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INSIGHT-004 CLINICAL TRIAL UPDATE

On December 19, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update on the INSIGHT-004 Phase I clinical trial to evaluate the combination of eftilagimod alpha ("efti" or "IMP321") with avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies (Press release, Immutep, DEC 19, 2019, View Source [SID1234552545]).

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Following full recruitment of the first cohort of 6 patients receiving avelumab (standard dose) and efti (6 mg), Immutep’s partner IKF has now commenced the recruitment of patients into the second cohort (standard dose avelumab, with 30 mg efti) which will involve also 6 participants.

No new safety signals or dose limiting toxicities have been reported from the first cohort of patients. The observed safety profile also aligns with the known safety profile of the monotherapies.

Participants enrolled in this trial are patients with late-stage cancer who have been heavily pre-treated for advanced, metastatic solid tumors. Typically, they have no other therapy options available. Out of 6 patients, 1 patient experienced a partial response according to RECIST 1.1.

More data from the study is expected to be reported in H1 CY2020.

Prof. Dr. Salah-Eddin Al-Batran, lead investigator of INSIGHT-004 commented: "We are really pleased that INSIGHT-004 recruitment is advancing and that we can start to enroll the second cohort of 6 patients. The treatment’s safety profile is consistent with previous trials of efti which is encouraging and it’s also good to see early activity signals with one patient reporting a partial response already."

INSIGHT-004 is the fourth arm of the INSIGHT trial which is being conducted by Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (IKF). It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc and is evaluating the safety, tolerability and recommended Phase II dose of Immutep’s lead immunotherapy product candidate efti when given in combination with avelumab in 12 patients with advanced solid malignancies.

Immutep Ltd, Level 12, 95 Pitt Street, Sydney NSW 2000

Phone: +61 2 8315 7003 Fax: +61 2 8569 1880

www.immutep.com ABN: 90 009 237 889

About INSIGHT-004

INSIGHT-004 is being conducted as an amendment to the ongoing INSIGHT Phase I clinical trial. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany ("IKF") is the sponsor of the clinical trial which is being conducted under the existing protocol of the ongoing INSIGHT clinical study. Prof. Dr. Salah-Eddin Al-Batran, the lead investigator of INSIGHT and member of Immutep’s clinical advisory board, is the lead investigator of INSIGHT-004.

For more information regarding INSIGHT-004 which forms part of the INSIGHT trial, visit clinicaltrials.gov (INSIGHT identifier NCT03252938). INSIGHT-004 refers to the fourth arm of the INSIGHT trial where IMP321 is given in combination with avelumab.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia,

Immutep Ltd, Level 12, 95 Pitt Street, Sydney NSW 2000

Phone: +61 2 8315 7003 Fax: +61 2 8569 1880

www.immutep.com ABN: 90 009 237 889

dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients include hyponatremia, lymphopenia, GGT increased, blood triglyceride increased and lipase increased, and grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

Abeona Therapeutics Announces Public Offering of Common Stock and Pre-Funded Warrants

On December 19, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that it intends to offer and sell shares of its common stock, and pre-funded warrants in lieu of common stock, in an underwritten public offering pursuant to an existing shelf registration statement (Press release, Abeona Therapeutics, DEC 19, 2019, View Source [SID1234552544]). All of the securities in the offering are to be sold by Abeona. 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.

An existing holder of the Company’s common stock, Great Point Partners ("GPP"), has indicated its intention to purchase up to $33 million in the offering, including pre-funded warrants in lieu of common stock, subject to allocation by the underwriter and market and other conditions, including the ability to nominate two directors, including a new Executive Chairman, to Abeona’s Board of Directors. GPP has indicated that it expects such director nominees would be industry professionals not affiliated with such holder. As a result, Steven H. Rouhandeh would step down as Executive Chairman and would retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne would exit the Board. These changes would be effective upon the Board’s qualification and election of GPP’s nominees.

Jefferies LLC is acting as sole book-running manager and underwriter for the offering. Abeona intends to grant the underwriter a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the securities sold in the offering, on the same terms and conditions.

Abeona intends to use the net proceeds of the offering to fund continued clinical development of pipeline products, as well as for working capital and corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224867) that was filed with the Securities and Exchange Commission (the "SEC") on May 11, 2018 and amended on June 1, 2018, and that was declared effective by the SEC on June 7, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus that form a part of the registration statement has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, via telephone at (877) 821-7388, or email at: [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security 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.

Rafael Holdings Launches Cancer Drug Development Initiative

On December 19, 2019 Rafael Holdings, Inc., (NYSE: RFL),reported that it has launched an initiative to identify and develop or in-license promising pre-clinical compounds targeting the unique cellular metabolism of cancers with high levels of unmet needs (Press release, Rafael Holdings, DEC 19, 2019, View Source [SID1234552542]).

The Rafael Holdings’ initiative is named the Barer Institute for Dr. Sol J. Barer, Chairman of the Board of Teva Pharmaceuticals, Chairman of Centrexion Therapeutics, Lead Director of Contrafect Corp, Chairman of Neximmune, and Board member of 3DBioteherapeutics and Aevi Genomic Therapeutics, Founding Chair of the Hackensack Meridian Center for Discovery and Innovation and advisor to the Israel Biotech Fund. Dr. Barer is a co-founder of Celgene Corporation and served as Celgene’s Executive Chairman, President, CEO, and COO. Previously, he was the founder of the biotechnology group at Celanese Corporation, which was subsequently spun off as Celgene.

In addition to a distinguished Board of Directors and management, the Barer Institute has assembled a renowned scientific leadership team including:

Chief Scientific Advisor: Chi Van Dang, M.D., Ph.D., Scientific Director of the Ludwig Institute for Cancer Research, Professor of the Molecular & Cellular Oncogenesis Program at Wistar, and Editor-in Chief of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s flagship journal, Cancer Research.

Board of Directors and Scientific Advisory Board Member: Richard Axel, M.D., recipient of the 2004 Nobel Prize in Physiology or Medicine, Howard Hughes Medical Institute (HHMI) professor, and professor of biochemistry and molecular biophysics, neuroscience, and pathology at Columbia University College of Physicians and Surgeons.

Scientific Advisory Board Member: Josh Rabinowitz, M.D., Ph.D.: Professor of Chemistry at the Lewis-Sigler Institute for Integrative Genomics at Princeton University and leader in 1-carbon metabolism research.

Scientific Advisory Board Member: Joseph M. Salvino, Ph.D.: Medicinal chemist and Professor at the Molecular & Cellular Oncogenesis Program at the Wistar Institute and Scientific Director of the Wistar’s Molecular Screening & Protein Expression Facility. The Salvino Laboratory at Wistar focuses on early drug discovery and small molecule tool compounds for in vivo target validation.

Dr. Dang said, "The Barer Institute, motivated by clinical responses of Rafael Pharma’s CPI-613 (devimistat), will drive pre-clinical development of new chemical modifiers of cancer immunometabolism. Our work to develop a new class of broadly applicable cancer therapies will be informed by our distinguished Scientific Advisory Board including Professors Richard Axel at Columbia, Josh Rabinowitz at Princeton and Joseph Salvino at the Wistar Institute."

Howard Jonas, Chairman and CEO of Rafael Holdings, will serve as Chairman of the Barer Institute.

The Barer Institute also will be led by its Director, Ari Landon, Ph.D., previously Director of Innovation at Rafael Holdings. Ari Landon earned his doctorate from the University of Maryland identifying translational strategies in lymphoma and was a post-doctoral fellow at the Yale School of Medicine developing methods to study mitochondria in lymphoma.

"We are excited to launch the Barer Institute," Dr. Landon said. "We have assembled top-flight scientific advisory and hands-on operational teams to develop novel strategies targeting cancer utilizing intellectual property developed internally or obtained through in-licensing agreements with academic institutions. Our streamlined and innovative approach enables scientists to focus entirely on collaborative development."

Nevro to Present at the 38th Annual J.P. Morgan Healthcare Conference

On December 19, 2019 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President, will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020, beginning at approximately 9:00 a.m. (Pacific Time) at the Westin St. Francis in San Francisco, CA (Press release, Nevro, DEC 19, 2019, View Source [SID1234552540]).

A live webcast of this event will be available on the Investors section of Nevro’s website at www.nevro.com. A webcast replay will be available approximately one hour after the live webcast ends and will be accessible for approximately 30 days.

Zimmer Biomet Holdings Announces Audio Webcast and Conference Call of Fourth Quarter 2019 Results

On December 19, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported its fourth quarter sales and earnings conference call will be broadcast over the Internet on Tuesday, February 4, 2020, at 8:30 a.m. Eastern Time (Press release, Zimmer Holdings, DEC 19, 2019, View Source [SID1234552539]). A news release detailing the quarterly results will be made available at 6:00 a.m. Eastern Time the morning of the conference call.

The live audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit https://investor.zimmerbiomet.com. A digital recording will be available after the completion of the conference call, from February 4, 2020 to March 4, 2020. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.