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.

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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."

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]).

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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.

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]).

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"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.

On June 13, 2023 Feldan Therapeutics, a biopharmaceutical company that specializes in the development of treatments based on intracellular delivery of therapeutics, reported the initial closing of a $16.5 million Series B investment (Press release, Feldan Therapeutics, JUN 13, 2023, View Source [SID1234632681]). The funds will primarily be used to conduct clinical phases I/II for Feldan’s FLD-103, an intralesional treatment against basal cell carcinoma (BCC), and to advance its pulmonary program to the preclinical stage.

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New investors Investissement Québec, Amgen Ventures (United States), GC Cell (South Korea) and FSIT2 join the renewed support of GC Holdings (South Korea) and other existing shareholders to help Feldan bring breakthrough treatments to clinical development.

"Feldan is excited to welcome a new group of investors to our existing syndicate as we are reaching an important milestone in our development," said Francois-Thomas Michaud, Chief Executive Officer and co-founder of Feldan. "We are very proud that despite the challenges that arose from the COVID pandemic and the current economic environment, a Québec-based company has been able to create a promising clinical-stage therapeutic and is now positioned to accelerate its development towards clinical trials. This highlights the great talent and resilience of our team, in addition to further establishing the potential of our technology."

Since having engineered a revolutionary peptide-based intracellular delivery technology, Feldan is determinedly working towards the development of treatments for patients with unmet medical needs. Feldan’s proprietary technology has been proven highly effective at delivering different types of molecules to various organs, allowing them to reach untapped intracellular therapeutic targets. The company has made notable breakthroughs in the delivery of Antisense Oligonucleotides (ASOs) to skin basal cells and lung epithelial cells.

Feldan’s focus is on the completion of clinical phases I/II of intralesional FLD-103 to treat basal cell carcinomas (BCC). BCC, the most common skin cancer and most frequent form of all cancers, affects 3.6 million people in the US and Canada each year and results in the development of tumors mainly in sun-exposed skin areas such as the face, neck and scalp. Patients affected by BCC mostly rely on surgery for removal of tumors, an effective yet disfiguring and invasive procedure leaving patients to deal with scarring and long recovery time. With FLD-103, Feldan aims to improve patients’ quality of life by offering them a nonsurgical, effective and minimally invasive therapeutic option.

Feldan will also be working on advancing its pulmonary delivery program towards preclinical development and further leveraging its intracellular delivery technology to offer life-changing therapeutics to patients.

"The life sciences are a strategic industry for Québec’s economy, and Feldan is a promising company in this sector. Investissement Québec’s support illustrates the critical role we play in bolstering local biopharmaceutical companies and bridging gaps in the financing chain. We are proud to support Feldan as their first product enters clinical trials and they continue to develop their technology." Guy LeBlanc, President and CEO of Investissement Québec.

"We are delighted that Amgen is investing in this leading Quebec-based biotech company," stated Ugur Gunaydin, General Manager of Amgen Canada. "As one of the world’s leading biotechnology companies, Amgen is fundamentally value based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Feldan’s novel and unique drug delivery technology is an example of the important innovation coming from Quebec’s Life Sciences sector. We are very excited to see this technology’s potential expanding in the development of next generation therapies for patients everywhere with unmet medical needs.

On June 13, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that the first patient has commenced treatment in its Phase 1-2 study evaluating the Company’s first-in-class antagonist of β-catenin, ST316 (Press release, Sapience Therapeutics, JUN 13, 2023, View Source;catenin-antagonist-st316-in-advanced-solid-tumors-301849508.html [SID1234632680]). Though a principal driver of many cancers, β-catenin has evaded drug discovery efforts for more than 30 years. ST316 is designed to selectively target oncogenic activation of the Wnt/β-catenin signaling pathway, without impacting its activity in normal cells.

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ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose-escalation portion of the study will test various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. With its first patient dosed on June 5, 2023, the Company expects to complete the Phase 1 portion of the study in the second half of 2024. Following completion of the study’s Phase 1 portion, the recommended dose will advance to the Phase 2 portion of the study, in which ST316 will be tested in four advanced solid tumor types that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. Sapience is conducting the Phase 1 study across several sites in the United States.

"Dosing our first patient with ST316 is a significant accomplishment for our team, which has remained undaunted by the challenge of drugging one of the most challenging cancer targets, the Wnt/β-catenin pathway," said Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer. "We are thrilled to advance our second molecule from the bench to the clinic. Given the relevance of Wnt/β-catenin in the development of multiple cancers, we are excited about ST316’s potential to make a meaningful difference for the many patients suffering from cancers driven by abnormalities in this pathway."

In March 2023, Sapience announced that it received IND clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1-2 clinical trial of ST316 for the treatment of solid tumors. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, Sapience presented late-breaking data on ST316 highlighting its immunotherapeutic potential. In May 2023, Sapience was awarded a $2 million SBIR grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support non-clinical studies for ST316.

About the Wnt/β-catenin Pathway
β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known pathway that is critically involved in embryonic development and adult tissue homeostasis. Wnt pathway hyperactivity is known to play a role in greater than 50% of solid tumors, in which it is a driver of oncogenesis and immune suppression. Because of the importance of the Wnt pathway in normal functioning adult cells, development of β-catenin-targeted therapies that block the Wnt pathway has been hampered by toxicity and off-target effects. There are currently no approved drugs that target the Wnt/β-catenin pathway.

About ST316
ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex that drives oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and inhibits formation of the Wnt enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven cancers without the toxicities previously seen with other Wnt pathway agents.

The Phase 1 dose-escalation portion of the Phase 1-2 study has begun enrolling and dosing patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase 2 dose-expansion portion will utilize the recommended ST316 dose to assess its safety and early efficacy in four specific tumor types that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway.