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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).

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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.

Privo Technologies, Inc. Awarded $3M NIDCR NIH Commercialization Readiness Pilot Grant

On August 20, 2021 Privo Technologies, Inc. ("Privo"), a biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported that the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) has awarded Privo approximately $3 million over three years in a Commercialization Readiness Pilot (CRP) grant as part of the Small Business Innovation Research (SBIR) Program (Press release, Privo Technologies, AUG 20, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-awarded-3m-nidcr-nih-commercialization-readiness-pilot-grant [SID1234586795]). The grant was awarded on February 3, 2021 and builds upon previous Phase 1 and Phase 2 SBIR awards from the NIDCR to support the late-stage development of PRV111, Privo’s lead asset that allows for locoregional control of chemotherapeutic via topical application.

"We are very grateful to the NIDCR and NIH for their continued support for the late-stage development and commercialization of PRV111," said Manijeh Goldberg, PhD, CEO of Privo Technologies, Inc. and Principal Investigator on the grants. "Here at Privo, we seek to transform the standard of care for patients suffering from mucosal cancers that typically require disfiguring and disabling surgeries. By alleviating the safety concerns with traditional chemotherapies, our lead asset facilitates locoregional sequestration of the chemotherapeutic to the tumor site and has demonstrated superior efficacy and safety profiles in comparison to standard chemotherapies. This grant will be instrumental in developing PRV111 from a clinical to a commercial stage asset."

Roche and KeChow Reach a Cooperation Agreement

On August 20, 2021 Shanghai Roche Pharmaceuticals Co., Ltd. (hereinafter referred to as "Roche Pharma China" or "Roche") and Shanghai KeChow Pharma, Inc. (hereinafter referred to as "KeChow Pharma" or "KeChow") reported that it entered into a cooperation agreement to improve market access of Zelboraf in China (Press release, Kechow Pharma, AUG 20, 2021, View Source [SID1234586792]). Under this collaboration, KeChow will promote Roche’s Zelboraf in China.

Zelboraf is an oral small molecule, selective BRAF inhibitor indicated for the treatment of patients with BRAF V600 mutation-positive advanced or inoperable melanoma. It is approved in more than 90 countries, and the first molecular-targeted oncology product approved by China’s National Medical Products Administration (NMPA) for the treatment of patients with BRAF-V600E mutation melanoma. Although melanoma is a rare malignant tumor in China, the mortality rate remains very high[1]. The estimated incidence of melanoma in China was 0.4/100,000 in 1990 and 0.9/100,000 in 2017, an increase of more than 110% during this period of time[2]. Approximately one-quarter of Chinese melanoma patients possess BRAF mutations. Advanced melanoma with activating BRAF mutations has been associated with an increased risk of death due to rapid disease progression. Zelboraf specifically targets and blocks activity of a mutated protein called BRAF, a molecule that helps regulate cell growth. Zelboraf interferes with abnormal BRAF signals to slow or stop out-of-control cell growth. Zelboraf is given orally with demonstrated efficacy and is well tolerated. In March 2017, Zelboraf was approved by NMPA and was successfully included in the NDRL in 2018.

The key objective of this cooperation agreement is to improve patients’ access to Zelboraf in China. Adhering to "doing now what patients need next", Roche is a global leader in cancer treatments, and is committed to exploring new cooperation models to accelerate new drug development to address key unmet medical needs. KeChow is committed to advancing best-in-class targeted therapies for treatment of cancers and immune diseases by leveraging its extensive pharmaceutical R&D expertise. KeChow has dedicated significant resources to expand its core competencies in the research, development and commercialization of targeted oncology therapeutics. This cooperation will leverage the parties’ expertise and dedicate resources to serve the unmet medical needs of Chinese melanoma patients.

"We are very excited to establish this collaboration with KeChow. The China market is a key part of Roche’s global strategy. Roche has a long-term commitment to the China market and strives to deliver more first-class and differentiated drugs to China. We’d like to establish cooperation with emerging biopharmaceutical companies such as KeChow in China to accelerate the discovery and development of novel treatments as well as improve accessibility of new medicines to Chinese patients," said Ms. Hong Chow, CEO of Roche Pharma China.

"We are very pleased to form this new cooperation with Roche, a global pioneer in pharmaceuticals and diagnostics. Roche is a leader in personalized healthcare and is the world’s leading oncology biopharmaceutical company. KeChow is an emerging biotech focusing on advancing best-in-class small molecule oncology therapeutics by leveraging our extensive experience in drug discovery and development. Our lead product HL085, a novel ATP non-competitive MEK inhibitor, is currently in phase I/II clinical development in China and the United States. HL085 is designed to selectively target malignant tumors with RAF or RAS mutations, such as melanoma and NSCLC. We look forward to working closely with Roche to meet the unmet medical needs of Chinese melanoma patients in this cooperation agreement," said Dr. Tian Hongqi, Founder and Chairman of KeChow Pharma.