On July 17, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that Sharron Gargosky, PhD, Chief Clinical and Regulatory Officer, presented a clinical update of the Company’s intratumoral therapy, ImmunoPulse tavokinogene telseplasmid (TAVO), as well as an overview of the ongoing and anticipated clinical programs involving TAVO in triple-negative breast cancer (TNBC) (Press release, OncoSec Medical, JUL 17, 2018, https://ir.oncosec.com/news/detail/1950/oncosec-presents-update-from-triple-negative-breast-cancer-program-at-3rd-global-insight-conference-on-breast-cancer [SID1234527738]). The presentation, titled "Intra-tumoral delivery of tavokinogene telseplasmid (pIL-12) by electroporation: immunomodulation in melanoma and triple negative breast cancer," took place at the 3rd Global Insight Conference on Breast Cancer in Valencia, Spain.

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"We were grateful for the opportunity to present at the 3rd Global Insight Conference on Breast Cancer and share progress from our TAVO clinical programs with the clinicians, biotechnology executives, and industry opinion leaders in attendance. Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," said Dr. Gargosky. "The marked synergy shown in these patients strongly suggest that IL-12 may have primed the tumor microenvironment, impacting the clinical result. The combination of TAVO and checkpoint inhibition represents a highly promising new therapeutic approach for TNBC and warrants a formal evaluation given the extremely low response rate in women who have failed multiple prior therapies."

The ongoing Phase 1 TNBC study, OMS-140 (NCT02531425), is designed to determine whether TAVO as a single cycle of monotherapy can elicit a pro-inflammatory molecular and histological signature in treated as well untreated tumors. The study has reached its target enrollment of 10 patients. Several of these patients were subsequently treated with an anti-PD-1 checkpoint inhibitor treatment(s) as their next therapy. As previously reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, immunological signals were observed on an individual patient basis, and clinically meaningful objective tumor responses have been observed in both TAVO treated and untreated lesions following the anti-PD-1 checkpoint inhibitor treatment. A detailed case study of one such patient, along with information regarding clinical observations and safety data, were presented at this conference.

Following these observations, the Company entered a clinical collaboration with Merck to evaluate the combination of TAVO with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 2 clinical trial, KEYNOTE-890 (NCT03567720). KEYNOTE-890 is a study of TAVO in combination with KEYTRUDA in TNBC patients with inoperable locally advanced or metastatic TNBC who have progressed on more than one line of prior therapy. Patients will be treated with the combination of TAVO with pembrolizumab. The proposed primary endpoint is to assess efficacy as measured by objective response rate (ORR) by independent central review (ICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. KEYNOTE-890 is expected to initiate in the third quarter of 2018.

On July 17, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that a patient in the lymphoplasmacytic lymphoma (LPL) arm with advanced Waldenstrom macroglobulinemia, enrolled in the CLR 131 Phase 2 trial, showed a 94% reduction in tumor burden and complete resolution in four of five targeted tumor masses (Press release, Cellectar Biosciences, JUL 17, 2018, View Source [SID1234527741]).

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Prior to study enrollment, this 67-year-old female patient was diagnosed with Waldenstrom macroglobulinemia and had received two lines of multi-drug therapy with the most recent treatment achieving a best response of disease progression. As part of Cellectar’s Phase 2 study in hematologic cancers, the patient received a single 25mCi/m2 dose of CLR 131 over a 30-minute infusion period. On day 52 post infusion, a CT scan showed a >50% reduction in tumor volume and was classified as a partial response.

Based on this initial response and additional clinical factors, the treating physician, Sikander Ailawadhi, M.D., Associate Professor, Division of Hematology/Oncology, Department of Medicine, The Mayo Clinic, Jacksonville, Florida, administered a second dose of CLR 131 on day 123. A CT scan taken 64 days after the second dose, showed a 94% overall reduction in tumor burden and complete resolution in four of five targeted tumor masses. The total targeted tumor mass shrank from approximately 4700mm2 prior to the first CLR 131 infusion to approximately 500mm2 at last reading, and we continue to monitor the patient’s progress.

"In addition to a robust clinical response, we were also happy to see resolution of symptoms that affected the patient’s quality of life, including shortness of breath associated with moderately-sized pleural effusion shortly after the patient’s first dose of CLR 131," stated Dr. Ailawadhi. "CLR 131 has shown good clinical response in LPL as well as other hematologic indications and could provide an excellent addition to the treatment armamentarium."

About Waldenstrom Macroglobulinemia

Waldenstrom macroglobulinemia is a rare type of cancer that begins in the white blood cells, according to the Mayo Clinic. Patients with Waldenstrom macroglobulinemia, typically have bone marrow that produces too many abnormal white blood cells, crowding out healthy blood cells. The abnormal white blood cells produce a protein that accumulates in the blood, impairs circulation and causes complications. Waldenstrom macroglobulinemia is considered a type of non-Hodgkin’s lymphoma and is sometimes called lymphoplasmacytic lymphoma or LPL.

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 in the trial include multiple myeloma (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 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. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On July 17, 2018 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV:APC) (FSE:0E8), is reported the collaboration of APC with Noria Pharmaceuticals Inc. in the rapidly growing field of antibody radioisotope conjugates (Press release, Advanced Proteome Therapeutics, JUL 17, 2018, View Source [SID1234530378]).

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APC will test its proprietary, site-selective, linker technology with Noria’s proprietary MacroPA radioisotope chelation technology in combination with antibodies known to preferentially target cancer cells. The scope of the current work will include investigations utilizing cell lines and animal studies.

Dr. Allen Krantz, CSO and Founder of APC commented, "APC’s linker technology represents a significant advance toward enabling the creation of a new generation of ADCs with superior potency and less toxicity. Our goal will be to extend the scope of our technology and make an important contribution to the emerging field of radioimmunotherapy that the company can capitalize on commercially."

Bill Dickie, President and CEO of APC added, "Radioimmunotherapy using alpha and beta emitting isotopes is an area of rapid development and investment. Major Pharma companies have made multi-billion-dollar acquisitions in the field and a number of emerging companies have benefitted from significant venture funding. Noria’s principals are radiopharmaceutical industry veterans who are demonstrating that they have best-in-class radioisotope chelation technology. APC is very pleased to be working with them."

Dr. Allan Green, President and CEO of Noria commented, "We are excited to extend our network of collaborators to include APC and look forward to working with them to create superior antibody-based therapies."

On July 17, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported that its second quarter 2018 financial results will be released on Wednesday, August 1, 2018 after the markets close (Press release, Exelixis, JUL 17, 2018, View Source;p=RssLanding&cat=news&id=2358696 [SID1234527742]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 5668207 to join by phone.

A telephone replay will be available until 8:30 p.m. EDT on August 3, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 5668207. A webcast replay will also be archived on www.exelixis.com for one year.

On July 16, 2018 SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the closing of its previously announced underwritten public offering of 6,845,000 shares of common stock, 4,675,000 pre-funded warrants exercisable for shares of common stock, and accompanying common stock warrants to purchase an aggregate of 11,520,000 shares of common stock (Press release, Sellas Life Sciences, JUL 16, 2018, View Source [SID1234527718]). At closing, SELLAS received aggregate net proceeds from the offering of approximately $21.6 million, after deducting underwriting discounts and commissions and estimated offering expense.

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SELLAS intends to use the net proceeds from the offering to commence a pivotal Phase 3 trial of GPS in acute myeloid leukemia (AML), and to develop GPS in combination with pembrolizumab (Keytruda) in a Phase 1/2 proof of concept study, as well as for general corporate purposes and funding its working capital needs.

Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. acted as joint book-running managers for the offering. Maxim Group LLC acted as lead manager.

A registration statement on Form S-1 relating to the offering was filed with the Securities and Exchange Commission (the "SEC") on May 23, 2018, amended on June 26, 2018 and July 11, 2018 and was declared effective on July 11, 2018. The offering was made only by means of a prospectus. SELLAS’ SEC filings are available to the public from the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the offering may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 6th Floor New York, New York 10022 or by email at [email protected] or Oppenheimer & Co. Inc., Attention: Equity Capital Markets, 85 Broad Street, 26th Floor, New York, NY 10004 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.