On April 16, 2020 Accuray Incorporated (NASDAQ: ARAY) reported that it will report results for its third quarter ended March 31, 2020 on Tuesday, April 28, 2020 after the market close (Press release, Accuray, APR 16, 2020, View Source [SID1234556388]). Management will host a conference call to review the results at 1:30 p.m. PT/4:30 p.m. ET on the same day.

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The conference call dial-in numbers are 877-270-2148 (USA) or 412-902-6510 (International). In addition, a dial up replay of the conference call will be available approximately one hour after the call’s conclusion for one week. The replay number is 877-344-7529 (USA), or 412-317-0088 (International), Conference ID: 10142781.

A live webcast of the call will also be available from the Investor Relations section of the Company’s website at investors.accuray.com. A webcast replay can be accessed on the website and will remain available until Accuray announces its results for the fourth quarter of fiscal 2020.

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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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

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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.

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.

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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

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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.

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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

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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.

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]).

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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.