On July 1, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported that 17 abstracts highlighting PyL (18F-DCFPyL) have been selected for presentation at the virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2020 Annual Meeting taking place July 11-14, 2020 (Press release, Lantheus Medical Imaging, JUL 1, 2020, View Source [SID1234561627]). PyL is the PSMA-targeted small molecule positron emission tomography (PET) imaging investigational agent designed to visualize prostate cancer, which the Company recently purchased as part of the oncology business of Progenics.

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The abstracts to be presented at the meeting will feature data on PyL from two presentations based on Company-sponsored studies, including the positive results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL in patients with biochemical recurrence of prostate cancer. A third abstract focuses on the digital solution the Company is developing in parallel with PyL to potentially support prostate cancer staging using an automated miPSMA Index of the PET/CT PyL-PSMA images.

"Physicians and patients continue to experience an unmet need for diagnostic imaging that could assist in staging high risk prostate cancer and reliably detect recurrent or metastatic disease. The unmet need is particularly important among patients with low PSA values," said Istvan Molnar, M.D., the Company’s Chief Medical Officer. "We believe that the demonstrated strong diagnostic performance of our PSMA-targeted PET imaging investigational agent, PyL, could provide clinicians with actionable information. In addition, the use of the widely available isotope fluorine-18 may result in broad patient accessibility. Data to be presented at SNMMI this year further highlights PyL’s clinical potential, including the positive Phase 3 results of the CONDOR study, which achieved its primary endpoint with a correct localization rate of 84.8% to 87.0% among the three blinded independent readers. We remain on track to submit a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for PyL in the third quarter of 2020."

SNMMI presentations will be made available on July 11, 2020 and can be found in the virtual Science Pavilion.

Details for the SNMMI 2020 presentations based on Company-sponsored studies and Company-led digital solution development are as follows:

Title: Diagnostic Performance of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the Phase 3, Multicenter CONDOR Study
Lead Author: Steven Rowe, Johns Hopkins University

Title: miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging
Lead Author: Kerstin Johnsson, Progenics Pharmaceuticals

Title: Measuring bias in quantitative PET biomarkers in-vivo
Lead Author: Martin Lodge, Johns Hopkins University

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (PET) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On July 1, 2020 Novocure (NASDAQ: NVCR) reported that it will report financial results for the second quarter 2020 on Thursday, July 30, 2020, before the U.S. financial markets open (Press release, NovoCure, JUL 1, 2020, View Source [SID1234561626]). Novocure’s management will host a conference call and webcast to discuss its financial results for the three and six months ended June 30, 2020, at 8 a.m. EDT on Thursday, July 30, 2020. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1484689.

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The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On July 1, 2020 Akari Therapeutics, Plc ("Akari" or the "Company") (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, reported that it has entered into a Securities Purchase Agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Akari Therapeutics, JUL 1, 2020, View Source [SID1234561625]). Under the terms of the Agreement, Aspire Capital has committed to purchase up to $30 million of Akari’s American Depositary Shares ("ADSs") at Akari’s request from time to time during a period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with the Agreement. Akari will control the timing and amount of all sales of its ADSs to Aspire Capital.

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"Akari is very pleased to announce a second facility with Aspire Capital, a long-term and supportive shareholder. During the second quarter 2020, Akari raised an additional $9.3 million from Aspire thereby completing our initial $20 million agreement. This new capital of $9.3 million plus opportunistic access to an additional $30 million under our new agreement leaves Akari in a strong and flexible financial position to execute on its further development of nomacopan in critical areas of unmet need including bullous pemphigoid, thrombotic micro-angiopathy, atopic keratoconjunctivitis and COVID-19. This is an important partnership, with Aspire one of our largest shareholders, ahead of what we hope will be a transformative year for Akari as we seek to transition nomacopan into pivotal, Phase III trials," said Clive Richardson, Chief Executive Officer of Akari Therapeutics.

"We’re delighted to extend this additional commitment to Akari during such an important and exciting transition period for the company. Given the strong safety and efficacy we have observed thus far across a broad range of inflammatory diseases, we firmly believe nomacopan is uniquely positioned amongst the field of complement inhibitors and other novel anti-inflammatory agents. Not only has nomacopan demonstrated deep and consistent suppression of aberrant complement activity in patients but its proven inhibition of leukotriene (LTB4) provides exciting differentiation and expands its potential application in disease settings where granulocyte infiltration is also driving pathology," said William Blank, Principal, Life Sciences at Aspire Capital.

Proceeds are intended to be used by Akari for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. Akari has the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligation under the Agreement, Akari will issue 40,760,900 ordinary shares at approximately $0.02 per ordinary share (equivalent to 407,609 ADSs at approximately $2.21 per ADS) to Aspire Capital as a commitment fee. Akari also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. Additional detail regarding the Agreement and the related Registration Rights Agreement is set forth in Akari’s Current Report on Form 6-K filed today with the SEC.

On July 1, 2020 EpicentRx Inc. ("EpicentRx"), a San Diego-based clinical cancer immunotherapy company and SciClone Pharmaceuticals International Ltd., ("SciClone") reported that they have entered into a licensing agreement for RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα with ongoing Phase III trial in Small Cell Lung Cancer ("SCLC") (Press release, EpicentRx, JUL 1, 2020, View Source [SID1234561624]).

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Under the terms of the agreement, SciClone will obtain exclusive licensing rights to co-develop and commercialize RRx-001, for the treatment of cancer in humans, within Greater China territory, including mainland China, Hong Kong, Macau and Taiwan. SciClone will be responsible for development, product registration and commercialization in these territories. Per the agreement, SciClone will pay EpicentRx an undisclosed upfront payment and conditionally agrees to invest in EpicentRx this year. EpicentRx will be eligible to receive an aggregate amount of up to $120 million upon achieving certain development, approval, and commercial milestones. In addition, EpicentRx is eligible to receive double-digit royalties in the Greater China territory. SciClone has the option to solely develop RRx-001 for Hepatocellular Carcinoma indication in Greater China, and is eligible to receive royalties from EpicentRx upon the approval of such indication in EpicentRx’s territory.

"SciClone is a dynamic, innovative and forward-thinking company with whom we have excellent personal chemistry and are fully aligned as we seek to improve cancer outcomes in the US, China and around the world," said Tony Reid, CEO of EpicentRx.

"This agreement marks our next phase of growth, expanding development of our Phase 3 study as a global trial and strengthening the company financially to support a number of exciting programs," added EpicentRx’s CFO, Franck Brinkhaus.

"RRx-001 was initially identified and sourced from the aerospace industry and has been developed by EpicentRx as a novel first-in-class therapy. This small molecule drug acts to normalize the tumor microenvironment, activate the tumor associated macrophages (TAMs) of the innate immune system, and sensitize solid tumors to standard therapies," said Hong Zhao, President and Chief Executive Officer of SciClone. "We are excited to partner with EpicentRx team to develop and commercialize RRx-001 for the treatment of various types of cancer. This strategic partnership recognizes SciClone’s capability as a leading biotech company with integrated platform of development and commercialization."

RRx-001 is a well-tolerated next generation small molecule immunotherapeutic that targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype as well as improves tumor blood flow to enhance oxygen supply and drug delivery. As an immunotherapeutic with a non-overlapping mechanism of action and the potential to convert "treatment-resistant" tumors into "treatment sensitive" tumors, RRx-001 may be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents. RRx-001 is currently a Phase 3 trial called REPLATINUM trial for the treatment of third-line and beyond SCLC. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma and are planned in leukemia and myelodysplastic syndrome.

On July 1, 2020 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 that it has appointed Dr. John Friend as chief medical officer, effective immediately (Press release, Cellectar Biosciences, JUL 1, 2020, View Source [SID1234561623]).

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"We are pleased to welcome John back to Cellectar to oversee CLR 131’s late-stage oncology clinical development plans and FDA engagement for our adult and pediatric programs" said Jim Caruso, president and CEO of Cellectar Biosciences. "John’s understanding and prior involvement with CLR 131 combined with his extensive experience in oncology drug development will prove invaluable to our overall development program and near-term pivotal study registration strategies."

Dr. Friend returns to Cellectar bringing more than 17 years of global drug development and medical affairs expertise in hematology/oncology as well as a variety of other therapeutic indications. Most recently, he was chief medical officer of DRGT and prior to his earlier tenure at Cellectar, Dr. Friend served as Senior Vice President of Research and Development at Helsinn Therapeutics (U.S.), Inc. leading its research and development, clinical, medical affairs and regulatory affairs divisions. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.

Dr. Friend noted, "I am excited to rejoin the Cellectar team and to lead the clinical development, global regulatory submission and post-approval support of CLR 131. The recent results from the company’s phase 2a B-cell study demonstrating 40% plus response rates for relapsed and refractory multiple myeloma and non-hodgkin’s lymphomas as well as a 100% response rate to date in Waldenstrom Macroglobulinemia validates my early belief in CLR 131 and the PDC technology platform. I look forward to working to bring CLR 131 to market for the many cancer patients that may benefit from its treatment."

Dr. Friend completed his post-graduate residency program in family medicine and subsequently served as Clinical Director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina. He earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS) and received his undergraduate degree in Chemistry from Southern Methodist University,

Grant of Inducement Option

In connection with his hiring, Cellectar has granted to Dr. Friend, effective as of his first day of employment with Cellectar, an option to purchase 100,000 shares of Cellectar’s common stock at an exercise price per share equal to the closing price of Cellectar’s common stock on the grant date as reported by Nasdaq. This grant was approved by the Compensation Committee of Cellectar’s Board of Directors and made as an inducement material to Dr. Friend entering into employment with Cellectar as contemplated by Nasdaq Listing Rule 5635(c)(4).

The stock option, which has a 10-year term, vests and becomes exercisable in three equal annual installments beginning on the first anniversary from the date of Dr. Friend’s first day of employment.

Cellectar provides this information in accordance with Nasdaq Listing Rule 5635(c)(4).

Resignation of Dr. Igor Grachev

Dr. Igor Grachev announced his resignation to pursue other opportunities. "We acknowledge and thank Igor for his contributions to our programs and wish him the very best in his future endeavors," said Jim Caruso, president and CEO of Cellectar Biosciences.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.