On April 4, 2018 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel glycan-targeted cancer therapeutics, reported that it will present new research findings for its ST1 monoclonal antibody (mAb) therapeutic program during a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, being held April 14-18, 2018, at McCormick Place in Chicago (Press release, Siamab Therapeutics, APR 4, 2018, View Source [SID1234525179]). Myeloid derived suppressor cells (MDSCs) are shown to express Sialyl-Tn (STn) across a wide range of patient tumor samples and may therefore represent an optimal therapeutic target for the ST1 program. MDSCs are major regulators of the tumor anti-immune response that act by suppressing T cells. Ovarian xenograft model data will be presented that further demonstrates the potential for targeting STn+ MDSCs with ST1 in a clinical setting. ST1, Siamab’s lead program, is in late stage preclinical development formatted as an antibody drug conjugate (ADC) for the treatment of STn-expressing solid tumors.

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"We are pleased to present new patient tumor data and ovarian carcinoma xenograft data for our ST1 antibody drug conjugate targeting STn at the AACR (Free AACR Whitepaper) 2018 annual meeting," said Jeff Behrens, president and chief executive officer of Siamab. "These research findings are exciting as they continue to show that STn provides a uniquely glycan-specific target for the treatment of solid tumors. Importantly, the findings demonstrate that our antibody therapeutic targeting STn offers the potential to go beyond tumor targeting to also directly target and deplete immune-suppressive MDSCs, enabling immune system re-engagement and increasing the potential for better patient outcomes."

The poster presentation will highlight new data showing the presence of STn on the surface of MDSCs in a growing body of patient tumor samples, as well as data in patients and xenograft models linking STn expression on MDSCs to tumor cell STn expression. In addition, the poster will highlight data that demonstrates depletion of STn+ MDSCs after treatment with an anti-STn ADC in an ovarian carcinoma xenograft model.

Details for the poster presentation are as follows:

Abstract Title and Number: Myeloid derived suppressor cells (MDSCs) express Sialyl Tn (STn) and are a therapeutic target for anti-STn antibody drug conjugates (#6892)
Date: Wednesday, April 18, 2018
Time: 8:00 a.m.-12:00 p.m. CT
Session Title: Therapeutic Antibodies, including Engineered Antibodies 4
Location: McCormick Place, Poster Section 28
Poster Board Number: 20

Siamab’s proprietary technology platform enables the development of highly specific mAb therapeutics, including ADCs, targeting cancer cell surface glycans called tumor-associated carbohydrate antigens (TACAs). TACAs are an emerging set of tumor specific antigens implicated in immune suppression, chemoresistance and a cancer stem cell (CSC) phenotype. STn, the sialylated version of the carbohydrate Tn antigen, is broadly expressed in human cancers including ovarian, gastric, colon, prostate, pancreatic and lung. The presence of STn in tumors is associated with metastatic disease, poor prognosis, and reduced overall survival. Tumor STn expression is well-established and can be leveraged for targeted cancer therapy; however, its expression on immuno-suppressive tumor infiltrating lymphocytes, such as MDSCs, is a new finding. Siamab has identified and utilized the presence of STn on MDSCs to target and deplete MDSCs in vivo, providing a potential novel therapeutic approach for the treatment of solid tumors.

A copy of the poster will be made available on the company’s website after the presentation.

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 Vaccibody AS, a clinical stage immunotherapy company focused on developing personalized neoantigen cancer vaccines to target solid tumors, reported that informed consent signed by the first patient and enrolment process initiated in the clinical trial. (Press release, Vaccibody, APR 4, 2018, View Source [SID1234525180]) The patient will be enrolled in Heidelberg, Germany at the National Center for Tumor Diseases by principal investigator, Prof. Dr. med. Jürgen Krauss, Head of Section for Clinical Immunotherapy.

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Prof. Dr. med. Jürgen Krauss, said, "We are very pleased to have initiated this clinical phase I/IIa for Vaccibody’s neoantigen vaccine. The neoantigen vaccine holds the potential to assist the patient’s immune system to generate specific T-cell responses to its individual cancer neoantigens and in this way may help the patient to more effectively fight the cancer. We hope this clinical trial will help pave the way for a novel class of new efficacious and safe treatment for cancer patients."

Mads Axelsen, MD, Chief Medical Officer in Vaccibody, said "We are proud and very pleased to work with so experienced cancer experts in this trial as Prof. Jürgen Krauss from Heidelberg, Prof. Angela Krackhardt from Munich and Prof. Elke Jäger from Frankfurt. This first-in-man trial is planned to enroll up to 40 patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder or head and neck cancer. The VB10.NEO vaccine will be given in combination with standard of care checkpoint inhibitors as a new treatment modality to help patients with cancer."

Dr. Agnete Fredriksen, President and Chief Scientific Officer in Vaccibody, commented "The first patient marks an important new phase in Vaccibody and we are very excited to start to tailor-make one vaccine per patient using our proprietary vaccination technology. The unique ability to induce strong CD8 T cell responses to multiple neoepitopes that we have observed in preclinical models, in addition to the manufacturing advantages essential for individualized vaccines, are basis for our enthusiasm moving this concept into clinical trials."

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.

BeyondSpring Pharmaceuticals 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, 20-F, BeyondSpring Pharmaceuticals, 2018, APR 3, 2018, View Source [SID1234527561]).

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