On December 13, 2021 Biosion, Inc. ("Biosion"), a global, clinical stage biotechnology company, reported that Biosion and OBI Pharma Inc. (4174.TWO) ("OBI Pharma") have signed an exclusive license agreement under which OBI Pharma will be granted a global exclusive license to Biosion’s proprietary anti-Trop2 humanized monoclonal antibody, BSI04702, for developing next generation biologics (Press release, Biosion, DEC 13, 2021, View Source;and-other-derivative-products-301442963.html [SID1234597014]). The license agreement enables OBI Pharma to conduct further preclinical and clinical development, registration, and commercialization of BSI04702 as an Antibody Drug Conjugate and other derivative products. Under the terms of the agreement, OBI Pharma will pay license fees to Biosion, including an upfront payment, future development milestones and net sales royalties. The specific terms of the agreement were not disclosed.

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"Biosion has been driving innovation to deliver breakthrough therapies for cures. The licensing of our anti-TROP-2 mAb to OBI Pharma for global development further exhibits the strength of our discovery engine and proprietary SynTracerTM HT-endocytosis platform to identify superior mAbs, ideal as ADCs" said Dr. Hugh Davis, Chief Operating Officer of Biosion, Inc. and President of Biosion USA. "We are looking forward to partnering with OBI Pharma to advance BSI-04702 into the clinical stage as fast as possible and making a difference for patients worldwide."

BSI04702 was created through Biosion’s proprietary SynTracerTM HT-endocytosis platform, a high-throughput endocytosis screening application that can identify antibody candidates with high internalization rates- a critical parameter for lead antibody success in next generation ADC development.

On December 13, 2021 Bionomics Limited (Bionomics or Company), a clinical-stage biopharmaceutical company, reported the launch of its initial public offering (the Offering) of 1,620,000 American Depositary Shares (ADSs), each representing 180 ordinary shares, in the United States (Press release, Bionomics, DEC 13, 2021, View Source [SID1234596999]). The target size of the of the Offering is US$25.0 million in gross proceeds.

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All ADSs to be sold in the Offering will be sold by Bionomics. In addition, Bionomics expects to grant the underwriters an option to purchase up to an additional 243,000 ADSs within 30 days from the date of the final prospectus at the initial public offering price, less underwriting discounts and commissions.

Bionomics has applied to have its ADSs listed on the Nasdaq Global Market under the symbol "BNOX." Bionomics’ ordinary shares are currently traded on the Australian Securities Exchange (ASX) under the symbol "BNO."

Evercore ISI and William Blair are acting as lead book-running managers for the Offering. Cantor, Berenberg and H.C. Wainwright & Co. are acting as book-running managers for the Offering.

The Offering will be made only by means of a prospectus under the U.S. Securities Act of 1933. When available, copies of the preliminary prospectus relating to and describing the terms of the Offering may be obtained from (i) Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at [email protected] ; or (ii) William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at [email protected] . Australian investors are only eligible to invest under the prospectus if they are exempt from disclosure as sophisticated or professional investors under the Corporations Act 2001 (Cth).

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy these securities be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. As disclosed in the registration statement, the underwriters may purchase and sell ADSs in the open market, including to cover over-allotments.

Released on authority of the Company Secretary.

On December 13, 2021 Nektar Therapeutics (NASDAQ:NKTR) reported two data presentations from the dose-escalation portion of its ongoing Phase 1 study of NKTR-255 in patients with relapsed/refractory hematologic malignancies at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, DEC 13, 2021, View Source [SID1234596998]).

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Initial clinical results from the Phase 1 study of NKTR-255 in patients with relapsed/refractory (R/R) hematologic malignancies were presented by Nina Shah, M.D., Associate Professor, Department of Medicine, at the University of California San Francisco on Monday, December 13th. A pharmacodynamic analysis of CAR-T cell persistence in patients treated in the Phase 1 study who had received prior treatment with CAR-T therapy was also presented by Alexandre V. Hirayama, M.D., Fred Hutchison Cancer Research Center on Sunday, December 12th.

"The data presented at this year’s ASH (Free ASH Whitepaper) meeting underscore the potential of NKTR-255 and provide clinical evidence of its unique ability to trigger the induction of natural killer and CD8+ T cells and highlight its potential role in rescuing and enhancing CAR-T cell persistence," said Jonathan Zalevsky, Ph.D., Head of Research and Development at Nektar. "Engaging the full spectrum of IL-15 biology, NKTR-255 can be combined with multiple mechanisms to potentially improve their efficacy. The clinical data presented at ASH (Free ASH Whitepaper) support the development of NKTR-255 in combination with anticancer agents that induce antibody dependent cellular toxicity as well as CAR-T therapies. We look forward to completing the dose escalation portion of this Phase 1 study in the first half of 2022 and further investigating NKTR-255 in combination with rituximab or daratumumab for patients with non-Hodgkin’s lymphoma or multiple myeloma."

2021 ASH (Free ASH Whitepaper) presentations are available for download at View Source

Highlights from the presentations are as follows:

Abstract #3134: "Safety, Tolerability, PK/PD, and Preliminary Efficacy of NKTR-255, a Novel IL-15 Receptor Agonist, in Patients with Relapsed/Refractory Hematologic Malignancies," Shah, N., et al.

NKTR-255 was well tolerated and early evidence of clinical activity was observed in this heavily pre-treated and highly refractory patient population with hematologic malignancies. Treatment-related adverse events were generally low-grade, transient and easily managed.
Evidence of on-target biological activity was observed despite highly compromised bone marrow hematopoietic capacity; NKTR-255 led to expansion and proliferation of natural killer (NK) and CD8+ T cells.
Among the 15 response-evaluable patients, 8 (53%) reported disease stabilization (5/8 [63%] patients with multiple myeloma (MM); 3/7 [43%] patients with non-Hodgkin lymphoma (NHL)).
One patient with NHL (with 3 prior lines of therapy) was treated at the 1.5 µg/kg dose and experienced a metabolic response in a splenic target lesion at cycle 5.1
Two patients with MM (with 3 prior lines of therapy) were treated at the 1.5 µg/kg and the 4.5 µg/kg doses and experienced disease stabilization for greater than 180 days.
The maximum tolerated dose/recommended Phase 2 dose has not been reached and dose escalation of NKTR-255 is ongoing.
Abstract #2815: "Pharmacodynamic Analysis of CAR-T Cell Persistence in Patients with Hematologic Malignancies Treated with NKTR-255, an IL-15 Receptor Agonist That Enhances CD8+ T cells: Preliminary results from a Phase 1 Study," Hirayama, A., et al.

This is the first clinical safety and pharmacodynamic assessment of the effects of any IL-15 agent on CAR-T cell counts in relapsed/refractory NHL or MM patients who had progressed or relapsed after CAR-T therapy.
Of the patients with detectable CAR-T cells in blood at baseline, 100% (4/4) showed an increase of CD3+ CAR-T cells following NKTR-255 treatment. NKTR-255 induced proliferation of CD8+ T cells and an increase of the total CD8+ cell fraction in all patients with CAR-T cells at baseline.
These preliminary data suggest that NKTR-255 administration represents a potentially novel means of CAR-T augmentation through enhancement and persistence of CD8+ T cells via generation of long-term memory CD8+ and provides promising evidence of CAR-T cell rescue.
Results support planned evaluation of NKTR-255 in combination with CAR-T therapy as a potential strategy to enhance the efficacy of CAR-T therapy.
NKTR-255 is currently being evaluated in dose-escalation in a Phase 1 study in patients with R/R non-Hodgkin’s lymphoma and R/R multiple myeloma (NCT04136756) and in a Phase 1b/2 trial in combination with ERBITUX for the treatment of R/R colorectal cancer and R/R squamous cell carcinoma of the head and neck (NCT04616196). In collaboration with Merck KGaA, Darmstadt, Germany, Nektar will also be investigating NKTR-255 in combination with BAVENCIO, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma in the randomized Phase II JAVELIN Bladder Medley study.

About NKTR-255
NKTR-255 is a novel polyethylene glycol-conjugate of recombinant human interleukin-15, which was designed to retain all known receptor binding interactions of the IL-15 molecule. The investigational candidate is uniquely designed to overcome known challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses. Through an extended circulating half-life and optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional natural killer cell populations and formation of long-term CD8+ mediated immunological memory, which may lead to sustained anti-tumor immune response.

On December 13, 2021 Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1b clinical development of its chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD20 (C-CAR039) (Press release, Cellular Biomedicine Group, DEC 13, 2021, View Source [SID1234596995]). C-CAR039 is a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens in the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r B-cell NHL).

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"This is fantastic news for us as we believe we may potentially have best-in-class therapeutics for patients with poor prognosis. The largest subtype of NHL is DLBCL, and those refractory patients whose treatment has failed have limited options. We look forward to initiating the C-CAR039 trial soon," said Tony (Bizuo) Liu, Chairman and CEO. "The FDA’s C-CAR039 IND application clearance is a significant milestone for CBMG. We are fond of our manufacturing, quality control, and clinical development teams for their dedication to our mission of ‘Saving Lives and Revitalizing Lives’ and bringing to market innovative targeted therapies to address cancers."

Yihong Yao, PhD, Chief Scientific Officer of CBMG, commented, "We are excited about the potential of C-CAR039 as a best-in-class treatment in r/r B-NHL. C-CAR039 clearly showed potential superior efficacy and favorable safety results for patients with r/r B-cell NHL. Our C-CAR039 trial is a testament of the teams’ translational medicine capability. We look forward to bringing more potentially promising development to clinical trials."

About C-CAR039
Early clinical results of C-CAR039 from an investigator-initiated trial (IIT) conducted across multiple sites in China demonstrate exciting efficacy and favorable safety data of C-CAR039 in r/r B-cell NHL. As of April 20, 2021, a total of 34 patients received C-CAR039 cell therapies, with 28 patients evaluable for safety analyses and 27 patients evaluable for efficacy analyses. Patients’ median age was 55.5 years, and 75% had cancer of Ann Arbor stage III/IV. Patients had a median of three prior lines of therapy. Bridging therapy had been given to 17.9% of patients. The best overall response rate (ORR) was reported to be 92.6%, with a complete response rate (CRR) of 85.2%. Patients had a median time to response of 1.0 month, and at a median follow-up of 7 months, 74.1% of patients continued to be in complete remission. The 6-month estimated progression-free survival rate was 83.2% (95% CI, 69.1%-100.0%). Cytokine release syndrome (CRS) occurred in 96% of patients. 92% of CRS was of grade 1/2 and only 1 patient had grade 3 CSR. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no ≥grade 2 neurologic events reported in the study. CBMG will continue to evaluate patients with longer follow-up (ClinicalTrials.gov Identifiers: NCT04317885, NCT04655677, NCT04696432, NCT04693676).

Separately, in June 2021, the FDA Office of Orphan Products Development granted CBMG an Orphan Drug Designation to C-CAR039 for the treatment of Follicular Lymphoma, an indolent form of non-Hodgkin lymphoma.

About CBMG
Cellular Biomedicine Group Inc. (CBMG) is a wholly owned subsidiary of CBMG Holdings. CBMG Holdings ("Holdings") develops proprietary cell therapies for the treatment of cancer and degenerative diseases. CBMG operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the United States. Holdings conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Holdings’ GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Holdings currently conducts ongoing studies in China, for CAR-T therapies targeting blood cancers, including C-CAR039, an anti-CD19, CD20 BiCAR treatment for non-Hodgkin lymphoma (NHL) and CAR088, an anti-BCMA treatment for Multiple Myeloma, in addition to T cell receptor (TCR-T) and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. Holdings has completed patient treatment in a Phase II trial for AlloJoin, its "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and a Phase II trial for ReJoin autologous haMPC therapy for the treatment of KOA.

On December 13, 2021 Ryvu Therapeutics (WSE: RVU) a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported updated clinical and preclinical data demonstrating the single-agent activity of its two lead oncology drug candidates, RVU120 and SEL24 (MEN1703) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, held December 11 – December 14, 2021, in Atlanta, as well as at the 44th Annual San Antonio Breast Cancer Symposium (SABCS) held December 7 – December 10, 2021 (Press release, Ryvu Therapeutics, DEC 13, 2021, View Source [SID1234596993]).

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Presented data included updated clinical results for RVU120, a selective CDK8/19 inhibitor being developed for the treatment of hematological malignancies and solid tumors. The first-in-human (FIH) Phase 1b dose-escalation trial (CLI120-001), which is currently enrolling patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS), has thus far demonstrated an acceptable safety profile and preliminary signs of efficacy for RVU120.

With a data cutoff of November 16, 2021, data highlights include:

A Complete Remission (CR) in an AML patient harboring mutations in DNMT3A and NPM1. Supportive translational data were also presented demonstrating the anti-leukemic activity of RVU120 in PDX AML models bearing DNMT3A and NPM1 mutations.
An erythroid response (ER) in a HR-MDS patient who had relapsed after several lines of previous treatment; as of the data cutoff, this patient remains on study treatment with stable disease for more than 15 months. Supportive translational data were also presented demonstrating that RVU120 induces erythroid differentiation in (Lin-) CD34+ cells.
Acceptable safety profile in 6 patients completing safety evaluations for cycle 1. None of these patients experienced dose-limiting toxicity (DLT). A total of 12 serious adverse events (SAEs) have been reported – none were deemed to be related to the study drug.
An additional poster on the potential efficacy of RVU120 in hormone-negative breast cancer models was presented at the 2021 San Antonio Breast Cancer Symposium, which showed that oral administration of RVU120 demonstrated strong anticancer activity in a TNBC xenograft model.

Ryvu licensee Menarini Group presented updated Phase 2 data for SEL24 (MEN1703) (DIAMOND-01, ClinicalTrials.gov identifier: NCT03008187), showing pharmacodynamics (PD) and genomic profiling in the First-in-Human Diamond-01 trial.

"We are delighted to present data update at the ASH (Free ASH Whitepaper) and SABCS conferences, including clinical responses in the Phase Ib trial of RVU120, and exciting translational data for this project", said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu Therapeutics. "We have managed to achieve several important development milestones across our pipeline in 2021, highlighting our commitment to challenge current treatment paradigms and develop therapeutics that address clinical limitations of current treatments in oncology. In 2022, we expect to achieve additional clinical milestones for our two lead oncology drug candidates, RVU120 and SEL24, as we remain focused on developing new and innovative therapeutics for patients suffering from cancer."

Posters presented at the 63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition included:

CLI120-001 Phase Ib Study of RVU120 (SEL120) in Patients with AML and High-Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation (Publication Number: 3418)
RVU120 (SEL120) CDK8/19 Inhibitor – a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation (Publication Number: 1518)
Inhibition of Cyclin Dependent Kinase 8 (CDK8): A Novel Approach to Target the Leukemia Initiating Cells (LICs) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) (Publication Number: 2250)
Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML (Publication Number: 2371)
SEL24(MEN1703) Inhibits PIM/FLT3 Downstream Target in Acute Myeloid Leukemia (AML) Patients: Results of the Pharmacodynamics (PD) Assay and Genomic Profiling in the First-in-Human Diamond-01 Trial (Publication Number: 3436)
Selective CDK8/CDK19 inhibitor RVU120 demonstrates efficacy against hormone-independent breast cancer cells in vitro and in vivo (#1766), presented at the 2021 San Antonio Breast Cancer Symposium.