On April 06, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that an Investigational New Drug ("IND") application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been approved by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, APR 6, 2022, View Source [SID1234611511]).

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SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"), submitted the IND, for a small Phase I clinical trial investigating safety, earlier this year. 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA triggered a $1 million milestone payment to SELLAS, which the Company expects to receive in the second quarter of 2022. 3D Medicines’ current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $191.5 million, not including future royalties.

"We are pleased that the 3D Medicines’ IND application filed earlier this year is now approved by China’s NMPA which allows 3D Medicines to move forward with their planned Phase 1 clinical trial. This marks the beginning of development of GPS in China which is an important milestone for SELLAS," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS.

About 3D189
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.

3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.

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.

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.

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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.

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.

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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.

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.

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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.