On December 20, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, reported that it just completed a pre-clinical study using its intranasal formulation of AccuTOXTM in the context of animals with pre-established lung cancer (Press release, Defence Therapeutics, DEC 20, 2022, View Source [SID1234626259]). The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals. This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination.

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AccuTOXTM as a pleiotropic anti-cancer treatment.

The AccuTOXTM molecule was originally designed to exhibit enhanced anti-tumoral properties compared to the original AccumTM molecule. In fact, the IC50 of AccuTOXTM is 30-fold lower than that of AccumTM clearly demonstrating improved therapeutic potency as shown using a large set of murine and human tumors. This is also exemplified by the enhanced therapeutic potency of the compound when directly injected in solid tumors in combination with various immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47).

The sum of these results paved the path to test the compound in another animal model of preestablished lung cancer delivered via the intranasal route. For that purpose, a series of maximum tolerated dose (MTD) studies was conducted to identify the volume, dosage and tolerance of mice to repetitive administration of AccuTOXTM. These studies show that AccuTOXTM is well tolerated up to 3 mg/kg (5-6 times lower than the injectable dose) with a regimen of 6 administrations over 2 weeks. When tested using this schedule on animals with lung tumors, AccuTOXTM decreased by over 50% the number of cancer nodules especially in the group combined with the anti-PD1 immune-checkpoint inhibitor.

"We are very pleased with the versatile use of AccuTOXTM as a cancer therapeutic. The compound has not only shown a great potential in treating solid tumors, but we have now data demonstrating that it can be further adapted and delivered via the intranasal route to treat lungs with metastatic tumors which is a new hope for lung cancer patients", says Mr. Plouffe, the CEO of Defence Therapeutics. "And this will open-up a completely new horizon for AccuTOXTM as an anti-cancer treatment", he adds. The global lung cancer therapeutics market size was estimated at USD 27.57 billion in 2021 and it is expected to surpass around USD 55.6 billion by 2030 with a registered CAGR of 8.11% from 2022 to 2030 according to Precedence Research.

The AccuTOXTM program is one of Defence’s most advanced immune-oncology programs. The Company is currently preparing for its FDA meeting to obtain approval for initiating a Phase I trial against solid tumors in 2023. By demonstrating great safety and tolerability profiles in patients, AccuTOXTM can become the next generation anti-cancer treatment for a wide range of indications.

On December 20, 2022 Sorrento Therapeutics, Inc. reported that it has been engaged in arbitration before the American Arbitration Association against NantPharma, LLC ("NantPharma") relating to alleged breaches of the May 14, 2015 Stock Sale and Purchase Agreement entered into between the Company and NantPharma related to the development of the cancer drug Cynviloq (the "Cynviloq Arbitration") (Filing, 8-K, Sorrento Therapeutics, 20 20, 2022, View Source [SID1234625505]).

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On December 20, 2022, the arbitrator in the Cynviloq Arbitration issued an award granting contractual damages of $125 million to the Company, reflecting the value of lost milestone payments for the approval of Cynviloq for the treatment of breast and lung cancers.

The Cynviloq Arbitration is just one of several pending actions filed by the Company against Dr. Soon-Shiong and entities he controls. As previously disclosed, in April 2019, the Company filed an action in the Los Angeles Superior Court derivatively on behalf of Immunotherapy NANTibody LLC ("NANTibody") against NantCell, Inc. ("NantCell") and Patrick Soon-Shiong, among others, related to several breaches of the June 11, 2015 Limited Liability Company Agreement for NANTibody entered into between the Company and NantCell (the "Derivative Action"). The suit alleges breaches of fiduciary duties and seeks, inter alia, a declaration that the Assignment Agreement entered into on July 2, 2017, between NantPharma and NANTibody is void and an equitable unwinding of the Assignment Agreement. The suit calls for the restoration of $90.05 million to the NANTibody capital account, thereby restoring the Company’s equity method investment in NANTibody to its invested amount as of June 30, 2017 of $40.0 million. The parties are currently engaged in discovery in the Derivative Action, with a jury trial likely in 2023.

In 2020, the Company additionally filed a legal action against Patrick Soon-Shiong in Los Angeles Superior Court, asserting claims for fraudulent inducement and common law fraud alleging that, among other things, Dr. Soon-Shiong acquired the drug Cynviloq for the purpose of halting its progression to the market. The Los Angeles Superior Court claims against Dr. Soon-Shiong had been stayed pending resolution of the Cynviloq Arbitration, and the Company expects that they will now resume. The Company will have the right to a jury trial to pursue these claims.

On December 20, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company") reported that it completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the planned U.S. expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, DEC 20, 2022, View Source [SID1234625467]). MAIA received positive feedback from the FDA regarding its manufacturing, preclinical and clinical development plan. MAIA also obtained guidance from the FDA on the assessment of its safety and efficacy in the THIO-101 Phase 2 trial that will be incorporated in the U.S. IND application. MAIA plans to file its U.S. IND in the first half of 2023 and commence enrolling patients in the U.S. in the second half of 2023.

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A pre-IND meeting provides an opportunity for open communication between a drug development company and the FDA to discuss the IND proposed filing and plan to obtain the agency’s guidance for the initial clinical studies of a novel drug candidate. The FDA reviewed the pre-IND package submitted by MAIA containing preclinical data, manufacturing and the Phase 2 clinical study protocol synopsis for THIO-101, provided guidance and recommendations, and addressed MAIA‘s questions on the initial development plan of THIO in the advanced NSCLC indication.

"We appreciate the FDA’s guidance as we prepare to file the IND application for our Phase 2 trial and open enrollment of patients in the U.S.," said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. "The successful completion of this engagement with the FDA is an important milestone that has helped provide regulatory direction with our planned THIO clinical development program."

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab), allowing for immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as preliminary clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through the initial treatment with an immune-check point inhibitor alone or in combination with chemotherapy. The clinical trial is currently enrolling patients in Australia and the European Union as regulatory approvals have been received.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab). Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On December 20, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the J.P. Morgan 41st Annual Healthcare Conference at 8:15 a.m. PT (11:15 a.m. ET) on Thursday, January 12, 2023 in San Francisco, CA (Press release, AngioDynamics, DEC 20, 2022, View Source [SID1234625466]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

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.