On December 5, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has directly entered into an agreement for the sale of its common stock in a private placement with a group of institutional investors (Press release, Athenex, DEC 5, 2019, View Source [SID1234551959]). The lead investor in the private placement is Kingdon Capital Management, LLC. The transaction is expected to result in gross proceeds to Athenex of approximately $60 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities for oral paclitaxel and encequidar; regulatory activities for tirbanibulin ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for oral paclitaxel and encequidar; manufacturing infrastructure; and working capital and general corporate purposes.

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The Company will issue 3,945,750 shares of common stock for a purchase price of $15.30 per share, for aggregate gross proceeds of approximately $60 million. The closing of the private placement is expected to occur on or about December 9, 2019, subject to customary closing conditions.

SunTrust Robinson Humphrey has acted as an exclusive placement agent to the Company in this private placement.

The offering of shares of common stock has not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and the shares are being offered pursuant to an exemption from the registration requirements of the Securities Act and similar exemptions under applicable state securities laws. At the closing of the offering, the Company will enter into a registration rights agreement with the investors, pursuant to which the Company will agree to file a registration statement with the Securities and Exchange Commission registering for resale the shares issued in this private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or 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.

On December 5, 2019 Zionexa, a radiopharmaceutical company specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) biomarkers, reported that they have entered into an exclusive agreement for the manufacturing and distribution of Zionexa’s new PET diagnostic drug, Fluoroestradiol (FES), which is pending approval by the Food and Drug Administration (FDA) (Press release, Zionexa, DEC 5, 2019, View Source [SID1234551977]).

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Fluoroestradiol (FES) is currently only approved for use in France for the characterization of estrogen receptor status in metastatic breast cancer.

"The Zionexa team is very excited to partner with PETNET in order to produce and distribute FES in the United States and ensure patients with metastatic breast cancer have access to this major innovation," said Bernard Landes, President & CEO Zionexa, "We are proud to work with the world-class team at PETNET to get this important diagnostic biomarker into the hands of clinicians. Studies have shown a high correlation between in-vitro immunohistochemistry assessment of estrogen receptor status and imaging findings using this biomarker. This new biomarker can provide clinicians with additional information to make more informed therapeutic decisions," said Peter Webner Zionexa CEO USA.

Barry Scott, Head of PETNET Solutions, added, "We are delighted to work with Zionexa to provide access to a new PET radiopharmaceutical that yields valuable clinical information to help physicians make treatment decisions. This agreement also allows PETNET to add to our portfolio of oncologic biomarkers and truly enable healthcare providers to practice precision medicine."’

On December 5, 2019 BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Corp. (CSE: CURE) (OTCQB: BICTF) ("CURE" or the "Company") reported that it has closed its Convertible Debenture financing. BPK has issued convertible debentures for gross proceeds of Korean Won660,000,000 (CAD732,600) (Press release, Biocure Technology, DEC 5, 2019, View Source [SID1234628753]). Its maturity date is December 5, 2029, with the coupon rate of 3%. The investor has a right to convert to common shares of BPK at CAD12.21 per share three years after the issuance of Convertible Debenture. All dollar values are based on the published Exchange Rate of CAD0.001110/KRW1 on December 4, 2019, Bank of Canada.

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On December 5, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported preliminary data from the triple combination arm of the ongoing Phase 2a COMBAT/KEYNOTE-202 study showing that the combination of BL-8040 (a CXCR4 inhibitor), KEYTRUDA and chemotherapy shows high response and disease control rates in patients with metastatic pancreatic cancer (Press release, BioLineRx, DEC 5, 2019, View Source [SID1234551961]). The data, summarized in an abstract published today, entitled, "A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 (a CXCR4 inhibitor) in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma (PDAC)," will be presented and discussed as a proffered paper (oral) presentation on Friday, December 13 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress (ESMO IO) 2019, which is being held December 11-14 at the Palexpo in Geneva, Switzerland.

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Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology, Senior Member of the Meyer Cancer Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study, said, "Metastatic pancreatic cancer has the worst prognosis of all solid tumors, with five-year survival rates of 3%, and a very poor response to the currently available immunotherapy treatments that are transforming care in other cancer indications. Therefore, it is highly important to develop novel combination treatments that will increase the responsiveness and survival of pancreatic cancer patients to immunotherapy. We are encouraged by these preliminary results and look forward to sharing additional data from this important trial next week at ESMO (Free ESMO Whitepaper) IO."

Preliminary Data from Triple Combo Arm of the COMBAT/KEYNOTE-202 Study
As of September 30, 2019 (the data cutoff date for the abstract), 22 patients were dosed (out of ~40 planned), of which 15 were evaluable. All patients enrolled were originally diagnosed with stage IV metastatic pancreatic adenocarcinoma (PDAC) and had progressed following first-line treatment with gemcitabine-based chemotherapy.

Best response for the evaluable population of 15 patients showed 4 partial response (PR) and 8 stable disease (SD) patients – resulting in overall disease control in 12 out of 15 patients;

Study is ongoing and median progression free survival (PFS) and overall survival (OS) were not yet reached; survival data remain on track for mid-2020;

The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone. Fifteen serious adverse events (SAEs) were reported by 10 patients and 2 patients discontinued the study due to SAEs.

"We are very excited by the preliminary data from this triple combination arm of our Phase 2a pancreatic study under our collaboration with Merck," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These data appear to confirm our hypothesis relating to the synergistic effect of cytotoxic chemotherapy, together with the T-cell trafficking, tumor microenvironment modulation and T-cell infiltration effects of BL-8040 seen in PDAC patients from multiple Phase 2 trials in combination with checkpoint inhibitors. Despite metastatic PDAC being one of the toughest diseases to treat, with so many prior clinical failures, we believe this combination of BL-8040, KEYTRUDA and chemotherapy may provide real hope to pancreatic cancer patients. We look forward to the additional data to be shared next week, as well as the complete study results expected to be released in mid-2020."

Investor Breakfast Meeting Today in New York
The preliminary results will be discussed at an Investor/Analyst Breakfast Meeting being hosted by BioLineRx today, December 5, 2019, in New York, between 8:10 am and 9:30 am EST. A live webcast and replay of the event will be accessible here.

Design of Triple Combination Arm of COMBAT/KEYNOTE-202 Study
The triple combination arm focuses on second-line pancreatic cancer patients and is expected to include approximately 40 patients originally diagnosed with unresectable metastatic pancreatic adenocarcinoma who have progressed following first-line gemcitabine-based therapy. Patients receive BL-8040 monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and BL-8040 until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About BL-8040 in Cancer Immunotherapy
BL-8040 is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

BL-8040 is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, BL-8040 has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

On December 5, 2019 US Oncology reported during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research will demonstrate detailed results from more than 20 studies covering topics including lymphoma, multiple myeloma, leukemia and more (Press release, US Oncology, DEC 5, 2019, View Source [SID1234551978]). The ASH (Free ASH Whitepaper) Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be held December 7-10 at the Orange County Convention Center in Orlando.

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"The future of cancer treatment is being cultivated at many practices in the community setting," said Michael Seiden, MD, PhD, president of The US Oncology Network. "I’m proud of the work being done by research investigators in The US Oncology Network. It’s amazing to see the quality of their research presented at ASH (Free ASH Whitepaper) every year. Their innovations are truly making a difference that impact cancer patients now and in the future."

Jeff Sharman, MD, medical director of Hematology Research for The US Oncology Network and director of Research at Willamette Valley Cancer Institute and Research Center (WVCI), will present an oral abstract titled, "ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL)," on Saturday, December 7 at 7:30am ET in Hall D, Level 2.

"BTK inhibitors have revolutionized the treatment of CLL," said Dr. Sharman. "This study led to the FDA approval of acalabrutinib in previously untreated CLL and presents compelling evidence of both safety and efficacy of the drug. With a second approved BTK inhibitor in CLL, there are now more available options for patients in need of therapy."

Additionally, Dr. Sharman will share his expertise during an education program on indolent lymphomas. His presentation titled, "Targeting CD20: Teaching an Old Dog New Tricks," will take place Saturday, December 7, 2:00pm-3:30pm ET as well as Sunday, December 8, 9:30am-11:00am ET in Tangerine 1 (WF1), Level 2.

"CD20 is an established target for the treatment of both lymphoma and chronic lymphocytic leukemia," said Dr. Sharman. "For nearly 2 decades, rituximab was an unequaled therapeutic in this space as the standard of care. With novel subcutaneous formulations, biosimilar molecules, second generation anti-CD20 antibodies, immunologically synergistic combinations and novel bispecific approaches, CD20-directed therapies are undergoing a dramatic change."

Christopher Yasenchak, MD, associate chair of Hematology Research for The US Oncology Network and hematologist with WVCI, is presenting an oral abstract titled, "Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥60 Years," on Saturday, December 7 at 2:30pm ET in W224, Level 2.

"Elderly patients with Classical Hodgkin Lymphoma experience markedly inferior outcomes with conventional chemotherapy when compared to younger patients. This is due to differences in disease biology, increased rates of advanced disease, medical co-morbidities and treatment-related morbidity and mortality. As such, novel treatment strategies are needed," said Dr. Yasenchak. "The combination of brentuximab vedotin and nivolumab delivered in the frontline setting shows a high response rate and improved toxicity profile. This regimen may fill an unmet need for elderly patients unfit for conventional chemotherapy."

Furthermore, Robert Rifkin, MD, FACP, medical director of Biosimilars for McKesson, associate chair of Hematology Research and myeloma disease lead for The US Oncology Network, and hematologist with Rocky Mountain Cancer Centers (RMCC), will present "Daratumumab (DARA) Maintenance Therapy Improves Depth of Response and Results in Durable Progression-Free Survival (PFS) Following Dara Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) Induction Therapy in Multiple Myeloma (MM): Update of the Lyra Study." The oral presentation will take place Monday, December 9 at 5:30pm ET in Hall E2, Level 2.

"This is an important study for multiple myeloma patients treated in the community setting as it gives them a treatment option that is relatively non-toxic that may increase the depth of response and achieve durable remissions," said Dr. Rifkin. "Additionally, DARA-Cy-Bord is safe and easy to manage."

Physicians with US Oncology Research worked with McKesson Data, Evidence and Insights investigators on a real-world evidence (RWE) study titled, "Treatment Patterns and Outcomes of Patients with Relapsed Follicular Lymphoma Treated with Idelalisib in a Community Oncology Setting." The poster presentation will take place Sunday, December 8, 6:00pm-8:00pm ET in Hall B, Level 2.

"This study evaluated patient profiles, treatment patterns and clinical outcomes among adult patients with relapsed or refractory follicular lymphoma who initiated treatment with Idelalisib within The US Oncology Network," said Presenting Author David Andorsky, MD, a hematologist with RMCC, a practice in The US Oncology Network. "These findings enhance available data on relapsed follicular lymphoma patient outcomes in real-world practice."

The full schedule of affiliated data presentations, including location and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or [email protected] or Edie DeVine at 209.814.9564 or [email protected].