on November 17, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will host an investor conference call to discuss AUTO1 and AUTO3 data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Congress 2020 and will also participate in the Jefferies Banking Conference (Press release, Autolus, NOV 17, 2020, View Source [SID1234571272]):

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19 November 2020 – Dr. Christian Itin, chairman and chief executive officer, will participate in an analyst led fireside chat and host virtual one-on-one meetings at the Jefferies Virtual London Healthcare Conference at 11.25 am ET, 4.25 pm GMT. A live audio webcast of the fireside chat will be available on the investor relations section of the Company’s website at Autolus. An archived replay will be available for a period of 30 days after the conference.

7 December 2020 – Dr. Christian Itin, chairman and chief executive officer, along with the Autolus clinical team, will host an investor call and webcast at 4.00 pm ET, 9.00 pm GMT to discuss presentations related to its AUTO1 and AUTO3 programs, the company’s CAR T cell therapies being investigated in adult Acute Lymphoblastic Leukemia (ALL) and relapsed/ refractory diffuse large B cell lymphoma (DLBCL), respectively, during the ASH (Free ASH Whitepaper) conference. To listen to the webcast and view the accompanying slide presentation, please go to Autolus. After the conference call, a replay will be available for a period of one week.

On November 17, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed on prior platinum-based chemotherapy, met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) patient population at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC) (Press release, BeiGene, NOV 17, 2020, View Source [SID1234571270]). The safety profile of tislelizumab was consistent with the known risks of tislelizumab, with no new safety signals identified.

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"The RATIONALE 303 trial is the third Phase 3 trial of tislelizumab in NSCLC that has achieved a positive outcome at interim analysis, and more importantly, marks the first global pivotal trial with a positive outcome in the tislelizumab clinical program, demonstrating BeiGene’s capabilities in global clinical development. We look forward to sharing the full results at an upcoming medical conference and providing additional updates on our lung cancer program in the future," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "As we continue to advance tislelizumab in its broad clinical program, which targets a wide range of prevalent cancer types, we expect to see a growing body of clinical evidence that we believe will help further evaluate this potentially differentiated checkpoint inhibitor and support potential regulatory filings in China and globally."

RATIONALE 303 Trial of Tislelizumab Compare to Docetaxel in Patients with Locally Advanced or Metastatic NSCLC Who Progressed on Prior Platinum-Based Chemotherapy

RATIONALE 303 is a Phase 3 randomized, open-label, multicenter global clinical trial (NCT03358875) designed to evaluate the efficacy and safety of tislelizumab compared to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on a prior platinum-based chemotherapy. The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression; key secondary endpoints include objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and safety. A total of 805 patients were randomized 2:1 to either the tislelizumab arm or the docetaxel arm in 10 countries.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer remains the most common type of cancer and the leading cause of cancer-related death worldwide.i NSCLC accounts for approximately 85% of all lung cancer cases and is usually diagnosed at an advanced stage.ii The five-year survival rate with treatment for stage IIIB and stage IV NSCLC is 5% and 2%, respectively.iii

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review, for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On November 17,2020 PharmaMar (MSE:PHM) and STADA Arzneimittel have reported a commercial licensing agreement for Yondelis (trabectedin) with the STADA Arzneimittel AG’s subsidiary in the United Arab Emirates named STADA MENA DWC-LLC (herein together referred to as "STADA") in Algeria, Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates (UAE) and Yemen (Press release, PharmaMar, NOV 17, 2020, View Source;sid=2 [SID1234571268]).

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Under the terms of the license and commercialization agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including a regulatory milestone payment. PharmaMar will retain exclusive production rights of trabectedin and will sell the product to STADA for its clinical and commercial use on an exclusive basis in the 15 MENA markets.

This new agreement follows PharmaMar’s announcement on August 26th, 2019, regarding the agreement entered into with Janssen Products LP (Janssen), by which PharmaMar recovered the commercialization rights of the product in more than 40 countries, formerly licensed to Janssen, where Yondelis has already been approved.

Yondelis is currently registered and marketed in several MENA countries for the treatment of soft tissue sarcoma and relapsed ovarian cancer. Through this licensing agreement, and once the marketing authorizations are formally transferred, STADA will be authorized to commercialize and distribute the product in MENA countries on an exclusive basis.

According to Luis Mora, Managing Director of PharmaMar’s Oncology Business Unit: "This new agreement with STADA will allow us to bring trabectedin to patients throughout the 15 MENA countries covered by the deal. We see STADA’s infrastructure and internal capabilities playing a key role in helping us to maximize the access to this unique drug for as many sarcoma and ovarian cancer patients as possible."

Carsten Cron, Executive Vice-President of Emerging Markets at STADA, commented: "This alliance with PharmaMar for the Yondelis unique treatment option for sarcoma and ovarian cancer significantly strengthens our specialty pharmaceuticals portfolio in the MENA region. This builds on our purpose of "Caring for people’s health as a trusted partner."

"The agreement," he added, "is also testament to how STADA is using its position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer healthcare products, to build a broad oncology offering."

On November 17, 2020 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM) (Press release, Cellectis, NOV 17, 2020, View Source [SID1234571264]).

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Cellectis worked closely with the FDA over the past months, to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety. Cellectis continues to work with the clinical site staff and investigators to efficiently obtain the required local approvals to reopen the trial and resume patient enrollment.

"We remain confident in the potential clinical benefit of UCARTCS1 product candidate for patients with relapsed/refractory multiple myeloma, a widely unmet medical need that Cellectis will continue to address. The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program," said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.

Patient enrollment is ongoing in Cellectis’ two other proprietary Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.

About MELANI-01
MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clinical study evaluating UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on MM tumor cells. Learn more about the ongoing clinical trials at www.clinicaltrials.gov

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM’s pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,270 new cases of MM will be diagnosed, and 12,830 deaths are expected to occur in 2020 in the U.S. alone.

On November 17, 2020 Istari Oncology reported that UH Seidman Cancer Center became one of just six sites participating in a Phase II clinical trial to test the safety and efficacy of oncolytic polio/rhinovirus recombinant (PVSRIPO), a modified polio vaccine-based viral immunotherapeutic, in patients with recurrent malignant glioblastoma (rGBM) (NCT02986178) (Press release, Istari Oncology, NOV 17, 2020, View Source [SID1234571263]).

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The first-in-man Phase I trial, conducted at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, showed encouraging results. The study found that survival rates were significantly higher in rGBM patients who received an intratumoral infusion of PVSRIPO immunotherapy compared to similar patients receiving standard treatment at the same institution. Overall survival among patients who received PVSRIPO plateaued at 21 percent at 24 to 36 months and appeared to last for up to five years based on a publication of the interim trial results (Desjardins, et al., 2018 NEJM). The overall survival rate was sustained at 36 months in these patients.

"We’ve never seen survival rates like this before," says Andrew E. Sloan, MD, FACS, Director of the Brain Tumor & Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and UH Neurological Institute, and Professor and Vice Chairman, Department of Neurosurgery at Case Western Reserve University School of Medicine, who serves as principal investigator for the trial. "The long-term survival rate is very exciting. We are proud that University Hospitals was selected as one of a handful of top brain tumor centers, including the Stephen E. and Catherine Pappas Center for Neuro-Oncology at Massachusetts General Hospital and UCSF Brain Tumor Center, to participate in the Phase II clinical trial based on our expertise in immunotherapy and reputation for treating brain tumors."

To date, Dr. Sloan has treated seven patients with rGBM at UH Seidman Cancer Center according to the trial protocol, all of whom are surviving. Building on this experience, he is now seeking to enroll patients with rGBM into a new Phase I/II trial of PVSRIPO, but this time with a difference. This trial combines PVSRIPO with the immune checkpoint inhibitor pembrolizumab (Keytruda). The hypothesis is that the combination of the two therapies will be able to generate a potent and specific anti-tumor response in rGBM patients, given their different but complimentary mechanisms of action. This new trial is now open at UH Cleveland Medical Center. When it adapts to a Phase II trial in the coming weeks, it will be offered at approximately six total sites nationwide.

"The tumor we’re targeting is one of the most aggressive tumors known to man," Dr. Sloan says. "The virus can counteract some of that, but we want to test whether we can perhaps give it a little boost. PVSRIPO and pembrolizumab together may be more effective than either on its own."

That is, in fact, the working theory. According to Istari Oncology, Inc., which is sponsoring the new trial, "pre-clinical data and limited clinical use suggest that PVSRIPO followed by pembrolizumab may be associated with synergistic anti-tumor responses."

As in the first trials, patients in the new trial will receive PVSRIPO via a catheter into the tumor, a process known as convection enhanced delivery (CED). The infusion will be performed in the NeuroIntensive Care Unit at UH Cleveland Medical Center. The PVSRIPO infusion will be followed by intravenous pembrolizumab at approximately 14 days post-procedure, and then every three weeks thereafter, for up to 24 months, provided no toxicity or disease progression.

Dr. Sloan says he’s hopeful that the combination of PVSRIPO and pembrolizumab will prove successful for his patients with rGBM. In fact, he says, approaches that seem to hold the most promise for this intractable cancer are those that seek to increase expression of tumor-specific neo-antigens, coupled with checkpoint inhibition. This clinical trial fits that bill.

"That’s likely what’s necessary to overcome the profound immune blockade associated with this disease," he says.