On July 18, 2022 Sesen Bio (Nasdaq: SESN) reported that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum (Press release, Sesen Bio, JUL 18, 2022, View Source [SID1234616725]). The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA) . This decision enables Sesen Bio to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Additionally, the Company intends to seek a partner for the further development of Vicineum.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have had four productive meetings with the FDA since August 2021 and we believe we have a full understanding of the FDA’s evolving position and guidance on the following variables: accelerated versus standard approval, single-arm versus randomized controlled trials, comparative versus non-comparative efficacy endpoints, and adequate versus less-than-adequate BCG patient populations," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We have also recently observed an evolution of the current treatment paradigm in NMIBC, with substantial uptake of intravesical chemotherapy (monotherapy and combination therapy) during the ongoing BCG shortage. In assessing the impact of the regulatory and commercial landscape, we have made the decision to pause the clinical development of Vicineum."

Dr. Cannell continued, "We continue to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with larger infrastructure, and as such, we intend to find a partner that can execute further development to realize the full potential of Vicineum. We now turn our primary focus to the careful assessment of strategic alternatives, which we hope to have complete by the end of the year."

As of June 30, 2022, the Company had $161.2 million in cash and cash equivalents, no outstanding debt and fewer than 0.2 million outstanding warrants. These amounts are preliminary and are subject to change upon completion of the Company’s financial statements for the quarterly period ended June 30, 2022.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate for the treatment of 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 has completed the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. The Company intends to seek a partner for further development of Vicineum while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. 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 therapies, 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.

On July 18, 2022 GE (NYSE:GE) reported the brand names of the future companies it will create through its planned separation into three industry-leading, global, investment-grade public companies focused on the growth sectors of healthcare, energy, and aviation (Press release, GE Healthcare, JUL 18, 2022, View Source [SID1234616724]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GE HealthCare will be the name of GE’s healthcare business. GE’s existing energy portfolio of businesses, including Renewable Energy, Power, Digital, and Energy Financial Services, will sit together under the brand name GE Vernova. GE Aerospace will be the name of GE’s aviation business. All three planned companies will continue to benefit from GE’s heritage and global brand valued at nearly $20 billion*.

Additionally, GE announced today that following the completion of the planned spin-off, shares of GE HealthCare will be listed on The Nasdaq Global Select Market under the ticker symbol "GEHC." By listing on Nasdaq, GE HealthCare will benefit from the exchange’s profile and track record as a market for innovative, technology-led public companies, particularly in the healthcare sector.

H. Lawrence Culp, Jr., Chairman and CEO, GE, and CEO, GE Aerospace said, "Today marks a key milestone in GE’s plan to become three independent, laser-focused companies. Leveraging GE’s multi-billion-dollar global brand gives us a competitive advantage in our end markets, allowing these businesses to win in the future. Built on a foundation of lean and innovation, these brands will continue our mission of building a world that works and provide our customers with an important reminder of the strengths they value in GE."

GE intends to execute the tax-free spin-off of GE HealthCare in early 2023, creating an independent company driving innovation in precision health to improve patient outcomes and address critical patient and clinical challenges. Building on a more than 100-year history, the GE HealthCare name and Monogram will serve as an enduring badge of safety, quality, trust, and innovation. The new brand color for GE HealthCare is called "compassion purple" to reflect more humanity and warmth and achieve greater distinction. The company will continue to be at the forefront of provider and patient care with more than four million product installations and over two billion patient exams a year.

In early 2024, GE plans to execute the tax-free spin-off of GE Vernova, GE’s portfolio of energy businesses, which together with its customers provides one-third of the world’s electricity and is focused on accelerating the path to reliable, affordable, and sustainable energy. The new name is a combination of "ver," derived from "verde" and "verdant" to signal the greens and blues of the Earth, and "nova," from the Latin "novus," or "new," reflecting a new and innovative era of lower carbon energy that GE Vernova will help deliver. These attributes also are reflected in GE Vernova’s new "evergreen" brand color. With an installed base of more than 7,000 gas turbines and 400 GW of renewable energy equipment, GE Vernova’s Monogram will serve as a reminder of the company’s lasting commitments to deliver quality, partnership, and ingenuity to its customers.

Following these planned spin-offs, GE will be an aviation-focused company called GE Aerospace. With an installed base of 39,400 commercial and 26,200 military aircraft engines, the company will continue to play a vital role in supporting the industry through a historic recovery while shaping the future of flight. The GE Monogram, new name, and new "atmosphere blue" brand color—representing the upper limits of the atmosphere—maintain the brand’s strong standing in the aviation sector, while setting forth a confident vision to compete and advance in the field of aerospace and defense for future generations. Following the planned separations, GE Aerospace would own the GE trademark and would provide long-term licenses to the other companies.

GE Chief Marketing Officer Linda Boff said, "Over the course of the last six months, we engaged in a thorough, customer-led process to understand the intrinsic value of the GE brand for our planned future companies. Based on data and analysis drawn from thousands of conversations, it became clear that the GE name and our century-plus old Monogram represent a legacy of innovation, symbol of trust by global customers, pride for our team, and a talent magnet for future leaders. We’re proud these future businesses will be able to build on GE’s DNA of innovation."

By creating three separate companies, each will benefit from greater focus, tailored capital allocation, and strategic flexibility to drive long-term growth and value.**

Click here to watch Culp and Boff discuss the new brands.

*According to Interbrand Best Global Brands 2021.

**These plans may be subject to the outcome of legally mandated consultation in some parts of the world.

On July 18, 2022 Oxford Science Enterprises (OSE), the independent investment company created to found, fund and build transformational businesses via its unique partnership with the University of Oxford, reported it has raised a further £250 million ($300 million) in funding. This brings the total amount raised by OSE to more than £850 million (>$1 billion) since inception in 2015.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These funds significantly deepen OSE’s capital pool and enable the Company to identify further exceptional science from the University of Oxford, providing initial funding, hands-on support and access to expert networks and start-up infrastructure, to create new spinouts across Life Sciences, Health Tech and Deep Tech.

In addition, OSE will continue to support its existing and maturing portfolio, deploying increasingly large amounts of capital in later-stage funding rounds. This ability to provide scale-up capital is crucial for OSE to enable its businesses to advance through key development milestones, maximising their chances of success and increasing potential returns and impact.

Alexis Dormandy, Chief Executive Officer, said: "We are delighted to successfully complete this new fundraising. Attracting such high quality new and existing global investors reflects their enthusiasm for the strength of Oxford’s science and our plans to drive positive impact from it.

"This fundraise comes at an exciting and pivotal time for OSE. We have built a talented team and proved our model of translating ground-breaking science into a diverse portfolio of transformational businesses. Our companies are making remarkable breakthroughs from cancer, heart failure and infectious diseases, to climate change, food security and quantum computing. Over the next few years, we expect these companies will continue to make important progress; with our ongoing efforts, and the support of our shareholders, we look forward to helping them deliver impact and returns."

The fundraise announced today involved a diverse group of international investors, with strong participation from existing and new blue-chip investors, sovereign wealth funds, family offices, pension funds and asset managers.

Since founding in 2015, OSE has invested in over 80 ambitious companies built on Oxford science, committing £0.5 billion itself and attracting over £1 billion from blue-chip, global co-investors. To date OSE has helped progress 27 companies from seed to Series A and 21 to Series B and beyond, including 2 IPOs and 5 trade exits.

In addition to funding, OSE provides strategic business-building and operational support to its portfolio companies, including access to a global network of entrepreneurs and advisers, and has added over 55,000 sq ft of state-of-the-art lab and start-up space.

On July 18, 2022 Curaleaf International (the "Company" or "Group"), Europe’s largest vertically integrated cannabis company, reported that it has appointed Miles Worne as President, effective 11 July 2022 (Press release, EMMAC Life Sciences, JUL 18, 2022, View Source [SID1234616722]). Antonio Costanzo, the Company’s former CEO, will remain with the Company in a consultancy capacity, with his role transitioning to focus on M&A and Regulatory Affairs. Mr Worne’s appointment as President is part of the Company’s long-term strategy to drive growth as the European cannabis market opens up to adult-use, as well to ensure continued expansion in the medical cannabis market. The appointment of a President reflects Curaleaf’s commitment to capitalise on the ever-changing landscape and opportunities within the international cannabis marketplace.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Miles Worne has significant experience in building consumer brands and joins Curaleaf International from Glanbia plc, where he was European Managing Director of Glanbia Performance Nutrition, the global leader in sports nutrition and weight management. During the past four years at Glanbia, Mr. Worne grew brands such as Slimfast, Body & Fit, Optimum Nutrition and Amazing Grass across European markets.

There is meaningful momentum and a growing acceptance for cannabis in Europe, and a recent European wide poll conducted by Hanway Associates, an advisory firm specialising in strategy, research and M&A in the cannabis sector, demonstrated that more than half of Europeans in eight countries support adult-use cannabis legalisation and support the highest levels of regulation. Of particular importance to European consumers was companies’ adherence to the highest standard of service and regulation in their approach to legal recreational cannabis in a regulated retail offering. In addition to the growing acceptance amongst consumers for recreational cannabis, several governments in Europe have taken steps towards legalising cannabis. Notably Germany’s government has committed to legalising recreational cannabis and as it represents the largest economy in Europe, this presents a significant inflection point for European adult-use. In addition, Spain recently announced it will be creating regulations to allow medical cannabis, and Switzerland has removed medical cannabis access limitations following a rise in demand.

Antonio Costanzo, Former CEO of Curaleaf International, said: "It has been an honour to have co-founded and served as CEO of Curaleaf International since the Company’s inception in 2018. In that short time we have built Europe’s largest vertically integrated cannabis company, culminating in the acquisition by Curaleaf Holdings in 2021. I look forward to working with Miles and the wider team as we take the Company forward to its next stage of development and growth. The market is evolving considerably with significant opportunities across Europe, and I look forward to applying my significant regulatory and M&A experience to help drive the company forward as the global industry leader."

Miles Worne, President of Curaleaf International, said: "I am delighted to join Europe’s largest vertically integrated cannabis company, which already has a market-leading medical cannabis offering. I believe Curaleaf International is ideally positioned to leverage the growing European recreational opportunity and will utilise my significant experience of building strong consumer brands in Europe to help take advantage of the growing momentum in the cannabis industry. I look forward to working with my new colleagues at Curaleaf International in this incredibly exciting period for cannabis in Europe."

Matt Darin, CEO of Curaleaf Holdings, Inc., added, "I would like to welcome Miles Worne as President of Curaleaf International. Miles’s expertise in building strong household name global consumer brands will be invaluable as the European cannabis opportunity continues to evolve. We are extremely excited by the growing opportunity for cannabis across Europe and beyond, and are bullishly optimistic for the next few years as cultural and government acceptance grows. I would also like to thank Antonio Costanzo for what he has achieved as CEO of Curaleaf International, in building Europe’s largest vertically integrated cannabis company. Antonio’s experience in M&A and regulatory savvy will be invaluable to Curaleaf International as we capitalise on the growing European opportunity."

On July 18, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Monday, August 1, 2022, at 5:00 pm eastern time to discuss the financial results for the second quarter of 2022, recent business developments, revenue guidance for the third quarter of 2022, and financial outlook for full year 2022 (Press release, Emergent BioSolutions, JUL 18, 2022, View Source [SID1234616721]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Information
Participants can access the conference call live via webcast from the Investors page of Emergent’s website. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

A replay of the call can be accessed from the Investors page of Emergent’s website.