Tune Therapeutics Launches with Pioneering Epigenomic Control Platform to Master Gene Networks, Treat Broad Range of Diseases

On December 2, 2021 Tune Therapeutics, a biotechnology company pioneering the creation of epi-therapeutic medicines, reported it launched with its powerful and precise genetic tuning platform, TEMPO (Press release, Tune Therapeutics, DEC 2, 2021, View Source [SID1234630692]). This cutting-edge technology dials gene expression up or down to desired levels – with the potential to reverse pathways of cancer, genetic disease, and aging by changing cell fate and function at will.

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"Genetic medicine is at a tipping point," said Matt Kane, CEO of Tune Therapeutics. "We now understand that the driving force of human health and disease is not our genes, but the epigenomic elements that shape and control them. Until now, scientists and bioengineers lacked the combined understanding, clinical expertise, and technology needed to make epigenomic therapies a practical reality. Now, we have all three."

TEMPO Platform

Tune’s proprietary TEMPO platform can rapidly target and adjust the epigenomic machinery of the cell, which shapes DNA and controls gene expression. By varying specific control modules in an iterative process, TEMPO can fine-tune expression toward healthy levels – even in diseases involving multiplex or polygenic interactions.

Unlike genome editing, the tuning process does not generate double- or single-strand breaks in DNA and makes no permanent changes to the DNA sequence. This de-risks the precise targeting of entire gene networks, allowing Tune to simultaneously turn silenced genes on and dial over-expressed genes down, in a practical, therapeutic context.

Tune has already shown that TEMPO can locate epigenomic elements involved in several intractable genetic conditions – revealing targets and networks that would be invisible or inaccessible to gene editing approaches. Moreover, Tune can optimize TEMPO to command expression of individual genes or networks with remarkable specificity and precision. This opens the door to an entirely new class of epi-therapeutics.

"The exciting challenge in front of us is taking these transformative advances in technology and extending their potential for our greater society," said Charlie Gersbach, PhD, Acting Chief Scientific Officer, Tune Therapeutics. "From proof of concept in rare, single-gene disorders to common conditions that aren’t linked to a single gene mutation – but are treatable through epigenomic control and constitute the vast majority of human diseases."

Veteran Genomic Medicine Leadership Team

Tune is launching with a veteran leadership team, endowed with deep expertise in gene and cell therapy, genome editing, and epigenetics.

Matt Kane, Chief Executive Officer
Akira Matsuno, Co-Founder, President and Chief Financial Officer
Charlie Gersbach, Ph.D., Co-Founder, Acting Chief Scientific Officer
Fyodor Urnov, Ph.D., Co-Founder, Scientific Advisory Board
Heidi Zhang, Ph.D., Executive Vice President, Head of Technical Operations
Blythe Sather, Ph.D., Vice President, Head of Research
In addition, Tune’s Board of Directors includes Mr. Kane, Dr. Gersbach, Ali Behbahani, M.D., (New Enterprise Associates), and co-founder Dan McHugh (Emerson Collective).

Drawing upon deep, local talent pools in Durham and Seattle, Tune has assembled two highly seasoned discovery and development teams, secured foundational intellectual property from Duke University, and raised $40 million from top-tier investors – including co-leads New Enterprise Associates and Emerson Collective, with Hatteras Venture Partners, Mission BioCapital, and others joining the round. This financing will enable Tune to rapidly advance its preclinical research, attract top-tier talent, and further develop its therapeutic platform.

"Tune is effectively pioneering a brand-new therapeutic modality," said Dr. Behbahani. "With the unbound potential of this approach, and their collective successes in the field, Tune is primed to become a transformative presence in modern biomedicine."

Delcath Corporate Presentation

On December 2, 2021, Delcath Systems, Inc. Presented the Corporate Presentation (Presentation, Delcath Systems, DEC 2, 2021, View Source [SID1234596394]).

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InteRNA Technologies Announces U.S. FDA Clearance of IND Application for Phase I Clinical Trial with Lead microRNA Candidate INT-1B3 in Patients with Advanced Solid Tumors

On December 2, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported it received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Phase I clinical trial evaluating lead miRNA candidate, INT-1B3, in patients with advanced solid tumors (Press release, InteRNA Technologies, DEC 2, 2021, View Source [SID1234596412]). INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer.

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The IND approval enables InteRNA to expand the number of clinical sites and to facilitate the enrollment of patients for the dose expansion (Phase Ib) part of the trial in the United States. The first part of the Phase I trial was initiated in Europe at the beginning of 2021, with the dosing of the first patient in the dose escalation (Phase Ia) part in February. The treatment of the first patient in the Phase Ib cohort is planned for the second half of 2022.

"Receiving such a positive outcome from the FDA shortly after submitting a full IND application is a major achievement for us," commented Laurens van Pinxteren, Chief Operating Officer of InteRNA. "It underlines the high potential of our novel miRNA-based approach that enables us to address the multi-facetted disease cancer from different angles with one drug providing a novel therapeutic entity to patients with hard-to-treat solid tumors, such as advanced breast cancer or hepatocellular carcinoma."

Roel Schaapveld, CEO of InteRNA, added: "The IND approval enables us to enroll an international, diversified patient population, marking significant progress in the clinical evaluation of our novel therapeutic modality. The rapid, positive feedback by the FDA is highly encouraging and we look forward to start patient recruitment in the United States next year."

The multicentric, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at up to 15 clinical centers in the United States and Europe. The Phase Ia part of the trial is currently ongoing in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. In the second part (Phase Ib) of the trial, approximately 50 patients with hepatocellular carcinoma or triple negative breast cancer will be enrolled in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment.

Bolt Biotherapeutics to Present Interim Clinical Data on BDC-1001 Phase 1/2 Clinical Trial at ESMO Immuno-Oncology Congress 2021

On December 2, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that the company will be presenting interim clinical data in a virtual poster on BDC-1001, starting on December 6, 2021 in conjunction with the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 taking place on December 8 – 11, 2021 (Press release, Bolt Biotherapeutics, DEC 2, 2021, View Source [SID1234618692]). BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated to a TLR7/8 agonist with a non-cleavable linker.

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"The data we will be presenting at ESMO (Free ESMO Whitepaper) I-O includes more than 50 patients at increasing exposures and builds upon the data presented at ASCO (Free ASCO Whitepaper) 2021. We will be presenting additional insights into BDC-1001’s safety and tolerability profile, pharmacokinetics, tumor and serum biomarkers, and early signs of clinical activity. These interim results support continued investigation towards an optimal dosing regimen, as well as the initiation of a combination dose-escalation study with Opdivo by year-end," said Edith A. Perez, M.D, Chief Medical Officer of Bolt Biotherapeutics.

The poster will be available in the e-Posters section of the conference virtual platform as of December 6 at 12 p.m. CET:

Abstract Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Timing: On-Demand Access

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study at 8:00 a.m. ET/5 a.m. PT on Monday, December 6, 2021.

A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

Opdivo is a trademark of Bristol-Myers Squibb Company.

CTI BioPharma to Present at the JMP Securities Hematology & Oncology Summit on Monday, December 6

On December 2, 2021 CTI BioPharma Corp. (NASDAQ: CTIC) reported that management will provide a corporate overview at the JMP Securities Hematology & Oncology Summit at 3:40 p.m. ET (Press release, CTI BioPharma, DEC 2, 2021, View Source [SID1234596395]). The conference will be held in a virtual meeting format.

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Presentation details:
Event: JMP Securities Hematology & Oncology Summit
Date: Monday, December 6, 2021
Time: 3:40 p.m. ET

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.