On April 5, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter financial results on Thursday, April 26, 2018 after the close of financial markets (Press release, Seattle Genetics, APR 5, 2018, View Source;p=RssLanding&cat=news&id=2341209 [SID1234525192]). Following the results announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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LIVE access on Thursday, April 26, 2018

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-263-0877 (domestic) or +1 646-828-8143 (international); conference ID 9171561
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 26, 2018 through 5:00 p.m. PT on Monday, April 30, 2018 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 9171561
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On April 5, 2018 FORMA Therapeutics reported that it has successfully completed a critical objective under its strategic collaboration agreement with Celgene Corporation, triggering an undisclosed payment from Celgene (Press release, Forma Therapeutics, APR 5, 2018, View Source [SID1234525190]). Previously, FORMA and Celgene entered into a collaboration in the promising area of protein homeostasis to discover, develop and commercialize innovative drug candidates. This collaboration enables Celgene to evaluate select therapeutic candidates and programs in protein homeostasis during preclinical development.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Jim Winkler, Ph.D., Vice President, Biology at FORMA Therapeutics said, "We are pleased with Celgene’s continued confidence in FORMA’s discovery research. This program represents a potential first-in-class therapeutic mechanism, by conferring both anti-tumor and immune-modulatory effects. We believe the field of protein homeostasis will deliver a promising pipeline of drugs, moving beyond cancer into immuno-oncology, inflammation and neurodegeneration."

About Protein Homeostasis

Protein homeostasis, which is important in oncology, neurodegenerative and other disorders, involves a tightly regulated network of pathways controlling the biogenesis, folding, transport and degradation of proteins. Exploring the maintenance and regulation of such competing, yet integrated, biological pathways using a chemical biology approach, should directly contribute to the understanding of diseases associated with excessive protein misfolding, aggregation and degradation

On April 5, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will present Phase 1 dose escalation data regarding the use of the Company’s pegzilarginase in patients with advanced solid tumors at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois on Sunday, April 15 (Press release, Aeglea BioTherapeutics, APR 5, 2018, View Source [SID1234525187]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Title: Phase I Dose Escalation Trial of Pegzilarginase in Patients with Advanced Solid Tumors

Session Title: Phase I Clinical Trials 1

Session Date and Time: Sunday, April 15, 1:00 p.m. to 5:00 p.m. CT

Session Location: McCormick Place South, Hall A, Poster Section 42

Poster Board Number: 23

Permanent Abstract Number: CT030

An electronic version of the presentation will be available for download from the Presentations & Events section of the Company’s investor relations website after the poster presentation.

About Pegzilarginase (AEB1102) in Cancer
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

On April 4, 2018 Nordic Nanovector ASA (OSE: NANO) reported an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial, and its financial outlook (Press release, Nordic Nanovector, APR 4, 2018, View Source [SID1234553508]). A presentation by the company’s management team will take place tomorrow in Oslo at 10 am CEST, see details below.

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• A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.

• The company will focus its resources towards PARADIGME and other Betalutin clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin for the foreseeable future; this study was being prepared to start in 2H 2018.

• Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.

• Financial resources are expected to be sufficient to reach data read-out from PARADIGME

Lisa Rojkjaer MD, Nordic Nanovector CMO, said: "While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020.

"The PARADIGME study reflects our conviction in the significant potential of Betalutin based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin as an important new treatment option for 3L FL patients."

PARADIGME – clear focus for company

PARADIGME is a global randomised Phase 2b study comparing two Betalutin dosing regimens in 3L R/R FL patients, which have shown a promising clinical profile in the LYMRIT 37-01 Phase 1/2a trial. The pivotal PARADIGME study was initiated at the end of 2017 in Europe and the first patient is expected to be dosed during the first half of 2018. The trial is aiming to enrol 130 patients in 20 countries.

To date, PARADIGME is open for enrolment at 13 sites and in six countries.

In Norway, PARADIGME is pending approval and the company is working closely with the Norwegian regulators to address its questions.

In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment during mid-2018.

Humalutin – first human trials postponed

Nordic Nanovector was preparing a Phase 1 study of Humalutin, a novel 177Lu-conjugated chimeric anti-CD37 antibody, in NHL patients. The company previously guided that it expected to start this study in the second half of 2018. As a consequence of the revised timelines for PARADIGME and the need to conserve cash until data read-out, Nordic Nanovector has decided to put the Humalutin study on hold for the foreseeable future.

ARCHER-1 and LYMRIT 37-05 – on track

ARCHER-1 is a planned clinical study designed to evaluate the safety and efficacy of combining Betalutin with rituximab in second line (2L) FL patients. The company expects the first patient to be dosed in the second half of 2018 as previously guided.

LYMRIT 37-05 is an on-going Phase 1 study evaluating Betalutin in patients with R/R DLBCL. As previously guided, the company expects preliminary data read-out from this study in the second half of 2018.

Presentation and webcast

A presentation by Nordic Nanovector’s management team will take place tomorrow at 10 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Aker

The presentation will be recorded as a webcast and will be available, with the presentation, at www.nordicnanovector.com in the section: Investors & Media

On April 4, 2018 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported the closing of a $55 million Series C financing (Press release, Arvinas, APR 4, 2018, View Source [SID1234529237]). The financing was led by new investor Nextech Invest, with participation from additional new investors Deerfield Management, Hillhouse Capital, and Sirona Capital. All existing investors also participated in this financing round, including Canaan Partners, 5AM Ventures, RA Capital Management, OrbiMed, and New Leaf Venture Partners.

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Proceeds from the financing will support the advancement of the Company’s two lead programs toward clinical investigation. The two programs, which target the androgen receptor for castration resistant prostate cancer and the estrogen receptor for ER+ positive breast cancer, both nominated orally available clinical candidates in the fourth quarter of 2017. These proceeds will also advance the Company’s early stage oncology pipeline, CNS pipeline, and efforts on undruggable targets.

"This past year has been exciting for us with two clinical candidate nominations, the expansion of our collaboration with Genentech and the announcement of a new collaboration with Pfizer," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "With this additional financial support from existing and new investors who believe in our innovative protein degradation platform, we will continue executing on our strategy of progressing our lead programs to the clinic, expanding the use of the platform outside of oncology, and tackling undruggable targets."

In connection with the financing, Jakob Loven, Ph.D., partner with Nextech Invest, will join the Arvinas board of directors.

"The Arvinas PROTAC platform is an elegant, novel therapeutic modality that circumvents delivery challenges associated with existing therapeutic approaches to eliminate protein function, and Arvinas has proven to be the clear leader in developing a new era of targeted medicines using its protein degradation technology," said Dr. Loven.

The Company’s PROTAC Platform offers potential improvements over traditional small molecule inhibitors by using the cell’s natural and selective ubiquitin proteasome system to degrade disease-causing proteins. By removing target proteins directly rather than simply inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance. With multiple protein targets, Arvinas’ PROTAC platform has demonstrated that a transient binding event at a range of binding sites and affinities can translate into very potent degradation of the target protein.