On August 27, 2020 BioInvent reported that Interim Report January 1 – June 30, 2020 (Press release, BioInvent, AUG 27, 2020, View Source;june-30-2020-301119462.html [SID1234564067])

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BioInvent is fully focused on moving our clinical projects forward. Our successful financing of SEK 625 million has strengthened our institutional investor base and is truly transformative for the company as it allows us to broaden and develop our exciting pipeline and creates a solid financial base going forward."

Martin Welschof, CEO BioInvent

Financial information

Second quarter 2020

Net sales SEK 15.6 (32.9) million.
Loss after tax SEK -39.3 (-32.8) million.
Loss after tax per share before and after dilution SEK -0.08 (-0.07).
Cash flow from operating activities and investment activities SEK -28.4 (-35.3) million.
January – June 2020

Net sales SEK 32.4 (50.3) million.
Loss after tax SEK -72.0 (-60.6) million.
Loss after tax per share before and after dilution SEK -0.14 (-0.15).
Cash flow from operating activities and investment activities SEK -63.9 (-75.8) million.
*Liquid funds as of June 30, 2020: SEK 182.3* (210.3) million.

*Liquid funds as of 30 June 2020 include SEK 95 million of the total net capital approx. SEK 589 million from the share issues. Remaining net capital SEK 494 million has been received in Q3 2020.

Events in the second quarter

BioInvent successfully completed a directed share issue of approximately SEK 487 million before transaction costs. Investors included new investors such as HBM Healthcare Investments Ltd., Swedbank Robur Medica and Invus Public Equities, L.P. as well as existing shareholders Van Herk Investments B.V., Omega Funds, The Fourth Swedish National Pension Fund and Handelsbanken Healthcare Fund. (R)
Promising progress was reported in the Phase I/lla trial of lead program BI-1206 in combination with rituximab. A complete response was observed in one follicular lymphoma patient and complete depletion of circulating tumoral cells in a mantle cell lymphoma patient. (R)
First patient enrolled in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA for patients with solid tumors.
BioInvent and Transgene presented preclinical data at AACR (Free AACR Whitepaper) Virtual Session II, demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I clinical trial expected to start before the end of 2020.
BioInvent presented new proof-of-concept data at AACR (Free AACR Whitepaper) Virtual Session II for BI-1808 and BI-1910, two different types of monoclonal antibodies targeting TNFR2. Both antibodies showed significant antitumor activity in several immunocompetent models.
A clinical trial application was submitted to begin a Phase I/IIa, first-in-human study of BI-1808 for the treatment of solid tumors or cutaneous T-cell lymphoma. The trial is expected to start before the end of 2020.
Manufacturing agreement signed with U.S. cell therapy company.
Events after the reporting period

In July 2020, BioInvent’s agreement with Pfizer Inc. was further extended until the end of 2020 to permit the companies to further identify and characterize new targets and antibodies binding to these targets.
The Extraordinary General Meeting on July 3 resolved to increase the Board of Directors with one member through new election of Dr. Thomas Hecht as a Board member. (R)
In July 2020, BioInvent’s Board of Directors resolved on a repair rights issue of a maximum of approximately SEK 139 million. It was completed in August and was heavily oversubscribed. (R)

(R)= Regulatory event
Comments from the CEO

BioInvent is continuing to make good progress toward our targets as we move into the second half of 2020. In particular, we successfully completed a directed share issue, followed by a repair rights issue which was heavily oversubscribed.

We were pleased to see such strong interest in these share issues and are grateful for the continued support and trust of all our investors. In total these share issues raised approximately SEK 625 million before transaction costs, which not only gives us the means to continue the development of BI-1206 in both hematological cancers and solid tumors, but also enables the development of a number of exciting new drug candidates. In short, these financings enable us to broaden and develop our pipeline and are truly transformative for the company.

Our lead drug candidate BI-1206 is progressing well in hematological cancer and solid tumors. The first patient has been enrolled in a Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in solid tumors. We believe BI-1206’s potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as KEYTRUDA may be a powerful approach for the future treatment of a broad range of solid tumors and hematological cancer types. We are also progressing the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and are looking at the need to add additional sites to ensure good patient enrolment.

We hosted a successful virtual key opinion leader meeting in July with Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center and renowned expert in immunotherapy. At this meeting, Prof. Eggermont discussed the clinical challenges associated with the use of checkpoint inhibitors in solid tumors and the potential for an enhanced response with immune-modulatory antibodies, specifically those targeting FcγRIIB, such as BI-1206. He concluded that BI-1206 has the potential to be effective against multiple tumor types, much like KEYTRUDA, which is approved in over 20 different cancers.

Our pipeline is becoming increasingly broad and robust, based on the productivity of our proprietary n-CoDeR/F.I.R.S.TTM platforms. In addition to BI-1206, we have a number of other candidates now progressing to clinical development.

Together with our partner Transgene, we presented preclinical data demonstrating high cure rates in solid tumors of BT-001 at AACR (Free AACR Whitepaper) Virtual Session II. BT-001 is a multifunctional oncolytic virus which was engineered to encode a Treg-depleting anti-CTLA4 antibody from n-CoDeR/F.I.R.S.TTM and we believe that the potential to combine anti-CTLA4, anti-PD-1/PD-L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors. This sets the stage for starting a Phase I clinical trial with BT-001 before the end of 2020.

We have submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). This trial is expected to start before the end of 2020. Meanwhile, new proof-of-concept data on BI-1808 and BI-1910, presented at the AACR (Free AACR Whitepaper) Virtual Session II, showed that both these antibodies had significant antitumor activity in several immunocompetent models.

As well as all this, our work with Pfizer continues and we have extended our cancer immunotherapy research collaboration and license agreement until the end of 2020.

All this exciting progress is underpinned by our technology platform, which continues to produce new potential treatments ready for clinical development to address major unmet medical needs. With financing in place and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline.

We are now in a very strong position and I am confident we will be able to continue to add shareholder value going forward. We look forward to further updating you on all of our value adding projects next time and in the meantime, wish you all the best.

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."