On March 30, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 30, 2020, View Source [SID1234556000]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "In light of the recent COVID-19 outbreak and overall economic outlook, we have attempted to determine the impact of the outbreak on our present and future operations, including the impact on our suppliers, manufacturers and commercial partners. The good news is that at the present time we have not seen a material impact of COVID-19 on demand for our products, and we have not yet seen any significant negative impact on our supply chain or distribution network. If the outbreak appreciably worsens and/or if governmental restrictions persist for a protracted period, that could of course affect our outlook."

"Having said that, the outbreak and governmental mandated social distancing and sheltering in place have caused some near-term impact and disruption to our employees and daily operations. For that reason, and to allow some time to gain additional visibility into the 2020 year, we have determined to postpone our regularly scheduled earnings conference call. My sincere hope is that we can have a more meaningful call in the future and provide a clearer picture of the remainder of 2020 and the outlook for the company."

"In the meantime, we remained focused on completing the additional work to allow us to supplement our NDA for our naloxone injection product (ZIMHI). We are actively addressing the issues the FDA raised in the Complete Response Letter we received late last year. We continue to believe ZIMHI can play an important role in combating the ongoing public health crisis of opioid overdose, and we look forward to the eventual approval of ZIMHI. SYMJEPI sales continue to be far lower than we ever expected. We are currently working with Sandoz to determine what needs to occur to accelerate its growth in the epinephrine market. Sales of pharmaceutical preparations through our US Compounding drug outsourcing facility had strong growth for 2019 versus the year prior."

Product Updates

SYMJEPI (epinephrine) Injection

On January 16, 2019, we announced that Sandoz had launched SYMJEPI (epinephrine) 0.3 mg Injection in the U.S. market, initially available in the institutional setting. On July 9, 2019, we announced the full launch (institutional and retail) by Sandoz of both dose forms of the SYMJEPI injection products.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories. On October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

ZIMHI (naloxone) Injection

On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 19, 2019, Adamis provided an update indicating that it had provided responses to the comments included in the CRL and submitted them to the FDA along with a request for a meeting. On February 12, 2020, the Company had a Type A meeting with the FDA to discuss the company’s response to the CRL and the process and timeline for resubmission of the NDA to the FDA. At the meeting, Adamis obtained concurrence from the agency on the information required for resubmission of the NDA.

The company believes it can generate the additional data, and assuming successful testing, resubmit the NDA in the second quarter of 2020. The FDA expressed its intent to review the resubmission in a rapid and timely manner consistent with agency guidelines. The company continues to have discussions with potential commercial partners for ZIMHI.

Drug Outsourcing Facility

During the fourth quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 13% in the fourth quarter compared to the same quarter in the prior year. For the year, USC increased revenues approximately 22% versus 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from increasing sales and marketing efforts.

2019 Financial Results

Adamis total revenues increased approximately 47%, from $15.1 million to $22.1 million, for the year ended December 31, 2018 and 2019, respectively. Total revenues increased by approximately 33%, to $5.5 million from $4.2 million fourth quarter of 2019 compared to the same period in 2018. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") for the years ending December 31, 2019 and 2018 were approximately $25.3 million and $26.0 million, respectively, a decrease of approximately 3%. The decrease was primarily attributable to decreases of approximately $2.1 million in compensation expenses, occupancy costs, and other related expenses. These amounts were partially offset by an increase of approximately $1.4 million attributable to increases in consulting, legal, patent, insurance, PDUFA fees, marketing and selling expenses.

Research and development expenses were approximately $10.4 million and $18.8 million for the years ended December 31, 2019 and 2018, respectively, a decrease of approximately 45%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the year was approximately $8.8 million. In February, the Company increased its cash position by raising approximately $6.7 million before deducting the placement agent’s fees and other estimated offering expenses, in an equity financing transaction. The net loss for the year was approximately $29.3 million.

Targeted Milestones

●Increasing sales of SYMJEPI in the U.S.;
●Resubmission of New Drug Application for ZIMHI;
●FDA approval and commercial partner for ZIMHI;
●Following FDA approval, begin selling ZIMHI in the U.S.;
●Increasing sales and margins at US Compounding; and
●Completing a Phase III ulcer study in horses.

On March 30, 2020 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that the Board has the intention to carry out a rights issue of approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAR 30, 2020, View Source [SID1234556018]). An extraordinary general meeting will be held around May 5, 2020 (the "EGM") where the EGM is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof. The EGM is also proposed to resolve to authorize the Board of Directors to resolve on a directed share issue, corresponding to approximately SEK 30 million, with deviation from the shareholders’ preferential rights (the "Over-Allotment Option"), in order to meet potential additional demand from strategic investors and thereby broaden the shareholder base. The notice to the EGM will be announced through a separate press release. The Rights Issue and the potential Over-Allotment Option will require the Company’s articles of association to be amended by the EGM in respect of the level of share capital and number of shares that can be issued.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the US, Canada, Japan, Australia, Hong Kong, New Zeeland or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

Summary

The Board of Directors announces its intention to carry out the Rights Issue and the potential Over-Allotment Option (provided that the Rights Issue is oversubscribed). An EGM scheduled to be held around May 5, 2020, that will be announced through a separate press release, is proposed to resolve to authorize the Board of Directors to resolve on the Rights Issue and the terms thereof and the potential Over-Allotment Option (as a directed share issue).
The Rights Issue and the potential Over-Allotment Option will require that the EGM resolves on amendments of the articles of association of the Company in respect of the level of share capital and number of shares that can be issued (which will be announced in the notice to the EGM).
The net proceeds from the Rights Issue and the potential Over-Allotment Option will be used to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes.
Subject to the EGM’s resolutions, the Rights Issue is fully guaranteed, including commitments from members of the Board of Directors and Management team to subscribe for their pro rata shares amounting to SEK 0.8 million, as well as guarantee commitments from existing shareholders and non-shareholders, including the Chairman of the Board, Pär-Ola Mannefred (through Aktiebolaget Äpplet).
The potential Over-Allotment Option will be conditional upon the Rights Issue being oversubscribed.
The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.
Isofol’s CEO Ulf Jungnelius comments: "Strengthening our cash position will secure the recruitment of patients for the Phase III AGENT trial and to maintain critical activities to maintain our recruitment pace. We currently have over 260 patients included and with maintained recruitment rate we expect to have 440 patients recruited by the fourth quarter. The COVID-19 pandemic may have an impact on our program and the company needs to use the proceeds of the capital raise to secure our clinical program and as the FDA has indicted, amend study protocols in light of the new circumstances pertaining to clinical development. Furthermore, we are also working to secure a commercial partner in Japan during 2020. I look forward to continuing the development of arfolitixorin with the clear goal to launch the drug globally during 2023."

Background and intention

Isofol is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival.

Arfolitixorin – the key active metabolite of widely used folate-based drugs – can potentially benefit all patients with advanced colorectal cancer as it does not require complicated metabolic activation to become effective. Arfolitixorin is currently being studied in the global Phase III trial, AGENT.

The Phase III AGENT trial is a randomized, controlled, multi-center study assessing the efficacy and safety of arfolitixorin, [6R]-5, 10-methylene-tetrahydrofolic acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), a number of curative metastasis resections, safety and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. The study is designed to show superiority of arfolitixorin over leucovorin.

The AGENT study is ongoing at approximately 80 sites in the U.S., Canada, Europe, Australia and recently also Japan, where the trial is planned to start in up to 15 clinics.

Isofol raised SEK 430 million in April 2017 through an initial public offering (the "IPO") focused on the funding of the Phase III AGENT study for its lead drug candidate arfolitixorin. The study targets 440 patients to receive first line treatment for metastatic colorectal cancer and has an adaptive design, meaning that there is an option to, based on an interim analysis of 330 patients, increase the sample with an additional 220 patients. The potential upsizing in number of patients was not funded at the time of the IPO. Some limited additional activities were included in the stated use of proceeds, including a few limited studies intended to support arfolitixorin’s path toward market authorization, some lean business development activities as well as general corporate purposes.

However, at the time of the IPO, the Phase III AGENT study was only an outline and after a 5-month regulatory process, the U.S Food and Drug Administration (the "FDA") concluded, after an SPA-process, that Avastin was required as a part of the study arms to reflect USA-approved standard of care. The consequences of this decision were not taken into account in the use of proceeds of the IPO.

Furthermore, the Phase III AGENT study has taken longer to recruit (3 months delay) with significantly higher costs pertaining to Avastin and the approval of Avastin biosimilars in the US and Canada. Thus, Isofol has asked the FDA to approve the use of Avastin biosimilars in the protocol which was accepted by FDA as long as the study protocol was amended. The amendment process is ongoing which has led to higher CRO costs, increases in costs per patient as well as regulatory & IPR-related costs.

Additionally, Isofol has expanded the scope of some of the additional studies to enhance the safety database and gene expression analyses of folate relevant genes that were not included in the original budget at the time of the IPO.

The Board of Directors intends to carry out the Rights Issue and the potential Over-Allotment Option to ensure the continued and successful development of the Company, in accordance with its business plan and strategy. The intention of the Rights Issue and the potential Over-Allotment Option is primarily to i) fund the ongoing Phase III AGENT study to enable interim analysis based on 330 patients and enroll the 440 patients as per protocol (both expected to take place in H2 2020), (ii) additional clinical development activities including final analysis of the ISO-CC-005 study, iii) further gene expression analysis of additional populations including other cancer indications, iv) selected pre-commercialization activities and (v) general corporate purposes. Through the potential Over-Allotment Option, if exercised in full, the Company will receive an additional financing of approximately SEK 30 million before transaction costs. The potential Over-Allotment Option is conditional upon the Rights Issue being oversubscribed.

Isofol believes the planned interim analysis will be a major inflexion point. One outcome from this analysis is that the independent Data and Safety Monitoring Board will recommend that an additional 220 patients are recruited in order to achieve statistical significance. In such a scenario, additional financing will have to be secured to fund an additional 220 patients at an estimated cost of SEK 150 million. In addition to this, Isofol estimates an additional funding requirement of SEK 150 million to take the Company to market authorization.

Subscription undertakings and guarantee commitments

The Rights Issue is fully guaranteed through subscription and guarantee commitments.

A number of investors, including the Chairman of the Board, Pär-Ola Mannefred (who through Aktiebolaget Äpplet has provided a guarantee commitment corresponding to SEK 1 million), have provided guarantee commitments, which together with subscription undertakings from certain members of the Board of Directors and Management, represent SEK 150 million.

In addition, certain shareholders including Handelsbanken Fonder and Swedbank Robur have expressed that they are positive to the Rights Issue and that they intend to subscribe for their pro rata shares.

The Fourth Swedish National Pension Fund ("AP4") has expressed its intention to apply for subscription of shares in the Rights Issue corresponding to up to approximately 3 percent of the total number of shares in the Company following the Rights Issue. AP4 does not hold any shares in the Company today.

Members of the Board of Directors and Management, comprising Ulf Jungnelius, Pär-Ola Mannefred, Gustaf Albèrt, Sven Erickson and Robert Marchesani, who hold approximately 0.5 percent of the Company’s outstanding shares have committed to subscribe their pro rata shares in the Rights Issue amounting to approximately SEK 0.8 million.

EGM and expected timetable for the Rights Issue

The Board of Directors convene the shareholders to the EGM through a separate press release and the EGM will take place around May 5, 2020. A detailed timetable and terms of the Rights Issue will be announced if the Board of Directors resolves on the Rights Issue. The subscription price in the Rights Issue and the potential Over-Allotment Option will not exceed SEK 9.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Baker McKenzie acts as legal adviser to the Joint Bookrunners.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU) No 596/2014. The information was submitted for publication through the agency of the Company’s CEO at 08:00 CET on March 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On March 30, 2020,Trovagene, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Purchaser"), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, an aggregate of (a) 800,000 shares (the "Shares") of common stock, par value $0.0001 per share ("Common Stock") and (b) Series I pre-funded warrants (the "Series I Pre-Funded Warrants") to purchase up to 131,967 shares (the "Series I Warrant Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), which will be exercisable immediately upon issuance for a period of five years after the date of issuance, and (ii) in a concurrent private placement, Series J warrants (the "Series J Warrants") to purchase up to 931,967 shares (the "Series J Warrant Shares") of Common Stock, for aggregate gross proceeds to the Company of approximately $1.0 million, before deducting estimated offering expenses payable by the Company (Filing, 8-K, Trovagene, MAR 30, 2020, View Source [SID1234556043]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The combined purchase price for each Share, together with one Series J Warrant, is $1.073 per Share/Series J Warrant. Each Series J Warrant shall be exercisable beginning on the six-month anniversary of the date of issuance and for a period of five years after such date (or five-and-a-half years after the issuance date), at an exercise price of $0.948 per Series J Warrant Share. The exercise price of the Series J Warrants and the shares of the Company’s Common Stock issuable upon the exercise of the Series J Warrants (the "Series J Warrant Shares") will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Series J Warrants.

The aggregate exercise price of the Series I Pre-Funded Warrants ($1.073 per Series I Warrant Share), except for a nominal exercise price of $0.01 per Series I Warrant Share, will be pre-funded to the Company on the date of issuance of the Series I Pre-Funded Warrants and, consequently, no additional consideration (other than the nominal exercise price of $0.01 per Series I Warrant Share) shall be required to be paid by the holder to effect any exercise of the Series I Pre-Funded Warrants. The Company shall not be required to return or refund any portion of such pre-paid aggregate exercise price of the Series I Pre-Funded Warrants for any reason, including in the event such Series I Pre-Funded Warrants shall not have been exercised prior to expiration. Each of the Series I Pre-Funded Warrants and the Series J Warrants may be exercised on a "cashless" basis under certain circumstances set forth in the warrants.

The Shares, Series I Pre-Funded Warrants and the Series I Warrant Shares issuable upon exercise of the Series I Pre-Funded Warrants are being offered by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on June 25, 2019, and was declared effective on July 1, 2019 (File No. 333-232321) (the "Registration Statement").

The Series J Warrants and the Series J Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Per the terms of the Purchase Agreement, the Company has agreed to certain restrictions on future stock offerings, including that during the 60-day period following the closing, the Company will not issue (or enter into any agreement to issue) any shares of Common Stock or Common Stock equivalents, subject to certain exceptions.

The closing of the offering described above is subject to satisfaction of specified customary closing conditions.

The foregoing summaries of the offerings, the securities to be issued in connection therewith, the Purchase Agreement, the Series I Pre-Funded Warrants and Series J Warrants do not purport to be complete and are qualified in their entirety by reference to the definitive transaction documents. Copies of the form of Purchase Agreement, the Form of Series I Pre-Funded Warrant and the Form of Series J Warrant are attached hereto as Exhibits 10.1, 10.2 and 10.3, respectively, and are incorporated herein by reference.

On March 29, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported its annual results for the year ended December 31, 2019 (Press release, Ascentage Pharma, MAR 29, 2020, View Source [SID1234555966]). During the reported period, Ascentage Pharma further increased its investments in innovation, and achieved significant progress in clinical development, external collaborations, intellectual property rights, and the building of its manufacturing capabilities. In 2020, Ascentage Pharma plans to submit its first New Drug Application (NDA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Achieving significant progress with drug candidates while advancing global clinical development

As of December 31, 2019, Ascentage Pharma has developed a robust pipeline of eight clinical-stage small molecule drug candidates, currently being evaluated in more than 30 Phase I or II clinical trials in the United States, Australia, and China. The Company’s pipeline consists of inhibitors that target key proteins in the apoptotic pathways, including the Bcl-2, IAP, and MDM2-p53 pathways, to restore normal apoptotic functions; and next-generation tyrosine kinase inhibitors (TKIs) that target mutant kinases in cancers.

With increased investments in innovation, the Company’s research and development expenses for the year ended December 31, 2019, totaled RMB464 million. During the reported period, Ascentage Pharma achieved significant progress with the global clinical development of its drug candidates.

HQP1351, Ascentage Pharma’s core drug candidate and a third-generation BCR-ABL/KIT inhibitor, has achieved several milestones during the reported period. As of December 31, 2019, the Company had completed enrollments for two pivotal Phase II clinical trials of HQP1351 in patients with chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML) in China, and had initiated a third pivotal Phase II trial in CML patients resistant/intolerant to first and second-generation TKIs in China. Meanwhile, the development program of HQP1351 in the United States is also progressing well, with the Phase Ib trial having been initiated in July 2019 and the first patient dosed in January 2020. It is worth noting that results from the Phase I clinical trial of HQP1351 were selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings two years in a row, and was nominated as "Best of ASH (Free ASH Whitepaper)" research in 2019. Ascentage Pharma plans to submit an NDA for HQP1351 in China in 2020 and expects HQP1351 to become the Company’s first commercialized product.

APG-2575, a key drug candidate in the Company’s pipeline targeting apoptosis, is a novel, orally administered Bcl-2 selective inhibitor that has also met numerous milestones with its global clinical programs during the reported period. In July 2019, APG-2575 dosed the first patient in the Phase I trial in China, and became the first China-developed Bcl-2 selective inhibitor entering clinical stage. Previously, the Company had already initiated a multi-center Phase I study of APG-2575 as a monotherapy for the treatment of hematologic malignancies in the United States and Australia. In March 2020, the Company obtained approvals from the U.S. Food and Drug Administration (FDA) for two global Phase Ib/II clinical trials of APG-2575, as a single agent and in combination with other agents, one study in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and another one in patients with Waldenström macroglobulinemia (WM). The Phase Ib/II study in patients with relapsed/refractory CLL/SLL has recently dosed its first patient in the United States. Upon receiving the recent approval from the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), Ascentage Pharma will soon initiate a Phase Ib study of APG-2575 as a single agent or in combination for the treatment of relapsed/refractory acute myeloid leukemia (AML) in China.

In addition, the Company has further advanced the development of several other drug candidates, including APG-1252, a novel Bcl-2/Bcl-xL dual inhibitor; APG-115, a MDM2-p53 inhibitor; and APG-1387, an IAP inhibitor.

Building a global IP portfolio and expanding strategic partnerships to accelerate transition toward commercialization

Intellectual property rights are of vital importance to Ascentage Pharma, a China-based innovative biopharmaceutical company with a global footprint. Utilizing its robust R&D capabilities, Ascentage Pharma has strategically developed a global intellectual property portfolio. As of December 31, 2019, the Company has 80 issued patents and more than 200 patent applications globally, of which about 67 patents had been issued overseas.

While building a highly capable R&D team, Ascentage Pharma has cultivated partnerships with leading biotechnology and pharmaceutical companies, and academic institutions around the world. In April 2019, Ascentage Pharma entered into a clinical collaboration agreement with Junshi Biosciences to explore the synergies of the IAP inhibitor, APG-1387, and Junshi Biosciences’ anti-PD-1 therapy, toripalimab, in clinical trials in solid and hematologic tumors in China. The clinical study has already been approved and initiated in China. In November 2019, the Company entered into a strategic collaboration with Shanghai Henlius Biotech, to conduct clinical trials of combination therapy between APG-2575, Ascentage Pharma’s novel, orally administered Bcl-2 selective inhibitor and 汉利康 (rituximab injection) for the treatment of CLL in China.

In the meantime, Ascentage Pharma has begun executing its industrialization strategies. In November 2019, Ascentage Pharma broke ground on its global headquarters, R&D center, and manufacturing facility in the Suzhou Industrial Park. At the new facility, which has a planned building area of approximately 10,000m2, the Company plans to produce drug products for clinical development or, in the future, commercial use. Ascentage Pharma expects this facility to consist of two oral-solid-dosage production lines, for both tablet and capsule formulations, and two parenteral liquid/lyophilization powder-for-injection production lines.

"2019 marked some major milestones for Ascentage Pharma, as we pressed ahead with the implementation of our innovation strategies globally. In the past year, we made tremendous headways with our drug candidates, including HQP1351, a core drug candidate in our pipeline, advanced several global clinical programs, which further elevated Ascentage Pharma’s influence in the global medical and scientific community. We continued to increase investments in R&D, which strengthened our innovation capabilities. Our effort to expand external collaborations led to the partnerships with Unity, Junshi Biosciences, and Shanghai Henlius Biotech. By commencing the construction of the Company’s global headquarters, R&D center, and manufacturing facility in Suzhou, Ascentage Pharma has begun its transition toward manufacturing," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Moving forward, we will continue to boost our R&D capabilities, accelerate clinical development programs, and prepare ourselves for the first NDA submission and product commercialization, in fulfilling our mission of ‘addressing unmet clinical needs in China and around the world’."

On March 28, 2020 Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML) (Press release, Ryvu Therapeutics, MAR 28, 2020, View Source [SID1234555967]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors. A clinical phase 1b study of SEL120 is currently enrolling in 6 investigational sites in USA, investigating safety and preliminary efficacy of SEL120 in treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (HR-MDS).

"The FDA’s granting orphan drug designation to SEL120, is a significant encouragement for advancement of our clinical strategic plan addressing the unmet medical needs in the area of AML treatment, a disease where patients still face poor prognosis" said Setareh Shamsili, MD, PhD, Chief Medical Officer and Executive VP at Ryvu Therapeutics. "SEL120 has shown strong proof of concept in the preclinical studies and has received a strategic support from The Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Program (TAP). SEL120 may have the potential to offer an important therapeutic benefit in AML and in particular to those refractory/relapsed AML patients with the poorest prognosis, worldwide."

Orphan drug status (ODD) is intended to advance drug development for rare diseases. The FDA provides ODD to drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The FDA’s orphan drug designation allows the drug for the designated indication to be eligible for requesting a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as potential of other development assistance and financial incentives: View Source

About SEL120

SEL120 is an oral, selective inhibitor of CDK8, a kinase which is a part of the mediator complex and is essential for the activity of super-enhancers important to the regulation of RNA transcription. CDK8 kinase is implicated in the development of hematological malignancies and solid tumors. SEL120 was discovered with the Ryvu Therapeutics discovery engine platform and is currently in Phase 1b study in adult patients with AML or HR-MDS who are refractory to treatment or have relapsed after previous therapies. Patients are enrolled in the study independent of specific tumor mutational burden. The study will also assess pharmacokinetic and pharmacodynamic parameters of SEL120.

SEL120 has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: View Source

About Acute Myeloid Leukemia

Acute myelogenous leukemia or acute myeloid leukemia (AML) is a heterogenous hematological malignancy involving the clonal expansion of myeloid blasts in the bone marrow and peripheral blood with possible spread to liver and spleen. It is estimated that there are around 90 000 cases of AML worldwide each year, and American Cancer Society estimates that approximately 20 000 of these in U.S. only. The median age at diagnosis is 66 years, with 54% patients over 65 years, and 33% over 75 years. Of those diagnosed at a later age, the diagnosis is often associated with underlying myelodysplastic syndromes (MDS), sometimes linked to cancer chemotherapy and radiotherapy exposure.