On November 18, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product (Press release, PharmaCyte Biotech, NOV 18, 2019, View Source [SID1234551429]). The product is now ready for "release testing." The data from the "release testing" of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA) to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).

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The capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte’s clinical trial syringes and then frozen. Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo "release testing" related to the "safety" of the product. Austrianova will conduct "release testing" in-house related to the "functionality" of the encapsulated cells.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.

"Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On November 18, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported the appointment of Badrul Chowdhury, M.D., Ph.D., to the newly created position of Chief Medical Officer (CMO), effective immediately (Press release, Savara, NOV 18, 2019, View Source [SID1234551428]). Dr. Chowdhury will be Savara’s senior physician overseeing the medical and regulatory strategy of the Company’s investigational programs from late-stage development through to approval. He will also provide oversight of medical affairs and patient safety across the portfolio.

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Dr. Chowdhury joins Savara from AstraZeneca, where he was Senior Vice President, Chief Physician-Scientist for Respiratory, Inflammation, and Autoimmunity Late Stage Development, in Biopharmaceuticals R&D. For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) where he provided scientific and regulatory oversight of both common and rare diseases such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, rheumatoid arthritis, systemic lupus erythromatosis, and various autoimmune and inflammatory diseases. Dr. Chowdhury is a medical doctor, and also holds a Ph.D. in Immunology. He completed Internal Medicine residency training from the Wayne State University School of Medicine, Detroit, Michigan, and Fellowship training in Allergy and Immunology from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, Maryland. He is double board certified in Internal Medicine and Allergy and Immunology.

Over the course of his career, Dr. Chowdhury has been a member of many committees within the FDA, NIH, World Health Organization (WHO), United Nations Environmental Programme (UNEP), and the American Academy of Allergy, Asthma, and Immunology (AAAAI). Additionally, he has published scientific articles in more than 60 peer-reviewed scientific and medical journals and has been bestowed numerous research, academic, and service awards/honors.

"It is with great enthusiasm that we welcome an accomplished regulatory strategist, Dr. Chowdhury, to the role of CMO," said Rob Neville, Chief Executive Officer, Savara. "His appointment comes at a critical time as we continue discussions with the FDA and EMA on the best path forward for the Molgradex aPAP program. With two decades of regulatory leadership experience at the FDA’s Pulmonary Division, where he presided over numerous approvals of medicines for pulmonary and orphan diseases, Dr. Chowdhury brings a unique perspective to the Company and we believe he will be instrumental in helping us achieve our goals."

"As a physician and researcher with a passion for addressing significant unmet needs in pulmonary diseases, I am excited to join the Savara team," said Dr. Chowdhury. "I am inspired by the Company’s dedication to becoming THE orphan lung disease company, spearheaded by the Molgradex aPAP program. After reviewing the clinical data from the Phase 3 IMPALA study, I believe that Molgradex can provide a meaningful therapy for these patients. I look forward to working with the executive team to navigate the regulatory pathway for Molgradex in aPAP and the Company’s other pipeline programs."

On November 18, 2019 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the selection of an abstract highlighting updated single agent data from the Phase 1 clinical trial evaluating the HER2-targeted bispecific antibody, ZW25, in patients with HER2-expressing solid tumors for a mini oral presentation at the ESMO (Free ESMO Whitepaper) Asia 2019 Congress, taking place November 22 – 24 in Singapore (Press release, Zymeworks, NOV 18, 2019, View Source [SID1234551427]).

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The presentation, entitled "Safety, Anti-Tumor Activity, and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors," is scheduled for Friday November 22 at 3:30 pm SGT (local Singapore Time) during the mini oral session Developmental and Precision Medicine in room 311. The presentation number is 61O.

About the Phase 1 Clinical Trial

Zymeworks’ Phase 1 study has three parts. From part one of the study (the dose-escalation phase), the recommended single-agent dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg weekly. In the second part of the study (the cohort expansion phase), additional patients are being enrolled to further assess ZW25’s single-agent tolerability and anti-tumor activity against a variety of cancer types in different settings. The third part of the study (the combination phase) is underway and evaluating ZW25 in combination with selected chemotherapy agents in gastroesophageal and breast cancer patients with HER2 high or lower HER2 expression levels. More information about ZW25 clinical trials can be found at clinicaltrials.gov.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

On November 18, 2019 Varian (NYSE: VAR) reported the South Florida Proton Therapy Institute (SFPTI), a Proton International facility, on the campus of Delray Medical Center, reported that it has treated its first patient utilizing the Varian ProBeam Compact single-room proton therapy system (Press release, Varian Medical Systems, NOV 18, 2019, View Source [SID1234551426]). Proton therapy can be used to treat many types of tumors including in the brain, head and neck, central nervous system and lung, and more precisely targets cancer cells while reducing side effects, minimizing risk to surrounding tissue and organs.

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"Proton therapy is the latest and by far the most advanced radiation treatment available, and at SFPTI we use these highly precise particle beams instead of traditional x-rays to treat tumors more precisely, with much less exposure to the surrounding normal tissues," said Tim Williams medical director, SFPTI. "Proton therapy can be used to treat children with cancer as well as adult tumors of the brain, spine, head and neck, lung, prostate, GI tract, and breast tumors. I am truly grateful to finally be able to make this long-standing vision of bringing this world-class technology to south Florida a reality."

"We are proud of the partnership between Varian, SFPTI and Proton International to help bring this advanced treatment technology to more cancer patients who are in need of this life-saving therapy," said Kolleen Kennedy, president, Proton Solutions and chief growth officer at Varian. "This first patient treatment is another important step in the growing availability of proton therapy for more patients and continues Varian’s mission of creating a world without fear of cancer."

Proton therapy uses protons, accelerated to about two-thirds the speed of light, or more than 100,000 miles per second, to destroy cancer cells, while minimizing exposure to nearby healthy tissues. SFPTI will treat a variety of oncology patients with the Varian system, including brain and spine, head and neck, breast, liver, lung, pancreatic, prostate and pediatric cancers.

Currently 27 leading proton centers have selected the Varian solution, 12 of the centers are in clinical operation and eight more are expected to begin treating patients within the next 12 months. To learn more about the Varian proton therapy solutions, visit View Source

About South Florida Proton Therapy Institute
The South Florida Proton Therapy Institute (SFPTI), a Proton International facility, is a radiation oncology center that opened in 2018 on the campus of Delray Medical Center. Led by Medical Director Tim R. Williams, M.D. and featuring the most innovative technology available, SFPTI provides those in Palm Beach County and the surrounding communities with a tremendous new resource in the fight against cancer. For more information, visit View Source

On November 18, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the Jefferies London Healthcare Conference, being held at the Waldorf Hilton on Aldwych, in London, UK (Press release, TG Therapeutics, NOV 18, 2019, View Source [SID1234551425]). The presentation is scheduled to take place on Wednesday, November 20, 2019 at 11:20 AM GMT.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source