On June 22, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 myeloid checkpoint mechanism, reported the change of the Company’s name to ALX Oncology (Press release, Alexo Therapeutics, JUN 22, 2018, View Source [SID1234527433]). The new name and logo will differentiate ALX Oncology (ALX) from other companies in the field as the Company advances its clinical programs.

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"Our new name further identifies us as an oncology drug developer and distinguishes us from other companies in this sector," said Jaume Pons, Ph.D., ALX Oncology’s President and Chief Executive Officer.

ALX Oncology is developing ALX148, a high affinity CD47 blocker currently in clinical development (NCT03013218). Preliminary results from the Phase 1 trial were recently presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. "Our study results show that ALX148 is generally well tolerated as a single agent and in combination with pembrolizumab, trastuzumab, or rituximab in patients with advanced solid tumors and non-Hodgkin lymphoma," said Sophia Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. "We look forward to reporting the results of ALX148 combinations in expanded patient populations at upcoming conferences."

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key myeloid immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218).

On June 22, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, reported that results from a retrospective review of more than 2,500 patient records with metastatic adenocarcinoma of the pancreas (mPAC) from nine countries (Press release, Shire, JUN 22, 2018, View Source [SID1234527429]). The results – presented on 20 June at the 20th ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona – showed variation across Europe in the symptoms reported at initial diagnosis, and in treatment decisions made in the first-line and second-line metastatic settings. The research suggests that enhanced recognition of symptoms and a standardized treatment approach, especially in the second-line setting, may help improve diagnosis, patient care and outcomes.1,2,3

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"Pancreatic adenocarcinoma is typically diagnosed late in the course of the disease, when outcomes are generally poor," said Floris de Jong, Ph.D., Global Medical Franchise Lead Solid Tumors at Shire Pharmaceuticals. "These analyses from patient records and NAPOLI-1 collectively provide important new insights for the diagnosis and treatment of patients with this difficult-to-treat cancer. Specifically, the results of the retrospective review indicate that enhanced awareness of, and attention to symptoms both by health care providers and the public at large may help improve mPAC diagnosis, care and outcomes

Researchers also presented new data from four subgroups of the global phase III NAPOLI-1 study in an oral session4. These subgroups included: the presence of metabolism and nutrition disorders at baseline, including diabetes mellitus and decreased appetite; the location of the primary tumor site; the presence of a biliary stent at baseline and response to prior therapy.5,6,7,8

The search for innovative new therapies in pancreatic cancer remains a serious unmet need. Relatively little progress has been made in preventing, detecting and treating the disease relative to other leading cancer killers, and survival rates for pancreatic cancer remain one of the lowest among other types of cancer.9

"While first-line treatments are approved for patients with pancreatic adenocarcinoma, disease progression after initial therapy is inevitable and patients with this disease have a poor prognosis and low survival rate,"9,10 said Teresa Macarulla Mercadé, M.D., Ph.D., Clinical Investigator, Gastrointestinal Tumor Program, Vall d’Hebrón Institute of Oncology, Barcelona. "To further our understanding of the use of nal-IRI in the treatment of mPDAC, we conducted four separate NAPOLI-1 subgroup analyses investigating the effect of selected baseline parameters. These analyses demonstrated that a consistent treatment benefit was observed in patients treated with nal-IRI in combination with 5-FU/LV across the subgroups tested."

The full list of Shire abstracts presented at the 20th ESMO (Free ESMO Whitepaper)-GI in Barcelona includes:

Geographic variation in systemic treatment of metastatic pancreatic adenocarcinoma (mPAC) patients in real world across Europe2
O-002 (oral presentation)
Selected subgroup analyses of liposomal irinotecan (nal-IRI) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 phase III trial4
O-004
Baseline characteristics and second-line treatment for metastatic pancreatic adenocarcinoma (mPAC) patients receiving first-line FOLFIRINOX, gemcitabine+nabpaclitaxel or gemcitabine-monotherapy in routine clinical practice across Europe3
PD-004 (poster presentation)
Prognostic effect of primary tumor location in the NAPOLI-1 phase III study in metastatic pancreatic ductal adenocarcinoma (mPDAC)6
P-150
Prognostic value of baseline biliary stents on outcomes in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 trial7
P-151
The effect of best response to prior anticancer therapy on efficacy outcomes in the NAPOLI-1 trial of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy8
P-152
Decreased appetite (DA) at baseline impacts prognosis in the NAPOLI-1 phase III study in metastatic pancreatic ductal adenocarcinoma (mPDAC)5
P-153
Symptoms reported at initial diagnosis of (metastatic) pancreatic adenocarcinoma ([m]PAC) in routine clinical practice and variation in frequencies across Europe1
P-167 (poster presentation)
More detailed data on each abstract can be found by visiting: View Source

About Pancreatic Cancer
Pancreatic adenocarcinoma is a disease with limited treatment options and is almost always fatal.11 At the time of diagnosis, more than 80 percent of people diagnosed with pancreatic adenocarcinoma have metastatic disease or locally advanced disease that cannot be removed with surgery.12 The disease has a median five-year survival rate of about five percent,9 and an median overall survival of typically less than a year, as illustrated by real-world European systematic review.10 The only curative treatment for pancreatic adenocarcinoma is surgical resection in the early stage, which can improve five-year survival to 10 percent.13

The signs and symptoms of pancreatic adenocarcinoma are non-specific (common presenting symptoms include jaundice, abdominal pain, weight loss, steatorrhoea and new-onset diabetes).9 Clear symptoms may not appear until the disease has spread locally or metastasized. As a result, most patients are not candidates for surgery upon diagnosis.12

Pancreatic adenocarcinoma accounts for less than three percent of all cancer cases,14 yet is the seventh leading cause of cancer death worldwide and the fourth in Europe.9 Worldwide, pancreatic cancer prognosis is typically poor, with an estimated 338,000 new cases and 331,000 deaths each year.11

About NAPOLI-1
NAPOLI-1 is the first global, randomized open-label Phase 3 trial to show extended overall survival in metastatic pancreatic adenocarcinoma after gemcitabine-based therapy through treatment with ONIVYDE combined with 5-FU and LV. Patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America and Australia. The study evaluated ONIVYDE (80 mg/m2), expressed as irinotecan hydrochloride trihydrate (which is the equivalent of 70 mg/m2 ONIVYDE expressed as irinotecan free base) in combination with 5-FU/LV administered intravenously every two weeks and as a monotherapy (120 mg/m2) administered every three weeks. Each ONIVYDE containing arm was compared to a control arm of 5-FU/LV.15

About liposomal irinotecan (nal-IRI)
Liposomal irinotecan (nal-IRI) is approved in the EU under the name ‘ONIVYDE.’ ONIVYDE is approved for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-FU/LV, in adult patients who have disease progression following gemcitabine-based therapy.16

Shire is responsible for the development and commercialization of ONIVYDE outside of the United States and Taiwan under an exclusive licensing agreement with Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, (Euronext: IPN; ADR: IPSEY). Ipsen markets ONIVYDE in the United States after completion of the acquisition from Merrimack Pharmaceuticals.

ONIVYDE received US Food and Drug Administration (FDA) approval in October 2015 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have progressed following treatment with gemcitabine-based therapy. ONIVYDE product license was granted in Taiwan in March 2016, where PharmaEngine holds the commercialization rights.

Important Safety Information
The most common adverse reactions (incidence ≥20 percent) seen with ONIVYDE in combination with 5-FU/LV were: diarrhea, nausea, vomiting, decreased appetite, neutropoenia, fatigue, asthenia, anaemia, stomatitis and pyrexia.15 In the clinical study, Grade 3 or Grade 4 diarrhea occurred in 12.8 percent of patients receiving ONIVYDE in combination with 5-FU/LV. Early-onset (within one day of treatment) diarrhea occurred in 30 percent of patients on ONIVYDE combined with 5-FU/LV and was usually transient.15 Early-onset diarrhea was accompanied by cholinergic symptoms in 3.4 percent of patients taking ONIVYDE in combination with 5-FU/LV.15 Median time to late-onset diarrhea was eight days following the ONIVYDE dose.15 Of patients taking ONIVYDE combined with 5-FU/LV, 11 percent of patients discontinued treatment vs 7% of patients receiving 5-FU/LV alone.15

On June 21, 2018 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, reported its financial results for the quarter ended March 31, 2018, and provided an update on the Company’s operations (Press release, BeyondSpring Pharmaceuticals, JUN 21, 2018, View Source [SID1234527596]).

"During the past few months, we have continued to execute on our strategy to establish our lead asset, Plinabulin, as a potentially superior new therapy for the treatment of chemotherapy-induced neutropenia, or CIN, while also advancing our Phase 3 non-small cell lung cancer trial and earlier-stage programs," said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. "We recently highlighted data from the Plinabulin development program describing its differentiated mechanism of action and positive results from the Phase 2 portion of 105 Study, which together, further articulates the potential of our novel candidate to prevent severe neutropenia with less bone pain and an overall more favorable product profile than G-CSF therapy. We look forward to building on this momentum as we approach key Phase 3 data readouts for CIN and non-small cell lung cancer beginning later this year, advance our early-stage pipeline of immuno-oncology therapies and research activities for our ubiquitination protein degradation research platform, and prepare to initiate Phase 1 trials later this year for multiple triple-combination immuno-oncology programs. We have already started the process of preparing to commercialize in both China and the U.S., including identifying and securing the resources and talent we need to put in place for commercial success for Plinabulin in both markets. With significant upcoming milestones, BeyondSpring is well positioned to transition into a multinational, commercial-stage oncology company."

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Recent Highlights

Data from the Phase 2 portion of Study 105 comparing Plinabulin and Neulasta (pegfilgrastim) for prevention of CIN presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

In June 2018, results of the Phase 2 portion of Study 105, a prospective Phase 2/3 trial of its lead asset, Plinabulin, were presented by BeyondSpring in a poster session at the ASCO (Free ASCO Whitepaper) Annual Meeting. The Phase 2 portion of Study 105 was designed as a head-to-head comparison of different dose levels of Plinabulin to Neulasta in a total of 55 patients. The Phase 2 portion met its primary endpoint, which was to determine the recommended Phase 3 Plinabulin dose. Data from the study demonstrated that patients treated with Plinabulin dosed 30 minutes after docetaxel for the prevention of docetaxel CIN reported less bone pain, which was clinically meaningful, and had superior neutrophil counts and comparable neutropenia reduction compared to patients treated with Neulasta 24 hours after docetaxel. The data suggested that Plinabulin has the potential to be at least as effective as Neulasta for prevention of CIN, with an overall product profile that could address the limitations of the current standard of care.

Plinabulin mechanism data highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting

In April 2018, BeyondSpring presented preclinical data related to Plinabulin’s differentiated mechanism of action at the AACR (Free AACR Whitepaper) annual meeting. The data demonstrated Plinabulin’s novel mechanism in preserving neutrophils in bone marrow after docetaxel chemotherapy treatment – a mechanism that is differentiated from that of G-CSF, which is the current standard of care in the prevention of CIN.

The Company offered shares through a registered direct offering for gross proceeds of $20.0 million

On May 29, 2018, BeyondSpring entered into private placement agreements with certain third-party investors pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company, an aggregate of 739,095 shares of the Company’s ordinary shares at a purchase price of $27.06 per share, for aggregate gross proceeds of $20.0 million. These investors, including an insurance company and a pharmacy retail chain owner in China, may be strategic to BeyondSpring’s planned commercial initiatives in China.

Edward Dongheng Liu appointed Chief Financial Officer

In March 2018, the Company announced the appointment of Edward Dongheng Liu as Chief Financial Officer. Mr. Liu was a senior banker at J.P. Morgan and Jefferies in Hong Kong, and was a partner and executive director of Epiphron Capital, a cross-border healthcare fund and Series B investor in BeyondSpring.

Financial Results of Three Months Ended March 31, 2018

Research and development (R&D) expenses were $14.1 million for the quarter ended March 31, 2018, compared to $46.7 million for the quarter ended March 31, 2017. R&D expenses for the first quarter of 2017 included a $42.3 million non-cash charge for acquiring the worldwide patent of Plinabulin excluding the People’s Republic of China (PRC) and Hong Kong, which is determined based on the fair value of issued 2,112,963 ordinary shares at $20 per share. Excluding the impact of this purchase, the R&D expense for the quarter ended March 31, 2018 would have increased by $9.7 million, compared to the quarter ended March 31, 2017. This increase is largely attributable to $4.9 million of non-cash share-based compensation expense recorded in the first quarter of 2018, $2.8 million related to increased clinical trial expense and $1.4 million related to increased professional services expense.

General and administrative ("G&A") expenses were $0.7 million for the quarter ended March 31, 2018, compared to $1.0 million for the quarter ended March 31, 2017. First quarter 2018 G&A expenses included a $0.7 million non-cash credit relating to the forfeiture of certain restricted shares.

U.S. GAAP net loss was $14.1 million for the quarter ended March 31, 2018, compared to $47.7 million for the quarter ended March 31, 2017. Net loss for the first quarter ended March 31, 2017, included a $42.3 million non-cash charge for acquiring the worldwide patent of Plinabulin excluding the PRC and Hong Kong.

Cash and short-term investments were $21.5 million at March 31, 2018, compared to $30.6 million at December 31, 2017. The Company anticipates that its current financial resources, including the proceeds from the private placement, would enable it to advance its ongoing clinical trials and submit New Drug Application (NDA) in China for Plinabulin for the treatment of CIN and non-small cell lung cancer in late 2018 or early 2019 and in the first half of 2019, respectively, and to advance its immuno-oncology pipeline, as well as its ubiquitination protein degradation research platform.

Key Upcoming Milestones

The following outlines the Company’s key anticipated upcoming milestones for the next 12 months.

Announce Phase 3 interim analysis data for Study 105 evaluating Plinabulin + docetaxel for CIN – 4Q 2018

Announce topline Phase 2 data for Study 106 evaluating Plinabulin + TAC (Taxotere/Adriamycin/cyclophosphamide) for CIN – late 2018

Announce Phase 3 interim data for Study 103 evaluating Plinabulin + docetaxel for non-small cell lung cancer (NSCLC) – early 2019

Submit NDA to China Food and Drug Administration (CFDA) for Plinabulin for CIN – late 2018/early 2019

Advance two Plinabulin triple-combination immuno-oncology programs into Phase 1 – 2H 2018

Submit NDA to CFDA for Plinabulin for NSCLC – 1H 2019

Advance ubiquitination protein degradation research platform, BPI-001, first target of mutant KRAS, lead asset – 2019

Advance new pipeline asset, BPI-002, an oral CTLA-4 inhibitor, into Phase 1 – 2019

About Plinabulin
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. Studies of Plinabulin’s mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to up-regulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia by reducing the neutrophil breakdown.

On June 21, 2018 PharmaEngine Inc. (TWO: 4162) and its corporate partner, Nanobiotix S.A. (Euronext: NANO) reported that PEP503 (NBTXR3) in combination with radiotherapy met the primary endpoint of pathological Complete Response Rate (pCRR) as compared to radiotherapy alone in a global pivotal phase II/III trial in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall (Press release, PharmaEngine, JUN 21, 2018, View Source [SID1234527423]). The pCRR on the combination arm was 16.1% as compared to 7.9% for the control arm of radiotherapy alone (p = 0.0448). Also PEP503 activated by radiation demonstrated a significant increase of R0 resection rate as compared to radiation alone (p = 0.042). PEP503 demonstrated a good local tolerance among this patient population. The findings showed a very similar radiation-related safety profile in both arms.

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This prospectively randomized, multi-national, open-label and active controlled two-arm (1:1 ratio) pivotal phase II/III trial, referred to as Study 301 (act.in.sarc study) has been conducted in partnership with Nanobiotix. PharmaEngine is the co-sponsor of this study in Asia-Pacific Region. The antitumor activity and safety of PEP503 combined with radiotherapy in Study 301 was compared with that of radiotherapy alone, as preoperative treatment. The primary objective of Study 301 is to enhance pCRR by dosing PEP503 through intra-tumor injection and then activated by standard dose (25 x 2 Gy) of external beam radiation therapy (EBRT). The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the tumor volume changes; the resection margins (R0 rate) and the limb amputation rate, as well as the evaluation of the safety profile in term of clinical and laboratory adverse events. The detailed data analysis, with the exception of long-term follow up will be reported in an international medical conference in the next few months.

"We are very pleased to take part in the global study alongside with Nanobiotix, and are excited that PEP503 has achieved the primary and secondary endpoints of this pivotal study in STS patients," said C. Grace Yeh, Ph.D., President and Chief Executive Officer of PharmaEngine. "The promising results from this study validated its fundamental mechanism of action as a radio-enhancer, which is expected to be generally applicable in other cancers treated with radiotherapy. In addition, previously reported preliminary data from a small set of tumor samples in this study demonstrated that PEP503 activated by radiotherapy induces a specific adaptive immune pattern as an immune-enhancer, while radiotherapy alone did not show any impact on triggering adaptive immune response."

About Study 301 (act.in.sarc study)

The Study 301 recruited a total of 180 patients in Europe (36 sites in 10 countries) by Nanobiotix, and in Asia-Pacific region (7 sites in Australia, Hong Kong, and Philippines) by PharmaEngine. The Global Principal Investigator is Dr. Sylvie Bonvalot, MD, PhD (Head of Sarcoma and Complex Tumor Surgery Unit, Institut Curie, Paris, France). The primary endpoint of pCRR is defined as the rate of patients showing less than 5% of residual viable cancer cells in the tumor post treatment. A centralized evaluation of the pathological response was performed. For additional information, please visit www.clinicaltrials.gov. (Identifier: NCT02379845).

About PEP503 (NBTXR3)

PEP503, the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals. It is a first-in-class product designed to destroy, when activated by radiotherapy, tumors through physical cell death and metastasis via immunogenic cell death leading to specific activation of the immune system. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 in the Asia-Pacific region from Nanobiotix. In addition to STS, Nanobiotix and PharmaEngine are performing clinical trials in head & neck cancers, liver cancers (liver metastasis and hepatocellular carcinoma), rectal cancer, prostate cancer, as well as in combination with anti-PD1 antibodies in head & neck cancers and non-small cell lung cancer. PEP503 has been classified as a class III medical device in many European and certain Asian countries.

About Soft Tissue Sarcoma (STS)

STS are rare malignant tumors that arise from extraskeletal connective tissues, accounting for 0.7% of all cancers. They can occur anywhere in the body, but most originate in an extremity and the trunk (78%). The conventional treatment for STS is wide margin surgery whenever possible with the addition of radiotherapy. In locally advanced STS, however, clear margins are not often achievable, which could lead to higher local failure rates, and negatively affect overall survival. Scientific reports have demonstrated how preoperative radiotherapy can offset the negative prognostic impact of marginal resection on local outcome and survival for patients with STS, extending the limit of limb and function preservation.

Although improvements in surgical techniques and preoperative radiotherapy have been made, local tumor recurrence and distant metastases have been frequently noted to develop. PEP503 (NBTXR3), a radio-enhancer designed to maximize x-ray absorption within the tumor, aims to improve the efficacy of radiotherapy and increase the feasibility of surgical tumor removal.

On June 21, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present additional preclinical data for the drug candidate ATOR-1017 at the 3rd Annual World Preclinical Congress in Boston, US (Press release, Alligator Bioscience, JUN 21, 2018, View Source [SID1234527422]). ATOR-1017 is a monoclonal antibody being developed for the treatment of metastasizing cancer. ATOR-1017 activates the costimulatory receptor 4-1BB which is highly expressed on both T cells and NK cells in the tumor environment.

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These new data show that ATOR-1017 activates NK cells as well as T cells, both contributing to an effective immune-mediated killing of tumor cells. NK cells are immune cells that directly target tumor cells which attempt to evade the immune system. NK cells also enhance the cytotoxic response induced by tumor specific T cells. Agonistic antibodies recognizing 4-1BB will therefore strengthen the tumor killing capacity of both NK cells and cytotoxic T cells.

The data further support a best-in-class profile for ATOR-1017, with demonstrated high efficacy and potential for tumor-directed immune activation.

"These preclinical data provide further evidence of ATOR-1017’s unique positioning as a best-in-class 4-1BB antibody. ATOR-1017 has the properties and potential to minimize side-effects and to induce a powerful, long lasting immune response," said Christina Furebring, SVP Research, at Alligator Bioscience.

Dr Karin Enell Smith, Senior Scientist Preclinical Development at Alligator, will give an oral presentation with the title: "ATOR-1017 – A tumor directed Fcγ-receptor cross-linking dependent 4-1BB agonistic antibody" today at 3:30 p.m. EDT (9:30 p.m. CEST)

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CEST on June 21, 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects.