On December 2, 2019 Novartis reported to presenting data from the company’s expansive hematology portfolio at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH) (Free ASH Whitepaper), taking place December 7-10 in Orlando, Florida (Press release, Novartis, DEC 2, 2019, View Source [SID1234551810]). More than 140 abstracts will be presented, demonstrating our growing pipeline of differentiated immunotherapies and our bold ambition to research and develop medicines that transform the standard of care for patients.

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"Our data at ASH (Free ASH Whitepaper) are evidence of the hard work, dedication and pioneering mindset of our teams. Novartis is deeply committed to build on its deep legacy in hematology to provide new innovative treatments and solutions that help people with malignant and benign blood disorders live longer, better lives," said Susanne Schaffert, PhD, President, Novartis Oncology.

Data at the 2019 ASH (Free ASH Whitepaper) will focus on a range of disease areas, including:

Phase Ib data from the first anti-TIM-3 antibody in hematology, MBG453
Phase Ib study of the anti-TIM-3 antibody MBG453 in combination with decitabine in patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) [Abstract #570; oral presentation: Monday, December 9, 8:15 AM ET]

Data will show real-world Kymriah results as a therapy for adults with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and children and young adults with r/r acute lymphoblastic leukemia (ALL)
Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for adults with diffuse large B-cell lymphoma (DLBCL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [Abstract #766; oral presentation: Monday, December 9, 3:30 PM ET]
Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory children and young adults acute lymphoblastic leukemia (ALL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [Abstract #2619; poster presentation: Sunday, December 8, 6:00 PM ET]

Post hoc data from the SUSTAIN study, highlighting reductions in hospitalization for patients with sickle cell disease (SCD) treated with Adakveo (crizanlizumab) 5mg/kg; as well as international Sickle Cell World Assessment Survey (SWAY) insights on the impact of SCD
Crizanlizumab treatment is associated with clinically significant reductions in hospitalization in patients with sickle cell disease: results from the SUSTAIN study [Abstract # 2289; poster presentation: Sunday, December 8, 6:00 PM ET]
Impact of sickle cell disease symptoms on patients’ daily lives: interim results from the International Sickle Cell World Assessment Survey (SWAY) [Abstract #2297; poster presentation: Sunday, December 8, 6:00 PM ET]
Management strategies and satisfaction levels in patients with sickle cell disease: interim results from the International Sickle Cell World Assessment Survey (SWAY) [Abstract #1017; poster presentation: Saturday, December 7, 5:30 PM ET]

Evaluating new immune thrombocytopenia (ITP) quality of life index
The psychometric properties of the ITP Life Quality Index assessed in a large multinational "real-world" cohort of immune thrombocytopaenia patients [Abstract #386; oral presentation: Sunday, December 8, 7:45 AM ET]
Novartis plans to provide updates around the 2019 ASH (Free ASH Whitepaper) Annual Meeting on Novartis.com, Twitter, Facebook and LinkedIn, delving into the core of our commitment to reimagining medicine, including interviews with the scientists, people and principles behind our innovation; insights on new findings and developments, and breaking news.

Product Information

Approved indications for products vary by country and not all indications are available in every country. Safety and efficacy profiles have not been established for investigational compounds or are outside the approved indications for marketed products. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available or receive additional indications if already marketed.

For full prescribing information including important safety information about marketed products, please visit View Source

On December 2, 2019 Indivumed, a physician-led, integrated global oncology solution provider, reported its partnership with Biognosys, a leader in next-generation proteomics solutions (Press release, Biognosys, DEC 2, 2019, View Source [SID1234551826]). This partnership represents the next step in enriching IndivuType multi-omics cancer database with proteome-level data from thousands of samples using Biognosys’ cutting-edge proteomics technology to enable novel discoveries in cancer biology.

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The promise of precision oncology demands the development of patient-specific molecular and phenotypic cancer signatures, and research has shown that evaluating genomic data alone has its limitations. IndivuType is the result of more than fifteen years’ experience in collecting and curating high-quality cancer biospecimens through partnerships with leading healthcare institutions around the world. Only high-quality samples can produce reliable data enabling novel discoveries in cancer biology. IndivuType cancer database provides rich and deep information through analyzing multiple omics layers, including genomics, transcriptomics, proteomics, phosphoproteomics and immunophenotyping in combination with complete clinical and outcome data thus making it a powerful and unique resource for the cancer community worldwide.

Robust and reliable proteomics and phosphoproteomics analysis is greatly dependent on sample quality and processing techniques. The IndivuType ecosystem begins with stringent SOP-driven sample collection procedures across Indivumed’s global clinical network combined with thorough validation of clinical information and data integrity. These high-quality samples are analyzed with Biognosys’ innovative and robust solutions for highly multiplexed protein quantification, which will add a critical component to augment IndivuType multi-omics database.

Biognosys, a Swiss proteomics company, develops next-generation mass spectrometry-based proteomics technologies (HRM) that achieve unprecedented sensitivity and depth with high reproducibility from low microgram amounts of protein. The HRM technology enables profiling of protein expression and phosphorylation in large sample cohorts. Thousands of proteins can be quantified simultaneously in a single measurement. Since next-generation proteomics is a label-free method, it is applicable in all species across a wide range of sample types including tissue samples and body fluids for biomarker discovery and mechanism of action studies.

"We are very excited with this partnership", said Dr. Hartmut Juhl, Indivumed CEO and founder. "proteomics and phosphoproteomics play a crucial role in understanding cancer biology and adding Biognosys’ technology to the IndivuType multi-omics profile will enable relevant discoveries in our collaborations with pharma and biotech."

"The IndivuType project is at the forefront of multi-omics cancer profiling", says Dr. Oliver Rinner, CEO and founder of Biognosys. "Indivumed’s focus on sample quality and scale is unique in the field. Proteomics has long been known as a relatively low sample throughput technology. With the development of the parallel acquisition based next-generation technology, proteomics has become both, more sensitive and higher throughput. This has been the basis for our partnership. We are convinced that large scale proteomics and phosphoproteomics data from well-characterized sample cohorts will add a highly relevant new dimension to quantitative biology, and specifically to cancer biology."

On December 2, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that the Company now will present at the Piper Jaffray Annual Healthcare Conference on Wednesday, Dec. 4, 2019 at 12:30 p.m. Eastern (Press release, Mallinckrodt, DEC 2, 2019, View Source [SID1234551842]).

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Mark Trudeau, President and Chief Executive Officer, and Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

On December 2, 2019 ASLAN Pharmaceuticals (Nasdaq: ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported that it has commenced an underwritten public offering of its American Depositary Shares ("ADSs") representing ordinary shares (Press release, ASLAN Pharmaceuticals, DEC 2, 2019, View Source [SID1234551958]). In addition, ASLAN expects to grant the underwriter an option, exercisable at any time through and until one day before the potential closing date of this offering, to purchase up to an additional 15% of the ADSs being offered on the same terms and conditions. All ADSs to be sold in the offering will be offered by ASLAN. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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ASLAN intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund the clinical development of ASLAN004 and ASLAN003 and for general corporate purposes.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The securities described above are being offered by ASLAN pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by ASLAN with the Securities and Exchange Commission (the "SEC") and that was declared effective on November 8, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus and other documents we have filed with the SEC for more complete information about us and this offering. An electronic copy of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

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

On December 2, 2019 iCo Therapeutics ("iCo" or the "Company") (TSX-V: ICO) (OTCQB: ICOTF), reported financial results for the Quarter ended September 30, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS") (Press release, iCo Therapeutics, DEC 2, 2019, View Source [SID1234552430]).

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Stated Andrew Rae, President and CEO of iCo Therapeutics Inc., "Several important milestones have been achieved in recent weeks with ethics approval to enter our second oral Amphotericin B ("Oral Amp B") clinical study in Australia and the conclusion of court proceedings in the US and Israel, resulting in approval of Alexion’s asset purchase agreement related to iCo-008, an anti-eotaxin-1 antibody. Moving forward we currently expect the conclusion of the next Oral Amp B clinical study in Q1 2020, immediately followed by a 90-patient Phase 2 study in Q2 2020, comparing Oral Amp B to fluconazole in vulvovaginal candidiasis ("VVC")."

Q3 2019 Financial and Operational Highlights

On August 16, 2019, the Company closed a non-brokered private placement financing issuing 41,200,000 units at $0.05 per unit for aggregate gross proceeds of $2,060,000.
The Company completed its revised ethics submission for a multi-dose, escalation clinical study with its Oral Amp B formulation in healthy volunteers and received ethics approval on November 8, 2019. Screening recently commenced and first patient dosing is expected in December 2019.
On October 21, 2019, the US Court approved a sales order which assigned IMMUNE’s rights and obligations under the IMMUNE License Agreement to Alexion Pharmaceuticals Inc. This approval was followed by the Israeli courts approval of the US driven sales order. Alexion currently expects the sale to close in Q1 2020.

Financial results for Quarter ended September 30, 2019

We incurred a total comprehensive loss of $513,499 for the quarter ended September 30, 2019 compared to a total comprehensive loss of $418,516 for the quarter ended September 30, 2018, representing an increased loss of $94,983. The increase in the loss is primarily the result of higher general and administrative expenses and lower other income offset by lower research and development expenses recognized during 2019.

Research and development expenses were $84,253 for the quarter ended September 30, 2019 compared to $144,773 for the quarter ended September 30, 2018, representing a decrease of $60,520. The decrease related to lower contract research expenses related to the Oral Amp B Phase 1 clinical study. This study was completed in 2018.

With the initiation of the multi-dose, escalation clinical study in healthy volunteers, we expect research and development expenses to increase until the study is completed in Q1 2020. The net cost of this study is expected to be approximately $650,000 taking into consideration tax refunds from the Australian tax authorities related to this study. The Company believes it has sufficient funds to complete this study and initiate the companion 90 patient VVC study.

For the quarter ended September 30, 2019, general and administrative expenses were $440,257 compared to $309,137 for the quarter ended September 30, 2018, representing an increase of $131,120. The increase reflects increased professional fees and management consulting fees during the quarter due to the Company’s participation in the IMMUNE bankruptcy process.

Liquidity and Outstanding Share Capital

As at September 30, 2019, we had cash and cash equivalents of $1,560,866 compared to $10,140 as at December 31, 2018. As at November 29, 2019, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.