On August 12, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL) (Press release, InnoCare Pharma, AUG 12, 2022, View Source [SID1234618171]).

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Professor Jun Zhu of the Beijing Cancer Hospital said, "As the principal investigator, I am happy to see the treatment of R/R MZL patients with orelabrutinib reached the preset primary endpoint and showed sustainable efficacy at the dose of 150 mg QD. Orelabrutinib was well tolerated with a safety profile in the patients with MZL. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and we do hope that orelabrutinib can fill the gap in this therapeutic area. "

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: " MZL is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about 7-10% of all NHL1. The incidence is higher in the elderly population, especially those over 80 years old. Current treatment options for R/R MZL are quite limited. Orelabrutinib is expected to be the first BTK inhibitor to be approved for R/R MZL in China. We hope orelabrutinib will benefit MZL patients who are in urgent need of innovative treatment as soon as possible."

On December 25, 2020, orelabrutinib received approval from NMPA in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list. In March 2022, the NMPA accepted a supplemental New Drug Application for orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia.

About Marginal Zone Lymphoma

Marginal zone lymphoma (MZL) is a common B-cell non-Hodgkin’s lymphoma (B-NHL), accounting for about 7-10% of all NHLs. Its incidence rate ranked third after diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). According to WHO classification, MZL can be divided into three subtypes: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), nodal MZL (NMZL), and splenic MZL (SMZL). Although MZL is an indolent lymphoma, it is still an incurable malignant tumor based on the existing treatment options, and the prognosis of R/R MZL patients is even worse. At present, there is no consensus standard of care in clinical practice, and the therapies for R/R MZL patients are limited. As no effective targeted drug has been approved for the treatment of R/R MZL in China, there is an urgent unmet medical need for patients with R/R MZL.

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 chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

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.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r 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 SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

On August 11, 2022 Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutical company developing transformational vaccines to address significant global health challenges, reported the closing of its previously announced private placement of 3,683,280 shares of common stock (or common stock equivalents in lieu thereof) to several healthcare-focused institutional investors, that was priced at-the-market under Nasdaq rules (Press release, Onconetix, AUG 11, 2022, View Source [SID1234641110]). The Company also issued to investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 4,972,428 shares of common stock. The purchase price for one share of common stock (or common stock equivalent) and one investment option was $2.715. The investment options have an exercise price of $2.546 per share, are exercisable immediately upon issuance, and have a term equal to five years.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the private placement were approximately $10 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement for the research and development of its pipeline as well as for working capital and other general corporate purposes. The Company’s current cash position including the gross proceeds from this private placement is approximately $30.3 million.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, BWV has agreed to file a resale registration statement covering the securities described above within thirty days of August 9, 2022.

In addition, the investors in the private placement agreed to cancel preferred investment options to purchase up to an aggregate of 1,180,812 shares of the Company’s common stock issued in April 2022.

This press release does 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.

On August 11, 2022 Molecure S.A. ("Molecure": WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, reported it has filed a Clinical Trial Application (CTA) for OATD-02 with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Press release, Molecure, AUG 11, 2022, View Source [SID1234640064]). The Company plans to conduct a Phase I clinical trial with OATD-02 in patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.

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The Phase I trial is expected to be an open-label, multi-center, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study is expected to start in the fourth quarter of 2022, subject to regulatory approval.

Marcin Szumowski, Molecure CEO commented, "Today’s CTA filing represents a significant milestone in the development of OATD-02, potentially the first dual arginase inhibitor to enter the clinic. We have already seen promising pre-clinical data that shows OATD-02 has significant anti-cancer activity with potential to improve treatment outcomes in a broad range of solid tumors. Subject to regulatory approval we look forward to advancing OATD-02 into clinical development later this year."

The clinical part of the development of the OATD-02 compound is carried out within the framework of the project: pre-clinical and clinical development of arginase inhibitor for application in anti-cancer immunotherapy (POIR.01.01.01-00-0415/17), cofinanced by the European Union in the framework of European Funds Smart Growth and European Regional Development Fund.

About OATD-02 (oncology)

OATD-02 is being developed as a potential new therapeutic for a range of solid tumors. It is the first and only dual acting, highly potent arginase inhibitor in development for the treatment of cancer, involved in both tumor immunity and metabolism. Arginase 1 (ARG1) and Arginase 2 (ARG2) are validated targets that have been found on a variety of tumor types where their increased activity correlates with more advanced disease and worse clinical prognosis due to diminished arginine levels.

On August 11, 2022 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP) reported the filing with the United States Patent and Trademark Office of a provisional US patent application covering the Company’s novel approach for enabling chimeric antigen receptor (CAR)-T cell-based therapies to kill solid tumors through prevention of a process called "T cell exhaustion" (Press release, Regen BioPharma, AUG 11, 2022, View Source;develops-novel-dedifferentiation-approach-for-increasing-efficacy-of-car-t-cells-to-treat-solid-tumors-301604599.html [SID1234623881]).

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CAR-T cells are very effective at treating certain lymphomas and leukemias with an overall cure rate of over 50%4. However, solid tumors remain resistant to CAR-T therapies for many reasons. One reason is "T cell exhaustion", a term that means T cells that are initially recruited to the tumor to kill it end up losing their effectiveness .

The technology covered by this patent application introduces a novel type of T cell which is resistant to the immune suppressive effects of the tumor and prevents this exhaustion. The disclosed technology induces an intracellular program in T cells to endow them with certain features of "younger" cells, thus allowing for enhanced activity against conventional solid tumors such as lung, skin, breast and brain cancers. This includes inhibiting NR2F6, a T cell checkpoint which the Company has been focusing on.

"CAR-T cells have been in the clinic for 6 years but they have hardly made a dent in treating solid tumors," says David Koos, Chairman and CEO of the Company. "We hope that through the diligent work of our scientists and collaborators that advancements such as what we announced today will pave the way to bring this incredible cellular immunotherapy to patients suffering from solid tumors such as lung, colon, prostate and others.

The field of cancer immunotherapy represents an approximate 100-billion-dollar annual global market[1] and CAR-T cells, which are one type of cancer immunotherapy, are highly valued by the industry as demonstrated by the purchase of pioneering CAR-T companies such as the 2017 acquisition of Kite Pharma by Gilead Sciences for 12 billion dollars2 and the 2018 acquisition of Juno Therapeutics by Celgene for 9 billion dollars3.

In the area of cancer immunotherapy and not including the aforementioned application the Company has been granted, and thus owns, United States patents covering cord blood derived immunotherapy for cancer (patent # 11,141,471), cancer-killing Th17 cells (patent # 11,053,503), and mRNA vaccines for preventing cancer as well as treating existing tumors (patent # 11,090,332). "

On August 11, 2022 Oncopeptides reported interim report Q2 2022 (Presentation, Oncopeptides, AUG 11, 2022, View Source [SID1234618466]).

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