On March 30, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and related lymphomas (Press release, Daiichi Sankyo, MAR 30, 2020, View Source [SID1234555972]).

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In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company.

The Japan NDA submission is based on previous pivotal trial data conducted globally by Kite for axicabtagene ciloleucel in addition to results from a phase 2 bridging study conducted by Daiichi Sankyo in Japan. Both trials included patients with four aggressive types of relapsed/refractory B-cell lymphomas including diffuse large B cell lymphoma (DLBCL); primary mediastinal B-cell lymphoma (PMBCL); transformed follicular lymphoma (TFL); and high-grade B cell lymphoma. The Japanese trial met its primary endpoint for objective response rate, and data will be presented at an upcoming medical meeting.

"We are pleased to confirm submission of the NDA for axicabtagene ciloleucel following positive topline results from the phase 2 bridging study in Japan," said Wataru Takasaki, PhD, Corporate Officer, Head of Oncology Function and Head of R&D Division in Japan, Daiichi Sankyo. "We will continue to work with regulatory authorities to develop this important new cell therapy for eligible patients in Japan who need additional treatment options for relapsed or refractory DLBCL and related lymphomas."

About Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a CAR T cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight B-cell lymphoma. Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour and Welfare (MHLW) in 2018 for the treatment of DLBCL, PMBCL, TFL and high-grade B-cell lymphoma.

Axicabtagene ciloleucel is approved in the U.S. and Europe for patients with certain types of relapsed or refractory B-cell lymphoma based on the results of the pivotal ZUMA-1 study.

Unmet Treatment Need in NHL/B-Cell Lymphoma
There were an estimated 509,000 new cases and about 248,000 deaths globally from non-Hodgkin lymphoma (NHL) in 2018.[1] In Japan, there were nearly 21,000 new cases of NHL reported in 2012.[2]

About 85 percent of NHLs are B-cell lymphomas. DLBCL is the most commonly diagnosed NHL, representing about one in five cases.[3] Treatment advances have led to improved outcomes for patients with certain types of NHL, but relapsed or refractory disease has remained a significant treatment challenge.[4] DLBCL is considered an aggressive form of the disease; however, the majority of DLBCL patients do achieve complete and sustained remission on initial treatment (chemotherapy plus targeted therapy).[5] Approximately 40 percent of patients experience relapse or resistance and may subsequently receive additional chemotherapy and/or stem cell transplant (ASCT) if eligible; those who are ineligible for ASCT or who relapse after transplantation have a poor prognosis.5

New and novel treatments such as CAR T cell therapies are providing additional options for some patients with relapsed/refractory DLBCL after two or more lines of treatments have been tried.[6]

About the Japan Phase 2 Study
The phase 2 multicenter, open-label, single-arm study was planned to evaluate efficacy and safety of axicabtagene ciloleucel in Japanese patients with several aggressive types of large B-cell lymphoma that is refractory or relapsed following one or more lines of standard treatment including drug therapy or stem cell transplant (ASCT). The study enrolled patients with DLBCL, PMBCL, TFL and high-grade B cell lymphoma.

The primary efficacy endpoint is investigator-assessed objective response rate (ORR). Secondary efficacy endpoints include centrally evaluated ORR, duration of response, progression-free survival and overall survival. The study will also measure safety and pharmacokinetics. Enrollment has completed and the study is ongoing at several institutions in Japan. For more information, visit ClinicalTrials.jp.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On March 30, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2019.

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"This past year has been a very productive year for the company. We received orphan drug designations from the FDA, presented updated data at multiple conferences including ASH (Free ASH Whitepaper), ACR, SITC (Free SITC Whitepaper), and the Crohn’s & Colitis Congress, and completed enrollment in our Phase 1 study of ALPN-101, our lead therapeutic for the potential treatment of autoimmune and inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We have opened enrollment in BALANCE, a trial for ALPN-101 in acute GVHD, and NEON-1, a trial for ALPN-202 in advanced malignancies, beginning the next phase of evolution for the company as we test these novel molecules in patients in need of better therapeutic options."

Recent Corporate and Clinical Highlights

Key Clinical and Preclinical Data Presentations at Biomedical Meetings: We showcased clinical and/or preclinical data for our lead programs, ALPN-101 and ALPN-202, at the following recent medical meetings:

Initial ALPN-101 phase 1 healthy volunteer study data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December: In adult healthy volunteers, ALPN-101 was well tolerated as single intravenous or subcutaneous doses, without cytokine release, infusion-related reactions, hypersensitivity, or other signs of agonist activity. Dose-dependent pharmacodynamic activity was observed, including inhibition of T cell activation, assessed ex vivo based on inhibition of staphylococcal enterotoxin B (SEB)-induced cytokine production, and inhibition of antibody responses, assessed following immunization with keyhole limpet hemocyanin (KLH). Based on activity in models, together with favorable tolerability and pharmacodynamics in healthy volunteers, ALPN-101 has the potential to be a clinically meaningful immunomodulator for the treatment of inflammatory diseases such as GVHD.
ALPN-101 preclinical data presented at ACR: The two posters presented a unique potency of ALPN-101, often superior even to combinations of biologics individually targeting the CD28 and ICOS pathways, as measured by in vitro assays involving patient-derived immune cells and in vivo mouse models of inflammatory arthritis, lupus, and Sjögren’s Syndrome.
ALPN-202 preclinical data presented in posters at SITC (Free SITC Whitepaper): One poster presented mechanistic data supporting ALPN-202 inhibits both the PD-L1 and CTLA-4 checkpoint pathways while also providing PD-L1-dependent CD28 costimulation, as intentionally designed. A second poster demonstrated the ability of ALPN-202 to improve significantly upon the activity of existing cancer therapeutics when given alone and/or in combination in preclinical models. In addition, crystallographic study suggested ALPN-202 binds PD-L1 and CD28 at distinct, non-overlapping epitopes enabling its potentially unique functionality.
ALPN-101 preclinical data in IBD presented at 2020 Crohn’s & Colitis Congress: These new data showed ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors, and significantly reduced disease activity in the CD4+CD45RBhi T cell transfer mouse colitis model.
ALPN-101 Received FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease: Earlier this month, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, one for the prevention of and one for the treatment of acute GVHD.

Clinical Trials in Patients Now Open for Both Development Programs: A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) and a phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) are now both open for enrollment.

Full Year 2019 Financial Results

As of December 31, 2019, we had cash, cash equivalents, restricted cash, and short-term investments totaling $40.9 million. Net cash used in operating activities for the year ended December 31, 2019 was $35.3 million compared to $28.4 million for the year ended December 31, 2018. We recorded a net loss of $41.9 million and $36.5 million for the years ended December 31, 2019 and 2018, respectively.

Collaboration revenue for the year ended December 31, 2019 was $1.7 million compared to $0.7 million for the year ended December 31, 2018. The increase was primarily attributable to $1.3 million in revenue recognized from the Adaptimmune Collaboration Agreement and a $0.4 million milestone payment from Laurel from the sale of our GSNOR assets.

Research and development expenses for the year ended December 31, 2019 were $35.8 million compared to $29.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in clinical trial activity, direct research activities, personnel-related expenses as a result of growth in headcount to support ongoing discovery and development programs, related overhead and facility costs for these programs, and an increase in stock-based compensation.

General and administrative expenses for the year ended December 31, 2019 were $9.5 million compared to $8.4 million for the year ended December 31, 2018. The increase was primarily attributable to personnel-related expenses related to an increase in administrative headcount, increases in professional and legal services, and an increase in facility costs to support the growth of our business.

Fourth Quarter and Full Year 2019 Conference Call and Webcast Details

Alpine will hold a conference call and webcast to discuss results from the fourth quarter and full year 2019 on March 30, 2020 at 4:30 pm EDT. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 6877935. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 and/or ICOS – ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) is open for enrollment.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

On March 30, 2020 Cardax, Inc. (OTCQB:CDXI) reported its 2019 results (Press release, Cardax Pharmaceuticals, MAR 30, 2020, View Source [SID1234556015]). Highlights:

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CHASE Clinical Trial. On September 23, 2019, the Company announced findings from the pre-specified interim review of its ongoing CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) clinical trial. The CHASE clinical trial is a double-blind, randomized, placebo-controlled clinical trial evaluating the effect of the Company’s astaxanthin dietary supplement ZanthoSyn, on cardiovascular health, as measured by C-Reactive Protein or "CRP" levels in subjects with documented cardiovascular risk factors. Pre-specified secondary cardiovascular and inflammatory health markers, safety parameters, exploratory endpoints, and pre-specified sub-groups are also being assessed.

The interim review included several key cardiovascular health markers: CRP, triglycerides, total cholesterol, LDL cholesterol, oxidized LDL cholesterol, and blood pressure. The results demonstrated pleiotropic effects and excellent safety, which the Company believes provide further mechanistic support for its astaxanthin pharmaceutical development program, the basis for additional patent filings, and support for the cardiovascular health benefits of ZanthoSyn.*

The CHASE clinical trial recently suspended recruitment of new subjects and study visits for existing subjects due to the coronavirus disease 2019 (COVID-19) pandemic and the related governmental "stay-at-home" orders. The Company expects to resume clinical trial operations when permissible and safe to proceed.

Intellectual Property. The Company filed additional patents in 2019 that if issued would extend its patent coverage to 2040 for the composition of matter of CDX-101, the Company’s lead pharmaceutical candidate, and 2039 for certain cardiovascular uses based on the CHASE clinical trial results.

ZanthoSyn Net revenues rebounded with $500,586 in the second half of 2019 compared to $210,363 in the first half of the year. The rebound was primarily driven by a stronger correlation of inventory sell-in/sell-through patterns by the Company’s largest customer, General Nutrition Corporation ("GNC"). ("Sell-in" is defined as wholesale orders of ZanthoSyn by GNC. "Sell-through" is defined as retail sales of ZanthoSyn to GNC customers.)

Financial Results. The Company raised financing of $3,360,000 in 2019 vs. $1,244,037 (net) in 2018 using a combination of convertible notes, equity units (stock and warrants), and loans, the proceeds of which were used for general working capital and to fund research, development, and clinical programs.

Net losses increased to $5,093,037 in 2019 from $4,024,222 in 2018 primarily due to non-cash expenses related to convertible notes issued in 2019, including interest expenses and changes in derivative liability amounts. The loss from operations of $4,077,103 in 2019 was nearly unchanged from $4,022,495 in 2018.

Net revenues decreased to $710,949 in 2019 vs. $1,510,875 in 2018 primarily due to the decrease in GNC replenishment orders of ZanthoSyn in the first half of 2019 following larger stocking orders in 2018. Inventory sell-in/sell-through patterns were more strongly correlated in the second half of 2019.

Subsequent Events. Cardax released a white paper and accompanying press release on March 20, 2020 outlining the potential role of astaxanthin in the treatment of COVID-19 and is seeking strategic collaborations to further develop astaxanthin for COVID-19, including clinical trials. A provisional patent covering this use was also filed.

The Company believes that its financing, including any public or private offerings, and revenues may be affected in 2020 by the COVID-19 pandemic, although the extent of the impact is uncertain at this time.

Cardax raised $770,000 in Q1 2020, of which $150,000 was used to pay off a convertible note due in March 2020, and the balance is being used for general working capital.

"We believe the encouraging CHASE trial interim results and our new patent filings were important accomplishments in 2019. These milestones reflect the successful execution of key parts of our strategy to create value around our pharmaceutical development programs," said David G. Watumull, Cardax CEO. "On the consumer side of the business, we were glad to see the rebound in ZanthoSyn sales in the second half of 2019."

On March 30, 2020 ISA Pharmaceuticals reported that Just weeks after International Human Papilloma Virus (HPV) Awareness Day, new results from two long-time Cancer Research Institute (CRI) scientists highlighted the promise of immunotherapy against HPV-associated cervical cancer (Press release, ISA Pharmaceuticals, MAR 30, 2020, View Source [SID1234555973]).

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In a phase 1/2 study, women with advanced, recurrent, or metastatic cervical cancer were treated with the combination of an HPV-targeting vaccine and standard-of-care chemotherapy. Of 72 evaluable patients, 43 percent had their tumors shrink.

Led by Cornelis J. M. Melief, M.D, Ph.D., and Sjoerd H. van der Burg, Ph.D., this clinical breakthrough was the latest fruit borne by the duo, both of whom have been supported by CRI during their time at Leiden University Medical Center in the Netherlands. In addition to being a member of the CRI Scientific Advisory Council, Melief was the recipient of the 2019 AACR (Free AACR Whitepaper)-CRI Lloyd J. Old Award in Cancer Immunology and is currently the chief scientific officer at ISA Pharmaceuticals. Van der Burg, who earned his doctorate in Melief’s lab in 1998, is also affiliated with ISA as a member of their Scientific Advisory Board, as well as the Oncode Institute.

In 2002, CRI-funded preclinical work by Melief and van der Burg provided an early proof of principle that therapeutic HPV vaccines could eliminate HPV-associated cancers. To do so, they used synthetic long peptide (SLP) vaccines to target the E6/E7 oncoproteins produced by the HPV16 strain.

Next, they demonstrated that HPV-targeting vaccines could clear pre-malignant lesions. However, vaccination wasn’t effective against advanced cancers because of the presence of immunosuppressive myeloid cells. By adding chemotherapy to the treatment regimen, the current study sought to decrease the number of myeloid cells and thereby enable more potent anti-tumor immune responses after vaccination, especially by the immune system’s "killer" T cells.

In many patients, the combination appears to have done just that.

Two weeks after chemotherapy, when patients’ myeloid cells were at their lowest point, varying doses of the ISA-101 vaccine were administered. Half of them also received a molecule called pegylated type 1 interferon that may help boost adaptive immune responses. Overall, about one-third of patients analyzed had low levels of HPV-targeting T cells after chemotherapy alone and prior to vaccination. Post-vaccination, HPV-specific T cell responses were detected at all dose levels, and "the patients with higher than median strength responses survived the best," Melief told CRI.

"These results, provided they are validated in larger trials, could lead to significantly improved care for patients with cervical cancer."

In another ongoing study, this vaccine paired well with checkpoint blockade immunotherapy in patients with advanced head and neck cancer—another cancer linked to HPV infection. A similar trial will soon be testing that approach in cervical cancer, according to Melief, who believes we might benefit from going even further with vaccine combinations.

"Last year, we demonstrated the synergy between vaccination and anti-PD-1 checkpoint immunotherapy in patients with recurrent or metastatic HPV+ head and neck cancer. It is therefore tempting to combine all three therapeutic measures—anti-PD-1, vaccination, and chemotherapy—for additional synergy because chemotherapy and anti-PD-1 act by non-overlapping mechanisms. This chemotherapy combination also pinches in nicely with other types of immunotherapy because many types of late-stage cancer induce this kind of myeloid cell-mediated immunosuppression in patients."

On March 30, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported updated efficacy and safety data in patients with ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma from its ongoing Phase 1 dose escalation study evaluating XMT-1536 (Press release, Mersana Therapeutics, MAR 30, 2020, View Source [SID1234555998]). The Company will host a call today, Monday, March 30, 2020, at 5:00 pm ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data.

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"These data demonstrate that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, delivers confirmed responses and durable stable disease in heavily pretreated ovarian cancer and NSCLC adenocarcinoma patients who have exhausted all other treatment options. These data also show that XMT-1536 is well tolerated without the severe toxicities of other ADC platforms such as neutropenia, neuropathy and ocular toxicity. Moreover, these data establish the potential for a biomarker-response relationship to identify patients most likely to benefit from XMT-1536," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We look forward to advancing XMT-1536 for both ovarian cancer and NSCLC adenocarcinoma patients. Having already accumulated meaningful patient experience in the expansion cohorts, we remain on track to provide an interim update in the second quarter of 2020."

Of the 59 patients enrolled, tumor types included 37 ovarian cancer, 11 NSCLC adenocarcinoma, and 11 other tumor types previously disclosed at lower dose levels. Patients were heavily pre-treated, with a median of five prior lines of treatment (range 1-10). These data include new patients dosed at 30, 36 and 43 mg/m2. The majority of the ovarian cancer patients had received prior bevacizumab or PARP inhibitors. All NSCLC adenocarcinoma patients had received prior platinum and immunotherapy. Updated and new data as of February 3, 2020 includes:

·Safety profile consistent with previously reported data at lower doses.
oThe most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, headache and the most frequent Grade 3 TRAE was transient AST elevation.
oThere were no dose limiting toxicities observed in the 43 mg/m2 cohort.
oThere was no reported severe neutropenia, peripheral neuropathy or ocular toxicity.

·Additional confirmed responses in heavily pretreated patients and favorable biomarker-response trend observed.
oFirst confirmed partial response seen in a NSCLC adenocarcinoma patient with prior treatments including carboplatin, pemetrexed, paclitaxel and nivolumab.
oAt the 43 mg/m2 dose level, 2/7 (29%) patients achieved partial responses (PRs) and 4/7 (57%) patients achieved stable disease (SD) for a disease control rate (DCR) of 6/7 (86%). In January 2020, the expansion portion of the Phase 1 study dose was amended from 36 mg/m2 to 43 mg/m2 for newly enrolled patients.
oFor the subset of evaluable patients treated at >30 mg/m2 who had higher NaPi2b expression, 5/15 (33%) achieved PR and 6/15 (40%) achieved SD for a DCR of 11/15 (73%).
oIn contrast, for the subset of evaluable patients treated at >30 mg/m2 who had lower NaPi2b expression, 0/9 (0%) achieved PR and 5/9 (55%) achieved SD for a DCR of 5/9 (55%).

Response – Ovarian Cancer
and NSCLC
adenocarcinoma N=39* N (%)
All Higher
NaPi2b o Lower
NaPi2b oo Indeterminate
NaPi2b **
20 mg/m2 N 10 7 2 1
PR 1 (10%) 0 (0%) 0 (0%) 1 (100%)
SD 6 (60%) 4 (57%) 2 (100%) 0 (0%)
DCR (PR+SD) 7 (70%) 4 (57%) 2 (100%) 1 (100%)
30, 36, 40 mg/m2 N 22 12 7 3
PR 3 (14%) 3 (25%) 0 (0%) 0 (0%)
SD 10 (45%) 6 (50%) 3 (43%) 1 (33%)
DCR (PR+SD) 13 (59%) 9 (75%) 3 (43%) 1 (33%)
43 mg/m2 N 7 3 2 2
PR 2 (29%) 2 (67%) 0 (0%) 0 (0%)
SD 4 (57%) 0 (0%) 2 (100%) 2 (100%)
DCR (PR+SD) 6 (86%) 2 (67%) 2 (100%) 2 (100%)

*Excludes 3 patients discontinued due to investigator/patient choice and 1 without RECIST scan

**Hypocellular specimen/indeterminate for H-score or not determined yet

O Higher NaPi2b Expression: at / above lowest H-score at which response observed (>110)

OO Lower NaPi2b Expression: below the lowest H-score at which response observed (<110)

Mersana plans to enroll approximately 45 patients in each of the ovarian cancer and NSCLC adenocarcinoma patient cohorts in the expansion portion of the XMT-1536 Phase 1 study. The Company expects to present interim data from the dose expansion study in the second quarter of 2020.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 5:00 p.m. ET to review these data. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2889994. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.