On June 28, 2018 Kymab reported its clinical trial agreement with F. Hoffmann-La Roche Ltd under which Roche will provide its PD-L1 blocking antibody atezolizumab for use in combination with Kymab’s lead investigational anti-ICOS antibody therapy KY1044 in Kymab’s upcoming Phase I/II clinical studies in patients with advanced solid cancers (Press release, Kymab, JUN 28, 2018, View Source [SID1234537005]).

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"We have presented preclinical data demonstrating strong synergies between an anti-PD-L1 treatment in combination with KY1044 against multiple tumour types," says Arndt Schottelius, MD, PhD, Executive Vice President, Research and Development of Kymab. "We look forward to the initiation of our first studies and exploration of the potential synergy of our programs for the benefit of patients with advanced solid cancers."

Kymab will be responsible for conducting the clinical trials, and both companies will share data from the trials. Kymab continues to retain all commercial rights to KY1044.

KY1044 is designed to both deplete intratumoral Regulatory T-cells and stimulate T Effector cells to enhance the immune response against tumors.

Kymab plans to conduct a Phase I/II study in a variety of solid tumours both as monotherapy and in combination with atezolizumab. Indications that have elevated levels of both ICOS and FOXP3 might be especially responsive to this combination of checkpoint inhibitors.

Kymab will lead studies to evaluate this hypothesis: atezolizumab, an anti-PD-L1 antibody that acts as a checkpoint inhibitor, and KY1044, an antibody targeting ICOS expression, will be tested for synergistic action to recalibrate the immune response. Kymab plans to initiate monotherapy studies of KY1044 in the first half of 2019 and studies in combination with TECENTRIQ in the second half.

Notes to Editors
Issued Cambridge, UK, 28 June 2018

Read the PDF version of the issued Press Release

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About KY1044
KY1044 is a fully human monoclonal antibody discovered by Kymab’s unique suite of technologies. KY1044 has now been tested in number of highly illustrative syngeneic models, which demonstrate that KY1044 strongly inhibits tumor growth in cancers both as a monotherapy and in combination with other immunotherapies.

Inducible T Cell Co Stimulator (ICOS), is expressed upon activation on T cells and at high levels on the majority of FOXP3+ regulatory CD4+ T cells. Importantly, available data demonstrate that depletion of these immunosuppressive cells from the tumor microenvironment enhances the patient’s anti-tumor immune response.

Scientific Posters and Presentations can be located in the pipeline section on the Company’s website: View Source

On June 28, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the second quarter ended June 30, 2018 before the US financial markets open on July 26, 2018 (Press release, Alexion, JUN 28, 2018, View Source [SID1234527498]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 9096048 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

On June 28, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported that the company will expand patient enrollment in the diffuse large b-cell lymphoma (DLBCL) cohort of its currently enrolling Phase 2 clinical trial of CLR 131 (Press release, Cellectar Biosciences, JUN 28, 2018, View Source [SID1234527499]).

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The response rate of the DLBCL cohort exceeded pre-specified criteria. As a result, the company will expand the cohort up to an additional 30 patients. This group represents the second of four cohorts to be expanded in this Phase 2 study. Previously the company announced the expansion of the study’s multiple myeloma (MM) cohort. Additional updates on the two remaining select B-cell lymphoma cohorts will be provided when data are available.

"Relapse or refractory DLBCL is an aggressive cancer and the initial response rates from the cohort leave us optimistic in CLR 131’s potential to have a positive impact on patients with life-threatening hematologic cancers. We continue to see clinical benefit using CLR 131 across a range of cancer types and we look forward to providing future data updates on this indication and others," stated James Caruso, president and chief executive officer of Cellectar Biosciences.

About the Phase 2 Study of CLR 131

The Phase 2 study is being conducted in approximately 10 leading cancer centers in the United States for patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied include (MM, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).

The study’s primary endpoint is clinical benefit response (CBR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later.

In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. Cellectar has been awarded approximately $2 million in a non-dilutive grant from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About Diffuse Large B-Cell Lymphoma

According to the Lymphoma Research Foundation, diffuse large B-cell lymphoma (DLBCL) is an aggressive form of non-Hodgkin’s lymphoma (NHL), accounting for about 30 percent of newly diagnosed cases of NHL in the United States.

The American Cancer Society’s most recent estimates for NHL for 2018 project approximately 74,680 people (41,730 males and 32,950 females) will be diagnosed with NHL including both adults and children. They estimate that approximately 19,910 people will die from this cancer (11,510 males and 8,400 females).

DLBCL occurs in both men and women, although it is slightly more common in men. Although DLBCL can occur in childhood, its incidence generally increases with age, and roughly half of patients are over the age of 60.

DLBCL is an aggressive (fast-growing) lymphoma that can arise in lymph nodes or outside of the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain. Often, the first sign of DLBCL is a painless, rapid swelling in the neck, underarms, or groin that is caused by enlarged lymph nodes. For some patients, the swelling may be painful. Other symptoms may include night sweats, fever, and unexplained weight loss. Patients may notice fatigue, loss of appetite, shortness of breath, or pain.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized PDCs to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On June 28, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter financial results on Thursday, July 26, 2018 after the close of financial markets (Press release, Seattle Genetics, JUN 28, 2018, View Source;p=RssLanding&cat=news&id=2356365 [SID1234527500]). Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Thursday, July 26, 2018
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 877-260-1479 (domestic) or +1 334-323-0522 (international); conference ID 6908320
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, July 26, 2018 through 5:00 p.m. PT on Monday, July 30, 2018 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 6908320
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On June 28, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with triple negative breast cancer (TNBC) (Press release, CytRx, JUN 28, 2018, View Source [SID1234527501]). This is the third trial conducted by NantCell which will investigate aldoxorubicin combined with immunotherapy or high-affinity natural killer (haNK) cell therapy in certain high unmet need cancer indications.The first trial in pancreatic cancer patients commenced in January 2018and the second trial, for patients with advanced squamous cell carcinoma, commenced in February 2018.

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Eric Curtis, CytRx’s President and Chief Operating Officer stated, "The initiation of this third clinical trial speaks to NantCell’s commitment to investigating aldoxorubicin in combination with their proprietary haNK cell therapy and working to identify effective treatment alternatives for women challenged by TNBC, an aggressive, difficult to treat type of breast cancer."

The trial titled "QUILT-3.067 NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy," (NCT03387085) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of several combination therapies, including combinations with aldoxorubicin, in subjects with TNBC who have progressed on or after standard of care therapies. This trial is expected to enroll approximately 79 patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary endpoint for the Phase 2 portion of the trial is objective response rate (ORR) by RECIST.

About Triple Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a particularly aggressive form of cancer whose cells do not have estrogen, progesterone, or receptors of the HER2 protein. According to the National Institutes of Health, it is estimated that between 10 and 20 percent of breast cancer patients are diagnosed with TNBC and approximately 170,000 cases of TNBC have been reported annually worldwide, with higher rates among women under 50 years old and women of African American or Hispanic background. The disease may also be associated with inherited mutations in the BRCA1 gene.