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Synthon Biopharmaceuticals Relaunches as Byondis

On April 16, 2020 Synthon Biopharmaceuticals B.V., a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless cancers and autoimmune diseases, reported that it is relaunching as relaunch as Byondis (Press release, Synthon, APR 16, 2020, View Source [SID1234556387]).

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Byondis is creating safe and effective precision medicines based on its proprietary technologies, targeting intractable cancers and auto-immune diseases, which aim to improve the standard of care for patients.

The Company has a broad development pipeline, including advanced clinical programs, such as anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) for breast cancer. In the second half of 2020, Byondis is expecting results from its pivotal TULIP Phase III trial comparing SYD985 to physician’s choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Submission of a Biological License Application is scheduled before the end of 2020.

The Company anticipates entering the clinic with four additional programs in the course of 2020/2021. After progressing to clinical proof of concept, Byondis intends to enter into partnerships for late-stage development and commercialization.

Synthon Biopharmaceuticals was established in 2007 as part of Synthon B.V., and became a separate biopharmaceutical subsidiary in 2012, quickly building a promising pipeline of innovative R&D programs. In November last year, following the acquisition of Synthon International Holding B.V. by BC Partners, the founder, Dr Jacques Lemmens, decided to continue as an independent biopharmaceutical company, with its own management team and state-of-the-art facilities. This company relaunches today as Byondis.

"Our relaunch as Byondis is an exciting moment for the Company," said Dr Jacques Lemmens, Founder. "Building on our heritage, while preserving our company culture, we are further progressing in innovation, quality and scientific excellence."

"Now is the time to step up as an independent biopharmaceutical company, with our exceptional people, unique technologies and a well-established development pipeline, including our lead ADC, [vic-]trastuzumab duocarmazine. I am very proud of how the Company has grown and evolved. The new name, Byondis, represents the next chapter and embodies our entrepreneurial spirit and ambition to create innovative precision medicines to outsmart cancers and auto-immune diseases."

The Byondis management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. Dr Marco Timmers, CEO, and others in the senior team have collaborated for many years as part of Synthon. During this time, they have created a company driven by science and innovation, with unique technologies and significant validation deals. These include the out-licensing of a biosimilar version of the monoclonal antibody trastuzumab (marketed as KANJINTI) in a global partnership agreement with Amgen in 2012.

"As Byondis, we can now showcase our strong business and scientific proposition," added Dr Marco Timmers, CEO. "We have generated a portfolio of preclinical and clinical programs with the potential to deliver completely novel treatments for cancer and auto-immune diseases. We have unique technologies with differentiating potential, state-of-the-art facilities including our own GMP manufacturing, and broad licensing expertise that makes us an attractive partner for out-licensing. This is a really exciting time for Byondis and our team."

Byondis operates from its headquarters in Nijmegen in the Netherlands, with over 350 highly qualified employees working in state-of-the art research and development and GMP manufacturing facilities. The Company has strong links to academic institutions, global medical communities and the international pharma industry.

MedX Health Corp. Announces Proposed Extension of Non-Brokered Private Placement Offering

On April 16, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported that, subject to acceptance by the TSX-V the ultimate Closing Date for the non-brokered Private Placement of up to $2.5 million, which was previously announced on March 6, 2020, will be extended by up to 30 days (Press release, MedX Health, APR 16, 2020, View Source [SID1234556386]). The Company has already received Conditional Acceptance for the placement from the TSX-V, but closings have been delayed primarily as a result of Government-imposed restrictions in response to the COVID-19 Pandemic. The proposed placement, to accredited investors, is for the placement of up to 20,833,333 units at $0.12 per unit ("Unit"). Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.

ImmunoGen Announces Conference Call to Discuss Its First Quarter 2020 Operating Results

On April 16, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, May 1, 2020 to discuss its first quarter operating results (Press release, ImmunoGen, APR 16, 2020, View Source [SID1234556385]). Management will also provide a brief update on the business.

Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 7796220. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

A Novel Mechanism of Action for FS118 and the Potential to Overcome PD-(L)1 Resistance Published in Clinical Cancer Research

On April 16, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific antibodies (mAb2), reported the publication in Clinical Cancer Research of preclinical data highlighting the potential novel mechanism of action of its wholly-owned lead clinical asset FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody (Press release, F-star, APR 16, 2020, View Source;1 [SID1234556384]).

FS118 is currently in a Phase 1 study in patients with late-stage solid tumors who have relapsed following prior successful PD-(L)1 therapy.

Despite advances with therapies targeting the highly immuno-suppressive molecules PD-1 (programmed cell death protein 1) or its ligand, PD-L1, many cancer patients are refractory to, or relapse following treatment. Relapse is associated with upregulation of other checkpoint inhibitor receptors such as LAG-3 (Lymphocyte Activation Gene 3). FS118 was selected for development based on its ability to overcome immunosuppression mediated by both LAG-3 and PD-L1 in cancer patients.

The in vitro and in vivo studies reported in Clinical Cancer Research demonstrated that FS118 simultaneously bound LAG-3 and PD-L1 with high affinity. FS118 showed a greater enhancement in T cell activity, and reversal of LAG-3 and PD-L1 immunosuppression, than the combination of the single component parts of the bispecific antibody. The authors concluded that targeting both LAG-3 and PD-L1 in a single tetravalent bispecific antibody can work synergistically to overcome inhibition of T cell activation.

In tumor mouse models, a bispecific antibody targeting LAG-3/PD-L1 significantly suppressed tumor growth. The anti-tumor immune response was greater than using PD-L1 or LAG-3 antibody monotherapy and was also more effective than a combination of those monotherapies. These data demonstrated that a LAG-3/PD-L1 targeting tetravalent bispecific antibody can provide dual blockade of LAG-3 and PD-L1 in vivo and can enhance the anti-tumor immune response.

The authors concluded that the study demonstrated a benefit from FS118, not observed with the combination of single PD-L1 and LAG-3 monoclonal antibodies, to drive a potent anti-tumor response, supporting the further development of FS118 for the treatment of patients with cancer.

Neil Brewis, Chief Scientific Officer of F-star, said: "These data are the foundation for our confidence in FS118 and its potential to overcome cancer immune resistance. Currently only the minority of patients realize durable benefit from immunotherapy, so there remains a huge need to develop more effective options. At F-star we are developing antibodies with an innovative tetravalent bispecific format and the potential to elicit better biological responses compared to traditional antibodies or combinations. We believe FS118, with its novel approach to overcoming resistance to PD-(L)1 blockade will be an important part of the exciting next wave of checkpoint therapies. We look forward to providing additional data from our ongoing Phase I study to validate our approach later this year."

A link to the full study, entitled "FS118, a bispecific antibody targeting LAG-3 and PD-L1 utilises a novel mechanism to enhance T cell activation resulting in potent anti-tumor activity" can be found here.

About FS118

Currently in a Phase 1 study at four clinical sites in the United States, FS118 is a potentially first-in-class medicine for the treatment of resistant and refractory cancer. This tetravalent, bispecific antibody is developed to overcome tumor evasion mechanisms promoted by two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously blocking both inhibitory pathways, FS118 has preclinically demonstrated a potent anti-tumor growth activity as well as a highly differentiated mechanism of action when compared to checkpoint monotherapies alone or in combinations. In April 2018, a Phase 1 clinical study started in patients who have relapsed following a prior PD-(L)1-containing therapy. Information about the trial is available on clinicaltrials.gov NCT03440437. FS118 is manufactured at 2000L scale using standard mAb manufacturing processes.

RefleXion Raises $100 Million for Cancer Treatment Commercialization

On April 16, 2020 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT) for all stages of cancer, reported the close of a $100 million equity financing led by Public Sector Pension Investment Board (PSP Investments), one of Canada’s largest pension investment managers that focuses on long-term investments with partners demonstrating strong value orientation strategies (Press release, RefleXion Medical, APR 16, 2020, View Source [SID1234556383]).

"RefleXion’s bold vision for the future of cancer care stands to completely reshape how physicians think about treating patients with stage 4 cancer," said Loïc Julé, managing director, Global Investment Partnerships Portfolio, PSP Investments."This is exactly the mindset of companies we strive to build long-term relationships with. We are thrilled to support RefleXion during this next phase of their growth as they ramp up market and clinical adoption of this groundbreaking technology."

RefleXion’s existing investors, TPG’s The Rise Fund, KCK Group, Sofinnova Partners, Venrock, T. Rowe Price, and global pharmaceutical leaders, Pfizer Ventures and Johnson & Johnson Innovation, JJDC Inc., all participated in the round. BofA Securities and Morgan Stanley & Co., LLC acted as placement agents for the company.

"This new influx of capital continues our momentum initiated first by FDA clearance of the RefleXion X1 platform last month, then quickly followed by the close of our first system order at one of the world’s leading cancer centers," said Todd Powell, president and CEO of RefleXion. "The support of this top-tier investment syndicate enables us to further scale operations around commercializing the X1 platform.

"Moreover, these funds allow us to validate the practical implications of using BgRT on a daily basis as we transform radiotherapy from early-stage cancer treatment to an option for patients with all stages of cancer," continued Powell.

The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that currently restrict radiotherapy to one or two tumors. When available, RefleXion will scale BgRT to treat all visible tumors, even those that move rapidly due to bodily functions such as breathing or digestion, in the same treatment session.

RefleXion recently announced FDA clearance for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT), and its first clinical and commercial client.