1stOncology™: Cancer Intelligence Service – Page 11218 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

FINAL RESULTS ANNOUNCEMENT for the twelve months ended 31 December 2019

On April 30, 2020 ImmuPharma plc (LSE:IMM), (Euronext Growth Brussels: ALIMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its final results for the twelve months ended 31 December 2019 (the "Period") (Press release, ImmuPharma, APR 30, 2020, View Source [SID1234556801]).

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!

Key Highlights (including post Period review)

Stable financial performance over the Period
– Cash balance of £1.4 million (31 December 2018: £4.9 million)
– Loss for the period of £6.1 million (31 December 2018: £7.2 million)
– Research and development expenses of £2.7 million (31 December 2018: £4.7 million)
– Administrative expenses of £1.8 million (31 December 2018: £1.7 million)
– Share based expense of £2 million (31 December 2018: £1.8 million)
– Basic and diluted loss per share of 3.99p (31 December 2018: 5.19p)
– 2 successful fundraisings, completed in June 2019 and March 2020, securing in total approximately £4.2 million spread over 24 months
– Dual listing on Euronext Growth Brussels in December 2019
‘Autoimmunity’: Lupuzor

Open label extension study – following completion of Lupuzor’s Phase III trial, an open label extension study undertaken. Analysis of results announced on 28 June 2019
– 62 eligible patients enrolled throughout the US/EU completing 24-week treatment period
– Primary endpoint successfully achieved confirming safety profile of Lupuzor
– No ‘serious adverse events’ related to Lupuzor reported
– Insights into the Phase III data allow optimised Lupuzor phase III design to progress
Licence and development agreement signed in November 2019 with Avion Pharmaceuticals
– Exclusive rights for US with Avion
– Avion to fund new ‘optimized’ international Phase III trial, up to $25m
– Milestones up to $70m & tiered double-digit royalties up to 17%
– Data from Phase III trial allows approvals in key ex-US markets
– Avion to explore peptide’s potential in other auto-immune diseases for US market
– Discussions continue with potential partners for Lupuzor outside of US in key territories
Post review period
– Avion strengthened advisory team for Lupuzor Phase III trial, including collaboration with leading lupus patient group and formation of KOLs – all senior respected consultants within lupus and autoimmune community in US/EU
Proof of Concept study planned for Lupuzor in CIDP patients – potential Orphan Drug designation
Other program developments: Nucant and Peptide program combined to form Ureka Pharma SAS

Three therapy areas: Cancer, Metabolism and (new) Anti-Infectives (Anti-Viral, Anti-Bacterial, Anti-Fungal) – these programs include:
– Anti-Infective: new BioAMP-B (Anti-Fungal) product for lung infections
– Metabolism: new BioGlucagon product – rescue therapy for low sugar events in diabetes
– All programs provide future partnering opportunities
Incanthera plc oncology specialist in which ImmuPharma retains 11.9% shareholding, listed on Aquis Stock Exchange ("AQSE", formerly NEX Exchange) in February 2020

Athenex Announces Acceptance of Oral Paclitaxel Phase II Study in Angiosarcoma Abstract at ASCO20 Virtual Scientific Program

On April 29, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that an abstract for its ongoing Phase II study of oral paclitaxel and encequidar (Oral Paclitaxel; formerly known as Oraxol), for the treatment of angiosarcoma, has been accepted for presentation in a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, to be held from May 29 to May 31, 2020 (Press release, Athenex, APR 29, 2020, View Source [SID1234573878]).

Presentation details are as follows:

Title: (Abstract 11517) A Phase II Study of Oraxol in the Treatment of Unresectable Cutaneous Angiosarcoma
Poster Session: Sarcoma
Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program
This Phase II study is an ongoing, single arm study evaluating the activity, safety and tolerability of oral paclitaxel (205 mg/m2) with encequidar administered orally, once daily, for 3 consecutive days per week in patients with cutaneous angiosarcoma (clinicaltrials.gov identifier: NCT03544567).

The abstract title is currently available on the ASCO (Free ASCO Whitepaper) Meeting Library, with the full abstract scheduled to be published on May 13, 2020, at 5:00 PM EDT.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

About Angiosarcoma
Angiosarcomas are a type of soft tissue sarcoma characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood and lymphatic vessels. Angiosarcomas arise in various body sites, including cutaneous, soft tissue, and visceral locations. Angiosarcomas are frequently metastatic at diagnosis, with a natural history complicated by local recurrence, distant metastases, and poor overall survival. There is no approved treatment for angiosarcoma and survival is limited with treatments currently available. However, reports in the literature of objective tumor response support the use of intravenous paclitaxel in the treatment of angiosarcoma.

Fennec Announces Proposed Public Offering of Common Shares

On April 29, 2020 Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity from cisplatin in pediatric cancer patients, reported that it intends to offer its common shares in an underwritten public offering (Press release, Fennec Pharmaceuticals, APR 29, 2020, View Source [SID1234556935]). In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares offered in the public offering.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the proposed offering. Wedbush PacGrow is acting as the co-manager.

The common shares are being offered by the Company pursuant to a registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus, when filed with the SEC, may also be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

Kurome Therapeutics launched to develop therapies targeting cancer’s ability to evade treatment

On April 29, 2020 Seed investor CincyTech reported the formation of Kurome Therapeutics ("Kurome"), a preclinical stage company developing novel therapies targeting cancer cells’ adaptive resistance mechanisms beginning with hematopoietic, or blood cell, cancers (Press release, Kurome Therapeutics, APR 29, 2020, View Source [SID1234556932]). Kurome secured the license to develop the therapies from Cincinnati Children’s Hospital Medical Center ("Cincinnati Children’s"), a top ranked pediatric medical center and research institution.

Kurome is developing combined IRAK1/4 and panFLT3 inhibitors to target cancer cells that evade the effects of chemotherapy drugs by adaptive resistance, having co-opted immune signaling pathways to survive. Drug resistant cancers can be deadly for many patients, and Kurome’s approach may offer a novel strategy that keeps patients in remission longer and extends overall survival. Kurome’s pipeline of IRAK 1/4, panFLT3 inhibitors have demonstrated in preclinical studies to:

Induce rapid and irrecoverable cytotoxicity in cell line models and increase overall survival in patient-derived xenograft models, well beyond that of existing clinical FLT3 inhibitors.
Synergize with and improve potency of Venclexta (Venetoclax).
Maintain complete efficacy even in settings of adaptive resistance to FLT3 inhibitors.
Kurome’s initial focus is on improving health in poor prognosis acute myeloid leukemia (AML), a deadly blood and bone marrow cancer with a high mortality rate. Kurome may potentially expand its focus to work across a range of hematopoietic cancers, including pre-leukemic conditions such as myelodysplastic syndromes (MDS). Collectively, more than 30,000 new cases of MDS and AML are diagnosed in the United States each year. The median survival time for MDS is only 2.5 years after diagnosis, and the 5-year survival rate for AML is only 27 percent.

Kurome is founded on research at Cincinnati Children’s in collaboration with the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS).

Principal investigator and Co-Leader, Hematologic Malignancies Program at Cincinnati Children’s Cancer and Blood Diseases Institute, Daniel Starczynowski, PhD, commented, "It is a personal honor and privilege to have an impact on translating this strategy for cancer drug resistance into a therapy option against AML and cancers that act in similar ways."

CincyTech led the company’s seed investment round. "Kurome was created to accelerate the development of novel technology from world class cancer scientists at Cincinnati Children’s and NCATS. This pathway approach has the potential to add to a growing arsenal of genetically targeted cancer therapies," said John Rice, PhD, managing director of life sciences at CincyTech.

The company is being led by Jan Rosenbaum, PhD, a drug development professional, chief scientific officer and innovator with more than 25 years of pharma and biotech technical management experience. Rosenbaum is the former chief scientific officer of Airway Therapeutics, a 2011 spin-out of Cincinnati Children’s that is also a CincyTech portfolio company. She also serves as a business development advisor on the Therapeutics Development Team of the Harrington Discovery Institute.

BeiGene Announces Clinical Data to Be Presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 29, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that clinical data on its BTK inhibitor BRUKINSA (zanubrutinib) and its anti-PD-1 antibody tislelizumab will be presented in an oral presentation and three posters at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 29-31, 2020 (Press release, BeiGene, APR 29, 2020, View Source [SID1234556852]).

Oral Presentation:

Title:

ASPEN: Results of a Phase III Randomized Trial of Zanubrutinib Versus Ibrutinib for Patients with Waldenström Macroglobulinemia (WM)

Abstract #: 8007

Session Title:
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Lead Author:

Constantine S. Tam, MBBS, M.D., St. Vincent’s Hospital, Australia

Poster Presentations:

Title:
Three-Year Follow-up of Treatment-Naïve and Previously Treated Patients with Waldenström Macroglobulinemia (WM) Receiving Single-Agent Zanubrutinib

Abstract #: 8051

Poster #: 384

Session Title:
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Lead Author:
Constantine S. Tam, MBBS, M.D., St. Vincent’s Hospital, Australia

Title:

Phase 3 Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First line (1L) Treatment for Advanced Squamous Non-Small Cell Lung Cancer (sq NSCLC)

Abstract #: 9554

Poster #: 320

Session Title:

Lung Cancer—Non-Small Cell Metastatic Poster Session

Lead Author:

Jie Wang, M.D., Cancer Hospital Chinese Academy of Medical Sciences, China

Title:

Association Between Immune and Tumor Gene Signatures with Response or Resistance to Tislelizumab Monotherapy or in Combination with Chemotherapy in Gastroesophageal Adenocarcinoma

Abstract #: 3115

Poster #: 179

Session Title:

Developmental Therapeutics—Immunotherapy Poster Session

Lead Author
Jianming Xu, M.D., General Hospital of Chinese People’s Liberation Army, China