On November 18, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT), reported that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both Orphan Drug Designation and Fast Track designation for the potential treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue (Press release, PTC Therapeutics, NOV 18, 2020, ry-designations-for-ptc596-to-advance-treatment-of-two-rare-oncology-indications-301175743.html [SID1234571377]). Furthermore, the FDA has also granted PTC596 a Rare Pediatric Disease designation and Orphan Drug Designation for the potential treatment of Diffuse Intrinsic Pontine Glioma (DIPG), an ultra-rare childhood glioma. PTC596 is currently being studied in clinical trials in LMS and DIPG.

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"We are very pleased with the FDA’s decisions to grant PTC596 these designations," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "This brings us one step closer to providing truly novel therapeutic approaches to patients with devastating rare cancers seen in children and adults that do not have good treatment options."

PTC596 is an orally bioavailable small molecule tubulin binding agent that arrests tumor cells in G2/M phase, including cancer stem cells, through the action of inhibiting tubulin polymerization. It is currently in a Phase 1b study for LMS, which accounts for approximately 10 to 28% of all soft tissue sarcomas.1 Approximately 4000 patients are diagnosed with LMS annually in the US, the risk of developing metastases is approximately 40%, and the 5-year survival rate is estimated to be 13.6% for metastatic LMS.2 PTC596 is also currently in a clinical study for DIPG, an ultra-rare glioma arising in the brainstem that makes up 10 to 15% of all brain tumors in children.3 Approximately 300 patients are diagnosed with DIPG annually in the US, and the median overall survival with the current standard of care of radiation therapy, is approximately 9 months with a two-year overall survival rate of less than 10%.4

On November 18, 2020 Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s antitumor immunity by altering the composition and function of immune cells within the tumor microenvironment, reported the initiation of a Phase 1 clinical study investigating PY314 in patients with solid tumors (Press release, Pionyr Immunotherapeutics, NOV 18, 2020, View Source [SID1234571376]).

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PY314 targets TREM2, a protein found on the surface of a subpopulation of immunosuppressive, pro-tumor myeloid cells. PY314 works by depleting TREM2-expressing immune suppressive tumor associated macrophages (TAMs), which leads to activation of productive anti-tumor immunity. In preclinical studies, PY314 treatment not only depleted TAMs, but also promoted infiltration of activated anti-tumor cytotoxic T lymphocytes into the tumor microenvironment.

"Pionyr moving PY314 into clinical development is a major milestone for our company and our scientific platform," said Steven P. James, President and Chief Executive Officer, Pionyr. "This study initiation also comes shortly after receiving the FDA clearance of our Investigational New Drug (IND) Application for our second antibody program, PY159, which ‘turbocharges’ anti-tumor activity by targeting TREM1-expressing myeloid cells in the tumor microenvironment. With the acceptance of two INDs in two months, the start of the PY314 Phase 1 trial and the anticipated initiation of the PY159 trial by year end, we are rapidly advancing our mission of creating the new frontier of immuno-oncology therapies."

The Phase 1 study will enroll patients at multiple academic centers in the US and will evaluate PY314 as both a single agent and in combination with an approved checkpoint inhibitor. Once safety is determined, additional patients will be recruited in predefined tumor types where TREM2 expression is most likely implicated as a driver of resistant metastatic disease.

"PY314 represents a potentially foundational therapeutic opportunity to expand immunotherapy options for patients with advanced solid tumors," said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer, Pionyr. "We are excited to make this transition into a clinical-stage company and work with the leading clinical sites and investigators who have enthusiastically joined in this effort alongside us."

On November 18, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported partner Juventas has completed the equivalent of $65 million financing and has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) (Press release, CASI Pharmaceuticals, NOV 18, 2020, View Source [SID1234571375]).

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Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "Initiating the Phase II B-NHL registration study and enrolling the first patient is an exciting milestone for the development of CNCT19. Our partner Juventas is also making good progress in the Phase I clinical trial for the treatment of relapsed or refractory acute lymphoblastic leukemia (B-ALL) and is expecting to start the Phase II study by the end of 2020. Its financing provides Juventas with resources to continue moving CNCT19 through registration and we remain excited about its potential as a first-line treatment for B-NHL. In addition, as a large (16%) shareholder of Juventas, we are pleased to see Juventas’ progress in their overall pipeline and expect its financing to help accelerate its development. Juventas is an example of CASI’s entrepreneurial partnership model that is built on two components, co-development and equity investment. We believe investment in our partners deepens our collaboration and provides additional potential return to our shareholders. With this approach, we will continue to grow CASI’s pipeline, one asset at a time."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

On November 18, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2020 (Press release, Nordic Nanovector, NOV 18, 2020, View Source [SID1234571373]). A live webcast presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

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Lars Nieba, Interim CEO of Nordic Nanovector, said: "Following the successful interim analysis in August and completion of our private placement in September, we are progressing towards the major value inflection point of three-month top-line data from the PARADIGME clinical study, which is targeted for H2 2021. Generating these data will require us to successfully navigate the latest challenges of increased COVID-19 restrictions. We remain confident in our ability to achieve this goal, aided by the protocol amendments, the possibility to reduce the patient sample, and all the other measures we are actively implementing to drive patient recruitment into PARADIGME."

Q3’2020 Highlights

Result of PARADIGME Interim Analysis: Independent Review Committee recommendation to focus on single arm investigating the "40/15" dosing regimen
Target set to report three-month top-line data in H2’2021
Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial
Pivotal Phase 2b PARADIGME trial of Betalutin progressing in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL)
COVID-19 pandemic continues to have a negative impact on PARADIGME patient recruitment – the target patient population is a high-risk group for COVID-19
59 patients enrolled as of 18 November 2020
Private placement was oversubscribed and successfully completed raising approximately NOK 231 million (approximately USD 25 million) in gross proceeds, extending cash runway into Q3’2021
Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
Dr Christine Wilkinson Blanc appointed Chief Medical Officer
Events after Q3’2020

Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin plus rituximab in 2L R/R FL
Preliminary data readout expected in H1’2021
Trial to be paused pending analysis of data and evaluation of plans for further development
Results of preclinical studies demonstrating Betalutin reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine
Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenues for the third quarter and for the first nine months of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter were NOK 88.1 million (NOK 100.2 million); total operating expenses for the first nine months of 2020 were NOK 327.3 million (NOK 301.1 million)
Comprehensive loss for the third quarter amounted to NOK 88.2 million (loss of NOK 93.6 million); comprehensive loss for the first nine months of 2020 was NOK 305.4 (NOK 295.6 million)
Cash and cash equivalents amounted to NOK 380.7 million at the end of September 2020, compared to NOK 470.8 million at the end of December 2019
Outlook

The company continues to target the readout of three-month top line data from PARADIGME in H2’2021. Approval of protocol amendments is proceeding as planned and completed in the best-recruiting countries, and other initiatives to increase the rate of enrolment are underway. The company also targets the readout of three-month top line data from the second cohort of the Archer-1 trial in H1’2021.

However, the impact of the COVID-19 pandemic on patient recruitment has worsened in light of the emergence of a second wave resulting in severe travel restrictions being implemented in the various countries where we are executing our clinical studies. These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME. In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. Several proactive actions have been taken to minimize the impact of these travel restrictions which could blunt further delays in completing enrolment and delivering preliminary results as targeted.

The company has taken steps to conserve cash and following the recent successful private placement, Nordic Nanovector has a cash runway that extends into Q3’2021.

Despite the challenging times, the many positive actions the company has made in the last nine months have improved the prospects of delivering pivotal results from PARADIGME in H2’2021.

The company continues to believe that, if positive, these trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted therapy that can address the unmet needs of R/R FL patients.

Presentation and live webcast – Q3 2020 results

A presentation and live webcast by Nordic Nanovector’s management team will take place today at 8:30 am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

On November 18, 2020 Aflac Incorporated (NYSE: AFL) reported that its Board of Directors has declared the first quarter dividend of $0.33 per share, payable on March 1, 2021, to shareholders of record at the close of business on February 17, 2021 (Press release, Aflac, NOV 18, 2020, View Source [SID1234571370]). This represents a 17.9% increase over the previously declared fourth quarter dividend.

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Commenting on the announcement, Aflac Incorporated Chairman and Chief Executive Officer Daniel P. Amos said: "I am pleased with the Board’s action to increase the first quarter 2021 dividend. We treasure our record of 38 consecutive years of dividend increases, and we are looking to reward our shareholders by extending that track record in 2021. We remain committed to maintaining strong capital ratios on behalf of our policyholders and balance this financial strength with a focus on increasing the dividend, repurchasing shares and reinvesting in our business. Our dividend track record is supported by the strength of our capital and cash flows."