On November 19, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a clinical update on omburtamab for the treatment of diffuse intrinsic pontine glioma ("DIPG") (Press release, Y-mAbs Therapeutics, NOV 19, 2020, View Source [SID1234571422]). Data was presented at the Society for Neuro-Oncology ("SNO") Virtual Annual Meeting held November 19 through November 21, 2020. The omburtamab data was presented by Dr. Evan Bander from Weill Cornell Medicine.

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In a poster presentation, Dr. Bander presented infusion related data from the ongoing Phase 1 study in DIPG. The study showed the possibility of repeated convection enhanced delivery ("CED") infusions into the pediatric brainstem. Past CED treatments did not negatively influence the procedural workflow, technical application of the targeted interface, accuracy of catheter placement or distribution capacity. In the study, seven patients underwent two or more sequential CED infusions.

"The potential to retreat DIPG patients with multiple doses of omburtamab is truly exciting. We are planning for a multicenter Phase 2 study in DIPG, and hope to utilize this new insight to optimize the outcome for DIPG patients, who represent a significant unmet medical need," said Thomas Gad, founder, Chairman and President.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.

On November 19, 2020 Teneobio Inc., a clinical stage biotech company focused on discovery and development of novel multi-specific biotherapeutic antibodies, reported the presentation of interim clinical data from its Phase 1 trial evaluating TNB-383B in relapsed/refractory multiple myeloma (R/R MM) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will be held virtually Dec. 5-8, 2020 (Press release, TeneoBio, NOV 19, 2020, View Source;utm_medium=rss&utm_campaign=tnb-383b-anti-bcmaxcd3 [SID1234571421]). TNB-383B is a fully human bispecific antibody that targets BCMA on the surface of multiple myeloma (MM) cells and CD3 on the surface of T cells in order to trigger lysis of MM cells in R/R MM patients. The open-label multi-center trial is designed to assess the safety, pharmacokinetics and preliminary efficacy of TNB-383B administered intravenously once every 21 days.

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The interim results will be presented on Saturday Dec. 5 at 2:45 pm PT in an oral presentation by Cesar Rodriguez, M.D. (Wake Forest Baptist Health) titled "Interim Results of a Phase I Study of TNB-383B, a BCMAxCD3 T-cell Redirecting Antibody in Relapsed/Refractory Multiple Myeloma". The presentation will summarize interim data from 58 patients receiving escalating doses from 0.025 mg – 60 mg. Since the study is still ongoing, 81% of responders continue on treatment. Early results show an improved safety and efficacy profile.

"We are very pleased with the clinical data described in this presentation. It is encouraging to see the clinical benefit driven by T-cell mediated tumor lysis without the accompanying safety signals related to cytokine release that are typically associated with immune-activating therapies. The dosing schedule of once every three weeks allows for reduced clinic visits compared to other BCMAxCD3 bispecifics in development. Overall, we are excited to see the unique attributes of Teneobio’s CD3-engager platform validated in the clinic. We look forward to continued development of TNB-383B as well other bi-specific antibodies in our pipeline," said Ben Buelow, M.D., Ph.D., Chief Medical Officer of Teneobio.

On November 19, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that it has entered into a research agreement with Genmab A/S (Nasdaq: GMAB), an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, ImmunoPrecise Antibodies, NOV 19, 2020, View Source [SID1234571420]). IPA will generate novel bispecific antibody combinations using Genmab’s proprietary DuoBody platform and IPA’s proprietary antibodies in the field of infectious disease. The development of IPA’s proprietary antibodies into DuoBody constructs enables additional, novel formulations as the Company investigates a series of combinations in parallel.

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"Partnering with Genmab aligns with IPA’s mission to develop safe and effective therapies for patients, in this case, specifically pertaining to the growing demand in infectious disease," said Dr. Jennifer Bath, Chief Executive Officer of ImmunoPrecise Antibodies. "This agreement further complements our strategy to ensure that the full potential of our infectious disease programs is realized, which includes establishing productive partnerships to increase opportunities for ideal formulations with the highest safety and efficacy profiles."

The DuoBody technology is a proprietary platform of Genmab applied in the discovery and development of bispecific antibodies across several therapeutic areas including cancer, hemophilia, autoimmune, infectious, and central nervous system diseases. DuoBody technology has been successfully used in many Genmab internal or partnered investigational clinical therapies.

As a part of the partnership, Genmab and IPA will negotiate in good faith an agreement for the commercial use of resulting DuoBody products.

On November 19, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical stage biopharmaceutical company focused on developing novel treatments for chronic kidney diseases and neurological disorders, reported that Rick Pauls, President and CEO of DiaMedica, will participate in a fireside chat and host one-on-one meetings with investors at the Piper Sandler 32nd Annual Virtual Growth Conference (Press release, DiaMedica, NOV 19, 2020, View Source [SID1234571419]). The fireside chat will be available on the Piper Sandler Conference website to registered attendees on November 23rd at 10:00 AM ET to December 3, 2020.

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The Company will host the one-on-one meetings with investors on Tuesday, December 1, 2020, meetings can be requested exclusively via Piper Sandler.

A replay of the fireside chat can be accessed under Events and Presentations in the Investors section of our website at View Source

On November 19, 2020 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society (CTOS) annual meeting (Press release, Adaptimmune, NOV 19, 2020, View Source [SID1234571418]). The oral presentation given by Dr. Brian Van Tine of the Washington University School of Medicine is available on-demand for congress attendees. Dr. Van Tine will also participate in a "live stream" session entitled – Immunotherapy in Sarcoma: Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Synovial Sarcoma (Proffered Papers Panel Discussion) scheduled for 9 AM EST today (November 19).

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"The impact on patients treated with ADP-A2M4 is transformative, as they benefit from a durable response from a single treatment. This leads to the highest quality of life I have been able to provide patients with synovial sarcoma after treatment," said Dr. Brian Van Tine, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine.

"Data from this trial have enabled rapid execution of our pivotal trial, SPEARHEAD-1, and support our aim to commercialize ADP-A2M4 as the first engineered TCR T-cell product in the US in 2022," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "However, this is only the beginning of the tremendous potential of our products targeting MAGEA4. We will rapidly pursue additional indications, starting with the Phase 2 trial in gastroesophageal cancers with ADP-A2M4CD8 expected to initiate in the first half of 2021."

Data presented at CTOS were updated durability of response and safety data from the 16 patients with synovial sarcoma who were treated in the Phase 1 ADP-A2M4 trial, presented earlier this year at ASCO (Free ASCO Whitepaper). The data cut-off for this presentation was September 1, 2020 and results are summarized below:

Seven out of 16 patients (44%) had confirmed partial responses (PRs) per RECIST criteria, with disease control in 15 patients (94%)
There was a median duration of response of 28 weeks (range: 12-72+ weeks) with two PRs that were ongoing beyond 72 weeks at the time of data cut-off
Eleven out of 16 patients were alive at data cut-off and median overall survival had not been reached
Translational data indicate that induction of the IFNγ-related pathway by serum analyses is an emerging biomarker of response. MAGE-A4 expression and transduced cell dose correlate with tumor reduction
Most adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion chemotherapy and cellular therapy including low blood counts and cytokine release syndrome