On July 1, 2020 Context Therapeutics LLC, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that results from a safety review from preclinical and two Phase 1-2 studies evaluating its drug candidate onapristone extended release (ONA-ER) for the treatment of progesterone receptor (PR) positive cancers has been published in the journal Drug Safety. ONA-ER is an investigational, potentially best-in-class oral progesterone receptor (PR) antagonist (Press release, Context Therapeutics, JUL 1, 2020, View Source [SID1234561629]). If approved, ONA-ER would be the first FDA-approved medication for PR+ cancers.

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Antiprogestins demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone was previously evaluated in Phase 2 studies for metastatic breast cancer. Due to liver enzyme elevations identified during these studies, further development was halted. Evaluation of antiprogestin pharmacology and pharmacokinetic (PK) data suggests that liver enzyme elevations might be related to off-target effects associated with serum Cmax levels. If correct, this suggests the use of pharmaceutic strategies targeting efficacious systemic dose levels, but with a diminished Cmax. One such strategy – twice-daily dosing of an extended release (ER) formulation of onapristone (ONA-ER) – was developed and clinically evaluated in two phase 1-2 studies in PR-positive malignancies. In light of renewed interest in antiprogestin therapy for treating PR-positive breast and gynecologic cancer, the publication authors assessed the hepatotoxic potential of: (a) onapristone in liver-focused preclinical toxicology models, and (b) ONA-ER based on data from two phase 1-2 studies involving breast, ovarian, endometrial, and prostate cancer patients.

"These results suggest that the extended-release formulation by reducing drug exposure may be associated with a reduced risk of hepatotoxicity, and supports the continued clinical evaluation of ONA-ER for treating PR-positive cancers," said study author James H. Lewis, MD, Director of Hepatology at MedStar Georgetown University Hospital.

In the Phase 1-2 trials, ONA-ER at escalating doses of 10 mg to 50 mg twice-a-day had a favorable safety and tolerability profile at all doses. There were no treatment-related severe adverse events among patients treated with ONA-ER. No clinical trial subject receiving ONA-ER developed liver test elevations meeting Hy’s Law criteria or other clinically significant hepatic injury considered to be drug-related.

"Poor tolerability has limited the potential of antiprogestins for cancer patients," said Martin Lehr, Chief Executive Officer of Context. "We are pleased with the results from this review, which highlight the potential of ONA-ER to meet a significant unmet need for a well tolerated treatment for PR-positive cancers."

About Onapristone ER

Onapristone ER (extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target progesterone receptor (PR) positive cancers. Preclinical and clinical data suggest that onapristone ER has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. Onapristone ER is currently being evaluated in patients with PR+ rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR-positive endometrial cancers will be initiated in 2020. Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.

On July 1, 2020 Physicians’ Education Resource, LLC (PER), reported that Heather A. Wakelee, M.D., professor of oncology at Stanford Medicine in California, will join the prestigious panel of program co-chairs at the 21st Annual International Lung Cancer Congress (Press release, Physicians’ Education Resource, JUL 1, 2020, View Source [SID1234561628]). The conference will take place July 23-25 as a live, interactive CME-certified virtual webcast.

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The other co-chairs leading the 2020 congress are:

David R. Gandara, M.D., professor of medicine, division of hematology/oncology, UC Davis School of Medicine, Sacramento, California; director of the thoracic oncology program and senior adviser to director, UC Davis Comprehensive Cancer Center.
Roy S. Herbst, M.D., Ph.D., ensign professor of medical oncology, professor of pharmacology; chief of medical oncology, Yale Cancer Center’s Smilow Cancer Hospital in New Haven, Connecticut; associate cancer director for translational research, Yale Cancer Center.
"We are eager to have Dr. Wakelee join the leadership team for our upcoming comprehensive expert-developed lung cancer program this July," said Phil Talamo, president of PER. "As the leading go-to resource for continuing medical education, we are proud to work with such renowned in the field and look forward to the powerhouse panel of co-chairs to discuss the most relevant and impactful strategies in the treatment and management of lung cancers."

For 21 years, the International Lung Cancer Congress has brought together medical, surgical and radiation oncologists to foster awareness of state-of-the-art treatments for patients with lung cancer. During this two-day webcast, leading international and national experts will provide perspectives on how to apply the latest data on targeted agents, immunotherapy, surgery and radiation oncology in the clinic. Cutting-edge lectures, panel discussions, multidisciplinary tumor boards and interactive question-and-answer sessions will provide a unique opportunity for participants to engage with the faculty as they share their perspectives and personal experiences on the clinical challenges and ongoing controversies in lung cancer management.

Dr. Wakelee added, "The ILCC has played a central role in my career development since my first conference participation in 2002 when I was an oncology fellow. I have never missed a meeting and am delighted to now step into a leadership role along with Drs. Gandara and Herbst."

Accredited by the Accreditation Council for Continuing Medical Education and approved by the California Board of Registered Nursing, this live webcast will provide participants with the opportunity to earn up to 20.5 AMA PRA Category 1 Credits and 20.5 nursing contact hours.

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.