On August 3, 2020 AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, reported the publication of the paper, "An update on GM-CSF and its potential role in melanoma management," in the journal Melanoma Management. Robert O. Dillman, M.D., chief medical officer at AIVITA, authored the article (Press release, AIVITA Biomedical, AUG 3, 2020, View Source [SID1234562674]).

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GM-CSF (granulocyte-macrophage colony-stimulating factor) is a white blood cell growth factor used in cancer care to stimulate the recovery of immune cells in patients who have received chemotherapy. It is also required for differentiating monocytes into dendritic cells and has been used as monotherapy in treatment of cancer, though the efficacy of this practice has not been clinically validated.

In the review. Dr. Dillman discusses the GM-CSF’s investigational uses as an anti-melanoma monotherapy and as an adjuvant for anti-melanoma vaccines, finding a strong rationale for GM-CSF as a vaccine adjuvant. Specifically, it appears of benefit for strategies that directly involve dendritic cells, such as with vaccines in which dendritic cells are loaded with antigen ex vivo and injected admixed with GM-CSF. AIVITA currently utilizes GM-CSF as a vaccine adjuvant in clinical studies of its personalized vaccines.

"Randomized trials have failed to confirm significant anticancer activity for monotherapy GM-CSF, but it appears to provide immune enhancing effects and survival benefit when it is admixed with dendritic cells loaded ex-vivo with autologous tumor antigens," said Dr. Dillman. "Effects were also observed when cytolytic virus that secretes GM-CSF was injected locally into tumors."

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.

About AIVITA’S Clinical Trials

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On August 2, 2020 Varian (NYSE: VAR) reported that it has entered into a definitive agreement to combine with Siemens Healthineers AG (Frankfurt: SHL) in an all-cash transaction valued at $16.4 billion on a fully diluted basis (Press release, Varian Medical Systems, AUG 2, 2020, View Source [SID1234562777]). Under the terms of the agreement, which has been unanimously approved by Varian’s Board of Directors, Siemens Healthineers will acquire all outstanding shares of Varian for $177.50 per share in cash, representing a premium of approximately 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, the last trading day prior to the announcement of the transaction, and a premium of approximately 24% to the closing price of Varian’s common stock on July 31, 2020.

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The combination will create a multi-disciplinary global healthcare leader with the most comprehensive cancer care portfolio in the industry. The combined company will offer an integrated platform of end-to-end oncology solutions to address the entire continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship. By bringing together the highly complementary diagnostic tools, imaging, radiotherapy and AI capabilities across both companies, Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide.

"Today’s announcement represents an important milestone in our company’s history, and our Board is confident that this is the right path forward for Varian," said Dow Wilson, President and Chief Executive Officer of Varian. "In addition to delivering immediate and compelling value to our shareholders, the combination with Siemens Healthineers brings us even closer to realizing our transformative vision of a world without fear of cancer. Siemens Healthineers’ innovative leadership in detection and diagnosis will extend our ability to serve clinicians and patients from the very first stage in the fight against cancer. And, we will be positioned to transform care for a greater number of patients worldwide."

Wilson continued, "Varian’s innovative and patient-centric culture has enabled us to become an iconic leader in radiotherapy and multi-disciplinary cancer care, with a trusted global brand and strong customer loyalty. Siemens Healthineers values our talented and engaged employees and recognizes the strength of the Varian brand, our cutting-edge portfolio, and the relationships we’ve nurtured. We are thrilled to partner with them to extend our renowned customer care to reach more patients around the world. With Siemens Healthineers, we can accelerate our vision, meaningfully increase our patient care impact and broaden opportunities for our employees as part of a larger and more diversified organization."

Dr. Bernd Montag, CEO of Siemens Healthineers AG said, "With this combination of two leading companies we make two leaps in one step: A leap in the fight against cancer and a leap in our overall impact on healthcare. This decisive moment in the history of our companies means more hope and less uncertainty for patients, an even stronger partner for our customers, and for society more effective and efficient medical care. Together with Varian’s outstanding and passionate employees, we will shape the future of healthcare more than ever before."

The transaction is expected to close in the first half of calendar year 2021, subject to approval by Varian shareholders, receipt of regulatory approvals and other customary closing conditions.

Varian has established strong brand recognition, and expects to continue to operate under the Varian name as an independent company within Siemens Healthineers following the completion of the transaction.

Third Quarter Fiscal Year 2020 Financial Results

In a separate press release issued today, Varian announced financial results for its third quarter fiscal year 2020.

Advisors

Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Varian and Wachtell, Lipton, Rosen & Katz is serving as legal counsel.

On August 2, 2020 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully dosed in a Phase 1 clinical trial (CIBI322A101) of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) in China (Press release, Innovent Biologics, AUG 2, 2020, View Source [SID1234562667]).

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CIBI322A101 is a Phase 1a/1b clinical study conducted in China to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy.

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody. IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively binds to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and higher safety profile.

Professor Jie Wang, director of Oncology Department of Cancer Hospital of the Chinese Academy of Medical Sciences, said: "Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, a part of patients has developed drugs resistance and the efficacy of immune checkpoint inhibitors needs to be further enhanced. Therefore, it is of great value to develop the next generation of anti-tumor immune bispecific antibodies. CD47 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI322 clinical trials."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "By targeting effector cells directly to tumor cells, bispecific monoclonal antibody enhances cytotoxicity, antibody selectivity and functional affinity. The preliminary results showed that IBI322 had higher efficacy in vivo, tumor-rich distribution and better safety than the single-specific anti-CD47 antibody. Bispecific monoclonal antibody could bring a lower-cost solution to patients compared with a combination of monoclonal antibody therapies. Therefore, the development of the anti-CD47/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope IBI322 could benefit more patients in need."

About IBI322

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody developed by Innovent. As a class 1 innovative drug and a potentially first-in-class molecule, IBI322 can effectively induce the phagocytosis of tumor cells and stimulate the activation of T lymphocytes to exert anti-tumor activity. IBI322 is of more affinity to tumor cells, thus reducing the toxicity to normal tissue, providing more effective treatment to cancer patients. IBI322 has received an IND approval from both the NMPA and the US FDA, we are actively preparing to develop it globally.

About CIBI322A101

CIBI322A101 is a Phase 1a/1b clinical study conducted in China to evaluate IBI322 in the treatment of patients with advanced malignancies. The Phase 1b study will be carried out to evaluate the efficacy of IBI322 in lung, cervical, esophageal, head and neck squamous cell and liver carcinomas.

On August 2, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that its Board of Directors has appointed Dr. Frank Zhang to serve as Chief Executive Officer, effective immediately (Press release, Legend Biotech, AUG 2, 2020, View Source [SID1234562666]).

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Dr. Zhang will succeed Dr. Yuan Xu, who has resigned from her position as Chief Executive Officer for personal reasons. Dr. Xu has also resigned from the Board of Directors of Legend Biotech.

"On behalf of the Board of Directors and myself, I want to thank Dr. Xu for her service and the contribution she has made to the Board of Directors and Legend Biotech during her tenure. We wish her continued success in her future endeavors," said Dr. Zhang, "Legend Biotech’s strategic partner Janssen Biotech, Inc. expects to initiate the BLA filing for our lead cell therapy product JNJ-4528 to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency in early 2021. Legend has a robust pipeline of promising cell therapies entering various stages of clinical development. We are confident that we can continue to help patients in need and create shareholder value by leveraging our strong R&D capabilities."

In addition to his new role as Chief Executive Officer, Dr. Zhang will continue to serve as Chairman of Legend Biotech’s Board of Directors. Dr. Zhang has concurrently stepped down as Chief Executive Officer of GenScript, Legend Biotech’s majority shareholder, in order to focus his attention on Legend Biotech.

Dr. Zhang has served as the Chairman of Board of Directors of Legend Biotech since May 2015. Dr. Zhang has been the chairman, an executive director and chief executive officer of GenScript since 2015. He co-founded the GenScript group in 2002 and has been the director of various group companies prior to GenScript becoming the holding company of the group companies pursuant to the corporate reorganization for GenScript’s initial public offering in 2015. In 2015, Dr. Zhang founded Legend Biotech as a subsidiary of GenScript, expanding GenScript’s business goal to research, manufacture and commercialize a broad range of immunotherapy treatments. In 2018, Dr. Zhang was awarded Person of the Year at the China Healthcare Summit in recognition of his contribution to and significant impact on the healthcare field. Dr. Zhang has also authored more than 20 articles published in peer-reviewed journals and is an inventor of 9 scientific patents. Before founding GenScript, Dr. Zhang worked as a Principal Scientist at Schering-Plough from 1995 to 2002 where he received its Presidential Award. Dr. Zhang holds a Ph.D. in biochemistry from Duke University, a Master’s degree from Nanjing University and a Bachelor’s degree from Chengdu Institute of Geology.

Conference Call

Legend Biotech will host a conference call on Sunday, August 2, 2020 at 6:00 p.m. Eastern time to discuss the management transition. The conference call will be broadcast live by webcast at: View Source

Following the conference call, a recording of the call will be available for replay via the investor relations section of Legend Biotech’s website: View Source

On August 2, 2020 Legend Biotech (NASDAQ: LEGN) reported preliminary results for the first half of 2020 (Press release, Legend Biotech, AUG 2, 2020, View Source [SID1234562665]).

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For the six months ended June 30, 2020, Legend Biotech expects to record a loss from approximately US$89.0 million to US$103.0 million from continuous operations (before one-time charges, including commission fee for issuance of Series A convertible redeemable preferred shares ("Series A Preferred Shares"), changes of fair value of such Series A Preferred Shares, and listing expenses), including research and development expenses of approximately US$96.5 million to US$111.8 million.

In addition, Legend Biotech expects to report a one-time non-cash charge of approximately US$80.0 million caused by the changes of fair value of Series A Preferred Shares, which was derived from the automatic conversion of all outstanding Series A Preferred Shares (plus any dividends accrued but unpaid on the Series A Preferred Shares) into ordinary shares, par value $0.0001 per share, of Legend Biotech ("Ordinary Shares") upon Legend Biotech’s listing on the Nasdaq Global Market. The details of the automatic conversion of the Series A Preferred Shares into Ordinary Shares are described in Legend Biotech’s prospectus filed with the Securities and Exchange Commission on June 8, 2020. The changes in fair value led to an increase of share premium, which in essence, had no impact on the net assets of Legend Biotech and its subsidiaries.

As of June 30, 2020, Legend Biotech had approximately US$562.4 million of cash and cash equivalents and approximately US$75.6 million in time deposits.

The information contained in this press release is preliminary and is based on the latest estimated unaudited management accounts for the six month period ended June 30, 2020. Such information is not a comprehensive statement of Legend Biotech’s results for, and as of, this period, and are subject to the completion of management’s and Legend Biotech’s audit committee’s reviews and other financial closing processes and potential adjustments. Accordingly, Legend Biotech’s actual results for this period may differ materially from the preliminary estimated data presented in this press release. The information contained in this press release has not been, and is not based on information that has been, audited, or reviewed by Legend Biotech’s independent auditor.

This preliminary estimated data should not be considered a substitute for the interim financial results for the six months ended June 30, 2020, to be filed with the Securities and Exchange Commission (the "SEC") under cover of Form 6-K, which Legend Biotech expects to occur before the end of August 2020.