On December 20, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported that the Company has received approval from the Center for Drug Evaluation (CDE) to conduct a single-arm, open-label, multi-cohort phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with tafasitamab + lenalidomide for the treatment of patients with relapsed or refractory Non-Hodgkin’s lymphoma (NHL) (Press release, InnoCare Pharma, DEC 20, 2022, View Source [SID1234625465]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "We are dedicated to building a leading hematology-oncology franchise with orelabrutinib and tafasitamab + lenalidomide as backbone therapies. NHL remains an area of strong unmet medical need in China, and we will accelerate this clinical trial along with the registrational trial of tafasitamab in combination with lenalidomide for relapsed or refractory diffuse large B-Cell lymphoma (DLBCL) in China."

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filled in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).

Orelabrutinib received conditional approval from the NMPA in two indications: the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and the treatment of patients with relapsed or refractory mantle cell lymphoma. Orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.

NHL is one of the most common cancers in China, including DLBCL, follicular lymphoma, etc. Data shows that there were 92,834 new cases of NHL with 54,351 deaths in 2020 in China1.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with r/r mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.

The supplemental New Drug Application of orelabrutinib for the treatment of relapsed or refractory Marginal Zone Lymphoma (MZL) was accepted in China.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of relapsed or refractory MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of Systemic Lupus Erythematosus (SLE), Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

About Tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

On December 20. 2022 ONCOtherapeutics and Dr. James Berenson published promising new data demonstrating that ruxolitinib (RUX), an oral JAK1/2 inhibitor, with only methylprednisolone (MP) well tolerated and shows efficacy for treating heavily previously treated multiple myeloma (MM) patients (Press release, Oncotherapeutics, DEC 20, 2022, View Source [SID1234625464]).

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Recently published results from a Phase 1 trial conducted by ONCOtherapeutics among 28 heavily previously treated MM patients administered RUX, lenalidomide (LEN) and MP demonstrated that the therapy was well tolerated and RUX overcame refractoriness to LEN and steroids (Berenson et al., Clin Cancer Res. 2020). The clinical benefit rate (CBR) and overall response rate (ORR) were 46% and 28%, respectively, and all 12 responding patients were refractory to LEN. A recent update that included 49 MM patients showed similar results with a CBR of 49% and 36%, respectively (Berenson et al. Hematol Oncol. 2022)

To further evaluate whether the combination of RUX and MP without LEN demonstrates clinical activity and its tolerability in a similar MM patient population, an ongoing Phase I trial was expanded to also include a cohort of patients treated with only this two-drug combination (NCT03110822). RUX (15 mg BID) was given orally twice a day continuously and oral MP (40 mg every other day).

Twenty-nine previously treated patients were planned to be enrolled on the part of the trial with only RUX and MP treatment. Median lines of prior therapy were 6 (range, 3-12). The ORR was 31% (n=9). The median duration of response was more than 13 months (range, 2.8-22) and progression free survival ranged from 0.5-24.6 months (median 3.4). The combination was well tolerated with no unanticipated adverse effects.

As noted by lead investigator Dr. James R. Berenson, "Multiple myeloma patients continue to need new treatment options, especially for those who have become refractory to previously effective treatment options. We previously demonstrated ruxolitinib’s ability to resensitize lenalidomide for patients who were refractory to this immunomodulatory agent, and now have shown that the combination of only ruxolitinib and methylprednisolone is active and well tolerated in a heavily previously treated multiple myeloma patient population."

With these promising results, ONCOtherapeutics has expanded the current study to further investigate the potential of this novel two-drug combination for treating similarly heavily previously treated MM patients using a higher dose of RUX (20 mg BID) with MP. In addition, the combination of RUX, LEN and MP is being evaluated among MM patients with poor renal function.

On December 20, 2022 IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, reported the commencement of a proposed public offering of its ordinary shares (Press release, IceCure Medical, DEC 20, 2022, View Source [SID1234625463]). All of the securities to be sold in the offering are to be offered by IceCure. The proposed public offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the offering to fund the development of its next generation single Probe and MultiSense systems, collecting clinical data and adding regulatory approvals in new territories and indications, business development, marketing and selling activities as well as for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as lead placement agent for the offering on a best efforts basis. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the offering.

This offering of the ordinary shares is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-267272) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that IceCure may file with the SEC. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that IceCure has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about IceCure and such offering.

On December 20, 2022 Sirnaomics Ltd. (Stock Code: 2257.HK) (the "Company", together with its subsidiaries, "Sirnaomics" or the "Group"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the interim results from a Phase I clinical trial evaluating the safety, tolerability and anti-tumor activity of the Company’s siRNA (small interfering RNA) drug candidate, STP707 with intravenous (IV) administration in the United States (Press release, Sirnaomics, DEC 20, 2022, View Source [SID1234625462]). This is a basket study which enrolls various solid tumor types. The analysis included the first three cohorts in a five-cohort dose escalation study.

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The multi-center, open label, dose escalation and dose expansion tumor basket study evaluates the safety, tolerability and anti-tumor activity of STP707. Twenty participants with advanced solid tumors, who have been unresponsive to standard therapies, are included in the dose escalation analysis. Once maximum tolerated dose or recommended Phase II dose has been established, additional patients will be enrolled to confirm safety and explore anti-tumor activity. The study encompasses five total cohorts who will receive escalating doses of STP707 through IV administration on a 28-day cycle including 3 mg, 6 mg, 12 mg, 24 mg and 48 mg dosing cohorts. The interim analysis involves subjects from the 3 mg, 6 mg, and 12 mg dosing cohorts. The subjects were dosed once per week for a total of 4 doses over a 28-day treatment cycle and will continue to be dosed in the study until they exhibit progressive disease. Additional secondary endpoints are to determine the pharmacokinetics of STP707 and to observe preliminary anti-tumor activity. This interim data is from the first three cohorts treated with three different doses of STP707.

"We are very excited to see STP707, our leading siRNA drug product for treatment of multiple solid tumors through an intravenous administration in which the first three cohorts with twenty patients have been completed showing strong safety profile and efficacy readouts. This is the first time that an RNAi (RNA interference) cancer therapeutic has demonstrated a very promising clinical potential for metastasized tumors. The interim data of STP707 will allow us to expand our research with additional cohorts — a positive step forward in moving this treatment into the next phase," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "This Phase I basket clinical study result encourages us to proceed to a potential combination study with immune check point inhibitor drugs. We look forward to expanding clinical trials with STP707 that has the potential to address the unmet needs of patients with solid tumors and other cancers."

"The progress of our dose escalation STP707 solid tumor basket study is a significant milestone as we seek to advance this novel siRNA oncology therapeutic," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "We have passed each of the first three cohorts’ safety requirements for dose escalation and anticipate dosing our fourth cohort in the first quarter 2023. To date, STP707 has exhibited a strong safety profile when compared to other novel oncology therapeutics."

Dr. Molyneaux added, "The 20 subject data set demonstrates an encouraging efficacy signal with duration of response equal to or exceeding two treatment cycles or 56 days in 8 subjects examined over all dosing cohorts. There have also been a number of tumor types including liver, pancreatic, colon and uveal melanoma cancers that have exhibited stable disease beyond 100 days of treatment. It is important to emphasize the fact that the subjects in this study have received multiple forms of prior treatments including surgery, radiation, and tumor specific first- and second-line therapies. As all subjects demonstrated progressive disease on prior treatment regimens, this group of subjects represents a subset of resistant tumor types that have not responded to all prior therapies. It is encouraging to see very good safety combined with duration of response in such resistant tumor types, and we look forward to continuing this study."

STP707 takes advantage of a dual-targeted inhibitory property and a PNP-enhanced targeted delivery to solid tumors and metastatic tumors via intravenous administration. An initial preclinical study has demonstrated that simultaneously knocking down TGF-β1 and COX-2 gene expression in the tumor microenvironment increases active T cell infiltration. A further combination study demonstrated synergistic anti-tumor activity between STP707 and a PD-L1 antibody using a mouse orthotopic liver cancer model.

For more information about Sirnaomics’ clinical trials, please visit ClinicalTrials.gov (Identifier NCT05037149) and the Company’s website at www.sirnaomics.com.

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ sTP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. Over-expression of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, IV administration resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver, lung and xenograft tumor. In addition, in preclinical models STP707 had shown strong anti-tumor activity in various solid tumor types. Using a mouse liver orthotopic tumor model, a combination regimen of STP707 with an immune checkpoint antibody has demonstrated a potent anti-tumor activity.

On December 20, 2022 NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), reported that the U.S. FDA has granted Orphan Drug Designation to NS-018 (ilginatinib), an investigational treatment for myelofibrosis (MF), a rare and incurable blood cancer (Press release, NS Pharma, DEC 20, 2022, View Source [SID1234625461]).

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The FDA issues Orphan Drug Designations to support the development and evaluation of new treatments to prevent, diagnose, or treat a rare disease or condition.

MF is caused by buildup of excessive scar tissue in the bone marrow, which impairs the body’s ability to produce blood cells.1 In addition to impaired blood cell production, MF often leads to enlargement of the spleen (splenomegaly) which can lead to feelings of abdominal pain and pressure.1 Other common symptoms include fatigue, bone pain, fever, and weight loss.1 MF can be diagnosed at any age but is most common in men and women 65 years or older.1 The median survival of patients with MF is approximately six years.1

Several gene mutations are associated with MF, and the most common mutation is to the Janus kinase 2 (JAK2) gene.2 NS-018 is a highly selective and potent inhibitor of JAK2 developed by scientists from Nippon Shinyaku.