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Thermo Fisher Scientific and JW Therapeutics Announce CAR-T Partnership in China

On February 3, 2021 Thermo Fisher Scientific, the world leader in serving science, reported that it has signed an agreement with JW Therapeutics, a leading cell therapy company, to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28 (Press release, Thermo Fisher Scientific, FEB 3, 2021, View Source [SID1234574589]).

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The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics’ lead product relmacabtagene autoleucel ("relma-cel"). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The therapy’s new drug application (NDA) has been accepted by China’s National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.

The CTS Dynabeads platform is part of Thermo Fisher’s proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. The CTS product line is a comprehensive portfolio of products designed to work together, from cell isolation/activation and gene transfer to cell expansion, to address cell therapy developers’ manufacturing workflow challenges. Thermo Fisher’s Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results.

"As JW Therapeutics progresses through the formal acceptance of a New Drug Application (NDA) for relma-cel, and its commercial plans accelerate, we’ll be alongside them ready to rapidly scale," said Mark Stevenson, executive vice president and chief operating officer, Thermo Fisher Scientific. "Our strategy to support partners ‘in China for China’ ensures that we can provide reliable supply and technical expertise as they scale precision medicines."

"This partnership is a natural extension of an already strong collaboration," mentioned Dr. Harry Lam, executive vice president and chief technology officer, JW Therapeutics. "As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients."

GEMoaB Announces UniCAR-T-CD123 Data from its Ongoing Phase I Study in Patients with Relapsed/Refractory AML (rrAML) to be Presented at Virtual 3rd EHA-EBMT European CAR T-Cell Meeting

On February 3, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported interim data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the Virtual 3rd EHA (Free EHA Whitepaper)-EBMT European CAR-T-Cell Meeting, which is held from February 04-06, 2021 (Press release, GEMoaB, FEB 3, 2021, View Source [SID1234574588]). The data are being presented as oral presentation by Dr. Martin Wermke, University Hospital Dresden, Germany (February 05, 12:20 CET) and as a poster presentation by Dr. Sabrina Kraus, University Hospital Würzburg, Germany (Abstract 68).

"These clinical results present a promising step forward as we continue to evaluate the safety and efficacy of UniCAR-T-CD123," said Professor Gerhard Ehninger, Chief Medical Officer of GEMoaB. "We are highly encouraged by the fact that UniCAR-T-CD123 has demonstrated a favorable safety and efficacy profile in rrAML. The clinical data nicely confirm our UniCAR key platform claims and provide the clinical proof of UniCAR’s rapid switch on/off and re-activation capability. We look forward to progressing our study and positioning UniCAR as a potentially superior cellular immunotherapy platform for patients with hard-to-treat advanced hematologic malignancies and solid tumors."

Data highlights for the oral presentation titled: "Proof-of-Concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML" include:

UniCAR-T-CD123 has been well tolerated to date with CRS (cytokine release syndrome) grade 1-2; no ICU admissions or dose limiting toxicities have been observed by the cut-off date; UniCAR-T-CD123 dose escalation is ongoing
Robust expansion of UniCAR-T-CD123 in peripheral blood and bone marrow, comparable to conventional CD123-targeting CAR-T products
Rapid recovery of neutrophils after stop of treatment with targeting module TM123 in all treated patients
Encouraging efficacy signals in the first 3 fully treated patients, with 1 PR (partial remission) and 2 CRi (complete remission with incomplete hematologic recovery) observed
The poster named "Re-activation of UniCAR-T-Cells with 2nd Cycle of Targeting Module TM123 in a Patient with Relapsed/Refractory AML" is summarizing data obtained on re-activation and re-expansion of UniCAR-T cells, leading to a CRi in the respective patient.

Both presentations will be available on the GEMoaB website following the congress.

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post bridging therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping TM infusion. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen binding moiety, linked to a small peptide motif recognized by UniCAR-T.

Eucure Biopharma Announces Encouraging Antitumor Activity of Its anti-CD40 Antibody in PD-1 Refractory Ocular Melanoma when Combined with Junshi Biosciences’ Toripalimab

On February 3, 2021 Eucure Biopharma, a biopharmaceutical company dedicated to developing immuno-oncology antibody drugs, reported that its investigational anti-CD40 antibody drug (YH003), when combined with Junshi Biosciences’ anti-PD-1 antibody Toripalimab (TUOYI), demonstrated encouraging anti-tumor activity in an ongoing Phase I/II clinical trial in Australia (Press release, Eucure, FEB 3, 2021, View Source [SID1234574586]). The trial is a multicenter, open label study, with an initial multiple-dose-escalation phase designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of YH003 in combination with Toripalimab in subjects with advanced solid tumors. The second phase is a cohort extension phase to assess the safety and preliminary efficacy of YH003/Toripalimab with or without chemotherapy in PD-1 refractory, advanced unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma.

A 68-year-old female subject with ocular melanoma and liver metastases who failed prior immunotherapy, including first-line Nivolumab (an anti-PD-1 antibody) and second-line Nivolumab/Ipilimumab (an anti-CTLA-4 antibody) combination therapy, was enrolled in the 0.1 mg/kg cohort. The subject received a single three-week cycle of YH003 monotherapy, followed by three cycles of YH003/Toripalimab combination therapy over a total of 12 weeks. Imaging assessments indicated a partial response at week 10 post-treatment, with a 38.5% reduction in the total diameter of all target lesions. No dose-limiting toxicity (DLT) was observed in the study, and the drug was well tolerated in the first two cohorts and in the ongoing third cohort.

In response, Dr. Yuelei Shen, Chairman of Biocytogen and CEO of Eucure Biopharma, commented, "We are pleased to see a patient experiencing partial remission in this first YH003 trial, which is going fast and smoothly in Australia. This result further assured us that our anti-CD40 compound YH003 has great potential to be developed into an oncology therapy in this post PD-1 era. We will take advantage of expedited regulatory programs to hopefully put this product on the market as soon as possible. Then, we will explore the full potential of this compound in a broad spectrum of indications."

About YH003

YH003 is a humanized agonistic antibody that promotes CD40 activation on antigen-presenting cells, and thus stimulates the effector activity of anti-tumor T cells. Whether used alone or in combination with anti-PD-1 antibodies, YH003 demonstrated potent anti-tumor effects in Biocytogen’s CD40 humanized mice, and significantly increased the proportion of anti-tumor T cells. YH003 demonstrated an excellent safety profile at very high doses, both in mice and primates.

About Toripalimab (TUOYI)

Toripalimab is the first anti-PD-1 monoclonal antibody to obtain a marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, Toripalimab was included in the National Reimbursement Drug List (NRDL) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

In the United States, the FDA has granted Toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.

DURECT Corporation Announces Proposed Offering of Common Stock

On February 3, 2021 DURECT Corporation (Nasdaq: DRRX) ("DURECT"), a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program, reported that it is commencing an underwritten public offering of its common stock (the "Offering") (Press release, DURECT, FEB 3, 2021, https://www.prnewswire.com/news-releases/durect-corporation-announces-proposed-offering-of-common-stock-301221648.html [SID1234574585]). All of the shares to be sold in the Offering will be sold by DURECT, subject to customary closing conditions. In addition, DURECT intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering will be filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

IPA Increases Previously Announced Bought Deal Offering of Common Shares to $21.7 Million

On February 3, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1,616,293 common shares of the Company (the "Common Shares"), at a price to the public of $13.45 per Common Share, less underwriting discounts and commissions, for gross proceeds to the Company of approximately $21.7 million (Press release, ImmunoPrecise Antibodies, FEB 3, 2021, View Source [SID1234574581]). The closing of the offering is expected to occur on or about February 8, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as sole book-running manager for the Offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 242,443 Common Shares at the public offering price, less underwriting discounts and commissions. The Company intends to use the net proceeds from the Offering for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission (SEC). The Company also filed a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system (MJDS). The Common Shares will only be offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares will be offered or sold to Canadian purchasers.

The Offering is being made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the offering. A short form base shelf prospectus and accompanying preliminary prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Copies of the short form base shelf prospectus and accompanying final prospectus supplement will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the final prospectus supplement and registration statement, when available, may also be obtained from H.C. Wainwright & Co. LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

Prospective investors should read the base shelf prospectus and the prospectus supplement as well as the registration statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.