Vyant Bio, Inc., Orda?s Bio, and Cellaria, Inc. Announce Collaboration to Design and Qualify Biomarker-Specific Small Protein Therapeutics

On April 22, 2021 Vyant Bio, Inc. ("Vyant" or the "Company") (Nasdaq: VYNT), an emerging leader in novel drug discovery techniques, reported a collaboration that will seek to de-risk the development of small protein therapeutics (Press release, Cellaria, APR 22, 2021, View Source [SID1234578443]). In partnership with Ordaōs Bio ("Ordaōs") and Cellaria, Inc. ("Cellaria"), the Company is unveiling a model for rapid iteration of therapeutic design using artificial intelligence and in vitro ‘avatar clinical trials’ that will enable the design, development, and testing of potential therapeutics on specific patient populations, during preclinical development. The goal is to provide an early detection system of a drug’s efficacy in different patient cohorts, prior to clinical trials.

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The collaboration capitalizes on the unique capabilities of each company to design, manufacture, and test small-protein therapeutics that target multiple biomarkers derived from whole genome sequencing of patient populations. Using proprietary AI, Ordaōs will generate in silico protein sequences, designed to bind specific disease targets, and will serve as a blueprint for the collaborative team’s experts in in vitro and in vivo preclinical drug discovery, to produce the protein and rapidly iterate the structure using a highly efficient expression system. Using Cellaria’s Patient Specific Cell Model Cohorts, the purified protein will be critically evaluated for target binding and further optimized to improve performance across an array of disease-specific genetic biomarker expressing cells. Once fully optimized by the team, Vyant Bio’s objective will be to deliver regulatory readiness and a maximally de-risked drug candidate. The combined solution will provide data and human-based insights not usually available until after a costly clinical trial.

"Vyant Bio is committed to transforming the way that drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our collaboration with Ordaōs and Cellaria allows us all to work together to design and develop superior therapeutics and position them to be as successful as possible before they get into the clinic."

Cellaria Inc. uses cell biology in novel ways to provide insights into how a therapeutic may perform in specific patient populations, prior to clinical trials. In this collaboration, Cellaria provides the means for scientists to test how a drug will perform in a range of patient cohorts. The Cellaria in vitro and 3-D Models of tumor and metastatic niches are directly linked to a patient’s disease state and enable multiple parametric deep data sets in genomics, proteomics, and combinatorial analysis.

"Working with the Ordaōs and Vyant Bio teams has been incredibly important for us. Seeing the wealth of patient data and cells used so seamlessly to inform and guide the design of a therapeutic is highly rewarding," stated David Deems, President and Founder of Cellaria Inc. "We are developing a repeatable process that leverages well defined patient cohorts to learn as much as possible prior to embarking on a clinical trial."

Ordaōs uses generative AI technology to accelerate the mini protein drug discovery and development process. In this collaboration, Ordaōs provides a pipeline of digitally optimized therapeutics for further development. The company was founded by David Longo, a Stanford and Harvard-trained AI and biotech scientist, and Ulo Palm, MD, PhD, a 30-year veteran of clinical drug discovery and development at Allergan, Novartis, and Schering Plough.

"We are very excited about working with Vyant Bio and Cellaria to further our vision for transforming the way we bring therapeutics to patients. At Ordaōs, we believe that designing, rather than discovering, drugs is now possible with AI and will allow us to think bigger when we envision the impact we can have on people’s lives." said David Longo, CEO of Ordaōs.

Ülo Palm, Ordaōs’ Chief Medical Officer, added that "the ultimate goal is to use modern AI to design the next generation of highly effective and safe biologics for treating cancer and inflammatory diseases thereby creating transformative treatment options for potentially millions of patients worldwide. We expect that this new approach will significantly accelerate drug R&D overall and get the new drugs to patients much faster than with the traditional drug development approach. Patients who suffer from chronic and life-threatening diseases cannot wait. That is why this new collaboration is so important."

The three companies will continue to refine their strategies for drug design and development through a series of projects targeting cancer, pancreatic, and autoimmune disorders. As the project evolves, the therapeutic de-risking strategy will further incorporate the human-based biology and analytical software of StemoniX, a wholly owned subsidiary of Vyant Bio.

PEP-Therapy raises €2.75 million in Series A financing to advance its lead candidate, PEP-010, into the clinic

On April 22, 2021 PEP-Therapy, a biotechnology company developing cell penetrating peptides as targeted therapies for the treatment of cancers, reported it has raised a €2.75 million in a Series A financing round (Press release, PEP-Therapy, APR 22, 2021, View Source [SID1234578434]). The financing was led by Italian Angels for Growth (IAG), with participation from Doorway, Magna Capital Partner (MCP) and Business Angels des Grandes Ecoles (BADGE) as well as existing investors Seventure Partners (Quadrivium 1 Seed Fund) and Dr. Bernard Majoie (former Chairman and CEO of Laboratoires Fournier).

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The financing round is complemented by a €2.9 million grant from the French state innovation fund – Fonds Unique Interministériel (FUI) – previously received by PEP-Therapy, Institut Curie and Gustave Roussy to develop PEP-010 up to the end of Phase Ia/b clinical trials.

PEP-Therapy will use the funds to progress the clinical development of PEP-010, PEP-Therapy’s lead Cell Penetrating & Interfering Peptide (CP&IP), for the treatment of advanced solid tumors. With this Series A funding, PEP-Therapy expects to generate promising Phase Ia/b clinical data in two indications where patients have a poor prognosis and limited therapeutic alternatives: triple negative breast cancer (TNBC) and the platinum resistant ovarian cancer (OC).

Antoine Prestat, CEO and co-founder of PEP-Therapy said: "We are pleased to have raised these new funds from a syndicate of high-quality and international investors, as well as from our historic shareholders, who all share our ambition, commitment, and vision for PEP-Therapy’s development. We are preparing for the first-in-human trials with PEP-010 and look forward to generating the clinical results that we hope will confirm the very promising results seen in preclinical studies."

Michele Marzola, Life Sciences Lead Investor at IAG, said: "The investment in PEP-Therapy fulfils our objective of supporting innovative companies that will make a difference in the clinic as well as have an impact on society. We have been impressed by the excellent preclinical data that we have seen, and we expect the Company to demonstrate that PEP-010 can address unmet medical needs in difficult to treat ovarian cancer and triple negative breast cancer in the upcoming clinical studies."

Philippe Tramoy, Partner at Quadrivium 1 Seed Fund – Seventure Partners, said "We look forward to working alongside the company’s new investors to support PEP-Therapy in leveraging its CP&IP platform to generate a pipeline of best-in-class peptides, which promises to improve the treatment of aggressive cancers."

PEP-010 is the first of a new class of therapeutic peptides based on PEP-Therapy’s innovative CP&IP technology. These innovative molecules penetrate cells and specifically block relevant intracellular protein-protein interactions, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms.

PEP-Therapy and Institut Curie, France’s leading cancer center, have recently been granted approval from the French National Agency for Medicines and Health Products (ANSM) to start first-in-human clinical trial of PEP-010.

Bio-Path Announces Publication in Biomedicines

On April 22, 2021 Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines (Press release, Bio-Path Holdings, APR 22, 2021, View Source [SID1234578429]).

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The article, titled "The Challenges and Strategies of Antisense Oligonucleotide Drug Delivery," describes the challenges facing the antisense oligonucleotide drug delivery landscape, including stability in the bloodstream, delivery to target sites, and cellular uptake. In addition, the authors outline why prexigebersen, a liposome-incorporated antisense oligodeoxynucleotide targeted against the Grb2 mRNA, has the potential to overcome these challenges.

The article was authored by Maria Gagliardi, Ph.D., Research Scientist at Bio-Path Holdings and Ana Tari Ashizawa, Ph.D., Senior Vice President of Research, Development and Clinical Design at Bio-Path Holdings.

"We believe prexigebersen has the potential to overcome the challenges of antisense oligonucleotide drug delivery because it is uncharged and is essentially non-toxic, as demonstrated in preclinical and clinical studies. Additionally, its enhanced biodistribution makes it an attractive therapeutic modality for hematologic malignancies as well as solid tumors," said Dr. Ashizawa.

Bristol Myers, flush with pair of CAR-T approvals, blueprints first cell therapy factory in Europe

On April 22, 2021 Bristol Myers Squibb reported that upcoming cell therapy plant in the Netherlands should help slash turnaround times for patients receiving its CAR-T therapies there (Press release, Bristol-Myers Squibb, APR 22, 2021, View Source [SID1234578425]).

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Right on the heels of not one, but two CAR-T approvals in the U.S., Bristol Myers Squibb is bolstering its commercial cell therapy ambitions on the other side of the Atlantic.

The company on Thursday pegged Leiden, Netherlands, as the home of its first cell therapy factory in Europe and its fifth worldwide. With planning for site design and development underway, BMS expects construction to kick off later this year.

BMS’ swift cell therapy scale-up, which also includes a commercial plant-to-be in Massachusetts, follows FDA green lights for the company’s closely-watched CAR-T therapies Breyanzi and Abecma in February and March, respectively. Neither med has won an approval yet in Europe.

The new Leiden plant will be kitted out for commercial manufacturing of multiple cell therapy products using cutting-edge tech. For one, the company will tap virtual reality to train incoming cell processing workers, a BMS spokeswoman said via email. The company will make use of electronic batch records, as well as automated bioreactors and automated cartridge-based flow cytometers at the plant, she added.

The site, which will stand at around 19,000 square meters (204,514 square feet), will also be equipped to handle future capacity upgrades.

BMS offered a glimpse at some of the other tech it’s working on during a virtual cell therapy manufacturing tour with reporters last month. At the time, the company said it was working on a platform that could cut CAR-T manufacturing timelines from weeks to less than 10 days, plus new tech to speed up testing, which takes eight days now.

As part of BMS’ cell therapy push in Europe, the company will hire "several hundred" new staffers over the coming years, Ann Lee, Ph.D., senior vice president of cell therapy development and operations at BMS, said in a release.

CAR-T meds are created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill disease.

The company’s lymphoma CAR-T Breyanzi scored approval in early February with a 24-day target turnaround time from T-cell collection to delivery back to the patient. In the U.S., BMS handles the bulk of the manufacturing work itself.

The Leiden plant will help BMS collect and manufacture cell therapies in Europe without the barrier of intercontinental shipping. Reducing manufacturing lag time is critical for all CAR-T players.

CAR-T manufacturing is a complicated beast—a lesson BMS knows only too well. In December, the FDA hit a Lonza facility producing viral vectors for Breyanzi with a Form 483, a development that might have played a role in the company’s inability to score an FDA approval for the drug in 2020. Breyanzi’s approval by year-end 2020 was a key requirement for a multibillion-dollar payout for investors.

The FDA had also flagged concerns at BMS’ Bothell, Washington, plant in October. Now, however, the Bothell facility is equipped for commercial production, and the company’s Summit, New Jersey, plant is making the switch to turn out therapies for the market.

In late February, BMS unveiled designs on a 244,000-square-foot cell therapy factory in Devens, Massachusetts. The company hopes to start engineering runs at the plant in late 2021 or early 2022, Snehal Patel, global head of cell therapy manufacturing at BMS, said during last month’s tour. Once the plant is up and running, BMS says it will use the site for a good chunk of its commercial cell therapy manufacturing.

Agenus to Provide Corporate Update and First Quarter 2021 Financial Report

On April 22, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that it will release its first quarter 2021 financial results before the market opens on Thursday, May 6, 2021 (Press release, Agenus, APR 22, 2021, View Source [SID1234578411]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day to discuss the results and to provide a corporate update.

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Conference Call
Dial-in numbers: (800) 446-1671 (US) or (847) 413-3362 (International); Confirmation Number: 50150591.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source