On April 9, 2021 ONCURIOUS NV, a Belgium-based biotech company focused on developing innovative oncology treatments, reported that it will make two presentations at the upcoming AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021 which will take place from 9 to 14 April (Press release, Oncurious, APR 9, 2021, View Source,from%209%20to%2014%20April. [SID1234577793]).

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The first of these is an oral presentation of data from a Phase 1 dose escalation study of TB-403, a humanized monoclonal antibody against placental growth factor (PlGF), in pediatric cancer subjects for treatment of medulloblastoma:

Title: A Phase 1, open label, multicenter, dose escalation study of TB-403 in pediatric subjects with relapsed or refractory medulloblastoma, neuroblastoma, Ewing Sarcoma or alveolar rhabdomyosarcoma

Presented by: Dr. Giselle Sholler, Director at the Isabella Santos Foundation Solid and Rare Tumor Program, Chair at Beat Childhood Cancer Research Consortium, and Professor, Pediatric Oncology at the Levine Children’s Hospital in Charlotte, NC.

Presentation #: CT015

Session Title: Early Clinical Trials with New Anticancer Agents

Session Date and Time: Saturday 10th April from 1:30 PM to 3:30 PM US EDT

The second presentation is an e-poster presentation of preclinical data:

Title: Investigation of the best therapeutic approach to target CCR8 expressed on tumor regulatory T cells to boost anti-tumor immune responses

Authors: Heleen Roose, Elizabeth Allen, Helena Van Damme, Bruno Dombrecht, Rosa Martín-Pérez, Damya Laoui, Jo A. Van Ginderachter, Pascal Merchiers. Oncurious NV, Leuven, Belgium, Laboratory of Cellular and Molecular Immunology, Vrije Universiteit Brussel and Myeloid Cell Immunology Lab, VIB Center for Inflammation Research, Brussels, Belgium, VIB Discovery Sciences, Leuven-Ghent, Belgium.

Date and Time: The e-poster will be available on AACR (Free AACR Whitepaper)’s website on Saturday 10th April at 8:30 AM US EDT (the first day of the virtual AACR (Free AACR Whitepaper) Annual Meeting). The e-poster will remain available for viewing through to Monday 21st June 2021.

The abstract can be viewed here.

In February 2021, The Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (a BMJ journal) published a paper on the efficacy and safety of targeting CCR8 for the depletion of tumor-promoting tumor infiltrating Tregs in combination with anti-PD-1 therapy. For more information please see Oncurious press release here.

On April 9, 2021 Vascular Biogenics Ltd. ("VBL Therapeutics" or the "Company") (NASDAQ: VBLT), reported the pricing of an underwritten public offering of 5,150,265 ordinary shares and, to certain investors in lieu thereof, pre-funded warrants to purchase 8,050,000 ordinary shares in an underwritten public offering, at a price to the public of $1.90 per ordinary share and $1.89 per pre-funded warrant (Press release, VBL Therapeutics, APR 9, 2021, View Source [SID1234577792]). In addition, VBL Therapeutics has granted the underwriters a 30-day option to purchase additional ordinary shares up to 15% of the aggregate number of ordinary shares plus the ordinary shares underlying pre-funded warrants that are sold in the offering, at the public offering price less the underwriting discounts and commissions. The offering is expected to close on April 13, 2021, subject to the satisfaction of customary closing conditions. All of the securities in the offering are to be sold by VBL Therapeutics.

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The gross proceeds to the Company from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by VBL Therapeutics, are expected to be approximately $25.0 million. VBL Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Guggenheim Securities, LLC is acting as bookrunning manager for the offering. Oppenheimer & Co. Inc. is also acting as a joint bookrunner. Roth Capital Partners and JonesTrading Institutional Services LLC are acting as co-managers.

The securities described were offered by VBL Therapeutics pursuant to a shelf registration statement on Form F-3 (No. 333-251821), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April 9, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported plans to host a conference call and webcast on Friday, April 16, 2021 at 8:00 a.m. ET to discuss the selection of the NaPi2b biomarker cutoff and the commercial diagnostic development path for the ongoing UPLIFT registration strategy in platinum-resistant ovarian cancer (Press release, Mersana Therapeutics, APR 9, 2021, https://ir.mersana.com/news-releases/news-release-details/mersana-therapeutics-host-conference-call-and-webcast-discuss [SID1234577791]). The presentation will review the Company’s plan to deliver a robust, predictive and reproducible commercial diagnostic assay.

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To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 4598737. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On April 9, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in UPLIFT, a single-arm registration strategy to evaluate the safety and efficacy of upifitamab rilsodotin (UpRi, XMT-1536) in patients with platinum-resistant ovarian cancer who have received up to four lines of therapy (Press release, Mersana Therapeutics, APR 9, 2021, View Source [SID1234577790]).

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"UpRi has demonstrated clinically meaningful activity, a biomarker-response relationship and a differentiated tolerability profile without severe neutropenia, peripheral neuropathy or ocular toxicity in heavily pretreated ovarian cancer patients who have limited options and poor prognosis. The UPLIFT strategy is critical to bringing this promising agent to patients waiting for new therapies," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.

UPLIFT will evaluate the safety and efficacy of UpRi in patients with platinum-resistant ovarian cancer who have received up to four lines of therapy. Consistent with the bevacizumab label, patients previously treated with three or four lines of therapy may enroll without regard to prior bevacizumab treatment. There is no exclusion for patients with baseline peripheral neuropathy. Patients may enroll without regard to NaPi2b expression; however, the role of the biomarker will be evaluated. The primary endpoint will be the objective response rate (ORR) in the high NaPi2b population and the secondary endpoints will be the ORR regardless of NaPi2b expression, as well as duration of response and safety.

"We believe this study design, which is an amendment to the ongoing Phase 1 expansion study, allows for significant operational efficiencies and leverages our current momentum in patient enrollment. The study design also allows us the opportunity to fully evaluate the role of the biomarker with endpoints in both the high NaPi2b and overall populations. We are excited to open this cohort to this heavily pretreated patient population with few options," said Arvin Yang, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Mersana Therapeutics.

The single-arm registration strategy is an amendment to the ongoing multinational, multi-center, open label study protocol, and the Company expects to enroll approximately 100 patients with high NaPi2b expression and up to 180 patients overall.

On April 9, 2021 Seagen Inc. (Nasdaq: SGEN) reported that preclinical data from its pipeline of novel targeted oncology drugs will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 10-15, 2021 (Press release, Seagen, APR 9, 2021, View Source [SID1234577789]). The oral and poster presentations will highlight several early-stage programs utilizing Seagen’s leading antibody-drug conjugate (ADC) technology as well as its proprietary sugar-engineered antibody (SEA) technology.

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"Our research being presented at AACR (Free AACR Whitepaper) describes intriguing preclinical data for three novel pipeline programs that are in ongoing clinical trials. This includes SEA-TGT, an anti-TIGIT antibody using our SEA technology, and two vedotin-based ADCs, SGN-B6A and SGN-STNV. We believe these three programs represent potential best-in-class or first-in-class targeted therapies for cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Among the findings, we will show the enhanced therapeutic effect in combining SEA-TGT with a checkpoint inhibitor or a vedotin-based ADC across different tumor models. In addition, we will report for the first time our preclinical data with SGN-STNV, a novel ADC targeting a carbohydrate antigen that may have broad applicability across solid tumors."

Highlights of Seagen Programs Presented at AACR (Free AACR Whitepaper)

SEA-TGT

Preclinical data will be presented for SEA-TGT, a novel investigational nonfucosylated human IgG1 TIGIT antibody, which utilizes Seagen’s proprietary SEA technology that enhances functionality by targeting key immune activating Fc receptors. TIGIT is an inhibitory immune checkpoint that has emerged as a clinically relevant immuno-oncology target. The monotherapy and combinatorial activity of SEA-TGT was assessed and compared to TIGIT monoclonal antibodies (mAbs) with inert, standard, or effector function modified backbones in vivo and in vitro. Key preclinical findings were as follows:

the SEA-TGT backbone was distinct as it increased binding to activating FcγRIIIa with minimal binding to inhibitory FcγRIIb;
the empowered backbone had superior therapeutic properties including enhanced depletion of TIGIT-positive regulatory T-cells and activation of antigen-presenting cells both of which are important in promoting antitumor activity;
SEA-TGT demonstrated enhanced antitumor activity both as a single agent and in combination with anti-PD1 therapy; and,
SEA-TGT produced an enhanced therapeutic effect when combined with an immunogenic tumor cell death-inducing vedotin ADC.
A phase 1 trial evaluating SEA-TGT alone and in combination with anti-PD-1 therapy in patients with advanced solid tumors and select lymphomas is ongoing.

SGN-B6A

Preclinical data will also be presented on SGN-B6A, an investigational ADC targeting integrin beta-6, which is overexpressed in numerous solid tumors and has been demonstrated to be a negative prognostic indicator across a diverse range of cancers, including non-small cell lung cancer (NSCLC). Data demonstrate SGN-B6A is active when dosed weekly in patient-derived xenograft models of NSCLC, representing both squamous and adenocarcinoma histology. A phase 1 trial evaluating monotherapy SGN-B6A in advanced solid tumors is ongoing.

SGN-STNV

SGN-STVN is an investigational ADC with a unique mechanism for targeting a carbohydrate antigen called Sialyl-Thomsen nouveau (STn), which is highly expressed on a variety of solid tumors including non-small cell lung, ovarian and gastric cancers. The preclinical data demonstrate SGN-STNV is highly specific for STn independent of protein identity, which could allow for the targeting of a range of tumor types that express different glycoproteins. In xenograft studies across key tumor types, the specificity and ability to target STn on multiple tumor-associated proteins led to durable tumor regressions. SGN-STNV was well-tolerated in in vivo studies and is being evaluated in an ongoing phase 1 study.

Additional Details of Seagen Presentations at AACR (Free AACR Whitepaper) Annual Meeting 2021

All poster presentations will be available via on-demand view starting on April 10 at 8:30 a.m. Eastern Time. Oral symposium presentations will be available at the beginning of the session where the study is presented.

Abstract Title

Abstract #

Date

Presenter

Oral

Targeting Sialyl-Thomsen nouveau (STn) antigen with the SGN-STNV antibody-drug conjugate is effective in preclinical studies

#50

April 10 in session at 4:00 – 6:00 p.m. ET

A. Schwartz

E-Poster

SEA-TGT is an empowered anti-TIGIT antibody that displays superior combinatorial activity with several therapeutic agents

#1583

April 10

A. Smith

Activity of SGN-B6A in patient-derived xenograft models of non-small cell lung cancer

#914

April 10

R. Lyon

Pharmacokinetics of tucatinib in healthy and hepatically-impaired volunteers

#1371

April 10

A. Topletz-Erickson