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VACCIBODY UPDATES ON CANCER NEOANTIGEN PHASE I/IIA CLINICAL TRIAL: FIRST 10 PATIENTS ENROLLED, AND VACCINATIONS STARTED.

On October 10, 2018 Vaccibody AS, a clinical stage immunotherapy company focused on developing personalized neoantigen cancer vaccines to target solid tumors, reported that the first 10 patients have been enrolled in its phase I/IIa cancer neoantigen vaccine trial and that vaccinations with VB10.NEO have started (Press release, Vaccibody, OCT 10, 2018, View Source [SID1234529872]). The trial is planned to enroll up to 40 patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. The VB10.NEO vaccine is given in combination with standard of care checkpoint inhibitors.

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Mads Axelsen, MD, Chief Medical Officer in Vaccibody, said "We are very pleased with the enrolment in the neoantigen trial and with the interest we are experiencing from clinical investigator and from patients. To that end I would like to thank the experienced cancer experts and investigators in this trial namely Prof. Jürgen Krauss from Heidelberg, Prof. Angela Krackhardt from Munich and Prof. Elke Jäger from Frankfurt. Together with their dedicated teams they are doing an outstanding job with the neoantigen trial"

Halozyme To Host Third Quarter 2018 Financial Results Conference Call

On October 10, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the third quarter 2018 on Tues., Nov. 6 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, OCT 10, 2018, View Source [SID1234529865]). On the same date, Halozyme will release financial results for the third quarter ended September 30, 2018 following the close of trading.

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 55575898.

Allogene Therapeutics Announces Pricing of Initial Public Offering

On October 10, 2018 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T(AlloCAR T) therapies for cancer, reported the pricing of its initial public offering of 18,000,000 shares of its common stock at a price to the public of $18.00 per share (Press release, Allogene, OCT 10, 2018, View Source [SID1234529851]). The gross proceeds to Allogene Therapeutics from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $324.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 11, 2018 under the symbol "ALLO." The offering is expected to close on October 15, 2018, subject to customary closing conditions. In addition, Allogene Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 2,700,000 shares of common stock.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC are acting as the joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or via telephone: 1-866-471-2526, or via email: [email protected]; or
J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or via telephone: 1-866-803-9204; or
Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or via email: [email protected]; or
Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or via telephone: 1-877-547-6340, or via email: [email protected].
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 10, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Celltrion and Teva Announce FDA Oncologic Drugs Advisory Committee Recommends Approval of Celltrion BLA for CT-P10, a Proposed Rituximab Biosimilar

On October 10, 2018 Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan1 (rituximab) for the treatment of adult patients in three proposed indications (Press release, Celltrion, OCT 10, 2018, View Source [SID1234529850]). The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The FDA will take the Committee’s recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed Rituxan biosimilar.

The Committee based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development program for CT-P10 demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications.

"We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications," said Woosung Kee, Chief Executive Officer of Celltrion. "The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients."

"If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience," said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. "We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems."

Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize CT-P10 in the U.S. and Canada.

1 Rituxan is a registered trademark of Biogen and Genentech USA, Inc.

About CT-P10

Celltrion’s CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.’s Rituxan, is currently approved in 47 countries across the globe. CT-P10 is the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and was first launched in Europe in 2017. The active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells.

AUM LifeTech, CHOP and Penn Partnering to Advance Cancer Immunotherapy Against Lung Cancer Using Foxp3 Gene Silencing FANA ASO Therapy

On October 10, 2018 AUM LifeTech, Inc., a Philadelphia-based biotech company, reported that it has partnered with the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania to employ next-generation RNA silencing FANA technology as a new approach to cancer immunotherapy designed to treat lung cancer (Press release, AUM Lifetech, OCT 10, 2018, View Source [SID1234529849]). The preclinical results were presented at the 2018 Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in Seattle, WA.

The study demonstrated that by reducing levels of a key protein called Foxp3 in immune cells using FANA antisense oligonucleotides (FANA ASOs), a next-generation gene silencing technology, lung cancer survival could be improved. Foxp3 is found in a subset of immune cells called T-regulatory (Treg) cells that constitute 5-10% of T cells (a type of white blood cell). Typically, Tregs suppress inappropriate immune activity and autoimmune diseases, however, their presence in tumors can prove deleterious and promote progression of many types of human cancers. In such cases, Tregs prevent anti-tumor responses by stopping the body’s conventional immune cells from attacking the cancerous cells. Without Foxp3, Treg cells are unable to perform their immune suppressing function. The team showed that FANA ASO therapy effectively reduced the levels of Foxp3 protein in Tregs by silencing Foxp3 gene (messenger RNA or mRNA), thus mitigating Treg-induced immune suppression and allowing the body to mount a full attack on the tumor. "Lung cancer is the biggest killer amongst all cancers. Our preclinical data in a lung cancer animal model is very encouraging and showed complete tumor rejection in a statistically significant animal population that were dosed with FANA antisense oligonucleotide therapy. We are now pursuing the next set of preclinical studies as we move towards filing of an Investigational New Drug (IND) application. I am very thankful to our collaborators and proud of my entire team as we embark on this extraordinary and very important journey to fight cancer," said Veenu Aishwarya, co-founder and Chief Executive Officer of AUM LifeTech, Inc.

This research was co-led by Dr. Wayne Hancock, Chief of the Division of Transplantation Immunology at the Children’s Hospital of Philadelphia. Dr. Hancock, a globally recognized immunologist, is also a Professor of Pathology and Laboratory Medicine at the University of Pennsylvania School of Medicine and has been working in the immune oncology and cancer immunotherapy space for over three decades. "We are very excited about our preclinical data. Tregs are known to suppress anti-tumor responses by host CD8 and CD4 T cells, B cells, NK cells, macrophages and dendritic cells. The ability of FANA ASOs to silence Foxp3 in Tregs makes them very attractive candidates for cancer immunotherapy for lung cancer, especially because currently there are no effective ways to target Tregs. The biggest advantage of FANA ASO therapy is its ability to self-deliver without the need of any formulations," said Dr. Hancock. "There is a lot of enthusiasm in the field of immuno-oncology. Last week’s announcement of the Nobel Prize in Medicine to Dr. James Allison (for CTLA-4) and Dr. Tasuku Honjo (for PD-1) further demonstrates the importance of this field. We plan to use FANA antisense therapy to further advance cancer immunotherapy."

FANA therapy can add significant unprecedented advantages to conventional therapeutic modalities and also target undruggable targets. This is especially beneficial for very aggressive forms of cancer, several of which are difficult to diagnose at early stages. "Existing strategies to treat some forms of cancer include the use of checkpoint inhibitors (monoclonal antibodies) to target immune checkpoints like PD-1 or CTLA-4, which are cell surface proteins involved in regulating the immune system. In other cases, they block the interaction between PD-1 and its ligand PD-L1. Some recent promising strategies include the use of chimeric antigen receptor (CAR) T-cell therapy to treat cancer. Checkpoint inhibitors and CAR T-cell therapy intercept their target at the protein or cellular level respectively. Using FANA ASO therapy, AUM LifeTech has joined the fight against cancer, and is advancing cancer immunotherapy, at the genetic level by directly targeting key genes to achieve anti-tumor immunity," added Aishwarya.

This study used RNA silencing FANA technology which has some key advantages over conventional gene silencing approaches. "I am very happy to see multiple applications of our FANA technology especially in the field of cancer. FANA provides high sequence specificity, stability and efficacy. It has been a long journey for AUM and I am delighted to see that their work is getting ready for clinical applications," said Dr. Masad J. Damha who is Distinguished James McGill Professor at McGill University in Canada. Dr. Damha, an internationally known nucleic acid researcher, serves on the Scientific Advisory Board of AUM LifeTech.

AUM LifeTech has leveraged the space, resources and support of the University City Science Center in Philadelphia since 2013. "The Science Center is delighted to provide the resources and support that allows companies like AUM LifeTech to grow and thrive," said Steve Zarrilli, President & CEO of the University City Science Center. "This promising research and exciting partnership are a reminder of the robust community of innovators that is driving research forward and advancing healthcare in Philadelphia and beyond."