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]).

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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.

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.

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"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."

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.

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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.

On August 20, 2021 HebaBiz Biotech reported that it has come to its knowledge on August 16, 2021, that the U.S. Food and Drug Administration (FDA) had granted clinical trial approval for Siroquine (JP001), an innovative anti-cancer drug under development (Press release, HebaBiz Biotech, AUG 20, 2021, View Source [SID1234586791]). Such a clinical trial is to be conducted on newly diagnosed glioblastoma (GBM) — this marks an important milestone in the ongoing multicenter, open-label, phase II/III clinical trial to evaluate the overall survival benefit and safety of JP001 in combination with standard chemoradiotherapy in newly diagnosed GBM patients. The clinical trial will be conducted in Taiwan, the United States and Mainland China.

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Glioblastoma (GBM), the most common type of glioma, has a poor prognosis, with most patients reporting a median survival time of 10 to 15 months. The current standard treatment is surgical resection, followed by synchronous radiotherapy (RT) and temozolomide (TMZ) chemotherapy in the resection cavity, further followed by TMZ adjuvant therapy. The median survival time upon surgical resection alone is about 6 months, and the combination of surgical resection and radiotherapy extends the median survival time to 12.1 months. On this basis, the combined treatment with TMZ further extends the median survival time to 14.6 months. Although the survival time of GBM patients continues to improve slowly, treatment for GBM remains a significant challenge and yet fails to meet patients’ needs.

Autophagy is a lysosomal mediated catabolic process that helps maintain cellular homeostasis and cell survival by degrading cytoplasmic components in response to intracellular and extracellular stress. GBM is considered to demonstrate very strong autophagy and is a kind of tumor that is resistant to radiotherapy and chemotherapy, and the tumor microenvironment is immunosuppressed. Autophagy regulation is the main strategy to overcome the resistance of glioblastoma cells to cytotoxic chemotherapy and radiation-induced cell death.

JP001

JP001 is a dual autophagy modulator being developed by HebaBiz Biotech, which can improve tumor microenvironment (TME) and increase tumor cells’ sensitivity to chemoradiotherapy. HebaBiz Biotech was granted an exclusive global license for the anti-tumor indications of JP001 from Johnpro Biotech Inc. in November 2019. JP001 has been approved by the Ministry of Health and Welfare of Taiwan (TFDA) for phase I exemption and could directly proceed to clinical phase II/III study for the newly diagnosed GBM; safety and efficacy data of some patients have already been obtained. HebaBiz Biotech also has plans in place to commence concurrent phase II/III clinical trials of the same indication in the United States and Mainland China.

Given JP001’s nature as a dual autophagy modulator, it has an effect on a variety of cancers including GBM, such as sarcoma, refractory metastatic solid tumor, multiple myeloma treatment failure, lymphatic fibroids, bladder cancer, renal cell carcinoma, etc and a number of papers on this topic has been published. JP001 will adopt the strategy of used-in-combination with standard treatment, to develop more indications. To this end, preliminary estimates suggest coverage of at least 30% of tumor types by JP001.

The key advantages of JP001 are as follows:

Anti-cancer sensitizer
JP001 can induce autophagy, inhibit tumor cell proliferation, promote cell apoptosis, and increase the sensitivity of chemoradiotherapy.

Great development value
JP001 has a therapeutic effect on GBM, sarcoma, refractory metastatic solid tumor, multiple myeloma, lymphangiomyoma, bladder cancer, renal cell carcinoma, etc. It was found that JP001 demonstrate synergistic killing effect in connection with Clevudine (another drug candidate in HebaBiz Biotech’s pipeline) in liver cancer cell lines transfected with Hepatitis B virus, and the effect of single drug or used in combination on tumor cell metabolism is under study.

GBM treatment is significantly more effective than standard treatment
At present, the treatment of newly diagnosed GBM is basically surgical treatment combined with chemoradiotherapy as the standard treatment, and the treatment results are not ideal. The efficacy of JP001 in combination with standard treatment is shown to be significantly more effective than that of standard treatment, and its therapeutic efficacy is highly correlated with a specific Bio-marker.

Summary of JP001 Phase II/III clinical trial (enrolled patients)

The ongoing randomized phase II/III trial of radiotherapy with /without temozolomide for newly diagnosed glioblastoma will involve the enrollment of 370 patients in aggregate, under international multicenter in the United States, Mainland China, and Taiwan. Six patients so far have been randomly recruited into the study arm (standard treatment TMZ/RTZ in combination with JP001).

Of the six patients in the study arm, four are female and two are male, ranging in age from 41 to 58 years, with a median treatment period of 14 months, JP001 was well tolerated with no grade 3 toxicity.

Median progression-free survival (PFS) was observed to be over 14 months (PFS > 21 months in patient 006). Up to now, certain patients are still alive, and the longest overall survival (OS) is more than 29 months. Both PFS and OS are observed to be significantly higher than existing standard treatments and has a 100% correlation with a specific Bio-marker.

Commenting on this milestone, Dr. Zhou stated:

"We have been conducting phase II/III clinical trial in Taiwan on JP001. Preliminary clinical trial results show that JP001 is well tolerated. Four of the six patients in the treatment group responded significantly in positive ways, with two surviving with no signs of recurrence and PFS is >20 months and the longest OS is > 29 months.

Even more exciting is the high correlation between effective cases and a specific Bio-marker, which has important implications for the precision treatment of JP001, reduction of costs of clinical trials, and acceleration of the NDA approval, and gaining of market share. Meanwhile, we found that JP001 when used in combination with PD-1 can enhance the sensitivity of PD-1 to GBM, and we are actively coordinating for the commencement of a clinical trial program in the United States.

We are conducting a phase II/III international multicenter trial in the United States, Mainland China and Taiwan, and we have applied for a pre-IND meeting with CDE (Center for Drug Evaluation, National Medical Products Administration) in China. I am confident that JP001 will be a successful showcase under an innovative drug strategy that will help develop more and in a faster manner, new cancer drugs that truly meet the needs of patients."

Professor Kwan–Hwa Chi, principal investigator (PI) of JP001, also said:

"Autophagy is the subject of a Nobel Prize and is essential to every cell. Therapeutic targets for autophagy exist in every cell class, including tumor cells, cells in tumor microenvironment (TME), and normal cells in the body. Autophagy usually has a cellular protective effect when cells are stressed by starvation or chemotherapy (CT). The protective effect of autophagy is particularly prominent when tumor cells are induced to death via programmed cell death or tumor necrosis by chemoradiotherapy, so it is becoming an important target for the development of new anticancer drugs in recent years.

It is very effective to use JP001 on a stand-alone basis for lymphangioleiomyomatosis, a rare disease, and it shows better effect when used in combination with various anti-tumor therapies for most other cancers. The basic principle of JP001 also suggests that it has the advantage of sensitizing tumor cells to most anti-cancer drugs, which could demonstrate clinical value in more than 30% of advanced cancers. As an anti-cancer sensitizer, JP001 is not positioned on only one type of cancer, its market potential is much larger, an example is Bevacavastine, which it is claimed to have a global market of $12 billion by 2025 – it shows huge market potential for a used-in-combination strategy despite not being as effective when used on a stand-alone basis.

About Dr. Zhou

Dr. James Zhou is the founder, Chairman and Chief Scientist of HebaBiz Biotech. His academic and research achievements include the following:

Postdoctoral Fellow, Department of Biology / School of Medicine, Yale University
Ph.D. in Genetics, Iowa State University
National "Innovative Talents Promotion Plan" Scientific and Technological Innovation and Entrepreneurship Talents
Director, National & Local Joint Engineering Research Center for Anti-tumor Drug Development
863 Evaluation Expert in Agricultural Biology, Ministry of Science and Technology
863 Expert and Host of Special Biological Resources Major Project of Ministry of Science and Technology
Evaluation Expert in Biopharmacy of Evaluation Center of Ministry of Science and Technology
Zhongguancun "High-End Leading Talent"
About Professor Kwan–Hwa Chi

Professor Kwan–Hwa Chi has been engaged in cancer treatment for more than 30 years. He is now the principal investigator (PI) of JP001 and holds the following positions: PhD, Tokyo Medical University, Japan, Director of the Department of Cancer Therapy, Shin Kwang Wu Hoshi Memorial Hospital, and Professor, Department of Medicine, Yang-Ming University.

On August 20, 2021, Processa Pharmaceuticals, Inc. (the "Company" or "us" or "we") reported that it entered into an equity distribution agreement (the "Sales Agreement") with Oppenheimer & Co. Inc. (the "Sales Agent") under which we may issue and sell in a registered "at-the-market" offering shares of our common stock (the "Shares") having an aggregate offering price of up to $30,000,000 from time to time through or to our Sales Agent (the "ATM Offering") (Filing, 8-K, Processa Pharmaceuticals, AUG 20, 2021, View Source [SID1234586787]). We expect to use net proceeds, if any, from the ATM Offering over time as a source for working capital and general corporate purposes.

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Sales of our common stock through the Sales Agent, if any, will be made by any method that is deemed an "at-the-market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Sales Agent will offer the Shares at prevailing market prices and will use its commercially reasonable efforts to make such offerings consistent with its normal trading and sales practices. We will pay the Sales Agent an aggregate of up to 3.0% of the gross proceeds of the sales price per share of common stock sold through the Sales Agent under the Sales Agreement. We also may sell some or all of the Shares to the Sales Agent as principal for their own account at a price agreed upon at the time of sale.

We are not obligated to make any sales of our common stock under the Sales Agreement and no assurance can be given that we will sell any shares under the Sales Agreement, or, if we do, as to the price or amount of shares that we will sell, or the dates on which any such sales will take place. The Sales Agreement will terminate upon the earlier of (i) the sale of all of our common stock subject to the Sales Agreement, or (ii) termination of the Sales Agreement as provided therein.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. In connection with the Sales Agreement, the Company is filing the opinion and consent of its counsel, Foley & Lardner LLP, regarding the validity of the Shares that may be sold pursuant to the Sales Agreement as Exhibits 5.1 and 23.1 to this Current Report on Form 8-K, which are incorporated herein by reference.

The Shares will be sold and issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-257558), which was declared effective by the Securities and Exchange Commission on July 9, 2021, the base prospectus contained therein, and a prospectus supplement related to the offering of the Shares dated August 20, 2021.

This Current Report on Form 8-K, including the exhibits filed herewith, shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

All statements in this report that are not historical facts should be considered "Forward Looking Statements" within the meaning of the "Safe Harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Some of the forward-looking statements can be identified by the use of words such as "believe," "expect," "may," "will," "should," "seek," "approximately," "intend," "plan," "estimate," "project," "continue" or "anticipates" or similar expressions or words, or the negatives of those expressions or words. Except as otherwise required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or any other reason, after the date of this report.