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Pregene Enters into Innovative Partnership with CellPoint to Develop anti-BCMA CAR-T Cell Therapy in Europe and the US

On April 6, 2022 Shenzhen Pregene Biopharma, a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and commercializes innovative medicines and CellPoint, a cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), reported an exclusive license agreement for the development and commercialization of PRG-1801, Pregene’s single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the United States (Press release, PreGene, APR 6, 2022, View Source [SID1234611510]).

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PRG-1801 is a single domain antibody anti-BCMA CAR-T cell therapy in development for the treatment of relapsed/refractory multiple myeloma that has demonstrated strong signs of efficacy and an excellent safety profile in its initial investigator-initiated trial and Phase I/II clinical trials.

Under the terms of the collaboration, Pregene will receive over €20 million of upfront and near-term consideration, and is eligible to receive additional development, commercial milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US. As part of this partnership, Pregene will also provide translational and lentivirus manufacturing services to be reimbursed by Cellpoint.

"We are excited to partner with Cellpoint to develop CAR-T cell therapies via a POC platform," said Jishuai Zhang, Chief Technology Officer and Co-founder of Pregene. "The potential of our single domain antibody fully human BCMA CAR-T to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR-T product candidate. We expect the POC modality to enable faster treatment for broader patients using our differentiated CAR-T therapy, and we look forward to working with the team at CellPoint as they seek to develop and commercialize PRG-1801."

Tol Trimborn, Chief Executive Officer of CellPoint, said: "We are very pleased to add Pregene’s novel anti-BCMA CAR-T therapy to our CAR-T portfolio and look forward to develop it using our decentralised, POC manufacturing model. This is our second clinical stage program and we have demonstrated we can provide cell therapy to cancer patients in only 6 days vein-to-vein, from apheresis to infusion. We are excited to work closely alongside Pregene to bring this to patients with a convenient, readily available treatment alternative."

About PRG-1801 (anti-BCMA CAR-T)

PRG-1801 is an anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in an investigator initiated trial and Phase I/II clinical trials. In addition to multiple myeloma, Pregene is investigating PRG-1801 in patients with autoimmune diseases. In May of 2021, Pregene and Dr. Reddy’s Laboratories announced a license agreement whereby Dr Reddy’s acquired the exclusive rights in India for PRG-1801.

Clinical trials of PRG-1801 include:

Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma. Available clinical data showed overall response rate (ORR) of 100%. A Phase II clinical trial is now ongoing.
Investigator-initiated trial in China to evaluate the safety and efficacy of PRG-1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.

Plexium Announces Participation of its CEO, Percival Barretto-Ko, at Longwood Healthcare Leaders Spring MIT Web Conference

On April 6, 2022 Plexium, Inc. (Plexium), a leading next-generation targeted protein degradation (TPD) company, reported that Plexium President & CEO, Percival Barretto-Ko, will participate at the Longwood Healthcare Leaders Spring MIT webconference in a panel titled Cultivating An Ecosystem Of Partners on Wednesday, May 4, 2022 (Press release, Plexium, APR 6, 2022, View Source [SID1234611509]). The conference is being held virtually May 4-5, 2022.

Longwood Healthcare Leaders meetings bring together leading biotech and pharma CEOs, heads of R&D, top academics, and healthcare investors for off-the-record discussions to drive transparency and collaboration in order to accelerate the translation of discoveries into medicines to help patients. Substantial donations enabled by these meetings benefit several charities.

To learn more about the event, view the agenda, and request an invitation, visit www.longwoodhealthcareleaders.com.

IGM Announces Closing of $230.0 Million Public Offering

On April 6, 2022 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the closing on April 1, 2022 of its previously announced underwritten public offering of 8,695,653 shares of its non-voting common stock and, pursuant to the exercise in full by the underwriters of a 30-day option to purchase additional shares, 1,304,347 shares of its voting common stock, each at a price to the public of $23.00 per share (Press release, IGM Biosciences, APR 6, 2022, View Source [SID1234611508]). IGM received total gross proceeds of approximately $230.0 million from this offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM. All of the shares in the offering were sold by IGM.

J.P. Morgan, BofA Securities, Stifel, and Guggenheim Securities acted as joint book-running managers for the offering.

The securities in the offering were offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and declared effective on August 19, 2021. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255, or via email: [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

CTI BioPharma to Present at the 21st Annual Needham Virtual Healthcare Conference

On April 6, 2022 CTI BioPharma Corp. (NASDAQ: CTIC) reported that management will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference at 1:30 p.m. ET (Press release, CTI BioPharma, APR 6, 2022, View Source [SID1234611507]). The conference will be held in a virtual meeting format.

Presentation details:

Event: 21st Annual Needham Virtual Healthcare Conference
Date: Wednesday, April 13, 2022
Time: 1:30 p.m. ET

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

ArcticZymes is attending France Bioproduction Congress 6th Edition

On April 6, 2022 ArcticZymes Technologies reported that it is participating at the France Bioproduction Congress 6 edition in Paris-Saclay from the 7th to 8th of April (Press release, Biotec Pharmacon, APR 6, 2022, View Source [SID1234611505]).

Dr. Laurent Spenle is looking forward to meeting you at booth 8 for a discussion in how our Salt Active Nucleases can improve the efficiency of your bioproduction process.