Cellectar Presents a New Phospholipid Drug Conjugate (PDC) at the 2019 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference

On October 30, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported Jarrod Longcor, chief business officer of Cellectar, presented a poster highlighting preclinical data with CLR 180099 at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, being held from October 26– 30, 2019 in Boston, MA (Press release, Cellectar Biosciences, OCT 30, 2019, View Source [SID1234550031]). CLR 180099 is a Phospholipid Drug ConjugateTM (PDC) composed of a uniquely designed phospholipid ether conjugated to a flavagline (FLV) analogue payload.

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The poster, entitled: "CLR 180099, a lipid raft targeted phospholipid-drug conjugate, shows potent improved safety and efficacy against colorectal tumors," highlighted data demonstrating a greater reduction in tumor volume and improved survival with CLR 180099 than docetaxel in a colorectal cancer model. Additionally, as compared to the FLV payload alone, the PDC demonstrated improved tolerability with greater than a 20 fold increase in the maximum tolerated dose. CLR 180099 was also shown to have potent nanomolar activity in other select solid tumorsincluding breast cancer and lung cancer models.

"This new investigational program shows compelling efficacy and safety in these preclinical studies further demonstrating the versatility and potential of PDCs as a new therapeutic class of drugs for cancer," said Jarrod Longcor, chief business officer of Cellectar. "The ability to specifically deliver a variety of oncologic payloads to a broad range of tumor cells emphasizes the PDC technology’s unique and targeted treatment approach. These results further demonstrate this and represent another important advancement in the development and validation of our PDC platform."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (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.

Bristol-Myers Squibb to Take Part at the Wolfe Research Healthcare Conference

On October 30, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in a fireside chat at the Wolfe Research Healthcare Conference on Wednesday, November 6, 2019, in New York (Press release, Bristol-Myers Squibb, OCT 30, 2019, View Source [SID1234550030]). Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 3:10 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

Atara Biotherapeutics to Announce Third Quarter 2019 Operational Progress and Financial Results on Thursday, November 7, 2019

On October 30, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that its third quarter 2019 operational progress and financial results will be released before the market opens on Thursday, November 7, 2019 (Press release, Atara Biotherapeutics, OCT 30, 2019, View Source [SID1234550029]). Following the release, the Company will host a live conference call and webcast at 8:00 a.m. EST.

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Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

AIVITA Biomedical Announces Publication Detailing Immune Mechanisms Leading to Complete Remission of Measurable Metastatic Melanoma in Patient Treated with AIVITA Immunotherapy

On October 30, 2019 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative stem cell applications, reported the publication of an article titled "Genomic, Proteomic, and Immunologic Associations with a Durable Complete Remission of Measurable Metastatic Melanoma Induced by a Patient-Specific Dendritic Cell Vaccine" in the journal Human Vaccines and Immunotherapeutics (Press release, AIVITA Biomedical, OCT 30, 2019, View Source [SID1234550028]). Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, Gabriel Nistor, M.D., Chief Science Officer, and Aleksandra J. Poole, Ph.D., Vice President, Research & Development, authored the article.

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The article focuses on a melanoma patient treated in a prior Phase 2 study with AIVITA’s immunotherapy, autologous dendritic cells loaded with autologous tumor antigens derived from tumor-initiating cells. The analyses concern the immune mechanism of action that led to a complete response in the patient with progressive, refractory, metastatic melanoma. The analyses included elucidation of the genes in the patient’s tumor cells and normal cells, more than 100 blood markers before and after vaccination, and the patient’s immune cells.

The article is available at Taylor & Francis Online here: View Source

CLINICAL TRIAL DETAIL

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 cancer stem 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 cancer stem 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 cancer stem 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.

Ultragenyx to Host Conference Call for Third Quarter 2019 Financial Results and Corporate Update

On October 30, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, November 5, 2019 at 5pm ET to discuss third quarter 2019 financial results and provide a corporate update (Press release, Ultragenyx Pharmaceutical, OCT 30, 2019, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-third-quarter-2019-financial [SID1234550020]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 9946526. The replay of the call will be available for one year.