On October 14, 2018 Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that its IND application for a combination therapy of IBI308 (Sintilimab, an anti-PD-1 monoclonal antibody) and IBI305 (a biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab), has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical development (Press release, Innovent Biologics, OCT 14, 2018, View Source [SID1234529892]). Innovent will initiate clinical trials based on this combination to assess its safety and efficacy in patients with Non-Small Cell Lung Cancer (NSCLC) and hepatocellular carcinoma (HCC).

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"China has the highest burden of cancer patients of all countries in the world. Lung cancer and liver cancer account for about one third of all incident cases of cancers in China. At Innovent, an innovative biopharmaceutical company in China, we are dedicated to take advantage of the latest technological advances in science to develop and commercialize new medicines for cancer patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "Sintilimab’s New Drug Application (NDA) is currently under priority regulatory review and IBI305 has completed its phase 3 program. We believe the combination of IBI308 and IBI305 will provide more effective treatment for both lung cancer and liver cancer patients. We intend to capitalize on our company’s rich pipeline to explore new directions in combination therapy and to create even more innovative breakthroughs."

"Recent studies have shown there is a strong relationship between tumor induced angiogenesis driven by VEGFA and ANGPT2 and tumor induced immunosuppression driven by PD-1/PD-L1. Abnormal tumor-induced angiogenesis appears to limit the therapeutic effect of anti-PD-1/PD-L1 antibodies and other immunotherapy drugs. We believe the combination of sintilimab and bevacizumab biosimilar will be better able to control tumor growth through a two-pronged approach involving stimulation of the immune system with an anti-PD-1 antibody and blocking angiogenesis with an anti-VEGF antibody," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

About Non-Small Cell Lung Cancer

Lung cancer is the most common malignant tumor in China with the highest morbidity (781,000 new cases annually) and mortality (626,000 deaths annually). Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases. Seventy percent of NSCLC patients have non-squamous NSCLC and 40% of these patients harbor EGFR mutations. Treatment with a tyrosine kinase inhibitor (TKI: gefitinib, erlotinib or icotinib) is recommended for patients with advanced NSCLC who have EGFR mutations. After progression on TKI treatment, some patients acquire a T790M mutation and can be treated with osimertinib. In the absence of the T790M mutation or after treatment progression on osimertinib, the choice of systemic treatment is platinum-containing dual-agent chemotherapy. For such patients, new and more effective treatment options are urgently needed.

About Hepatocellular Carcinoma (HCC)

Liver cancer is the second leading cause of cancer-related death in China according to National Central Cancer Registry of China (NCCRC), with about 365,000 new cases and 319,000 deaths annually. Liver cancer with about 841,000 new cases and 782,000 deaths annually is the fourth leading cause of cancer-related death worldwide in 2018. Most primary liver cancers (70%-90%) are hepatocellular carcinoma (HCC) and most patients have locally advanced or metastatic disease at the time of diagnosis and are not eligible for radical treatment. With current therapy the global median survival time is only 7.9 months. However, for HCC patients in the Asia-Pacific region the median survival time is only 4.2 months. Hence, there is an urgent need for effective treatments for patients with advanced HCC in China and around the world.

About Sintilimab

Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.

About IBI305

IBI305, a biosimilar of bevacizumab, one of worldwide best-selling drugs, is currently in Phase III clinical trials. IBI305 specifically binds to vascular endothelial growth factors (VEGF), blocks the binding of VEGF to VEGF receptors and inhibits VEGF-induced angiogenesis and vascular permeability, thus limiting the growth of malignant tumors. Innovent has completed bioequivalence studies in healthy subjects and a randomized, double-blind, multicenter, phase III study in non-small cell lung cancer comparing IBI305 with Avastin.

About Combination Therapy

Combination strategies have become a key area of clinical research and may unlock the potential of immuno-oncology therapies by combining two anti-cancer agents that could have a synergistic mechanism of action. In IMpower150, a Phase III study, patients with non-squamous NSCLC and EGFR mutation who failed EGFR TKI treatment benefited from treatment with an anti-PD-L1 monoclonal antibody in combination with bevacizumab and chemotherapy . A Phase Ib trial (NCT02715531) of Atezolizumab combined with bevacizumab in the first-line treatment of advanced liver cancer showed that the combination was safe and effective with an objective response rate as high as 65%.

Sintilimab is a foundational agent for cancer therapies and Innovent will combine sintilimab with its rich development pipeline of innovative antibodies to form a diversity of tumor immunotherapies in our quest to provide affordable high quality biopharmaceuticals for even more patients.

On October 12, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the pricing of an underwritten public offering of 22,000,000 shares of its common stock at a public offering price of $9.97 per share (Press release, Iovance Biotherapeutics, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371434 [SID1234529874]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be $219.3 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,300,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about October 16, 2018, subject to customary closing conditions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of Iovance TIL as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus will be filed with the SEC, copies of which may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.

On October 12, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported updated results from the Phase 1 clinical trial of its investigational BTK inhibitor zanubrutinib, in an oral presentation at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). The IWWM meeting is taking place in New York City from October 11-13, 2018 (Press release, BeiGene, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371428 [SID1234529875]).

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"As we prepare our first U.S. New Drug Application (NDA) filing for zanubrutinib, which we expect to file in the first half of 2019 in patients with Waldenström’s Macroglobulinemia (WM), we are pleased to update data in patients with WM from the Phase 1 trial that will support our filing. With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses (VGPRs)," commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We believe that the maturing data across B-cell malignancies continue to support a multi-regional approval strategy for zanubrutinib, including the ongoing NDA review in China for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma by The National Medical Products Administration. We are hopeful that zanubrutinib, if approved, will represent a valuable treatment option across the globe for patients with several forms of B-cell malignancy."

Updated Results of Zanubrutinib in WM from Phase 1 Trial

A Phase 1 trial of zanubrutinib as a monotherapy in patients with different subtypes of B-cell malignancies, including WM, is being conducted in Australia, New Zealand, the United States, Italy, and South Korea. As of July 24, 2018, 77 patients with treatment-naïve or relapsed/refractory WM have been enrolled in the trial. Seventy-three patients were evaluable for efficacy in this analysis and the median follow-up time was 22.5 months (4.1-43.9). The median time to response (>PR) was 85 days (55-749). At the time of the data cutoff, 62 patients remained on study treatment. Updated results included:

The overall response rate (ORR) was 92 percent (67/73), the major response rate (MRR) was 82 percent, and 41 percent of patients achieved a VGPR, defined as a >90% reduction in baseline IgM levels and improvement of extramedullary disease by CT scan.

The 12-month progression-free survival (PFS) was estimated at 89 percent. The median PFS had not yet been reached.

The median IgM decreased from 32.7 g/L (5.3-91.9) at baseline to 8.2 g/L (0.3-57.8).

The median hemoglobin increased from 8.85 g/dL (6.3-9.8) to 13.4 g/dL (7.7-17.0) among 32 patients with hemoglobin <10 g/dL at baseline.

MYD88 genotype was known in 63 patients. In the subset known to have the MYD88L265P mutation (n=54), the ORR was 94 percent, the major response rate was 89 percent, and the VGPR rate was 46 percent. In the nine patients known to be MYD88WT, a less common genotype that historically has had sub-optimal response to BTK inhibition, the ORR was 89 percent, the major response rate was 67 percent, and the VGPR rate was 22 percent.

Treatment with zanubrutinib was generally well-tolerated and the majority of adverse events (AEs) were grade 1 or 2 in severity. The most frequent AEs of any attribution were petechia/purpura/contusion (43%), upper respiratory tract infection (42%), cough (17%), diarrhea (17%), constipation (16%), back pain (16%), and headache (16%).

Grade 3-4 AEs of any attribution reported in three or more patients included neutropenia (9%), anemia (7%), hypertension (5%), basal cell carcinoma (5%), renal and urinary disorders (4%), and pneumonia (4%). Serious AEs (SAEs) were seen in 32 patients (42%), with events in five patients (7%) considered possibly related to zanubrutinib treatment: febrile neutropenia, colitis, atrial fibrillation, hemothorax, and pneumonia (n=1 each).

Nine patients (12%) discontinued due to AEs: abdominal sepsis (fatal), septic shoulder, worsening bronchiectasis, scedosporium infection, gastric adenocarcinoma (fatal), prostate adenocarcinoma, metastatic neuroendocrine carcinoma, acute myeloid leukemia, or breast cancer (n=1 each, all considered by the investigator to be unrelated to treatment).

Atrial fibrillation/flutter occurred in four patients (5%). Major hemorrhage was observed in two patients (3%).

Four patients (3%) discontinued study treatment due to disease progression as assessed by investigator and one patient remains on treatment post-disease progression.
"We are encouraged that additional data on zanubrutinib in patients with WM confirms the initially reported experience, with consistent demonstration of robust activity and good tolerability. We are hopeful that zanubrutinib, if approved, could potentially provide an important new treatment option to patients with WM and other hematologic malignancies," said Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center, in Australia.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas.

On October 12, 2018 The imaging agent 5-Aminolevulinic Acid (5-ALA), which helps neurosurgeons see the edges of a tumor more clearly to improve removal, was used in brain cancer surgery at University Hospitals Seidman Cancer Center today for the first time since the FDA approved it for use in the United States (Press release, University Hospitals, OCT 12, 2018, View Source [SID1234530230]). Although the drug has long been a standard of care in Germany and much of Europe, it was only approved by the FDA for use in the U.S. in 2017.

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Andrew Sloan, MD, Director, Brain Tumor and Neuro-Oncology Center at UH Seidman and UH Cleveland Medical Center, who has been doing clinical trials with the drug for almost a decade based on his own FDA-approved IND clinical trial, was the first neurosurgeon in the U.S. to use the drug on a patient with brain cancer since FDA approval.

Several published studies — including those from Dr. Sloan — have shown that removing more tumor results in improved survival. However, this often is difficult.

"Glioblastoma are tumors which derive from the brain itself. They look like brain tissue, they feel like brain tissue, and at times, it’s hard to determine where tumor ends and inflamed brain tissue begins," said Dr. Sloan.

To help identify the difference between the border of tumors and healthy tissue and improve tumor removal, Dr. Sloan used 5-ALA during surgery so that the tumor cells glowed hot pink when illuminated with a special blue light incorporated into his operating microscope.

This novel technique enabled him to see the edges of the tumors more clearly, allowing him to remove them more completely from the brain.

On October 12, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2018 financial results will be released on Thursday, October 25, after the market closes (Press release, Gilead Sciences, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371354 [SID1234529876]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the third quarter 2018 and provide a general business update.

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The live webcast of the call can be accessed at the company’s Investors page at www.gilead.com/investors. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 1789278 to access the call. Telephone replay will be available approximately two hours after the call through 11:59 p.m. Eastern Time, October 27, 2018. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 1789278. The webcast will be archived on www.gilead.com for one year.