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Genmab Announces That AbbVie Will Submit Marketing Authorization Application to European Medicines Agency for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

On July 18, 2022 Genmab A/S (Nasdaq: GMAB) reported that AbbVie (NYSE: ABBV) will submit a conditional marketing authorization application (MAA) with the European Medicines Agency (EMA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in the second half of 2022 (Press release, Genmab, JUL 18, 2022, View Source [SID1234616727]). Genmab recently announced that the company will submit a biologics license application (BLA) for epcoritamab with the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), also in the second half of 2022.

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The MAA submission is supported by results from the large b-cell lymphoma (LBCL) cohort of the pivotal EPCORE NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL. In April 2022, Genmab and AbbVie announced the topline results from the Phase II expansion part of the EPCORE NHL-1 trial. In June 2022, primary results were presented in a late-breaking oral presentation as part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2022) in Vienna, Austria.

"The MAA submission will mark the next step towards potentially obtaining marketing approval in Europe and being able to deliver a new therapeutic option to patients with relapsed or refractory DLBCL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "While there are existing treatments for DLBCL patients across Europe, we recognize the significant medical need for alternative therapeutic options for patients unable to tolerate current treatments or whose treatments have failed."

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494).

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is a fast-growing type of NHL that affects B-cell lymphocytes, a type of white blood cell. DLBCL, the most common type of NHL worldwide, accounts for about 25 percent of diagnosed cases of B-cell NHL worldwide. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system. The disease occurs more commonly in the elderly and is slightly more prevalent in men.i,ii

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a phase 1 first-in-human, dose escalation part; a phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, which determined the recommended phase 2 dose, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

The primary endpoint of the phase 2 expansion part was overall response rate (ORR) as assessed by an IRC. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.iii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.iv,v

Fresenius Kabi launches its first generic contrast media agent in the U.S.

On July 18, 2022 Fresenius Kabi reported that Iodixanol Injection, a radiographic contrast agent, is now available in the United States (Press release, Fresenius, JUL 18, 2022, View Source [SID1234616726]). It is the first FDA-approved generic iso-osmolar, dimeric iodinated contrast media agent, which is used during diagnostic x-ray-based imaging such as computed tomography (CT) scans. The launch represents the first move of Fresenius Kabi North America into radiology, another key area of the hospital.

Sesen Bio Announces Strategic Decision to Pause Clinical Development of Vicineum™ in the US

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.

"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.

GE Unveils Brand Names for Three Planned Future Public Companies

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]).

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.

Oxford Science Enterprises Raises £250 Million

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.

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.