On August 27, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported interim safety data from its ongoing clinical Phase I study of the drug candidate ATOR-1017, its wholly owned 4-1BB antibody in development for the treatment of metastasized cancer (Press release, Alligator Bioscience, AUG 27, 2020, View Source [SID1234564066]).

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The data presented today displays an encouraging safety profile of ATOR-1017. Few drug related adverse events have been observed and all were mild or moderate (grade 1 or 2). The Data Review Committee that monitors the safety of the patients in the ATOR-1017 Phase I study, has cleared the 40 mg dose and approved to start dosing with the higher dose level of 100 mg, corresponding to approximately 1.6 mg/kg.

"Activation of the immune receptor 4-1BB holds enormous potential but has historically been associated with severe toxicity. ATOR-1017 demonstrates a very good tolerability profile this far, indicating that we have succeeded in generating a therapeutic antibody with potential for superior properties. I look forward to taking this drug candidate into clinical efficacy studies" commented Per Norlén, CEO at Alligator Bioscience.

Today at 2 p.m. CEST, Alligator hosts a public R&D update where CEO Per Norlén and COO Malin Carlsson will give an update on the latest development steps in the company’s clinical pipeline – focusing on the recent news on the drug candidate ATOR-1017. Guest speaker, Professor Ignacio Melero at University of Navarra, will give his view on the target 4-1BB. The clinical candidates ATOR-1015 and mitazalimab will be presented as well. The complete agenda is available below. View today’s presentations on the Alligator YouTube channel View Source

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST on August 27, 2020.

Agenda for the virtual R&D update on August 27, 2020
Program (approximate times):

2:00 p.m. Company introduction and clinical development update ATOR-1015 and mitazalimab
Speaker: Per Norlén, CEO

2:15 p.m. ATOR-1017 – Concept and latest news
Speaker: Malin Carlsson, COO

2:30 p.m. 4-1BB – An attractive target for cancer immunotherapy
Speaker: Professor Ignacio Melero, University of Navarra, Pamplona, Spain

2:45 p.m. Q&A session

3:00 p.m. Conclusions

About ATOR-1017
ATOR-1017 activates 4-1BB receptors which increases the ability of the immune system to detect and kill tumor cells. ATOR-1017 has a unique profile related to the fact that its immune-stimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation that can increase efficacy and reduce side effects for the patient.

The ongoing Phase I study is a dose escalation study in patients with advanced cancer. The study is conducted at three different clinics in Sweden and is planned to include up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

On August 27, 2020 Genmab A/S (Nasdaq: GMAB) reported that results from the phase 2 innovaTV 204 study evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Genmab, AUG 27, 2020, View Source [SID1234564050]). The abstract is scheduled to be available on Sep 19, 2020 and will be published online via the ESMO (Free ESMO Whitepaper) website.

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"We are very pleased that the innovaTV 204 study is selected as a late-breaking oral presentation at ESMO (Free ESMO Whitepaper)," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "There is a high unmet need for treatment options for women with advanced cervical cancer, following disease progression on standard-of-care therapy. Genmab and Seattle Genetics have a shared commitment to transform the treatment of advanced cervical cancer and we look forward to presenting the promising results from the innovaTV 204 study at this prestigious conference."

ESMO Oral Presentation Details
Title: Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: results from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study
Number: LBA32 | Channel: 3
Presenter: Robert L. Coleman, MD, FACOG, FACS, US Oncology Research, The Woodlands, Texas, USA
Date and Session: Monday, Sep 21, 2020, Proffered Paper 2 – Gynaecological cancers
Time: Lecture – 17:04 – 17:16 CEST | Live Q&A – 17:38 – 17:48 CEST

A trial in progress abstract, titled, "innovaTV 208: New weekly dosing cohort in the phase 2 study of tisotumab vedotin in platinum-resistant ovarian cancer" (882TiP) will be presented as a poster presentation on Thursday, Sep 17, 2020.

About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab if eligible per local standards. Patients were eligible if they had received up to two prior lines of therapy in the recurrent/metastatic setting. In the study operationalized by Genmab, 101 patients were treated with tisotumab vedotin at multiple centers in Europe and the U.S. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, time to response, progression-free survival, overall survival, safety and tolerability.
The study was conducted by Genmab in collaboration with Seattle Genetics Inc., European Network of Gynaecological Oncological Trial groups (ENGOT) and Gynecologic Oncology Group (GOG). For more information about the Phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seattle Genetics’ ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Tisotumab vedotin is being evaluated in ongoing clinical trials as a monotherapy in a range of solid tumors and in recurrent and/or metastatic cervical cancer in combination with commonly used therapies. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.

On August 27, 2020 The National Cancer Institute (NCI), part of the National Institutes of Health, reported that it will partner with Cancer Research UK to fund Cancer Grand Challenges, an international initiative to address profound and unanswered questions in cancer research (Press release, Cancer Research UK, AUG 27, 2020, View Source [SID1234564046]). Through Cancer Grand Challenges, NCI and Cancer Research UK will seek novel ideas from multidisciplinary research teams from around the world that offer the potential to make bold advances in cancer research and improve outcomes for people affected by cancer.

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The new partnership builds on Cancer Research UK’s Grand Challenge initiative, which is currently funding seven international teams of researchers across nine countries. Cancer Research UK is the world’s largest independent cancer research charity. Cancer Grand Challenges will foster a highly competitive process designed to stimulate scientific creativity of the highest order.

"This new partnership leverages the expertise of the world’s leading funders of cancer research in a bold effort to identify and pursue innovative ideas that address major challenges in understanding cancer," said NCI Director Norman E. "Ned" Sharpless, M.D. "We’re thrilled to join Cancer Research UK in this unique collaboration to support novel cancer research on a global scale."

The goals of the partnership include identifying important cancer research opportunities; facilitating global collaboration among multidisciplinary researchers to solve these challenges; giving the global teams the freedom and scale to innovate and carry out cutting-edge research; and further advancing fundamental biological knowledge and its clinical application to cancer. To gain essential perspectives from people affected by cancer, a patient committee will offer input and ideas throughout the Cancer Grand Challenges process.

NCI and Cancer Research UK plan to announce the list of new challenges in October 2020. Expressions of interest from research teams for the new challenges are expected to be accepted from October 2020 through April 2021. From these, a small number of teams will be selected to receive pilot funds to further develop their ideas into larger, final applications. Those selected to receive funding will be notified in June 2021, and the awards to final teams will be announced in 2022.

NCI and Cancer Research UK expect to co-fund approximately four awards for each round of Cancer Grand Challenges, with each multidisciplinary team being awarded approximately $25 million over five years. NCI anticipates that the Cancer Grand Challenges partnership will support three rounds of awards, with a new round of challenges announced every other year. NCI plans to use annual funding currently set aside for the Provocative Questions (PQ) initiative, and anticipates funding PQ awards and Cancer Grand Challenges awards in alternating years.

The process to determine the Cancer Grand Challenges is conducted through a series of international workshops to receive input from thought leaders from the cancer research community and people affected by cancer. The most compelling ideas generated from these workshops are then reviewed and the final challenges selected.

Cancer Research UK launched the Grand Challenge initiative in 2015 and has overseen two rounds of Grand Challenge awards to date. These awards are currently funding teams focusing on identifying preventable causes of cancer; creating virtual reality maps of tumors; preventing unnecessary breast cancer treatment; studying tumor metabolism from every angle; understanding why cancers grow in some tissues and not in others; finding new ways to tackle inflammation-associated cancer; and manipulating the microbiome to beat bowel cancer.

"Many of the ongoing Grand Challenge awards align with NCI research priorities, and our missions overlap in many ways," said Dinah S. Singer, Ph.D., NCI deputy director for scientific strategy and development. "This initiative will expand opportunities to identify new challenges based on insights from the cancer research community and to further our understanding of cancer. We’re looking forward to the new ideas proposed by creative teams from around the world."

On August 26, 2020 Trishula Therapeutics, a clinical stage, privately held company, reported that it was launched to be solely dedicated to the development of TTX-030, a first-in-class anti-CD39 antibody, being studied in advanced cancers (Press release, Trishula Therapeutics, AUG 26, 2020, View Source [SID1234572298]). The new company is designed to further progress and focus on the existing TTX-030 development collaboration with AbbVie.

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The Trishula launch is the result of the spin out of the TTX-030 program from Tizona Therapeutics with funds and employees to support its development. Shares in Trishula were distributed to Tizona shareholders, including MPM, Canaan, Abingworth, Lightstone, Interwest Partners, and AbbVie Ventures. Tizona’s current chief executive officer, Scott Clarke, will join the Trishula board and serve as its initial chief executive officer. Clarke will be joined by a seasoned team of experts focused on TTX-030, which is currently being studied in phase 1/1b clinical trials as a monotherapy and in combination with an anti-PD-1 agent and standard chemotherapy in adults with advanced cancer (NCT03884556 and NCT04306900).

"As a stand-alone company, Trishula will continue to deliver on the mission of bringing TTX-030, a novel, transformational medicine, to cancer patients in great need," said Scott Clarke, CEO, Trishula. "I have complete confidence that TTX-030 will continue to rapidly and effectively advance within Trishula and in partnership with AbbVie."

On August 26, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported that its Chief Executive Officer, Rob Fried , and Chief Financial Officer, Kevin Farr , will be presenting at the LD 500 investor conference (Press release, ChromaDex, AUG 26, 2020, View Source [SID1234568254]). The LD 500 will take place on September 1st through the 4th.

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The ChromaDex management team is scheduled to present on Wednesday, September 2, 2020 at 2:00 p.m. Eastern Time ( 11:00 a.m. Pacific Time ). The presentation will be webcast live via the link below on the investor relations section of the Company’s website at www.chromadex.com . ChromaDex management will also attend virtual one-on-one meetings with institutional investors throughout the day. For those interested in having a meeting with ChromaDex please contact David Scher at [email protected] or visit www.ldmicro.com for more information.