On June 14, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that it will host a virtual investor event on Wednesday, June 21, at 9:00 a.m. EDT / 3:00 p.m. CEST (Press release, MorphoSys, JUN 14, 2023, View Source [SID1234632672]).

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During the event, Jean-Paul Kress, M.D., MorphoSys’ Chief Executive Officer, and Tim Demuth, M.D., Ph.D., MorphoSys’ Chief Research and Development Officer, will discuss the potential of the company’s lead investigational asset, pelabresib. There will also be live presentations from – and a Q&A opportunity with – key opinion leaders John Mascarenhas, M.D., Professor of Medicine and Director of the Adult Leukemia Program at The Tisch Cancer Institute at Mount Sinai, New York, and Gabriela Hobbs, M.D., Assistant Professor of Medicine at Harvard Medical School, and Clinical Director of Leukemia Service at Massachusetts General Hospital.

Topics will include an overview of the disease burden for patients with myelofibrosis, including treatment gaps; a recap of encouraging findings in myelofibrosis from the pelabresib Phase 2 MANIFEST study in combination with ruxolitinib and background on the Phase 3 MANIFEST-2 study, which will report topline results by the end of 2023; and new proof of concept results and expansion plans for pelabresib in other myeloid diseases. The full agenda is below.

To access the live webcast, including audio, video and presentation slides, visit the Investors section of the MorphoSys website at View Source

A replay of the webcast and presentation will be available on the company’s website after the event.

Agenda:

Presenter Presentation
Jean-Paul Kress, M.D.
Chief Executive Officer, MorphoSys
Welcome and opening remarks
Gabriela Hobbs, M.D.
Assistant Professor of Medicine at Harvard Medical School and Clinical Director of Leukemia Service at Massachusetts General Hospital
Myelofibrosis burden of disease and medical need
John Mascarenhas, M.D.
Professor of Medicine and Director of the Adult Leukemia Program
at The Tisch Cancer Institute at Mount Sinai, New York
Pelabresib in myelofibrosis update
Tim Demuth, M.D., Ph.D.
Chief Research and Development Officer, MorphoSys
Pelabresib clinical development road map
All presenters Moderated Q&A

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.

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.

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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."

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.