On March 1, 2021 VBL Therapeutics (Nasdaq: VBLT) reported that patient dosing has been initiated in a Phase 2 clinical trial investigating ofranergene obadenovec (VB-111) for the treatment of recurrent glioblastoma multiforme (rGBM) (Press release, VBL Therapeutics, MAR 1, 2021, View Source [SID1234575855]). The study is sponsored by Dana-Farber Cancer Institute and is being conducted through a collaboration between VBL and seven leading neuro-oncology medical centers in the U.S.

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"This new study builds upon our previous successful Phase 2 trial of VB-111 in recurrent glioblastoma (rGBM) while incorporating lessons learned from the GLOBE study," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "It will use the same VB-111 treatment regimen that induced significant survival benefit in our prior Phase 2 study, this time in patients that go through a second tumor resection. I believe that our perseverance could lead to renewed hope for rGBM patients who are in desperate need of therapies that may change their disease course and prolong life."

The Phase 2 study is enrolling patients with rGBM who are scheduled to undergo a second surgery. VB-111 will be administered either before and after surgery (neo-adjuvant and adjuvant therapy) or after surgery only (adjuvant therapy) and each arm will be compared to a standard of care control arm. In addition to endpoints of progression-free survival (PFS) at 6 months and overall survival (OS), collection of tumor specimens will allow important analysis of the activity of VB-111 within the tumor and will evaluate its effect on the immune system in this immunologically `cold` tumor. Additional information about the new VB-111 study can be found on ClinicalTrials.gov (NCT04406272).

About VB-111 (ofranergene obadenovec)
VB-111 is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the U.S. and Europe, and fast track designation in the U.S. for prolongation of survival in patients with rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and recurrent platinum-resistant ovarian cancer (NCT01711970).

On March 1, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the Barclays Virtual Global Healthcare Conference at 8:00 a.m. ET on Tuesday, March 9, 2021 (Press release, AngioDynamics, MAR 1, 2021, View Source [SID1234575871]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On March 1, 2021 Suzhou Medilink Therapeutics Ltd. (Medilink), a global biotech company focusing on next-generation antibody-drug conjugate Research & development, reported the closing of a $50 million series A financing, to accelerate its innovative pipeline development and to support its unique conjugate technology platform (Press release, Suzhou Medilink Therapeutics, MAR 1, 2021, View Source;development-301236856.html [SID1234575893]). The financing includes a series-A1 round led by Apricot Capital, and a series-A2 round co-led by Loyal Valley Capital and Qiming Venture Partners.

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"Our team has extensive knowledge in ADC technology and project development. Our aim is to develop medicines with real benefit for patients around the world. The ADC field has experienced a series of significant breakthroughs in recent years and we believe that there is still an urgent need to develop more efficacious and safer ADC drugs " Said Dr. Tongtong Xue, Founder and CEO of Medilink, " With solid support from our prestigious investors, we will focus on our conjugate platform and swiftly build up our differentiated pipeline, to meet huge unmet needs worldwide."

Medilink Therapeutics was established in 2020 by a sophisticated team of industrial veterans. Dr. Xue has comprehensive experience in R&D, manufacture and business development. He used to serve as the CEO of Kelun-Biotech and managed a team of over 1000 scientists. Dr Jiaqiang Cai, CSO of Medilink, gathered nearly 30 years’ industrial experience in small molecule and ADC drug R&D and served previously as the VP at Shanghai Hansoh Pharmaceutical Ltd. Dr Liang Xiao, COO of Medilink, who was the VP at Kelun-Biotech and COO at Klus Pharma, has extensive experience in the development of biologics and ADCs.

Mr. Roy (Ronggang) Xie, Partner at Loyal Valley Capital said, "ADC is one of the most important approaches for cancer treatment. The advance of linker and payload technology has expanded the therapeutic applications of ADC. The Medilink team has the insight and knowledge edge in ADC R&D front. Since its founding, Medilink has shown strong execution capability and made rapid progress in fronts including projects, external collaborations and team buildings. We are honored to work with such an excellent team. Loyal Valley Capital will definitely be a long-term supporter of Medilink, which we believe will become a world-class leader in drug conjugate technology development. "

Dr. Kan Chen, Principal of Qiming Venture Partners, said, "Conjugated drugs have obvious advantages in fighting against cancers, especially malignant tumors. As the technical barriers are extremely high, ADC development is full of hope and challenges. Founded in Suzhou，China, Medilink has high ambitions for its ADC R&D to be globally competitive, and meet the needs of global patients in the future. The team has the vision, experience and capacities to achieve the goal."

Mr. Jing Qiang, Partner at Apricot Capital, said, "The ADC drug development is highly complex, which requires well-balanced approach of all components including antibody, linker, and payload. Medilink has shown their strong know-how and unique insights in every step of ADC design and development. It is highly appreciated about the entrepreneurship and chemistry among the team members, and we are confident that the company will be able to grow as a leading drug conjugate technology platform in the world."

On March 1, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following virtual healthcare conferences (Press release, Iovance Biotherapeutics, MAR 1, 2021, View Source [SID1234575950]):

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Cowen 41st Annual Health Care Conference – Cell Therapy Panel
Date/Time: Wednesday, March 3, at 1:20 p.m. ET
H.C. Wainwright Global Life Sciences Conference
Date/Time: Tuesday, March 9, at 7:00 a.m. ET
Barclays Global Healthcare Conference
Date/Time: Thursday, March 11, at 1:50 p.m. ET
Oppenheimer 31st Annual Healthcare Conference
Date/Time: Wednesday, March 17, at 1:10 p.m. ET
The live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source

On March 1, 2021 Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their biosimilar Bevacizumab, co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg) (Press release, Biocon, MAR 1, 2021, View Source [SID1234594757]). Abevmy is a biosimilar to Roche’s Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.

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The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the U.K., the Medicines and Healthcare Products Regulatory Agency’s "reliance procedure" will be followed, and the U.K. marketing authorization can be expected shortly after the EC decision.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said: "CHMP’s decision to recommend approval of our biosimilar Bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the EU along with our partner Viatris. It is an outcome of our commitment to expand access for patients leveraging our science and global scale manufacturing for a range of biosimilars. Through bTrastuzumab and bPegfilgrastim we are already making a difference to the lives of cancer patients in several EU countries. We look forward to a final decision from the European Commission approving biosimilar Bevacizumab, which will add to our efforts in cancer care."

Abevmy, bBevacizumab, is a recombinant "humanized" monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.