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Elektrofi and LEO Pharma Enter Licensing settlement for building of high-awareness, Low-quantity Formulations of Investigational Monoclonal Antibodies BOSTON & BALLERUP, Denmark–(enterprise WIRE)–Elektrofi, Inc., a Boston-primarily based biotechnology company concentrated on drug system and beginning improvements, and LEO Pharma A/S, a global leader in medical dermatology, these days announced an unique license contract to boost subcutaneously administered antibodies the usage of Elektrofi’s high-attention, low-quantity beginning expertise. beneath the terms of the agreement, Elektrofi will license its proprietary technology to LEO Pharma for LEO Pharma’s use and may codevelop superior formulations of investigational LEO Pharma antibodies. The license is exclusive to be used against a selected target in dermatology signs. Elektrofi will receive upfront funds for entry to its technology; milestone funds pending the success of pre-specific clinical, regulatory and commercial milestones; and revenue-based mostly royalty payments. different phrases of the agreement have been now not disclosed. “we now have loved a productive partnership with Elektrofi’s creative group due to the fact that 2017 in aid of our desires of constructing treatment options that are transformative in terms of the affected person journey,” referred to Kim Kjøller, government vp, analysis and construction, LEO Pharma. “we’re pleased to deepen our partnership with Elektrofi through this license contract with the mutual vision of redefining the forefront of biologics administration to advantage sufferers.” Elektrofi is working to tackle the long-standing and unmet want for stabilized, enormously focused biologics via its system platform. This platform, via a proprietary microparticle know-how, is designed to permit affected person-friendly, small-extent injections for monoclonal antibodies, therapeutic proteins and other gigantic molecule medication of becoming magnitude to human health. “Our know-how has the knowledge to force colossal exchange in the treatment panorama for sufferers across quite a lot of disorder areas and indications,” mentioned Chase Coffman, CEO and Co-Founder, Elektrofi. “This license agreement represents a big step forward in improving the start of biologics with an emphasis on affected person-centric innovation. we are excited about the growth of our relationship with LEO Pharma and we appear ahead to ongoing collaboration with a associate who shares our commitment to improving the journey for patients receiving biologic drugs.” About Elektrofi Elektrofi is a biotechnology business focused on improving administration for a wide array of medicines including monoclonal antibodies, therapeutic proteins, and different huge molecule drugs. Its breakthrough formulation platform aims to allow stabilized, enormously focused formulations for subcutaneous administration. The company is the use of this technology to transform cures that are administered intravenously, and to increase injectable products by way of decreasing the volume and frequency of dosing. Elektrofi companions with pharmaceutical organizations to jointly increase affected person-friendly beginning options. Headquartered in Boston, the business’s founding team of MIT engineers and scientists are shaping the way forward for biologics birth. talk over with www.elektrofi.com for greater information. About LEO Pharma LEO Pharma helps individuals achieve match dermis. The company is a pacesetter in medical dermatology with a robust R&D pipeline, a wide array of healing procedures and a pioneering spirit. based in 1908 and owned by way of the LEO basis, LEO Pharma has devoted many years of research and construction to improve the science of dermatology, environment new requirements of look after people with skin conditions. LEO Pharma is headquartered in Denmark with a worldwide crew of 6,000 individuals, serving 92 million patients in one hundred thirty international locations. In 2019, the business generated net income of DKK 10,805 million. what’s a Non-exclusive License? Chris blank is an independent writer and analysis advisor with greater than 20 years’ experience. clean specializes in social policy evaluation, latest hobbies, widely wide-spread tradition and shuttle. His work has regarded both on-line and in print publications. He holds a master of Arts in sociology and a Juris doctor. Sesen Bio pronounces an unique license agreement with Qilu Pharmaceutical for the development and commercialization of Vicineum™ in more suitable China CAMBRIDGE, Mass.–(business WIRE)– Sesen Bio (Nasdaq: SESN), a late-stage medical company establishing focused fusion protein therapeutics for the treatment of sufferers with melanoma, and Qilu Pharmaceutical, a number one vertically built-in pharmaceutical business in China specializing within the manufacturing and marketing of lively pharmaceutical components and drug items, these days announced that the corporations have entered into an exclusive licensing agreement for the manufacture, development and commercialization of Vicineum for the medication of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) and different forms of cancer in China, Hong Kong, Macau and Taiwan (“more desirable China”). “As a leader in the chinese pharmaceutical trade, we accept as true with there isn’t any stronger company than Qilu desirable to assist the expansion of our building and commercialization efforts for Vicineum,” referred to Dr. Thomas Cannell, president and chief government officer of Sesen Bio. “Qilu is well-revered for his or her commercialization and manufacturing abilities, and this partnership marks a vital milestone now not best in realizing what we consider to be a big market probability for Vicineum, however in strengthening our balance sheet via nondilutive capital while we stay focused on pursuing regulatory approval within the u.s. and the ecu Union. moreover, we are extremely joyful to have completed this agreement fully essentially, regardless of the current COVID-19 pandemic, which speaks volumes to the powerful execution capabilities of the Sesen team. This reinforces our center of attention on continuing to pursue extra business development opportunities for Vicineum outdoor the united states in this method.” “Sesen is the premier companion for us, given their capabilities in NMIBC and our complementary skillsets and the distinctive geographic focus between our two organizations,” stated Yan Li, chief government officer of Qilu Pharmaceutical. “We seem to be forward to working with Sesen and The country wide medical products Administration to carry Vicineum to patients who urgently want enhanced treatment options for BCG unresponsive non-muscle invasive bladder cancer in China.” “Vicineum is a potential first-in-classification, enormously differentiated product candidate that can address a major unmet need in China,” referred to Oliver Kong, M.D. chief scientific officer, company vp of Qilu Pharmaceutical. “The entertaining mechanism of action of Vicineum and linked potent scientific facts position Vicineum to make a significant have an impact on on the lives of patients.” below the terms of the contract, Sesen granted Qilu Pharmaceutical an exclusive license to strengthen and commercialize Vicineum in greater China. Sesen will get hold of an upfront payment of $12 million and is eligible to get hold of as much as an further $23 million in technology switch and regulatory milestone payments. Upon commercialization in stronger China, Sesen is also entitled to receive royalties on internet revenue in enhanced China. Sesen retains full development and commercialization rights for Vicineum for the treatment of NMIBC within the US and the leisure of the realm excluding stronger China. The phrases of the contract additionally encompass the transfer of the Vicineum manufacturing technology to Qilu Pharmaceutical, whose world-category manufacturing potential represents a future chance for production enlargement to satisfy the predicted gigantic global demand for Vicineum for the treatment of NMIBC. Torreya acted as a fiscal consultant and Hogan Lovells acted as a legal guide to Sesen for this transaction. convention call information contributors of the Sesen management team will host a conference name and webcast Friday, July 31, 2020 at eight:00 AM EDT to deliver an overview of the partnership with Qilu Pharmaceutical. To participate within the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (overseas) and check with convention identification 2177393. The webcast can also be accessed within the Investor relations portion of the company’s site at www.sesenbio.com. The replay of the webcast could be attainable within the investor section of the enterprise’s website at www.sesenbio.com for 60 days following the name. About Vicineum™ Vicineum, a in the community administered fusion protein, is Sesen Bio’s lead product candidate at the moment in the follow-up stage of a phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the business initiated the BLA submission for Vicineum to the FDA under Rolling evaluate. Vicineum is made from a recombinant fusion protein that targets epithelial mobile adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a amazing protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a good, genetically engineered peptide tether to be sure the payload remains connected until it is internalized by means of the cancer mobilephone, which is believed to lower the chance of toxicity to match tissues, thereby improving its security. In prior medical trials carried out via Sesen Bio, EpCAM has been proven to be overexpressed in NMIBC cells with minimal to no EpCAM expression accompanied on general bladder cells. Sesen Bio is at present conducting the phase 3 VISTA trial, designed to help the registration of Vicineum for the remedy of excessive-risk NMIBC in sufferers who’ve prior to now bought at least two courses of bacillus Calmette-Guérin (BCG) and whose ailment is now BCG-unresponsive. additionally, Sesen Bio believes that melanoma cell-killing properties of Vicineum promote an anti-tumor immune response that can also doubtlessly combine neatly with immuno-oncology drugs, reminiscent of checkpoint inhibitors. The exercise of Vicineum in BCG-unresponsive NMIBC is also being explored at the US national melanoma Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab. about the VISTA scientific Trial The VISTA trial is an open-label, multicenter, single-arm section 3 clinical trial evaluating the efficacy and tolerability of Vicineum™ as a monotherapy in sufferers with high-chance, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder melanoma (NMIBC). The fundamental endpoints of the trial are the comprehensive response fee and the period of response in sufferers with carcinoma in situ with or with out papillary disease. patients in the trial obtained in the community administered Vicineum twice per week for six weeks, adopted via once-weekly treatment for a further six weeks, then remedy each different week for up to two years. To be trained greater in regards to the phase 3 VISTA trial, please talk over with www.clinicaltrials.gov and search the identifier NCT02449239. About Sesen Bio Sesen Bio, Inc. is a late-stage scientific company advancing centered fusion protein therapeutics for the medicine of patients with melanoma. The company’s lead application, Vicineum™, also known as VB4-845, is at present in a part 3 registration trial for the remedy of excessive-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the business initiated the BLA submission for Vicineum to the FDA under Rolling evaluate. Vicineum is a in the neighborhood administered focused fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated kind of Pseudomonas Exotoxin A for the medication of high-possibility NMIBC. For extra counsel, please discuss with the business’s web page at www.sesenbio.com. About Qilu Pharmaceutical Qilu Pharmaceutical is without doubt one of the leading vertically integrated pharmaceutical groups in China focusing on the development, manufacturing and marketing of active pharmaceutical components (APIs) & entire formulations. Qilu at present has 12 subsidiaries, 10 manufacturing websites and over 23,000 employees worldwide. Qilu ranks No.eight in chinese pharmaceutical trade by earnings earnings in 2019. dedicated to offering extra within your budget drugs to the realm and enhancing people’s well-being, Qilu has exported its products to over 70 international locations. Qilu has at all times maintained an resourceful construction approach guided with the aid of the market demand and is reaching its biological boom method utilizing a robust pool of 2000+ scientists spread across 5 R&D systems primarily based within the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, Jinan). thus far, Qilu has launched 200+ items with 30+ items “First to launch” in China and three items “D181 launch” in US. The business also has a strong pipeline, together with 200+ time-honored products, 20+ biosimilar products and 50+ ingenious products. Qilu’s accomplished formulations and APIs had been authorized by way of US FDA, European drugs company (EMA), Therapeutic goods Administration (TGA) of Australia, drugs and Healthcare products Regulatory agency (MHRA) of UK, PMDA of Japan and different national regulatory authorities. Cautionary word on ahead-searching Statements Any statements in this press unencumber about future expectations, plans and prospects for the business, the business’s strategy, future operations, and other statements containing the words “anticipate,” “accept as true with,” “estimate,” “expect,” “intend,” “can also,” “plan,” “predict,” “task,” “target,” “knowledge,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, represent ahead-looking statements in the meaning of The deepest Securities Litigation Reform Act of 1995. actual consequences might also vary materially from those indicated via such forward-searching statements because of quite a lot of critical factors, together with: our capacity to correctly increase our product candidates and comprehensive our planned clinical courses, expectations related to the protection and efficacy of Vicineum, expectations concerning feasible milestone and royalty funds below the license settlement with Qilu, expectations concerning Qilu’s skill to fabricate, boost and commercialize Vicineum in better China, expectations concerning skills partnerships to advance and commercialize Vicineum backyard of the USA, and different factors discussed in the “chance elements” component to the enterprise’s Annual record on kind 10-ok, Quarterly stories on kind 10-Q and other experiences filed with the Securities and exchange fee. in addition, the ahead-searching statements included in this press release symbolize the enterprise’s views as of the date hereof. The business anticipates that subsequent activities and traits will cause the enterprise’s views to alternate. besides the fact that children, whereas the enterprise may additionally go with to update these forward-searching statements at some factor in the future, the company exceptionally disclaims any responsibility to do so. These forward-looking statements should now not be relied upon as representing the company’s views as of any date subsequent to the date hereof..

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