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CIDARA THERAPEUTICS TO PRESENT AT ADENOSINE PATHWAY TARGETED CANCER IMMUNOTHERAPY SUMMIT

On June 13, 2023 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, reported that the company will deliver an oral presentation including highlights from its ongoing preclinical studies of CD421, a CD73-targeting DFC candidate, as well as the development of its novel drug-Fc conjugates (DFCs) from Cidara’s Cloudbreak platform, at the 2nd Annual Adenosine-Pathway Targeted Cancer Immunotherapy Summit in Boston, MA, which is being held June 20-22, 2023 (Press release, Cidara Therapeutics, JUN 13, 2023, View Source [SID1234636987]).

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The Adenosine-Pathway Targeted Cancer Immunotherapy Summit is a three-day conference that brings together over 80 industry and academic thought leaders to discuss the most recent advances of the last year in this field. The meeting will aim to improve the understanding of adenosine signaling in the tumor microenvironment and discuss drug combinations to improve patient responses and overcome obstacles related to resistance and immunosuppression.

Oral presentation details are as follows:

Title: Cidara Drug-Fc-Conjugates (DFCs): A New Approach To Treatment Of Cancer
Presenter: James Levin, Ph.D., Senior Director, Preclinical Development at Cidara Therapeutics
Session Date/Time: Thursday, June 22, 2023 at 9:30 a.m. ET
Session Location: Boston, MA

To view the full schedule, visit the Adenosine Pathway Targeted Cancer Immunotherapy Summit website here.

About Cloudbreak DFCs
Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple targeted small molecule and peptide drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to multiple oncology programs, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza.

Mission Bio’s Tapestri® Platform Demonstrates Highly Robust And Reproducible Data

On June 13, 2023 Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported successful results of validation studies of the Tapestri Platform (Press release, Mission Bio, JUN 13, 2023, View Source [SID1234632711]). Data from a recently published white paper show how single-cell DNA sequencing technology could complement traditional bulk sequencing with the added advantage of detecting potential therapeutic resistance mutations.

Drug developers must understand why some patients respond to therapies, while others do not, in order to accelerate clinical trials and develop better treatments. Single-cell DNA and multi-omics analysis has already been shown in multiple publications to be well-suited to help untangle therapy resistance mechanisms that are impossible to discern through traditional methodologies. Now, Tapestri’s unique ability to sensitively detect rare cancer subclones and co-occurring cancer mutations using single-cell genomics offers a precise way to measure therapy response and disease progression.

Mission Bio’s Tapestri Platform Demonstrates Highly Robust And Reproducible Data

As described in a new white paper, scientists at Labcorp used the Tapestri Platform to interrogate 127 amplicons that target DNA mutations known to be present in patients with acute myeloid leukemia (AML). The goals of the experiments were to evaluate the effects of different sample preparation methods for human peripheral blood mononuclear cells (PBMCs) on the Tapestri cell encapsulation method, and to evaluate the robustness of detecting DNA mutations in controlled sample mixtures of human PBMCs and RAJI cell line cells using the AML gene mutation detection panel.

The assessment of assay performance including clonality, precision, accuracy, and analytical sensitivity demonstrated Tapestri’s unique ability to detect rare subclones at less than 1%, determine the zygosity of mutations, and measure the co-occurrence of multiple mutations in the same single cells. The robust and reproducible data generated on the Tapestri Platform gives drug developers a powerful tool to measure therapy response, potentially improve clinical trial outcomes, and ultimately deliver new targeted therapies.

"We are delighted to see the validation results, confirming the value add many of our partners have already seen," said George Kopitas, Senior Vice President, Sales & Customer Support at Mission Bio. "Biopharma companies need to know they can access cutting-edge and reliable technology through partners they trust. Labcorp is a global leader in drug development and a trusted partner for generating safety and efficacy data. We look forward to further validating Tapestri for use in CAP and CLIA settings."

Future Fields and Jenthera Therapeutics Collaborate to Develop Novel Protein for the Delivery of Cancer Biologics

On June 13, 2023 Future Fields, a pioneering biotechnology company that has built the world’s first synthetic biology system to use fruit flies for recombinant protein production, and Jenthera Therapeutics, a gene editing company focused on delivery of the CRISPR ribonucleoproteins (RNPs), reported a collaboration focused on the manufacturing of a first-of-its-kind cancer-fighting protein (Press release, Jenthera Therapeutics, JUN 13, 2023, View Source [SID1234632691]). The Future Fields platform, the EntoEngine, will be used to mass-produce this novel protein under development more sustainably and cost-effectively than conventional approaches to biopharmaceutical production techniques. Future Fields is actively engaging with big and small biotech companies alike to form research collaborations for strategic proteins of interest. The company is well-positioned with its flexible platform to take the lead in sustainably mass-producing specific, complex proteins cost-effectively and at scale.

Harnessing the power of CRISPR, Jenthera Therapeutics has created a new, safer in vivo delivery mechanism for protein-based drugs via intravenous injection, eliminating the use of viruses, lipids or nanoparticles, which are expensive to produce and require large manufacturing facilities. Following sustainable production with the EntoEngine, Jenthera can deliver tailored gene editing complexes that selectively target the genomes of cancer cells, delivering in vivo anti-cancer therapeutics. The direct delivery of the ribonucleoprotein presents the optimal safety profile in terms of off-target incidence and immunogenicity. In clinically relevant models in vivo, Jenthera’s gene editing complexes have shown high efficacy and tolerance, excellent bio distribution and safety from off-targets and immunogenicity.

"This collaboration with Future Fields reflects our commitment to seeking new and innovative approaches to cost-effectively provide high-quality gene editing biologics at scale, and enable us to advance our sustainability goals," said Philip Roche, PhD, CEO of Jenthera Therapeutics. "With the EntoEngine platform, we can achieve large yields of our novel protein therapeutic, and spool up towards GMP much faster than other cell-based methods. This is integral to our strategy of delivering groundbreaking therapeutics and transforming oncology."

Future Fields is advancing a new biomanufacturing paradigm by harnessing fruit flies. With its biomanufacturing platform, the EntoEngine, the company is focused on making significant strides to increase the supply of recombinant proteins for biological drugs, shrink the cost of research and development, and diminish the carbon footprint of bioreactors. Future Fields aims to help the biopharmaceutical industry reduce the carbon impact caused by traditional bioreactors and enhance sustainability through synthetic biology.

"We’re incredibly excited to partner with the Jenthera team to bring cutting-edge, low-cost, and sustainable therapeutic proteins to patients in the clinical setting," said Matt Anderson-Baron, co-founder and CEO of Future Fields. "This partnership is the first of many demonstrations of the EntoEngine’s capabilities for revolutionizing biologics production and we’re excited to be starting with Jenthera’s groundbreaking technology in high-fidelity gene-editing complexes. The potential impact of this partnership on treating human diseases is limitless."

Starton Therapeutics Receives Authorization from the FDA to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma

On June 13, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported updates on its Phase 1b STAR-LLD clinical trial of its investigational continuous delivery lenalidomide in multiple myeloma (Press release, Starton Therapeutics, JUN 13, 2023, View Source [SID1234632683]).

The U.S. Food and Drug Administration ("FDA") notified the Company that it may proceed with the U.S.-based program in second-line transplant-ineligible patients using the combination of STAR-LLD, Velcade, and dexamethasone. This treatment paradigm will replace oral Revlimid with STAR-LLD. The planned study that follows this development will evaluate six patients for tolerability, immune biomarkers, and signals of efficacy of continuously delivered lenalidomide at the highest planned daily dose. The study is expected to accrue six patients in the United States in three to four centers over a period of 10 months and will provide readouts in the tolerability of the regimen, the impact of continuous delivery on immune function by measuring biomarkers of T-cell, NK-cell, and B-cell upregulation, and cytokine production induced by lenalidomide. It will also provide signals of efficacy in assessing response rates, duration of response, progression free survival, and changes in minimal residual disease.

Pedro Lichtinger, chairman and CEO of Starton Therapeutics commented, "Today’s announcement marks a significant development for Starton and patients in need of approved drugs and improved quality of life, and we are excited to begin this critical program in transplant-ineligible patients with multiple myeloma. This study will provide initial evidence of the impact of continuous delivery of lenalidomide both in terms of safety and efficacy, as well as provide clarity for signals of improvement in patients outcomes."

As part of the development plans, the FDA agreed to have a meeting to review the initial data on safety and activity from the study as an interim analysis, while patients continue treatment for efficacy endpoints. This interim review is aimed at helping develop the plans for the approval path forward with Phase 2 studies for multiple myeloma, as well as other malignancies where lenalidomide has shown activity but is not approved for the new indications planned for study.

Dr. Jamie Oliver, Starton’s chief medical officer noted, "We are very happy with the agreed protocol, which allows a quick read for the key safety and efficacy data which we will review with the FDA. The upcoming Phase 1b clinical study in multiple myeloma is on track to begin enrollment in Q4 2023. Treatment of second-line patients at our proposed optimal dose of continuous lenalidomide in combination with the proteasome inhibitor Velcade and dexamethasone allows us to demonstrate activity in an established standard of care regimen by replacing Revlimid with STAR-LLD."

Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) ("Healthwell"). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% tumor elimination vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >93% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose for Revlimid.

HighField Biopharmaceuticals Receives US FDA IND Clearance for Phase 1 Trial of Immunoliposome HF158K1 for Treatment of HER2 low and HER2+ Cancers

On June 13, 2023 HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, reported that the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug (IND) application for HF158K1, a drug encapsulated immunoliposome containing doxorubicin (Press release, HighField Biopharmaceuticals, JUN 13, 2023, View Source [SID1234632682]).

"It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."

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The company will conduct a Phase 1 multi-regional, open-label, clinical trial in patients who have advanced refractory solid tumors with HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers.

The trial, expected to begin this summer, will be conducted in the U.S., China and other countries. A Phase 1a dose escalation portion of the study will enroll 24 patients followed by Phase 1b dose expansion trial with up to 60 patients. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HF158K1.

"The FDA’s clearance of this IND is another milestone for our company," said HighField Bio CEO Yuhong Xu. "It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."

In addition, Dr. Xu said, "We believe our immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, our immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types."

Unlike ADCs, HighField Bio’s immunoliposome can deliver larger doses of active drug and target tumor cells using multiple antibodies. This means they not only are suitable for less toxic API than ADCs, but may also deliver greater efficacy because they have larger drug to antibody ratios that result in wider therapeutic windows, targeting more cancer cells with less dose-limiting toxicities.

In the Phase 1a dose escalation portion of the clinical trial, patients will be enrolled into one of six dose groups to determine the highest tolerated dose. The Phase 1b study will assess HF158K1 in two types of solid tumors, and patients will be enrolled in one of two dose groups based on the Phase 1a findings. For more information visit NCT05861895 on clinicaltrials.gov.