On October 30, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that it will report financial results for its 2019 third quarter on Thursday, November 7, 2019, after market close (Press release, NantHealth, OCT 30, 2019, View Source [SID1234550053]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 3294717. The call will be broadcast via the Internet at www.nanthealth.com.

On October 30, 2019 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the launch of the #ChangeLungCancer social media campaign (Press release, LUNGevity Foundation, OCT 30, 2019, View Source [SID1234550069]). LUNGevity is proud to provide a new way for lung cancer advocates to get involved this November during Lung Cancer Awareness Month through this social media campaign.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The campaign will raise awareness of lung cancer and help inspire others to help drive change through a variety of downloadable signs with powerful messages. Participants simply take a selfie holding one of several #ChangeLungCancer signs and share it on social media with their personal reason for changing lung cancer.

"Each year during Lung Cancer Awareness Month, we try to equip individuals with the tools they need to help spread awareness about lung cancer," Andrea Ferris, President and CEO of LUNGevity, said. "We know our community is very active on social media, and we are incredibly excited about the potential to raise awareness and drive change through this new vehicle. Together we can have the greatest impact on this disease."

Follow LUNGevity on social media to see stories of the #ChangeLungCancer campaign participants. Among them are patients/survivors, including members of ALK Positive, EGFR Resisters, and RET Renegades; doctors, including Raja Flores from Mount Sinai and Drew Moghanaki from Atlanta VA Medical Center and Emory Winship Cancer Institute; and researchers, including the members of LUNGevity’s newest class of Career Development Awardees, among others.

Choose your favorite sign and download it at www.LUNGevity.org/LCAMsigns.

Throughout November, LUNGevity provides many ways to get involved for Lung Cancer Awareness Month. LUNGevity believes strongly that everyone can drive progress and change for people affected by the disease, and invites its constituents to get involved, whether through social media advocacy, distributing educational materials, attending a Breathe Deep event, or organizing events and activities to raise funds and awareness.

On October 30, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Designations from the European Commission (EC) for paclitaxel and encequidar ("Oral Paclitaxel") for the treatment of soft tissue sarcoma, following a positive opinion from the European Medicines Agency (EMA) (Press release, Athenex, OCT 30, 2019, View Source [SID1234573893]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "We are very pleased to receive Orphan Designations from the European Commission, as this further recognizes the potential benefits of Oral Paclitaxel. Earlier this year, we shared encouraging early results from a clinical study in angiosarcoma, a form of soft tissue sarcoma, that showed rapid responses in a difficult to treat patient population. We will soon be extending this study to include sites in Europe."

The EC grants Orphan Designation status to support development of medicines for the treatment of diseases that affect fewer than 5 in 10,000 people in the European Union and provide a significant benefit to those affected by the condition. Orphan Designation may provide certain benefits, including protocol assistance, fee reductions, and a ten-year period of market exclusivity if the drug is approved.

The U.S. FDA has granted oral paclitaxel and encequidar an Orphan Drug Designation in the treatment of angiosarcoma.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On October 20, 2019 NexImmune, a clinical stage immunotherapy company developing novel T cell therapies, reported that it received Investigational New Drug (IND) clearance for the company’s first cellular therapy product (Press release, NexImmune, OCT 30, 2019, View Source [SID1234554876]). NEXI-001 is being developed for the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients with relapsed disease after an allogeneic hematopoietic cellular transplant (allo-HCT). Scott Carmer, NexImmune’s President and CEO, commented "we are excited to initiate clinical trials with NEXI-001, and to provide these patients with a promising new treatment option. NEXI-001 is a product that is meaningfully differentiated from other cellular therapies in that it contains multiple populations of antigen specific endogenous T cells with enhanced anti-tumor properties. Because of this, we are confident NEXI-001 could address key limitations observed with other cellular immunotherapies; specifically, tumor escape through single target down-regulation and tumor relapse due to diminished T cell persistence."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1/2 trial of NEXI-001 will begin enrolling patients at clinical sites across the United States, including Memorial Sloan Kettering, MD Anderson, The City of Hope, The Dana Farber Cancer Institute, and AdventHealth. The trial is a multi-center, dose-escalating, open-label, single-arm study evaluating the safety, tolerability and initial efficacy of adoptively-transferred donor-derived T-cells as a treatment for AML or MDS patients with relapsed disease after allo-HCT. The trial will evaluate two increasing dose levels, with three patients enrolled in each dose escalation cohort. After the initial safety evaluation phase, up to 20 patients will be enrolled in the dose expansion phase. All patients will be followed for at least one year.

Miguel Perales, MD, Deputy Chief of Bone Marrow Transplant Services at Memorial Sloan Kettering Cancer Center and the trial’s lead investigator, stated "for patients receiving T cell therapy after allo-HCT, the primary treatment goal is to separate the efficacy benefits of Graft-versus-Leukemia (GVL) from the toxicities associated with Graft-versus-Host Disease (GVHD). This requires the ability to deliver a cell therapy product that contains a significant proportion of leukemia antigen specific memory T cells, and few-to-no T cell subtypes with allo-reactive potential. We believe NEXI-001 represents a T cell product with potential to deliver against these key treatment goals. Our center is excited to participate in this clinical trial, and we are enthusiastic about the promise NEXI-001 represents for our post-transplant AML/MDS patients with relapsed disease."

Lee Greenberger, MD, Chief Scientific Officer at The Leukemia and Lymphoma Society, commented further, "patients who relapse after allo-HCT are left with a dismal prognosis and limited treatment options, and are in need of new treatments that offer significant benefit. LLS is proud to partner with NexImmune on the development of products like NEXI-001 through our Therapy Acceleration Program (TAP). We believe this unique technology has the potential to meaningfully benefit patients who are in urgent need of novel approaches to treating this disease."

About AML / MDS relapse after Allogeneic Hematopoietic Cellular Transplant
Among patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS), allogeneic hematopoietic cellular transplantation (HCT) used as post-remission therapy for those with high-risk genetic profiles or as salvage therapy for those with disease refractory to chemotherapy offers the highest potential for long-term survival. However, relapse after allogenic HCT remains the major cause of treatment failure, is associated with an extremely poor prognosis, and represents a major therapeutic challenge. In this situation, no standard therapy is defined, but treatment options generally aim to reduce disease burden and to enforce a graft-versus-leukemia (GvL) effect. Commonly used treatment options for these patients are chemotherapy combined with cellular-based approaches, such as donor lymphocyte infusion (DLI)or second transplantation.

About NEXI-001
NEXI-001 is an endogenous cellular therapy and includes populations of primed antigen specific CD8+ cells directed at multiple leukemia relevant antigen targets. Generating T cells against multiple tumor targets minimizes the potential for tumor escape. In addition, NEXI-001 contains T cell subtypes that are predominantly memory phenotypes, with the majority being characterized as stem cell memory and central memory T cells. Importantly, each NEXI-001 product contains minimal populations of naïve T cells (average <5%). Minimizing the naïve T cell compartment reduces alloreactivity and Graft-versus-Host Disease (GvHD) in patients after an allo-HCT, while T cell products that contain high proportions of memory cells, particularly central memory and stem cell memory, have been associated with potent anti-tumor activity, long-term T cell persistence and durable anti-tumor response.

On October 30, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, OCT 30, 2019, View Source;3 [SID1234550015]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on October 31, 2019, to 5:00 p.m., New York City time, on November 4, 2019 (as the same may be further extended, the "Expiration Date").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on October 29, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source