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.

On April 22, 2021 Clinical Outcomes Solutions (‘COS’), a global leader in the collection, analysis and reporting of patient-centered outcomes data with offices in Tucson and Chicago (USA) and Folkestone (UK), reported a collaborative partnership with Carevive Systems (‘Carevive’), the leading oncology-focused health technology company (Press release, Carevive Systems, APR 22, 2021, View Source [SID1234578408]).

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The two organizations, both deeply experienced with the collection and analysis of oncology data, are proud to announce that Carevive is joining the Oncology Outcomes initiative, launched in February 2019, to deliver world-class data and analysis to improve the patient experience and enhance survival outcomes of cancer patients.

The partnership will leverage Carevive’s innovative digital oncology platform to capture the patient experience while on treatment, and COS’ deep experience in analyzing these types of data, providing invaluable insights for life science companies and regulatory authorities.

The Carevive platform PROmpt enables cancer care teams to monitor and manage their patients remotely, which improves survival outcomes and patient quality of life. The platform also enables large-scale digital data collection via the Oncology Pragmatic Trial Investigator Network (Carevive OPT-IN), merging electronic medical records (EMR) with patient reported outcomes (PRO) to offer cancer centers a holistic, longitudinal view of their patient population for quality improvement and pathway enhancement purposes.

COS is a global leader in delivering innovative science to capture and communicate the patient voice, in order to provide actionable evidence through qualitative and quantitative research, with a specific focus on Clinical Outcomes Assessments in the oncology space. Through the partnership, COS will apply this expertise to providing data analytic support to generate insights from these novel patient experience datasets.

Stacie Hudgens, Chief Executive Officer at COS, said: "We are very excited to announce this partnership with Carevive, an organization that shares our deep-rooted passion for world-class oncology research to improve the patient experience.

"The depth and breadth of the Carevive datasets provide access to a host of data on solid tumors and liquid cancers, and will enhance our ability to improve the patient journey."

Bruno Lempernesse, Chief Executive Officer at Carevive, said: "Carevive is committed to reshaping the way cancer care is delivered so that therapies can become more personalized through the use of real-world patient data. We are delighted to announce this partnership with COS, an organization that has supported the development of our patient experience data collection efforts from its inception. By combining COS’ FDA and industry expertise with Carevive data, this partnership provides a model of how to approach real-world evidence and patient-reported outcomes with cancer care teams, regulatory authorities and life science companies."

Tara Symonds, Chief Science Officer at COS, added: "We have seen the benefit from monitoring patient symptoms over time while on treatment across numerous cancer types. Oncology treatments are highly toxic and can cause significant side effects. Thus, effective, real-time monitoring enables far quicker intervention and the opportunity to improve the patient experience and enhance symptom management.

"Research conducted by renowned medical oncologist and PRO expert Ethan Basch M.D., has shown that such intervention can add six months to survival, a significant finding for the benefit of patients with cancer. Digital Health Solutions, such as the Carevive platform, are the key to demonstrating the extent to which patients’ symptoms and quality of life are improved by particular treatments, and are rapidly becoming a critical tool for our clients when conducting real-world assessments of the impact of their drugs.

"The platform also offers additional benefits, such as the opportunity to design real-world studies for our clients, which would not be possible without access to Carevive’s database."

On April 22, 2021 MonTa Biosciences, a Danish clinical stage biotech company located in Copenhagen, reported the first patient has been dosed with Monta Bioscienes MBS8 in a Phase I clinical trial (Press release, MonTa Biosciences, APR 22, 2021, View Source [SID1234578399]). Patients with solid tumors are enrolled at two danish hospitals in Copenhagen, Rigshospitalet and Herlev Hospital. 30-50 patients will be enrolled over the next 18 months.

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MonTa Biosciences lead candidate MBS8 was administered intravenously to the first patient in the trial at Rigshospitalet in Copenhagen on Wednesday, April 21. The primary objective of the trial is to evaluate the safety of multiple escalating doses of MBS8 for patients with advanced solid tumours and to establish the maximum tolerated dose (MTD/recommended Phase 2 dose (RP2D). The effects on biomarkers and objective tumor response in the patients will also be assessed.

MBS8 treatment is an innovative way to stimulate the immune system to help the body fight cancer. MBS8 is a nanoparticle that contains an immune stimulating compound called a TLR7 agonist that activate certain types of immune cells which are able to enter tumor tissue from the blood and kill tumor cells. After weeks of treatment MBS8 is also able to stimulate immune memory T-cells to recognize and eliminate cancer cells, which is of particular interest to cancer patients with metastatic disease, where there is a huge unmet medical need for better treatment.

MonTa Biosciences’ CEO, Simon S Jensen said "We are very excited to have the first patient dosed with MBS8 and hope the drug will demonstrate to be safe for the patients, and even more important also have an impact on their cancer. With the new mode of action for MBS8, which has never been seen for any cancer drug before, we have high expectations to MBS8 and hope we already in this phase I will be able to help patients in need. It is quite rare to see drugs acting as monotherapy on the immune system as efficiently as MBS8, often cancer immunotherapy treatments are combined with other treatments to enhance their therapeutic activity."