On March 29, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 therapies for cancer, reported the presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held March 29 – April 3, 2019 in Atlanta, GA (Press release, Arch Oncology, MAR 29, 2019, View Source [SID1234534764]).

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"We are excited to present these new sets of preclinical data at AACR (Free AACR Whitepaper), highlighting the progress our team is making with advancing our novel antibody programs," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "The most recent data on AO-176 build on the growing body of research showing that our highly differentiated anti-CD47 antibody selectively binds to and directly kills tumor cells while sparing normal cells. We will continue to work hard to advance AO-176 in our ongoing Phase 1 clinical trial in patients with select solid tumors. In addition, we are presenting for the first time preclinical data from our novel, discovery-stage anti-SIRP antibody program."

Poster Presentations:
Title: AO-176, a normal cell sparing humanized anti-CD47 antibody
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Poster Board Number: 4
Abstract Number: 540

Title: Evaluation of novel anti-SIRP antibodies as potential cancer therapeutics
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Poster Board Number: 12
Abstract Number: 548

Copies of these posters will be available as poster sessions begin at View Source

About Arch Oncology’s Anti-CD47 Antibody AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a best-in-class profile. Arch Oncology’s next-generation anti-CD47 antibody AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also works by directly killing tumor cells. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). AO-176 is being evaluated in a Phase 1 clinical trial for the treatment of patients with select solid tumors. Additional information about this trial may be found at www.clinicaltrials.gov using the trial identification number NCT03834948.

On March 29, 2019 CEL-SCI Corporation (NYSE American: CVM) reported that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data (Press release, Cel-Sci, MAR 29, 2019, View Source [SID1234534763]). The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.

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The IDMC made the following recommendation:

The IDMC recommendation is to continue the trial until the appropriate number of events have occurred.
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.

On March 29, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Bicycle scientists have been selected to present two oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta (Press release, Bicycle Therapeutics, MAR 29, 2019, View Source [SID1234534762]). These presentations will focus on preclinical programs that have shown target-dependent anti-tumor activity across a range of patient-derived Nectin-4 and EphA2 expressing cancer models.

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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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"Because of their small size and profound efficacy, Bicycle’s toxin conjugates are able to do what many previous antibody drug conjugate approaches could not," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "Preclinical data from both our BT5528 and BT8009 programs show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively, and we’re proud that AACR (Free AACR Whitepaper) has chosen to highlight our work."

In addition, Bicycle has also been selected to present a poster on its CD137 program, intended to activate cytotoxic T-cells, a type of cell used in the body’s immune response.

Added Keen: "We believe Bicycle’s work on CD137 has produced the first fully-synthetic immune oncology modulators, which may confer several advantages over existing modalities because of the multivalency and pharmacokinetic characteristics of Bicycles."

Details on Bicycle’s presentations at the 2019 AACR (Free AACR Whitepaper) Annual Meeting are as follows:

Oral Presentation Title: BT8009: A bicyclic peptide toxin conjugate targeting Nectin-4 (PVRL4) displays efficacy in preclinical tumor models
Presenter: Michael Rigby, Ph.D., project leader for BT8009, a Nectin-4 targeted Bicycle Toxin Conjugate
Session Title: Novel Therapeutics
Abstract: #4479
Date and Time: April 2, 2019, 3:00 p.m. – 5:00 p.m. EDT

Oral Presentation Title: BT5528, an EphA2-targeting Bicycle Toxin Conjugate (BTC): Profound efficacy without bleeding and coagulation abnormalities in animal models
Presenter: Gavin Bennett, Ph.D., Director of Preclinical Development and project leader for BT5528, an EphA2 targeted Bicycle Toxin Conjugate
Session Title: Novel Therapeutics
Abstract: #4481
Date and Time: April 2, 2019, 3:00 p.m. – 5:00 p.m. EDT

Poster Presentation Title: Activation of CD137 using multivalent and tumor-targeted Bicyclic peptides
Presenter: Johanna Lahdenranta, Ph.D., Director of In Vivo Pharmacology
Session Title: Novel Immunomodulatory Agents 1
Abstract: #3257
Date and Time: April 2, 2019, 8:00 a.m. – 12:00 p.m. EDT

On March 29, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported completion of enrollment in the potentially pivotal innovaTV 204 phase 2 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment (Press release, Seattle Genetics, MAR 29, 2019, View Source [SID1234534761]). Tisotumab vedotin is being developed in collaboration with Genmab A/S. The innovaTV 204 trial is intended to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target Tissue Factor antigen on cancer cells and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. Tissue Factor is overexpressed in cervical cancer and many other solid tumors.

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"Cervical cancer is a devastating disease with a significant need to develop improved therapies for patients with metastatic disease who have progressed after treatment," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Completing enrollment in this potentially pivotal phase 2 trial marks an important step forward in evaluating tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer."

For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer who progressed on or relapsed after treatment with doublet chemotherapy used alone or in combination with bevacizumab (Avastin). The study enrolled over 100 patients at multiple centers. The primary endpoint of the trial is objective response rate as assessed by blinded independent central review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.

On March 29, 2019 Celgene Corporation (NASDAQ:CELG) and Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook, LLC (collectively, Alvogen) reported the settlement of their litigation relating to patents for REVLIMID (lenalidomide) (Press release, Celgene, MAR 29, 2019, View Source [SID1234534755]).

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As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Alvogen from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022 volume-limited license date that Celgene previously provided to Natco. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Alvogen cannot exceed certain agreed-upon percentages. Although the agreed-upon percentages are confidential, they increase gradually each period to no more than a single-digit percentage in the final volume-limited period. In addition, Celgene has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026.

Alvogen’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.