On September 26, 2019 ZielBio, Inc., an early-stage biotechnology company that identifies novel high value disease targets and develops therapeutic interventions to improve patient outcomes, reported that it has closed a $25.1 million Series A financing round (Press release, ZielBio, SEP 26, 2019, View Source [SID1234539828]). The round is led by Morningside Venture Investments and Partners Innovation Fund (PIF). ZielBio’s lead candidate ZB131 is a proprietary humanized monoclonal antibody against cell surface plectin (CSP), a target that is highly expressed on the plasma membrane of multiple types of cancer cells, including ovarian, pancreatic, lung and colorectal. The funding will enable the company to conduct further research to prioritize potential cancer applications, validate additional targets and initiate a planned phase 1 clinical trial with ZB131. "We are excited to partner with Morningside and PIF whose resources and drug development experience will greatly accelerate ZB131 development," noted Kimberly Kelly, PhD, President and Chief Science Officer at ZielBio.

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"Since its first discovery by ZielBio founder Dr. Kimberly Kelly at Massachusetts General Hospital, we have been encouraged by the unique role that cell surface plectin plays in proliferation, migration and cell survival and its potential as a drug target for a range of difficult to treat cancers," said PIF Partner Meredith Fisher, PhD. "Extensive pre-clinical laboratory and animal research has demonstrated that ZB131 has a high affinity to bind to CSP, inducing growth arrest and necrosis of targeted tumor cells."

"Despite the incredible progress being made in immuno-oncology, current therapies have limits and there remains a profound need for new targets and options for many deadly cancers," said Jason Dinges, JD, PhD, Investment Advisor at Morningside Technology Advisory. "ZB131 has shown potentially superior immune activation to current checkpoint inhibitors and greater direct tumor cell killing than EGFR inhibitors."

In connection with the financing, Drs. Dinges and Fisher have joined Dr. Kelly on the ZielBio Board of Directors.

On September 26, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported multiple data presentations at the upcoming American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA (Press release, Aura Biosciences, SEP 26, 2019, View Source [SID1234539812]). Aura’s lead clinical asset, AU-011, will also be highlighted in presentations at related medical meetings taking place in San Francisco around AAO 2019, including the Ophthalmology Innovation Summit taking place October 10, 2019, and the American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting taking place October 13, 2019.

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Two key presentations at the AAO meeting include study updates by key opinion leaders Dr. Jay S. Duker, Director New England Eye Center, Professor and Chair Tufts Medical Center and Dr. Amy C. Schefler, Weill Cornell Medical College and Retina Consultants of Houston, which will include updated clinical data from Aura’s ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma. An additional presentation will be given at AAOOP 2019 by Dr. Abdhish Bhavsar, Board Certified Ophthalmologist at The Retina Center and an investigator for Aura’s Phase 1b/2 clinical trial.

"There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer," said Cadmus Rich, MD, Chief Medical Officer of Aura Biosciences. "Patients are currently treated with radiotherapy and surgery which typically results in severe vision loss, along with many other significant adverse effects and comorbidities. If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to not only provide tumor control, but also preserve vision. We are excited to have these presentations on our AU-011 program and we look forward to sharing our novel technology, clinical data and an update on new delivery methods for AU-011 with the ophthalmology community at AAO and the accompanying events this year."

The details for the AAO 2019 presentations are as follows:

Title: Aura Biosciences

Presenter: Jay S. Duker, MD, New England Eye Center, Tufts Medical Center

Session: SYM22 The Innovators Symposium

Date and time: Sunday, October 13, 2019 from 2:47 – 2:54 PM PT

Location: Moscone Center, Esplanade Room

Title: Virus-Like Particles for Uveal Melanoma

Presenter: Amy C. Schefler, MD, Weill Cornell Medical College/Retina Consultants of Houston

Session: SYM50 Delivery of Therapeutics to the Posterior Ocular Segment

Date and time: Tuesday, October 15, 2019 from 9:35 – 9:45 AM PT

Location: Moscone Center, West 2002

Additional presentations taking place at other events in San Francisco around AAO 2019 include:

Event: Ophthalmology Innovation Summit (OIS) @ AAO

Title: Update on Aura Biosciences

Presenter: Elisabet de los Pinos, PhD, Chief Executive Officer of Aura Biosciences

Session: Innovation Showcase 1

Date and time: Thursday, October 10, 2019 from 8:40-8:47 AM PT

Location: Hilton San Francisco Union Square, 333 O’Farrell Street

Event: American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting

Title: Study Update of an Ongoing Phase 1b/2 Open-label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Abdhish Bhavsar, MD, The Retina Center

Date and time: Sunday, October 13, 2019

Location: Grand Hyatt San Francisco, 345 Stockton Street

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On September 26, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported the appointment of Mona M Wahba, MD, MSM to the position of Deputy Chief Medical Officer (Press release, ITM Isotopen Technologien Munchen, SEP 26, 2019, View Source [SID1234539829]). Dr Wahba joined ITM on September 15, 2019 and will primarily be responsible for the development and implementation of ITM’s clinical strategy and presence in the United States (US), where Dr Wahba will be based. In this capacity Dr Wahba will also oversee the clinical conduct of the COMPETE phase III clinical trial in North America. This pivotal study is central to ITM’s global strategy of providing cutting edge radiotheranostic care to patients with neuroendocrine tumors.

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Prior to joining ITM, Dr Wahba has held several senior executive positions with major pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Novartis, and Bayer. With more than 20 years of experience in senior management roles in the industry, she has extensive knowledge in medical affairs, drug safety and clinical development. Dr Wahba was instrumental in leading US and global medical plans and launch readiness of Xofigo, a radiopharmaceutical drug designed to treat bone metastases in patients with castration-resistant prostate cancer (CRPC). At Ipsen Bioscience Dr Wahba served as Clinical Development Lead, advancing the vision and strategy for clinical development of radiotheranostics in various tumor types.

"We are delighted to welcome Mona at ITM. Given her extensive experience in the industry and her strong medical background in oncology, radiotheranostics and immunology, she will be a key member of the developing medical team and a key asset to our US presence," said Dr Philip E Harris, CMO of ITM. "She will provide important clinical and medical input to our developing pipeline and commercial operations particularly in the United States, where our Phase III clinical trial is in an accelerated phase of actively recruiting patients."

"I am excited to join ITM at this pivotal moment in the company’s history, in which many interesting projects are underway," commented Dr Mona M Wahba, newly appointed Deputy CMO of ITM. "I am looking forward to helping patients with new treatment options as appropriate, to growing the company’s US footprint and to furthering the success of our phase III clinical trial COMPETE, which is currently investigating our lead candidate Solucin for the treatment of gastroentero-pancreatic neuroendocrine tumors. Targeted Radionuclide Therapy is an extremely precise and promising field that has the potential to improve the lives of countless cancer patients worldwide. I am looking forward to participating in developing and executing ITM’s promising pipeline to address unmet medical needs."

On September 26, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat at the 2019 Cantor Global Healthcare Conference on Wednesday, October 2, 2019 at 1:15 p.m. ET in New York, NY (Press release, Aurinia Pharmaceuticals, SEP 26, 2019, View Source [SID1234539813]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of the presentation will also be archived on the Company website for thirty days following the event.

On September 26, 2019 Samsung Bioepis Co., Ltd. reported results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Samsung Bioepis, SEP 26, 2019, View Source [SID1234539830]).ii The study results will be presented for the first time today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain.

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"Data from this study showed that there were no clinically meaningful differences between SB8 and reference bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

The primary endpoint of the study was the overall response rate (ORR) by 24 weeks; risk ratio was analyzed in the full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference was analyzed in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%. The ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab; the risk ratio was 1.11 (90% CI: 0.975, 1.269). The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab; the risk difference was 5.3% (95% CI: −2.2%, 12.9%). The median progression-free survival (8.5 months vs 7.9 months) and overall survival (14.9 months vs. 15.8 months) were comparable between SB8 and reference bevacizumab. The overall incidence of treatment-emergent adverse events (92.1% vs 91.1%) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were also comparable between SB8 and reference bevacizumab.

Marketing Authorization Application (MAA) for SB8 was accepted for review by the European Medicines Agency (EMA) in July 2019.

The results of the SB8 Phase 3 study will be presented as a poster during ESMO (Free ESMO Whitepaper) as follows: [1565P] 12:00-13:00, September 28, Hall 4. Samsung Bioepis will also host a satellite symposium, titled ‘Quality Assurance to Optimize HER2+ Breast Cancer Treatment’, which will discuss the importance of quality maintenance in oncology biologics. The symposium will take place between 13:00-14:30 on September 30, 2019 in Toledo Auditorium, Hall 5, Fira Gran Via, Barcelona. Topics include:

Building confidence in biosimilars
Acknowledging importance of biologics quality in clinical practice
Reassuring biosimilarity based on clinical evidence
Interactive discussion: perspective on biosimilars in oncology
SB8 Phase 3 Study

The SB8 Phase 3 study is a randomized, double-blind, multicenter study evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). 763 patients were randomized (1:1) to receive SB8 or reference bevacizumab with paclitaxel and carboplatin Q3W followed by SB8 or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from the randomization of the last patient. The primary endpoint is the overall response rate (ORR) which is defined as the proportion of patients whose best overall response by 24 weeks is either complete response or partial response. Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.