On March 15, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported financial results for fourth quarter and full year 2017 (Press release, Agenus, MAR 15, 2018, View Source [SID1234524804]).

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"Innovation and speed are key drivers of success in I-O. With our current capabilities and our extensive portfolio of novel I-O approaches, we have positioned Agenus to develop combination treatments for more patients and more cancers. Our ability to rapidly advance clinical trials with our CTLA-4 (AGEN1884) and Keytruda as well as trials using our own proprietary combinations with AGEN1884 and PD-1 (AGEN2034) could lead to our BLA filing as soon as the end of 2019. We recently produced commercial grade CTLA-4 to assure our commercial readiness," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This year, we will also file several INDs for our novel I-O antibodies including first/best-in-class bispecific tumor microenvironment conditioning agents."

Milestones Achieved:

Clinical Trials

o Launched phase 2 trial with the combination of AGEN1884 with Keytruda in patients with 1L NSCLC and over 50% PD-L1 expression

o Completed dose escalation trials for AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1)

o Launched a phase 2 trial with the combination of our proprietary CTLA-4 (AGEN1884) and PD-1 (AGEN2034), identified optimal dose, and expanded trial into relapsed/refractory cervical cancer

o Reported initial safety and immunogenicity of our neoantigen vaccine AutoSynVax; combination trials with our checkpoint antibodies are planned.

· Pipeline – first and/or best-in-class monospecific and bispecific antibodies

o Developed our novel next generation CTLA-4 – IND filing expected in 2018.

o Developed molecules and initiated IND preparations for our first/best in class bispecific antibodies designed to condition the tumor microenvironment through regulatory T cell depletion and other undisclosed mechanisms; IND filings expected in 2018

·Launched AgenTus Therapeutics, our cell therapy subsidiary

oAppointed Bruno Lucidi as CEO of AgenTus, advanced our pipeline including our proprietary allogeneic format and our proprietary phosphorylated targets.

·Completed non-dilutive financial transaction

oCompleted a $230 million non-dilutive royalty transaction with HealthCare Royalty Partners on sales of GlaxoSmithKline’s QS-21 containing vaccines and eliminated liabilities associated with Oberland notes. Net proceeds to Agenus from this transaction were approximately $28 million.

2018 MILESTONES

·Efficacy data for AGEN 1884 plus Keytruda in 1L NSCLC and planning for BLA filing

·Efficacy data from AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1) trials

·Formalize regulatory engagements for the above combos for BLA filing

·IND filing for next generation CTLA-4 and two undisclosed bispecific antibodies

·Start combination trial with our CTLA-4 and PD1 with AGEN neoantigen vaccine AutoSynVax

·Complete IND enabling studies for AgenTus Therapeutics lead adoptive cell therapy program

Update on GMP manufacturing

·Expanded and upgraded antibody manufacturing capabilities

·Produced GMP grade CTLA-4 and PD1 antibodies for our clinical trials and acquired commercial grade AGEN1884 (anti-CTLA-4) and expecting commercial grade AGEN2034 (anti-PD-1) by mid-year.

Fourth Quarter and Full Year 2017 Financial Results

Cash, and cash equivalents were $60.2 million at December 31, 2017. Subsequent to the end of the year, Agenus received net proceeds of approximately $28.1 million from our royalty bond restructuring.

For the fourth quarter, Agenus’ cash used in operating activities was approximately $25.8 million compared to approximately $26.2 million during the third quarter while our reported net loss for the quarter was $35.0 million or $0.35 per share, compared with a net loss for the fourth quarter of 2016 of $26.1 million, or $0.30 per share.

Cash used in operating activities for the year ended December 31, 2017 was $94.2 million compared to $80.0 million for the year ended 2016. The Company incurred a net loss of $120.7 million or $1.23 per share, for the year ended December 31, 2017 compared with a net loss of $127.0 million, or $1.46 per share, in the same period in 2016.

On March 15, 2018 –AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, surgery and oncology, reported that Michael C. Greiner, Executive Vice President and Chief Financial Officer, will present at the Needham 17th Annual Healthcare Conference at 4:00 p.m. ET on Tuesday, March 27, 2018 in New York, NY (Press release, , 15 15, 2018, View Source [SID1234524828]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

Novavax has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Novavax, 2018, MAR 14, 2018, View Source [SID1234524765]).

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On March 14, 2018 Mar. 14, 2018– ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that three posters highlighting the Company’s expertise in ADCs will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held from April 14-18, 2018 in Chicago (Press release, ImmunoGen, MAR 14, 2018, View Source [SID1234524769]).

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"ImmunoGen has in-depth expertise in all aspects of ADCs, which has resulted in the most comprehensive toolbox of ADC technologies in the industry," said Richard Gregory, Ph.D., ImmunoGen’s chief scientific officer. "The data to be presented at AACR (Free AACR Whitepaper) further build on our leadership position in the space and demonstrate continued innovation, including further advancements to payloads and targets for anti-tumor activity, as well as insights into factors that determine the clinical efficacy of ADCs."

Details of ImmunoGen’s poster presentations are as follows:

Title: "A new class of DNA alkylating indolino-benzodiazepine agents (BIAs) linked with a DNA binding moiety for use with antibody-drug conjugates (ADCs)" (abstract #747)
Date:April 15, 2018
Time: 1:00 – 5:00pm CT

A new class of DNA alkylating effector molecules for use in ADC development in which an IGN (indolino-benzodiazepine) monomer subunit is connected to a DNA binding moiety (e.g., Bi-Aryl, or Bis-Aryl) are termed BIAs. BIA ADCs displayed potent, antigen-specific in vitro activity across a panel of FRα-expressing cell lines. In vivo, these ADCs demonstrated potent efficacy in xenograft models at doses well below the maximum tolerated dose.
Title: "Development of an in vivo model system to assess the interplay between the various drivers of antibody drug conjugate (ADC) activity" (abstract #753)
Date:April 15, 2018
Time: 1:00 – 5:00pm CT

To better understand the variables that impact ADC pharmacokinetics, tolerability, bio-distribution, and efficacy, a novel, cross-reactive model system was created. An anti-murine folate receptor alpha (FRα) antibody was generated that binds to both mouse and human FRα. The model system allows experiments to be designed in a cross-reactive system to examine how modifications to the antibody, linker or cytotoxic payload impact safety, and efficacy.
Title: "Evaluation of endoglin/CD105 as a tumor vasculature target with antibody drug conjugates" (abstract #2900)
Date:April 16, 2018
Time: 1:00 – 5:00pm CT

Endoglin/CD105 is a well-acknowledged endothelial cell proliferation marker, which is strongly expressed in tumor-associated vasculature. It was evaluated as an oncology target using ADCs of an anti-CD105 antibody with potent anti-microtubule maytansinoids DM1 and DM4, and the highly potent IGN DNA-alkylating payload, DGN549. Endoglin targeted huRH105-DM and huRH105-DGN549 conjugates produced modest anti-tumor activity and therapeutic indices in rat models.
Additional information and full abstracts can be found at www.aacr.org.

Immune Design has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Immune Design, 2018, MAR 14, 2018, View Source [SID1234524786]).

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