On September 20, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported that will have a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress (Press release, BeyondSpring Pharmaceuticals, SEP 20, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-positive-final-phase-3-dublin-3-data-with-the-plinabulin-docetaxel-combination-versus-docetaxel-alone-in-2nd-3rd-line-non-small-cell-lung-cancer-patients-with-eg [SID1234587951]). This includes the final intention-to-treat (ITT) dataset from the Company’s DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type. Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.

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The DUBLIN-3 Phase 3 trial is a randomized, active controlled, single blind to patients, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with measurable lung lesion. Patients were treated on a 21-day cycle with infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) or with docetaxel alone (75 mg/m2 on day 1). The primary endpoint of OS was met in the ITT population (DP: n=278; D: n=281). The following summarizes the clinical results:

Primary endpoint (Overall Survival, ITT population):
mean OS (SE) months (M): DP 15.08 M (0.848) vs. D 12.77 M (0.676); p=0.0332
median OS (95% CI): DP 10.5 M (9.3, 11.9) vs. D 9.4 M (8.4, 10.7)
Log-rank p=0.0399; HR = 0.82
Key secondary endpoints (ITT population):
ORR (DP: 12.2% vs. D: 6.7%; p=0.0275)
PFS:
mean (SE): DP 6.0 M (0.4) vs. D 4.4 M (0.3); p=0.006
median (95% CI): DP 3.6 M (3.0, 4.4) vs. D 3.0 M (2.8, 3.7)
Log-rank p=0.008; HR=0.76
Incidence of Grade 4 neutropenia, cycle 1 day 8 (DP: 5.3% vs. D: 27.8%; p<0.0001)
24 Month OS rate (DP: 22.1% vs. D: 12.5%; p = 0.0072)
36 Month OS rate (DP: 11.7% vs. D: 5.3%; p = 0.0393)
48 Month OS rate (DP: 10.6% vs. D: 0%; p value cannot be calculated)
Q-TWiST – Quality-adjusted Time Without Symptoms of Disease and Toxicity (DP: 12.40 M vs. D: 10.47 M; 18.43% relative gain in Q-TWiST, p=0.0393).
Subset Analyses:
PD-1/PD-L1 exposed patients (DP: n=62; D: n=67; approx. 50% China/50% Western):
mean OS (SE): DP 18.33 M (1.909) vs D 13.97 M (1.320); p= 0.0602
median OS (95% CI): DP 12.3 M (9.34, 22.88); D 12.1 M (9.76, 13.77)
Log-rank p = 0.0643; HR = 0.68
24 Month OS rate (DP: 35.8% vs. D: 11.9%; p = 0.0026)
36 Month OS rate (DP: 12.5% vs. D: 5.0%; p = 0.2676)
48 Month OS rate (DP: 12.5% vs. D: 0%; p value cannot be calculated)
Safety:
DP is well tolerated, with lower grade 4 and grade 3/4 AE events per patient per year vs. D. No unexpected AE concerns were identified.
Trevor M. Feinstein, M.D., of the Piedmont Cancer Institute and a principal investigator for DUBLIN-3 commented, "The treatment of 2nd and 3rd line NSCLC, especially with EGFR wild type (wt) where tyrosine kinase inhibitors do not work, is an area of severe unmet medical need. EGFR wt represents about 85% of Western and about 70% Asian NSCLC patients. With immunotherapies moved to first line, docetaxel-based therapies are the mainstay therapy here. However, docetaxel-based therapy, although effective, has been known to cause safety concerns such as >40% severe neutropenia and can negatively impact patients’ quality of life (QoL)."

Baohui Han, M.D., Ph.D, Professor, Department of Respiratory Medicine, Shanghai Chest Hospital in China, co-principal investigator of the DUBLIN-3 trial and first author of the ESMO (Free ESMO Whitepaper) presentation, added, "DUBLIN-3 data demonstrate that, compared to docetaxel, plinabulin and docetaxel combination significantly improved treatment efficacy, including extending survival, and significantly reduced severe neutropenia. The >18% gain in Q-TWiST, a measure of survival time spent with good QoL, demonstrated that adding plinabulin to docetaxel led to a clinically meaningful benefit and a favorable benefit/risk ratio. Importantly, in PD-1/PD-L1 exposed patients in Dublin-3, the combination showed more pronounced long-term survival benefit, consistent with Plinabulin immume MOA. Thus, this combination has the potential to be the preferred 2nd/3rd line treatment for NSCLC with EGFR wt."

Lan Huang, Ph.D., BeyondSpring’s co-founder, chief executive officer and chairwoman, concluded, "When treating advanced cancer, we should focus on improving both the quantity and quality of life for patients, which the plinabulin and docetaxel combination has demonstrated in the DUBLIN-3 study. This study offers clinical evidence that plinabulin could be an important new weapon with a novel MOA in the arsenal that oncologists have to help patients with advanced NSCLC. We’re diligently working to prepare the NDA submission package for this indication in both the U.S. and China and are planning to file these NDAs in 1H 2022. The long-term survival data shown in the DUBLIN-3 study is evidence of the potential of plinabulin’s durable anti-cancer benefit, which we believe will be the gateway for its utility in the triple immuno-oncology combinations in multiple cancer indications, with the potential to help many patients in need."

ESMO Presentation Details

Title: A Global Phase (Ph) 3 Trial with the Plinabulin/Docetaxel (Plin/Doc) combination vs. Doc in 2nd/3rd Line NSCLC Patients (pts) with EGFR-wild type (wt) Progressing on a Prior Platinum-Based Regimen

Session: Proffered Paper session – NSCLC, metastatic 2

Date: September 20, 2021 from 8:10 – 8:20 a.m. ET

Location: Channel 4

Presentation Number: LBA48

Speaker: Trevor Feinstein, M.D., medical oncologist at the Piedmont Cancer Center, Fayetteville, Georgia, USA on behalf of Baohui Han, M.D., Ph.D, Professor in the Department of Respiratory Medicine, Shanghai Chest Hospital, China

Conference Call and Webcast Information
BeyondSpring’s management will host a conference call and webcast today at 10:00 a.m. Eastern Time. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13723041. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 30 days.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). It is being developed as a "pipeline in a drug" in multiple cancer indications.

On September 20, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will report its fiscal fourth quarter and full year 2021 financial results before market open on Monday, September 27, 2021 (Press release, iBioPharma, SEP 20, 2021, View Source [SID1234587950]). iBio management will host a webcast and conference call at 8:30 a.m. Eastern Time to discuss the results and provide a corporate update.

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The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 7159935.

On September 20, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 10:40 AM (ET) (Press release, Anavex Life Sciences, SEP 20, 2021, View Source [SID1234587949]). The conference is being held September 27-30, 2021.

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A live audio webcast will be available at View Source or on the Company’s website at www.anavex.com. A webcast replay will be accessible for 30 days following the presentation.

On September 20, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, SEP 20, 2021, View Source [SID1234587948]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 20,104,438 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 17 September 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 21,297,972 B shares at an average share price of DKK 495.34 per B share equal to a transaction value of DKK 10,549,657,815.

On September 20, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors ("NETs") (Press release, Hutchison China MediTech, SEP 20, 2021, View Source [SID1234587947]). The first patient was dosed on September 15, 2021.

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Based on dialogue with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), it was agreed that the surufatinib Japanese new drug application ("NDA") for the treatment of advanced NETs include results from a pivotal study to be conducted in Japan, to complement the registration data package supporting the NDA to the U.S. Food and Drug Administration ("FDA") (accepted for review in June 2021) and the Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA") (validated in July 2021). The basis for the NDA and the MAA includes data from a U.S. Phase I/II study, as well as the completed Phase III SANET-ep and SANET-p studies used to support marketing authorization in China in advanced NETs, where surufatinib is currently marketed under the brand name SULANDA.

This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited. In Part 1 of the study, the safety and tolerability of surufatinib 300mg once daily after 28 days of treatment will be assessed in patients with relapsed/refractory non-hematological malignancies; pharmacokinetics ("PK") and anti-tumor activity of surufatinib are secondary endpoints. In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR). The secondary outcome measures include disease control rate (DCR), progression free survival ("PFS"), duration of response (DoR), safety, and PK.

Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan. A global Phase III registration study for fruquintinib, known as the FRESCO-2 study, is ongoing in patients with refractory metastatic colorectal cancer and is expected to enroll over 680 patients from over 150 sites in 14 countries, including Japan. A global single-arm, open-label study, known as the SAVANNAH study, is ongoing for savolitinib (partnered with AstraZeneca PLC) in combination with TAGRISSO in non-small cell lung cancer patients whose disease progressed following TAGRISSO due to MET amplification or overexpression.

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET ("pNET") or extra-pancreatic (non-pancreatic) NET ("epNET").

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely similar to the U.S. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide.1 Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 140,000 estimated patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.2 In Japan, approximately 6,700 people were diagnosed with gastro-entero-pancreatic neuroendocrine neoplasms in 2016.3

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development

epNETs in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China ("NMPA") for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology4. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

pNETs in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology5, demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), TUOYI (toripalimab) and TYVYT (sintilimab), which are approved as monotherapies in China.

NETs in the U.S. and Europe: A FDA NDA submission was accepted in June 2021, followed by a MAA submission to the EMA validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).