Affimed has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, Annual, Affimed, 2016, MAR 30, 2017, View Source [SID1234518326]).

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On March 30, 2017 Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held Boston-based biopharmaceutical company developing novel therapeutics and diagnostics targeting the epichaperome reported the launch of an expanded development program for the Company’s lead anti-epichaperome candidates, including PU-H71 in various cancers and PU-AD in neurodegenerative diseases (Press release, Samus Therapeutics, MAR 30, 2017, View Source [SID1234519320]).

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Samus was established in concert with the Memorial Sloan Kettering Cancer Center (MSKCC) in 2011 by Larry Norton, MD, and Gabriela Chiosis, PhD, based on research from the Chiosis Laboratory at the Sloan Kettering Institute ("SKI"), together with collaborators at Rockefeller University and Weill Cornell Medicine. Jonathan Lewis, MD, PhD, was recruited to Samus in 2016 to serve as Executive Chairman and Chief Executive Officer to lead and accelerate the development of the Company’s epichaperome platform.

Epichaperomes are foundational protein complexes that emerge from multiple diseases, including cancer and neurological disorders, the Company’s initial areas of focus. Following various forms of cellular stress, chaperome units are rewired into the epichaperome network. Targeting the epichaperome in cancer results in cell death, and, in neurodegenerative diseases, neuronal survival, with no effect in normal cells. Recent, seminal research on the molecular characteristics and composition of the epichaperome and PU-H71 in cancer were published by the Chiosis lab in the journal Nature (Rodina, A. et al., 538, 397–401, 20 October 2016). This research revealed a direct correlation between the abundance of epichaperomes in cancer cells, and their responsiveness to the cell killing effects of PU-H71, in a manner that is independent of the mutational diversity of the tumor cells, suggesting that PU-H71 may have activity in a wide range of human tumors.

"Samus Therapeutics was founded on novel insights into the structure and function of the epichaperome complex, the modulation of which has been shown to have profound and highly specific effects in preclinical models of cancer, neurodegenerative and other diseases," said Dr. Lewis. "These insights have translated into meaningful and durable results in early clinical Page 2 of 4 study, including responses lasting greater than 24 months in patients with myelofibrosis who stopped responding to ruxolitinib.

" Dr. Lewis added: "We are extremely excited to further elucidate these seminal insights and early results in studies conducted under the support and leadership of Drs. Larry Norton, James Armitage, and Daniel Von Hoff, who will focus on breast, hematologic, and pancreatic cancers, respectively. We also look forward to leveraging the deep experience and expertise of Dr. Geoffrey Ling in neurological disease by exploring the tremendous potential of antiepichaperome small molecules in this challenging and vastly underserved area of medical need."

The Company’s advisors are each a preeminent thought leader in their area of study,
• Larry Norton, MD, is Deputy Physician-in-Chief for Breast Cancer Programs, Medical Director of the Evelyn H. Lauder Breast Center and Norma S. Sarofim Chair in Clinical Oncology.
• Gabriela Chiosis, PhD, is a Member in the Chemical Biology Program of SKI and a TriInstitutional Professor at Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine and Rockefeller University.
• James Armitage, MD, is the Joe Shapiro Professor of Medicine, Division of Oncology & Hematology, at the University of Nebraska Medical Center; and former Dean, University of Nebraska Medical School.
• Daniel D. Von Hoff, MD, is the Physician in Chief, Distinguished Professor, Translational Research at the Translational Genomics Research Institute ("TGen") Senior Consultant, Clinical Investigations for the City of Hope, and Professor of Medicine at the Mayo Clinic.
• Geoffrey Ling, MD, PhD, is Professor of Neurology at the Johns Hopkins School of Medicine, and the former Director of the DARPA Biological Technologies Office, and professor and Acting Chair of the Department of Neurology at the Uniformed Services University of the Health Sciences.

Clinical Development Programs in Cancer and Neurodegenerative Disease

PU-H71, the Company’s lead program targeting the epichaperome network, has demonstrated potent anticancer activity in preclinical in vitro and in vivo studies, including both therapeutic synergy, and reversal of resistance, in combination with multiple standard of care therapies. A Phase 1 study, conducted under an MSKCC-initiated investigational new drug application (IND), has been completed, identifying a maximum tolerated dose, establishing a well-tolerated toxicity profile, and demonstrating activity supporting further combination clinical study.
The Company announces today the launch of several studies in cancer including:
• A Phase 1b/2 combination study in myelofibrosis under a second Company IND, expected to be filed in early Q2. In Phase 1, treatment with PU-H71 demonstrated durable results (>24 months) in this indication in patients who had previously failed ruxolitinib;
• A Phase 1b combination study in advanced breast cancer at MSKCC, with the first patient expected to be treated in early Q2; •
A Phase 1b combination study in chemo-naïve front-line metastatic pancreatic cancer under the Company’s first IND, recently accepted by the U.S. Food and Drug Administration (FDA), with the first patient expected to be treated early Q2.

A companion diagnostic for determining patient selection, response to treatment and dose and schedule, PU-H71-PET, is also being explored in an ongoing Phase 1 study, and the Company Page 3 of 4 is developing a companion diagnostic for in vitro measurement of circulating epichaperome positive cells in blood by flow cytometry ("PU-CYT"). Further, the Company is evaluating trials in other hematologic cancers, and the Chiosis lab was recently awarded a SKI "Big Bet" grant for the study of epichaperome inhibitors in combination with immunotherapy in oncology.

Samus’ second anti-epichaperome small molecule, PU-AD, along with the diagnostic PU-ADPET, are expected to move into neurodegenerative disease-directed clinical studies, including Alzheimer’s disease and chronic traumatic encephalopathy ("CTE"). A Phase 1 positron emission tomography ("PET") diagnostic study is currently active and recruiting Alzheimer’s patients at MSKCC, which the Company expects to expand to include patients with CTE. The Company expects to file an IND for the PU-AD therapeutic and diagnostic in neurodegenerative disease, and an exploratory Phase 1 clinical study for CTE with outside collaborators is currently in the planning stage.

The development of Samus’ candidates will be led by a deeply experienced management and advisory team, including Dr. Lewis, who brings more than 20 years of experience in leadership roles in biotechnology and medicine, Dick Bagley, President and Chief Financial Officer, who has over 40 years of senior leadership in both pharma and biotechnology, and senior level professionals with experience in translational research, clinical trial design and execution, manufacturing, quality control, intellectual property, and global regulatory approvals.

On March 30, 2017 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, reported its financial results for the fourth quarter and year ended December 31, 2016, and provided a business update (Filing, Q4/Annual, RXi Pharmaceuticals, 2016, MAR 30, 2017, View Source [SID1234518411]).

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"We believe RXi is well positioned for a strong business and development performance in 2017 due to the acquisition of MirImmune Inc. and the strengthening of our balance sheet through a financing at the end of 2016. As a result, the Company has already initiated programs in the immuno-oncology and cell therapy space, an exciting therapeutic area in health care today," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added that, "The capital that we received from our shareholders allows us to put a strong focus on these immuno-oncology programs while completing and reporting our ongoing clinical trials in dermatology and ophthalmology in the second half of 2017."

The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 888-669-0684. International participants may access the event by dialing: +1 862-225-5361. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Fourth Quarter and Fiscal 2016 Financial Highlights
Cash Position
On December 21, 2016, the Company closed an underwritten public offering of (i) 2,131,111 Class A Units, at a public offering price of $0.90 per unit, consisting of one share of the Company’s common stock, and a five-year warrant to purchase one share of common stock at an exercise price of $0.90 per share and (ii) 8,082 Class B Units, at a public offering price of $1,000 per unit, consisting of one share of Series B convertible preferred stock, which is
convertible into 1,111.11 shares of common stock, and 1,111.11 warrants. The offering included an over-allotment option for the underwriters to purchase an additional 1,666,666 Class A Units, which the underwriters fully exercised. The total net proceeds of the offering, including the exercise of the over-allotment option, was $10.1 million after deducting underwriting discounts and commissions and offering expenses paid by the Company.
At December 31, 2016, the Company had cash of $12.9 million, compared with cash, cash equivalents and short-term investments of $10.6 million at December 31, 2015. The Company believes that its existing cash should be sufficient to fund operations for at least the next twelve months.
Research and Development Expenses
Research and development expense for the quarter ended December 31, 2016 was $1.3 million, which included less than $0.1 million of non-cash stock-based compensation expense, as compared with $1.7 million for the quarter ended December 31, 2015, which included $0.1 million of non-cash stock-based compensation expense.
Research and development expense for the year ended December 31, 2016 was $5.4 million, which included $0.2 million of non-cash stock-based compensation expense, as compared with $6.9 million for the year ended December 31, 2015, which included $0.6 million of non-cash stock-based compensation expense.
The decrease in research and development expense quarter over quarter and year over year was primarily due to cash and equity fees payable to Hapten Pharmaceuticals, LLC upon the close of the Samcyprone licensing agreement and manufacturing expenses for the RXI-109 drug product, both of which occurred in 2015. Additionally, the Company saw a decrease in stock-based compensation expense due to the full vesting of stock options in 2016 from stock options that had been granted in 2012.
General and Administrative Expenses
General and administrative expense for the quarter ended December 31, 2016 was $1.0 million, which included $0.1 million of non-cash stock-based compensation expense, as compared with $0.9 million for the quarter ended December 31, 2015, which included $0.2 million of non-cash stock-based compensation expense.
General and administrative expense for the year ended December 31, 2016 was $3.6 million, which included $0.5 million of non-cash stock-based compensation expense, as compared with $3.3 million for the year ended December 31, 2015, which included $0.9 million of non-cash stock-based compensation expense.
The increase in general and administrative expense quarter over quarter and year over year was primarily due to the Company’s focus on business development activities and an increase in legal expenses due to the Company’s acquisition of MirImmune Inc. These increases in general and administrative expense were offset by a decrease in stock-based compensation expense due to the full vesting of stock options in 2016 from stock options that had been granted in 2012.
Convertible Preferred Stock
Accretion of convertible preferred stock and dividends were $2.1 million for the quarter ended December 31, 2016. There was no such expense for the quarter ended December 31, 2015.
Accretion of convertible preferred stock and dividends were $2.1 million for the year ended December 31, 2016, compared with $0.2 million for the year ended December 31, 2015.
The increase quarter over quarter and year over year was due to the one-time charge related to the beneficial conversion feature of the Series B convertible preferred stock issued in connection with the completion of the Company’s December 2016 underwritten public offering offset by a decrease related to the fair value of dividends on the Company’s Series A and Series A-1 convertible preferred stock. The Company no longer had any Series A or Series A-1 convertible preferred stock authorized, issued or outstanding as of December 31, 2016 and 2015.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the quarter ended December 31, 2016 was $4.4 million, compared with $2.6 million for the quarter ended December 31, 2015.
Net loss applicable to common stockholders for the year ended December 31, 2016 was $11.1 million, compared with $10.4 million for the year ended December 31, 2015.
The increase in net loss applicable to common stockholders for the quarter and year ended December 31, 2016 as compared to the same prior year periods was due to the one-time charge related to the beneficial conversion feature of the Company’s Series B convertible preferred stock offset by a decrease in operating expenses, as described above.
Select Fourth Quarter 2016 and Recent Corporate Highlights
Select Business and Corporate Highlights
Building on the pioneering discovery of RNAi by RXi founder and Nobel Laureate, Dr. Craig Mello, scientists at RXi have harnessed the naturally occurring RNAi process which has the ability to "silence" or down-regulate the expression of a specific gene that may be overexpressed in a disease condition. RXi developed a robust RNAi therapeutic platform, including self-delivering RNA (sd-rxRNA) compounds, that have the ability to highly selectively block the expression of any target in the genome, thus providing applicability to many therapeutic areas.
Immuno-Oncology
In March 2015, MirImmune Inc., a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, entered into an exclusive license agreement for use of RXi’s sd-rxRNA technology in developing innovative cell-based cancer immunotherapies. MirImmune’s progress in cell therapy using RXi’s technology formed a strong foundation for therapeutic development in the immuno-oncology space. As a result, RXi entered into an agreement to acquire MirImmune which was completed earlier this year. The Company’s goal, through internal research and external partnerships, is to develop more effective treatments resulting in better quality of life and extended survival for patients.
The Company has initiated a program developing cell-based immunotherapies to treat cancer based on its proprietary sd-rxRNA therapeutic compounds. To date, the unique applicability of sd-rxRNA for immune checkpoint modulation in cellular immuno-oncology therapies has been demonstrated, including:

• Selection of lead sd-rxRNA compounds against six different extracellular and intracellular immune check points

• Demonstrated silencing of all tested checkpoint targets in vitro, singly and in combinations

• Efficient and long-lasting silencing of immune checkpoints in vivo

• Applicability of sd-rxRNA transfection in cell therapy to solid tumors

• Filing of intellectual property that covers the use of RNAi compounds for use in cell therapy
To support this ongoing initiative, Alexey Eliseev, PhD has been appointed as RXi’s Chief Business Officer. Dr. Eliseev is a highly accomplished leader with over 20 years of experience in academia, biotechnology industry and venture capital and most recently was the founder and CEO of MirImmune Inc. In addition, RXi has appointed two leading oncology experts to its Scientific Advisory Board. RXi’s new SAB members are Dr. Rolf Kiessling, Professor in Experimental Oncology at Karolinska Institutet and Senior Chief Physician of Radiumhemmet at Karolinska Hospital as well as medical oncology expert Dr. James D. Griffin, Chairman, Department of Medical Oncology, Dana-Farber Cancer Institute. Dr. Griffin also serves as Professor, Medicine, Harvard Medical School and Director, Medical Oncology, Brigham and Women’s Hospital.
Dermatology
The Company’s ongoing Phase 2 clinical trial, RXI-109-1402, is being conducted to evaluate its first clinical candidate RXI-109, an sd-rxRNA compound targeting connective tissue growth factor (CTGF) to reduce scar formation in the skin following scar revision surgery. This study is now fully enrolled and the Company will provide full read-out, for Cohorts 3 and 4, H2-2017.
Samcyprone, the Company’s second clinical candidate, is a topical immunotherapy currently being evaluated in a Phase 2a clinical trial. RXI-SCP-1502 is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart. The Company expects to share early read-outs H2 2017.
Consumer Health Program
RXi’s consumer health compound RXI-231 targets tyrosinase, a key player in the production of melanin. A formulation has been developed at RXi that allows delivery of the compound into the epidermis. We are in the process of finalizing the first two protocols for testing in volunteers. To support these initial studies, RXI-231 was manufactured and is being formulated for topical use.
Ophthalmology
As in dermal scarring, CTGF is known to play a role in retinal scarring. Reduction of CTGF in the eye by RXI-109 treatment may reduce the formation of retinal fibrosis that often accompanies late stage AMD and contributes to permanent vision loss. Enrollment in the first two cohorts in the Company’s Phase 1/2 trial, RXI-109-1501, is complete. RXI-109 has been well-tolerated in the eye to date; enrollment into the third cohort at the next higher dose level is ongoing.

On March 31 2017 Johnson & Johnson (NYSE: JNJ) reported that its Swiss subsidiary, Janssen Holding GmbH ("Janssen"), published the provisional notice of the interim result of its all-cash public tender offer in Switzerland to acquire all publicly held shares of Actelion Ltd (("Actelion") SIX:ATLN) for $280 per share, payable in U.S. dollars, per the offer prospectus of February 16, 2017 (Press release, Actelion, MAR 30, 2017, View Source [SID1234518407]).

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At the expiration of the main offer period on March 30, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST, a total of 78,629,955 Actelion shares were tendered, corresponding to 73.25% of the 107,339,642 Actelion shares covered by the tender offer. Including the Actelion shares tendered, Janssen and Actelion, a person acting in concert with Janssen, held as of the end of the main offer period 83,195,346 Actelion shares, corresponding to 77.20% of the voting rights and the share capital of Actelion.

Subject to the satisfaction of certain conditions, Janssen has declared the tender offer successful. The additional acceptance period of ten trading days (at the SIX Swiss Exchange) for the subsequent acceptance of the tender offer will commence on April 6, 2017 and expire on April 21, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST.

Johnson & Johnson also announced that the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Janssen’s proposed acquisition of Actelion have either expired or been terminated early. The Japan Fair Trade Commission and the Israeli Antitrust Authority have cleared the proposed acquisition of Actelion.

Based on the current understanding of the regulatory approval proceedings in different jurisdictions, the settlement of the tender offer is expected to occur, subject to the satisfaction of all relevant conditions to the tender offer, including regulatory approvals, in the second quarter of 2017.

As previously announced, as part of the transaction, Actelion will spin out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company ("Idorsia Ltd"). The shares of Idorsia Ltd are expected to be distributed to Actelion’s shareholders as a dividend in kind and listed on the SIX Swiss Exchange on the day of the settlement of the tender offer. Johnson & Johnson will initially hold 16 percent of the shares of Idorsia Ltd and have rights to potentially increase to 32 percent through a convertible note.

On March 30, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, reported its broad presence at the upcoming 108th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held April 1 to 5, 2017, in Washington, D.C., including 14 presentations on antibody-drug conjugate (ADC) and immuno-oncology technology advances and development programs (Press release, Seattle Genetics, MAR 30, 2017, View Source;p=RssLanding&cat=news&id=2257546 [SID1234518388]). Data in multiple presentations demonstrate potential improvements in linker technologies for multiple payloads which may enable development of novel ADCs, including the planned clinical program SGN-CD48A for multiple myeloma. The company’s SGN-2FF program was selected for an oral presentation in the New Drugs on the Horizon symposium focusing on the preclinical rationale and phase 1 trial design for this small molecule immuno-oncology agent. Seattle Genetics’ scientific leadership will also be featured in an Educational Session and a Forum focused on advances in ADC research and the value of ADCs over other drug conjugate therapeutics in the cancer treatment landscape.

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"Over nearly 20 years, Seattle Genetics has continued its tradition of innovation to produce industry-leading ADC and empowered-antibody technologies designed to improve outcomes for patients with cancer," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. "In 14 presentations, including four orals, our new data at the AACR (Free AACR Whitepaper) Annual Meeting will highlight key improvements to linker technologies for cancer cell-killing payloads, including novel auristatins and tubulysins, preclinical combination regimens with checkpoint inhibitors, and progress with our immuno-oncology therapeutic candidates."

ADCs are targeted cancer treatments that harness the specificity of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS, Seattle Genetics’ first commercially available product, vadastuximab talirine, a phase 3 candidate in acute myeloid leukemia (AML), and enfortumab vedotin, an advancing clinical-stage bladder cancer candidate, are three of more than 20 ADCs in clinical development using the company’s proprietary technology.

Multiple oral and poster presentations are being featured at AACR (Free AACR Whitepaper) that highlight Seattle Genetics’ ADC and immuno-oncology advances. Abstracts can be found at www.aacr.org and include the following:

Saturday, April 1, 2017

Expanding the payload scope and drug load of ADCs through drug-linker design (Session #ED03, oral presentation at 2:00 p.m. ET)
Sunday, April 2, 2017

Antibody-drug conjugates containing glucuronide-tubulysin payloads display activity in MDR+ and heterogeneous tumor models (Abstract #56, poster presentation)
Reducing toxicity of antibody-drug conjugates through modulation of pharmacokinetics (Abstract #60, poster presentation)
Elucidating the roles of antibody pharmacokinetics and maleimide stability in the toxicology of antibody-drug conjugates (Abstract #70, poster presentation)
Development of homogeneous dual-drug ADCs: Application to the co-delivery of auristatin payloads with complementary antitumor activities (Abstract #982, oral presentation at 4:05 p.m. ET)
SGN-2FF: A Novel Small Molecule Inhibitor of Fucosylation with Preclinical Antitumor Activity through Multiple Immune Mechanisms (Abstract #DDT02-02, oral presentation at 3:24 p.m. ET)
Monday, April 3, 2017

Cysteine Mutant Location Affects Chemotype Lability in Site-Specific Antibody Drug Conjugates (Abstract #LB-066, poster presentation)
Targeted Delivery Using Antibody Drug Conjugates (Session #FO01, oral presentation at 5:00 p.m. ET)
Tuesday, April 4, 2017

Therapeutic activity of effector function-enhanced, non-fucosylated anti-CD40 antibodies in preclinical immune-competent rodent tumor models (Abstract #3647, poster presentation)
Superior T cell activity of a membrane-proximal binding antibody when targeting Glypican-3 with an Antibody-Coupled T cell Receptor (ACTR) armed T cell (Abstract #3762, poster presentation; collaboration with Unum Therapeutics)
Effect of PEG Chain length on Antibody-Drug Conjugate Tumor and Tissue Distribution in Tumor Bearing Xenograft Mice (Abstract #4075, poster presentation)
Efficient targeting of BCMA-positive multiple myeloma cells by Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells in combination with an anti-BCMA antibody (Abstract #4605, poster presentation; collaboration with Unum Therapeutics)
Assessment of Myeloblast CD33 Receptor Occupancy (RO) by Vadastuximab Talirine in Patients with Acute Myeloid Leukemia (AML) Receiving Monotherapy Treatment (Abstract #CT120, poster presentation)
Wednesday, April 5, 2015

Brentuximab vedotin-driven immunogenic cell death enhances antitumor immune responses, and is potentiated by PD1 inhibition in vivo (Abstract #5588, poster presentation)