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.

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.

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.

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

On April 22, 2021 EDAP TMS S.A. (NASDAQ: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported the launch of a follow-on public offering of its American Depositary Shares, or ADSs, each representing one ordinary share of the Company (Press release, EDAP TMS, APR 22, 2021, View Source,ordinary%20share%20of%20the%20Company. [SID1234578410]).

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Piper Sandler is acting as the sole book-running manager for the offering.

A shelf registration statement on Form F-3 (including a prospectus) relating to the Company’s American Depositary Shares was filed with the Securities and Exchange Commission (the "SEC") and has become effective. The Company has also filed a preliminary prospectus supplement with respect to the proposed offering. Before purchasing ADSs in the offering, you should read the preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

The Company also announced that it expects to report that total revenues were between €10.0 million and €10.4 million for the three months ended March 31, 2021, primarily driven by strength in its Distribution division, as compared to €7.6 million for the same period in 2020, with the Company’s gross margin expected to be between 40% and 44% for the period, as compared to 40.2% gross margin for the same period in 2020. The Company also expects to report that its cash and cash equivalents were approximately €24.4 million as of March 31, 2021.

In this press release, the Company has presented preliminary estimates of certain unaudited financial information for the three months ended March 31, 2021. The Company has provided ranges, rather than specific amounts, for the preliminary estimates of the unaudited financial information primarily because its financial closing procedures for the three months ended March 31, 2021 are not yet complete and, as a result, its final results upon completion of its closing procedures may vary materially from the preliminary estimates. The preliminary results are not a comprehensive statement of the Company’s financial results for this period. In addition, even if the Company’s actual results are consistent with these preliminary results, those results or developments may not be indicative of results or developments in subsequent periods. The preliminary estimates for the three months ended March 31, 2021 presented in this press release have been prepared by, and are the responsibility of, management. KPMG S.A., the Company’s independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to such preliminary data. Accordingly, KPMG S.A. does not express an opinion or any other form of assurance with respect thereto, and you should not place undue reliance upon these preliminary estimates.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.