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Sesen Bio Announces Partnership with Eczacibasi Pharmaceuticals Marketing (EIP) for the Commercialization of Vicineum™ in Turkey

On August 5, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Eczacibasi Pharmaceuticals Marketing (EIP), part of the Eczacibasi Group and one of Turkey’s pioneering pharmaceutical companies with a focus on innovative, branded products, reported that the companies have entered into a licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)1 (Press release, Sesen Bio, AUG 5, 2021, View Source [SID1234586044]). The Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum, is currently under Priority Review with the US Food and Drug Administration (FDA) for the treatment of BCG-unresponsive NMIBC in the US with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

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"EIP is a partner of choice in Turkey and has a proven track record and experience in marketing innovative, life-saving medicines with an expertise in oncology and urology," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "This partnership with EIP marks a further step in realizing our mission to save and improve the lives of patients, and in achieving the significant global opportunity projected for Vicineum."

"International partnerships are a central component of EIP’s growth strategy and Sesen Bio is an ideal partner given their mission and expertise in NMIBC," said Muge Satir, General Manager of EIP. "Vicineum is a potential first-in-class treatment with a differentiated clinical profile which we believe can make a significant impact on patients with NMIBC. We look forward to working with Sesen Bio closely to expeditiously bring Vicineum to patients in Turkey."

In Turkey, bladder cancer is the sixth most commonly diagnosed cancer with about 36,000 cases, and it ranks 11th in cause of death with approximately 4,000 deaths per year. Approximately 75% of these patients are diagnosed with NMIBC, of which many will initially be treated with BCG. If BCG fails, there are no second line treatment options for patients except radical cystectomy, total surgical removal of the bladder. Additionally, over 99% of the population in Turkey is fully insured with access to medications and healthcare services. If approved in Turkey, Vicineum will be the first product approved for patients with BCG-unresponsive NMIBC in over 20 years with a high level of access to physicians and their patients anticipated.

Under the terms of the licensing agreement, Sesen granted EIP an exclusive license to register and commercialize Vicineum in Turkey for the treatment of BCG-unresponsive NMIBC. Sesen Bio will receive an upfront payment of $1.5 million and is eligible to receive additional regulatory and commercial milestone payments. Upon commercialization in Turkey, Sesen Bio is also entitled to receive a 30% royalty on net sales in Turkey. Sesen retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China, the Middle East and North Africa (MENA) and Turkey.

In the US, the Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date of August 18, 2021.

Hogan Lovells and Paksoy acted as legal advisors to Sesen Bio for this transaction.

1
The geography under the licensing agreement includes Turkey and Northern Cyprus.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the US FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

Data from Medivir’s MIV-818 phase 1b study to be presented at the ESMO Congress

On August 5, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that an e-poster entitled "Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM)" will be presented by Dr Debashis Sarker, King´s College London, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress (Press release, Medivir, AUG 5, 2021, View Source [SID1234586040]).

The Abstract will be released on the ESMO (Free ESMO Whitepaper) website 13 September 00.05 CEST (View Source). The results from the completed phase 1b monotherapy dose escalation part of the study (e-poster presentation number 527P) is scheduled for presentation during the ESMO (Free ESMO Whitepaper) congress 16-21 September.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse aetiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Pharmaxis Cancer Drug Decreases Tumour Burden in Pre Clinical Liver Cancer Model

On August 5, 2021 Pharmaxis Ltd (ASX: PXS) reported the first public presentation of data from a preclinical study of PXS-5505 in the liver cancer, cholangiocarcinoma (CCA) at the Americas Hepato-Pancreato-Biliary Association (AHBPA) conference in Miami, USA (Press release, Pharmaxis, AUG 5, 2021, View Source [SID1234586039]).

Under the guidance of Dr Roberto Hernandez-Alejandro, MD (Chief Division of Transplantation / Hepatobiliary Surgery), a research team at the University of Rochester Medical Center, New York State, has been investigating the role of lysyl oxidase enzymes in liver cancer and whether Pharmaxis cancer drug PXS-5505 can improve the efficacy of current chemotherapy drugs by inhibiting these enzymes.

CCA is the second most frequently diagnosed primary liver malignancy and has nearly doubled in incidence over the last decade. A prominent feature of CCA is the presence of highly fibrotic tissue that increases tumour stiffness, and decreases drug perfusion.

The oral presentation by Dr Paul Burchard, MD at today’s meeting covered two main aspects of the team’s research.

Firstly, they examined tumour tissue specimens collected from patients at their institution over a 10-year period and found that LOX enzymes are significantly elevated in human CCA and correlate with poor prognosis.
Secondly, they examined the effect of PXS-5505 with or without chemotherapy treatment in a pre-clinical model of CCA and found that the combination of PXS-5505 and chemotherapy significantly improves survival, delays tumor growth, and reduces intratumoral pressure.
Finally, they propose that PXS-5505 in combination with standard chemotherapy represents an innovative therapeutic strategy with potential for clinical translation in primary liver malignancy
Pharmaxis CEO Gary Phillips said, "The role of LOX enzymes in fibrosis is well established and there is a growing body of evidence that in cancers such as those of the liver and pancreas, the poor outcomes experienced with current chemotherapy regimens is due to fibrotic tissue restricting drug access and stimulating tumour growth. Pharmaxis is working with a number of independent research groups globally on different tumour types with our anti fibrotic cancer drug PXS-5505 and I’m very encouraged by the results presented today by Dr Burchard that show a potential disease modifying role for our drug in liver cancer.

"PXS-5505 is currently progressing well through a phase 1c/2 clinical trial looking for evidence of disease modifying effects in bone cancer myelofibrosis as a monotherapy. Exploring the potential of PXS-5505 to address liver cancers such as cholangiocarcinoma or other cancers where fibrosis is limiting the clinical benefit of current chemotherapy is something we will continue to assess with our scientific and clinical collaborators."

The phase 1c/2a trial MF-101 in myelofibrosis, cleared by the FDA under the Investigational New Drug (IND) scheme, aims to demonstrate that PXS-5505 is safe and effective as a monotherapy in myelofibrosis patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs. An effective pan-LOX inhibitor for myelofibrosis would open a market that is conservatively estimated at US$1 billion per annum.

Second Genome Announces Collaboration with Arena Pharmaceuticals to Identify Gastrointestinal Biomarkers

On August 5, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4-sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, reported they are entering a strategic collaboration with Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) to identify microbiome biomarkers associated with clinical response for their lead program in gastroenterology, etrasimod (Press release, Second Genome, AUG 5, 2021, View Source [SID1234586037]).

Under the terms of the agreement, Second Genome will utilize its proprietary sg-4-sight discovery engine to identify microbiome biomarkers associated with clinical benefit or adverse effects observed within data from the CULTIVATE clinical trial. Arena’s CULTIVATE trial is a Phase 2/3 clinical trial evaluating the efficacy and safety of etrasimod, a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator, in patients with moderately-to-severely active Crohn’s disease. This work will help inform patient stratification and optimize potential treatments for patients in the future.

"The multi-disciplinary capabilities of our sg-4-sight platform and our team’s deep expertise enable Second Genome to collaborate with partners as we continue to advance our own pipeline of precision therapeutics and biomarkers," said Karim Dabbagh, Ph.D., President and Chief Executive Officer of Second Genome. "Arena shares our commitment to unlocking innovative ways to improve human health. We look forward to working with Arena and applying our sg-4-sight platform to discover microbiome signals in Crohn’s disease patients."

"There is substantial evidence that gut microbiome is intricately involved in therapy response in gastrointestinal diseases," said Amit D. Munshi, President and Chief Executive Officer of Arena Pharmaceuticals. "We are pleased to collaborate with Second Genome to discover microbiome biomarkers predictive of clinical response as we continue to progress our CULTIVATE clinical trial."

Cytocom Inc. Provides Update on Completed Merger with Cleveland BioLabs

On August 5, 2021 Cytocom Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported shareholders with an update regarding its recent merger with Cleveland BioLabs (Press release, Cleveland BioLabs, AUG 5, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-provides-update-on-completed-merger-with-cleveland-biolabs-301349236.html [SID1234586036]). The all-stock transaction, first announced in October 2020, was formally completed on July 27, 2021.

"With the Cleveland BioLabs merger completed and Cytocom now operating as a publicly-traded company, the management team at Cytocom is in the process of integrating both companies as we are rapidly advancing our late-stage clinical programs and expanding our toll-like receptor platforms," stated Michael K. Handley, President and CEO of Cytocom Inc. "Furthermore, we believe, through the combination of the two companies, we have created one of the most compelling platforms in the immunotherapy space with 21 programs utilizing eight different assets."

Mr. Handley continued, "We expect to achieve a number of financial and developmental milestones over the next 12 to 18 months that support our goal of becoming a recognized leader in immune-modulating treatments including neutropenia/anemia, emergent viruses, cancer, and autoimmune diseases. We intend to showcase the power of our drug development platform and further generate shareholder value."

Additional information related to the merger close can be found in the Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on July 28, 2021, including the exchange ratio of private Cytocom stock to the new public stock. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of public Cytocom common stock in accordance with the exchange ratio. Continental Transfer & Trust is in the process of completing these activities and will then initiate communication directly to shareholders to provide the necessary forms for former shareholders to receive their new registered freely tradable shares of common Cytocom Inc. stock.

Cytocom acquired ImQuest Life Sciences in an all-stock deal, first announced on July 20, 2020, and completed on June 23, 2021. Pursuant to the terms of the acquisition agreement, Cytocom escrowed stock that is accounted for in the current public company’s capital structure that will be used to provide an aggregate of $12 million in value of Cytocom shares based on the volume-weighted-average trading price of such shares over the period beginning 30 trading days following the closing of such merger. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of Cytocom common stock to former shareholders of ImQuest in accordance with the exchange ratio.

All other aspects related to merger integration and stock conversion are proceeding as expected. Management will provide a detailed update of the post-merger activities on the company’s quarterly earnings call later this month. All questions regarding the distribution of Cytocom common stock should be directed to Continental Stock Transfer & Trust. Continental Stock Transfer & Trust may be contacted by mail at 1 State St., 30th Floor, New York, NY, 10004-1561 or by phone at (212) 509-4000.