Immutep Announces US$5.2 Million Financing Led by U.S. Specialist Healthcare Investor, Altium Capital

On December 19, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors to purchase 260,000,000 ordinary shares represented by 2,600,000 American Depositary Shares ("ADSs") at a purchase price per ADS of US$2.00 in a registered direct offering, for total gross proceeds of approximately US$5.2 million (equivalent to A$7.2 million) (Press release, Immutep, DEC 19, 2018, View Source [SID1234532165]). In a concurrent private placement, the Company has agreed to issue warrants to purchase up to 208,000,000 ordinary shares represented by 2,080,000 ADSs. The warrants will have an exercise price of US$2.50 per ADS and will be exercisable immediately following the close of this private placement and will expire three years from the date of effectiveness of the registration statement registering for resale the ordinary shares underlying the warrants. The registered direct offering is being led by Altium Capital, a U.S.-based healthcare investment fund founded by CEO, Jacob Gottlieb, with participation from another investor.

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The proceeds from the financing are expected to extend Immutep’s cash runway into mid-2020. Immutep intends to use the net proceeds from this offering to continue its LAG-3 related programs, especially the ongoing clinical development of eftilagimod alpha ("efti" or "IMP321"), including the AIPAC, TACTI-mel, TACTI-002, and INSIGHT clinical studies, as well as the preclinical development of IMP761, and general corporate purposes.

Immutep’s CEO, Marc Voigt, commented, "We are pleased to have Altium Capital lead this financing. Altium joins a growing number of specialist healthcare funds we have welcomed as investors in Immutep over the past year, as they recognize Immutep is leading the excitement around LAG-3. This financing, raised in a difficult market environment, has extended Immutep’s cash runway beyond the estimated AIPAC data readout in H2 2019, as well as potential meaningful data points from our ongoing and planned TACTI clinical studies."

Jacob Gottlieb, Altium Capital’s CEO, commented, "The potential therapeutic relevance of LAG-3 is becoming increasing appreciated within both the biopharma industry and the investment community. Immutep has already established itself as a clear leader in the understanding of the LAG-3 immune control mechanism, having built partnerships with five of the world’s largest pharmaceutical companies and operating under the research direction of Dr. Frederic Triebel."

"We are pleased to have the opportunity to support Immutep’s innovative clinical and preclinical product candidates. We have a particular interest in the potential of IMP761, its preclinical agonist antibody for autoimmune diseases. This investment is consistent with our fundamental long-term investment strategy," Gottlieb concluded.

The registered direct offering is expected to close on or about December 20, 2018 New York time, subject to the satisfaction of customary closing conditions. Pursuant to a registration rights agreement, we have agreed to file a registration statement for the ordinary shares underlying the warrants within 30 days.

The sale of ordinary shares represented by ADSs described above (but not the warrants or the ordinary shares underlying the warrants) is being made in the United States pursuant to a shelf registration statement on form F-3 (File No. 333-211702), as amended and previously filed with the Securities and Exchange Commission (the "SEC") on May 27, 2016 and declared effective on June 17, 2016. Such ordinary shares represented by ADSs are being offered only in the United States by the means of a prospectus. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the registered direct offering will be filed with the SEC. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the registered direct offering may be obtained at the SEC’s website at www.sec.gov.

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 other jurisdiction in which such offer, solicitation or sale would be unlawful.

Varian to Present at the J.P. Morgan Healthcare Conference

On December 19, 2018 Varian (NYSE: VAR) reported that Dow Wilson, chief executive officer, and Chris Toth, president of Oncology Systems, will present at the J.P. Morgan Healthcare Conference in San Francisco, scheduled for 9:30 a.m. Pacific Time on January 7, 2019 (Press release, Varian Medical Systems, DEC 19, 2018, View Source [SID1234532163]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/inv­estors.

Jazz Pharmaceuticals to Present at the J.P. Morgan Healthcare Conference on January 7

On December 19, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Jazz Pharmaceuticals, DEC 19, 2018, View Source [SID1234532162]).

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Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update at the conference on Monday, January 7, 2019 at 10:30 a.m. PST / 6:30 p.m. GMT.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at View Source Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at View Source

Auron and Elucidata Announce Scientific Collaboration to Identify and Validate Targets for Differentiation-Based Therapies in Oncology

On December 19, 2018 Auron Therapeutics and Elucidata Corporation reported a scientific collaboration using Elucidata’s AI-based target discovery platform to identify and validate targets for differentiation9-based therapy for Acute Myeloid Leukemia (AML) and eight other oncology indications (Press release, Auron Healthcare, DEC 19, 2018, View Source [SID1234532161]). As part of this collaboration, Elucidata will use its data analytics platform PollyTM, to analyze transcriptomic, metabolomic and epigenetic data from biological samples, as well as disease and treatment response data from patients. This four-year collaboration is among the broadest efforts to date to apply the differentiation-based approach for oncology therapies and has the potential to improve outcomes for patients living with these diseases.

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Elucidata’s AI-based platform combines different forms of omics data using advanced computational analysis techniques to characterize healthy and diseased states at the molecular level. Auron will provide phenotypic data along with transcriptomic, metabolomic and epigenetic data from hundreds of patient samples which will be analyzed on PollyTM to identify and validate targets to develop new therapies with improved treatment efficacy and minimal side effects for a subgroup of patients. The insights generated from this collaboration will further enable stratification of subtypes of different cancers.

"I am extremely impressed by the PollyTM platform that Elucidata has built and the power it has to digest, integrate and analyze large data sets," said Kate Yen, Ph.D., Founder and CEO of Auron Therapeutics. "The unique partnership that we have allows us to work hand-in-hand with the software engineers, scientists, and program managers to rapidly develop novel hypotheses which we can test in the lab. In just a short period of time, we have made significant progress that has had a substantial impact on Auron’s growth."

"With our platform, we are seeking to develop an atlas of differentiation paths of healthy and diseased cells that will help us identify and characterize disease mechanisms," said Abhishek Jha, Co-founder and CEO of Elucidata. "This collaboration with Auron is an incredible opportunity to realize the promise of big data analytics to discover new targets that will deliver more precise medicine to patients."

Celgene Corporation and Acceleron Pharma are presenting results from the Phase III MEDALIST trial to evaluate luspatercept in patients with myelodysplastic syndromes at the ASH 2018 Congress

On December 19, 2018 Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) reported its results from the pivotal Phase III trial MEDALIST in early December 2018 (Press release, Celgene, DEC 19, 2018, View Source [SID1234532160]). The study evaluated the efficacy and safety of the investigational product luspatercept for the treatment of patients suffering from anemia due to ring dermoblast-positive (RS +) myelodysplastic syndrome (MDS), transfusions with packed red blood cells (EC), and where erythropoietin therapy was unsuccessful , there was an intolerance to it or such therapy was out of the question. The results were Alan F. List during the scientific plenary session on the 60th

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"Severe anemia leading to red blood cell transfusion dependence is a significant burden for patients at low risk MDS. For patients who become resistant or refractory to currently available therapies, there are only limited alternatives, "said Drs. List, President and CEO of the Moffitt Cancer Center. "The results from the MEDALIST study are very promising. They support the hypothesis that luspatercept promotes the maturation of erythroid progenitor cells, allowing patients to become transfusion-independent. Luspatercept could thus improve the treatment of anemia in RS + MDS patients. "

The MEDALIST trial reached its primary endpoint: A statistically significantly greater proportion of patients achieved RBC-TI independence of ≥ 8 weeks in the first 24 weeks of treatment with luspatercept compared to placebo. In addition, all important secondary endpoints of the study were achieved. Compared to placebo, a significantly greater proportion of patients in the luspatercept arm achieved RBC-TI ≥ 12 weeks in the first 24 and 48 weeks of study, respectively, and hematologic erythropoiesis (HI-E after IWG 2006) of 8 weeks or more.


endpoints Luspatercept placebo p-value
RBC-TI ≥ 8 weeks (Week 1-24) 37.9 % (58/153) 13.2 % (10/76) <0.0001
RBC-TI ≥ 12 weeks (Week 1-24) 28.1 % (43/153) 7.9 % (6/76) 0.0002
RBC-TI ≥ 12 weeks (Week 1-48) 33.3 % (51/153) 11.8 % (9/76) 0.0003
HI-E ≥ 8 weeks (IWG 2006, weeks 1-24) 52.9 % (81/153) 11.8 % (9/76) <0.0001

Summary of safety data from the MEDALIST study

Third or fourth degree treatment-associated adverse events (TEAEs) were observed in 42.5% (65/153) of patients receiving luspatercept and 44.7% (34/76) of patients receiving placebo. Disease progression to acute myelogenous leukemia (AML) occurred in a total of four patients: three patients (2.0%) treated with luspatercept and one patient (1.3%) receiving placebo. Five patients receiving luspatercept (3.3%) and four patients receiving a placebo (5.3%) experienced one or more TEAEs that were fatal.

The most common TEAEs of any grade in more than 10% of patients in either study arm


Luspatercept
n = 153

placebo
n = 76

fatigue 26.8 % 13.2 %
diarrhea 22.2 % 9.2 %
asthenia 20.3 % 11.8 %
nausea 20.3 % 7.9 %
dizziness 19.6 % 5.3 %
back pain 19.0 % 6.6 %

"The results of the MEDALIST study illustrate the potential clinical benefits of Luspatercept to make patients with RS + low-risk MDS less dependent on red blood cell transfusion. This is an area where new therapies are needed. " med. Alise Reicin, President of Global Clinical Development at Celgene. "These findings reinforce our belief that this first-in-class erythropoietic-based drug can help these patients address the underlying cause of their disease-related chronic anemia."

"It is a great honor to present the results of the MEDALIST study as the first presentation at the ASH (Free ASH Whitepaper) plenary session," said Habib Dable, President and Chief Executive Officer of Acceleron. "The results of the MEDALIST study give us confidence that luspatercept can provide a relevant treatment option for patients with low-risk RS + MDS anywhere in the world. We look forward to continuing our clinical development program for MDS, beta-thalassemia and myelofibrosis, while investigating other applications of luspatercept in a variety of anemia-related diseases. "

Luspatercept is not approved in any region and for no indication. Acceleron and Celgene are planning to submit regulatory filings for Luspatercept in the US and Europe in the first half of 2019.

About MEDALIST

MEDALIST is a randomized, double-blind, placebo-controlled, multicentre phase III trial to evaluate the safety and efficacy of luspatercept in patients with very low, low or medium risk RS + myelodysplastic syndromes (MDS). All patients were RBC transfusion-dependent and either refractory to previous therapy with erythropoiesis-stimulating agents (ESA), did not tolerate them or were ESA naive with endogenous serum erythropoietin ≥200 U / L and had no previous treatment with disease modifying agents receive. The median age of the study participants was 71 years in the luspatercept treatment group and 72 years in the placebo group. The mean transfusion load in both study arms was 5 RBC units / 8 weeks. A total of 229 patients were randomized to receive either luspatercept 1.0 mg / kg (153 patients) or placebo (76 patients) every 21 days as a subcutaneous injection. The study was conducted at 65 sites in 11 countries.

About Luspatercept

Luspatercept, the erythrocyte-ripening substance, is the first active ingredient in a new erythroid maturation agent (EMA). It promotes erythrocyte maturation in the late stages of erythropoiesis. Acceleron and Celgene are developing Luspatercept as part of a global collaboration. Phase III clinical trials are evaluating the safety and efficacy of luspatercept in patients with MDS (MEDALIST trial) and patients with beta thalassemia (BELIEVE trial). The COMMANDS phase III study in low-risk first-line MDS patients, the BEYOND non-transfusion-dependent beta-thalassemia phase II study and a phase II study in myelofibrosis are ongoing. For more information, seewww.clinicaltrials.gov .