarker panel is a promising tool in the fight against this dreadful disease and may change the way chemotherapy is prescribed for patients around the world."

The research cohort was comprised of data accumulated from over 450 patients who were molecularly profiled to identify innovative biomarkers for the treatment and stratification of patients with pancreatic cancer.

"Understanding the biology of PDAC patients will be critical in increasing life expectancy for one of the most common and devastating types of pancreatic cancer," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "At BERG, we are committed to continuing to do the hard work to improve the quality of life, treatment, and patient stratification for those inflicted with pancreatic cancer. This week’s presentation is just the next step in our journey as we work to transform the treatment of this disease."

Pancreatic Cancer is the third leading cause of death of all cancers with only a 10% survival rate. Lack of early detection often leads to advanced diagnosis in most cases, resulting in devasting impacts on the family unit.

"Losing my father to this devastating disease put a fire in me to work tirelessly to help support research for early diagnoses and treatment after experiencing the effect of pancreatic cancer. BERG has led a bold conquest to use leading-edge technology to create both diagnostic and therapeutic approaches to improve the lives of patients and families. The partnership led by BERG and BIDMC has been the most forward-thinking collaboration in this area of medicine, it provides hopes and real solutions", said Kendra Bahneman Haywood, Executive Director, Alliance of Families Fighting Pancreatic Cancer (AFFPC).

Presentation Details:

Presentation Title

Poster
Display
Session
Number

Presenter

On-Demand

E-Poster Display
Dates

Identification Of Novel Protein
Biomarkers For FOLFIRINOX-Based
Chemotherapy Response In
Advanced Pancreatic Adenocarcinoma
Using Patient Omics And Bayesian AI

1485P

A.J. Moser

September 16-21,
2021

The Abstract is available online, and the Poster will be available to registered ESMO (Free ESMO Whitepaper) 2021 Congress attendees starting Thursday, September 16th.

On September 16, 2021 Valo Health, LLC ("Valo"), the technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence driven compute, reported that its CEO and founder, David Berry, is participating on the "Tech Solutions: a Biotech Perspective" panel at the BofA Securities 2021 Virtual Tech Solutions for Drug Discovery Conference on September 20, 2021 at 9:00 AM Eastern Time (Press release, Valo Health, SEP 16, 2021, View Source [SID1234587851]).

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The pre­sen­ta­tion will be web­cast live and avail­able for replay on the investor rela­tions page of the Valo web­site.