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ImmuneOnco received FDA approval of IMM2902 as an Investigational New Drug (IND) in the United States

On August 21, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that the U.S. Food and Drug Administration (FDA) has granted permission to IMM2902, a bi-specific antibody-receptor recombinant protein targeting Human CD47xHER2 for HER2-expressing advanced solid tumors for the Investigational New Drug (IND) application in the United States (Press release, ImmuneOnco Biopharma, AUG 21, 2021, View Source [SID1234655625]).

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By targeting both CD47 and HER2, IMM2902 is one of the best drug candidates under global clinical researches. IMM2902 project was previously approved by the National Drug Products Administration (NMPA) in China on June 29, 2021, and it is one of three new drug candidates based on CD47 to enter the clinical study. Permission to enter clinical study of IMM2902 by FDA is another important milestone for the company to develop global market.

"We are very pleased to receive FDA approval for the IMM2902 IND in the United States." said Dr. Wenzhi Tian, the founder of ImmuneOnco. "IMM2902 is a bi-specific molecule for CD47 and HER2 developed based on our mAb-Trap technical platform. Through the high affinity to HER2, this molecule preferentially bind to tumor cells. The product has a unique feature that it doesn’t bind to human red blood cells to form ‘Antigenic sink’, thus greatly enhancing the specific synergistic effect of the double targets against tumor. We believe IMM2902 has promising developmental value and huge commercial potential." Dr. Tian is quite confident about the prospects of IMM2902 clinical development.

The NGS based CDx Human NTRK1/2/3 Genomic Alteration Test Kit to inform treatment decisions for larotrectinib developed by OrigiMed in cooperation with Bayer was granted the NMPA Special Review Procedure for Innovative Medical Devices in China

On August 21, 2021 OrigiMed reported that the Human NTRK1/2/3 Genomic Alteration Testing Kit has been granted the Special Review Procedure for Innovative Medical Devices by the Center for Medical Device Evaluation of NMPA (Press release, OrigiMed, AUG 21, 2021, View Source [SID1234586798]). This testing kit is developed by OrigiMed in cooperation with Bayer.

The Human NTRK1/2/3 Genomic Alteration Testing Kit is developed to detect NTRK 1, 2 and 3 gene fusions in solid tumors. It is the first companion diagnostic specifically developed for larotrectinib in China and will help identify NTRK gene fusion-positive patients for whom treatment with larotrectinib may be appropriate.

Larotrectinib, a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, is approved in more than 40 countries including the U.S., countries of the EU, and Japan for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion. Additional filings in other markets, including China, are underway or planned.

The Human NTRK 1/2/3 Genomic Alteration Testing Kit is based on DNA- and RNA-based next-generation sequencing (NGS) and applies the innovative OriFusion independently patented by OrigiMed as its core technology. Fusion candidates are identified by hybrid-capture based technology. Besides the known fusion, it also can effectively detect novel fusions with high sensitivity and specificity.

About Larotrectinib

Larotrectinib, a highly selective TRK inhibitor, was exclusively designed to treat tumors that are NTRK1/2/3 gene fusion positive (TRK fusion cancer). The compound has demonstrated high response rates and durable responses over three years in adults and children with TRK fusion cancer, including responses and a high disease control rate in central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The dataset of 218 patients was presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2021.

Larotrectinib is approved under the brand name Vitrakvi in more than 40 countries, including the U.S., countries of the EU, Japan, and other markets around the world, for pediatric and adult patients solid tumors that harbor an NTRK gene fusion. Additional filings in other markets, including China, are underway or planned. The Human NTRK1/2/3 Genomic Alteration Detection Kit is a companion diagnostic test for larotrectinib in treating adult and pediatric patients in China with solid tumors that harbor an NTRK gene fusion once larotrectinib is approved for medical use.

About TRK fusion cancer

TRK fusion cancer is rare overall, affecting both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

Plus Therapeutics Announces Presentation of Data from the ReSPECT™-GBM Trial and Plans for Treating Pediatric Brain Cancer

On August 21, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported data from the NIH-supported ReSPECTTM Phase 1 clinical trial evaluating its lead investigational drug, Rhenium-186 NanoLiposome (186RNL), in recurrent glioblastoma (GBM) (Press release, Cytori Therapeutics, AUG 21, 2021, View Source [SID1234586794]). Data from the trial shows that the administration of 186RNL, which is designed to allow for targeted beta radiation to the tumor via convection enhanced delivery (CED) with limited exposure to surrounding tissues, was well tolerated in adult patients with recurrent GBM at significantly higher doses than with standard treatment modalities such as external beam radiation therapy (EBRT).

This data is being presented as an E-Poster video entitled "A two-part, Phase 1 study of Rhenium-186 NanoLiposome (186RNL) delivered by convection enhanced delivery for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG) and newly diagnosed diffuse intrinsic pontine glioma (DIPG)" at the 2021 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, which is being held virtually August 21-25, 2021.

"The ReSPECTTM trial demonstrates how 186RNL can deliver a very high dose of radiation directly to adult brain tumors safely, effectively and conveniently," said Michael G. DeCuypere, MD, PhD, FAANS, Northwestern University Feinberg School of Medicine, and presenter of the E-Poster. "Children with brain tumors have limited options and 186RNL delivered with a minimally invasive procedure could be an important new potential option for these patients."

Additional key findings from ReSPECT clinical trial for adult recurrent GBM:

The mean dose of 186RNL when coverage was 75% or greater (n=10) was 392 Gy (CI 306 – 478).
The treatment has been well tolerated, with no dose-limiting toxicity or serious adverse events observed (n=18).
"We are eager to explore the use of 186RNL in children with pediatric brain tumors of various types," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "Dr. DeCuypere and the team at Lurie Children’s Hospital in Chicago have been great academic partners and are uniquely positioned to bring RNL forward rapidly to treat these tough problems in children."

In addition, the Company presented plans for a proposed two-part, Phase 1 dose-finding study to be followed by an expansion cohort to explore the efficacy of 186RNL in pediatric patients with brain tumors. Part one of the trial will enroll up to 18 subjects to determine the maximum feasible dose of 186RNL administered by CED with the tumor diameter limited to four centimeters and a volume of 34 milliliters. While Part two of the study will independently evaluate 186RNL in up to 39 patients across three different cohorts based on their specific disease diagnosis. The primary endpoint of the study will be the overall response rate, and the secondary endpoints will include progression free survival-24 and overall survival-24 or progression free survival-12 and overall survival-12 in cohort A and cohorts B and C, respectively. Patient enrollment for this study is expected to begin by mid 2022.

A copy of the presentation will be made available under the Presentations tab of the Investors section of the Company’s website when presentations go live at www.plustherapeutics.com.

Mabwell Receives IND Clearance from FDA for Initiating Clinical Trials for its Anti-CD47/PD-L1 Bispecific Antibody

On August 20, 2021 Mabwell Bioscience Co., Ltd. ("Mabwell") , an innovative biopharmaceutical company with the whole industrial chain, reported that it has received IND clearance from FDA for initiating clinical trials towards advanced solid tumors for its anti-CD47/PD-L1 bispecific antibody (R&D code: 6MW3211) (Press release, Mabwell Biotech, AUG 20, 2021, View Source [SID1234617924]).

6MW3211 is a humanized bispecific antibody developed through Mabwell’s internal bispecific/bifunctional antibody development platform. It is designed to selectively bind to CD47 and PD-L1 on tumor cells to attenuate CD47-SIRPα signal and block the PD-1/PD-L1 checkpoint inhibition, thereby triggering stronger tumor cell phagocytosis and enhancing T cell activation. The IgG-like structure with a common light chain is the strategy to overcome pairing problem and simplify the production process. In addition, 6MW3211 specifically binds to CD47 on tumor cells, but doesn’t bind to erythrocytes of humans and monkeys, suggesting that 6MW3211 has a good safety potential for erythrocytes. A comprehensive battery of nonclinical studies has been designed and conducted to evaluate the target binding characteristics, mechanism of action, anti-cancer efficacy and safety to support the proposed clinical trial.

"I am so excited that it’s Mabwell’s first bispecific antibody and the first innovative biological medicine which receives IND clearance both in China and US," said Dr. Datao Liu, Co-founder & CEO of Mabwell, "Meanwhile it demonstrates our robust capabilities in pharmaceutical development, registration and clinical development. We’ll have more clinical projects to be conducted both in China and US in the future and aim to provide more effective and accessible innovative medicines to fulfill global medical needs."

Sesen Bio withdrew its marketing authorization application to the European Medicines Agency for Vysyneum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”)

On August 20, 2021, Sesen Bio reported that it withdrew its marketing authorization application ("MAA") to the European Medicines Agency ("EMA") for Vysyneum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") (Press release, Sesen Bio, AUG 20, 2021, View Source [SID123a4586986]).

Given that certain components in the EMA’s review are interrelated with elements of the US Food and Drug Administration’s ("FDA") decision to issue a complete response letter regarding the Company’s Biologics License Application ("BLA") for Vicineum for the treatment of BCG-unresponsive NMIBC, the Company is pausing its plans to pursue regulatory approval of Vysyneum in Europe until there is more clarity from the FDA on the next steps in the United States.

Sesen Bio plans to request a Type A meeting as soon as possible with the FDA to discuss next steps for the potential regulatory path forward for Vicineum in the US, and the Company expects this meeting to occur in the fourth quarter of this year.

The Company believes additional information from the FDA will equip the Company to better synchronize the regulatory reviews of Vicineum in the US and Europe. Sesen Bio is committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum. The Company intends to work closely with the FDA to understand next steps.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:

This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, the Company’s plans to pause pursuing regulatory approval of Vysyneum in Europe until there is more clarity from the FDA on next steps in the US, the Company’s expectations regarding the timing for the FDA’s scheduling of a Type A meeting with the Company, the Company’s belief that additional information from the FDA at the Type A meeting will clarify the next steps for a potential regulatory path forward for Vicineum in the US and equip the Company to better synchronize the regulatory reviews of Vicineum in the US and Europe, the Company’s commitment to ethics and integrity, the Company’s belief in the safety and efficacy data of Vicineum and the Company’s intentions to work closely with the FDA to understand next steps for Vicineum, are based on the Company’s current expectations and inherently involve significant risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including the risk that the FDA may not schedule a Type A meeting with the Company in the fourth quarter of this year, or at all, the risk that the Company may not resume its plans to pursue regulatory approval for Vicineum in the US, the risk that the Company may not resume its plans to pursue regulatory approval of Vysyneum in Europe upon receiving any clarity from the FDA, or at all, the risk that the FDA may not approve the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits the BLA at a future time, among other risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company’s most recent annual report on Form 10-K and the Company’s quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.