On June 11, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported it has entered into an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s proprietary HexaBody technology (Press release, Genmab, JUN 11, 2019, View Source [SID1234536987]). Under the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development activities until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma. Based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38. Should this occur, Janssen will pay Genmab a USD 150 million option exercise fee and up to USD 125 million in development milestones, as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13-20% tiered royalties on sales thereafter. Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialize HexaBody-CD38 for DARZALEX-resistant patients, and in all other indications except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed.

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The agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma and leukemia models.

"With this agreement, we hope to build upon the successful and productive relationship that we have established with Janssen. As a result of our collaboration, DARZALEX has dramatically improved outcomes for patients with multiple myeloma, yet there are still unmet needs for patients. We are excited that Genmab’s world-class antibody expertise and passion for innovation has led to the novel HexaBody-CD38 product concept. Encouraging pre-clinical data suggest that HexaBody-CD38 could be superior to daratumumab for certain tumor cell types and may expand and extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukemia, and potentially beyond," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Additional details of the collaboration are not being disclosed and this news does not materially impact Genmab’s 2019 Financial Guidance.

On June 10, 2019 Sosei Group Corporation ("the Company"); (TSE: 4565) and its strategic alliance partner Pfizer reported that a new clinical candidate from their multi-target drug discovery collaboration was nominated to advance into clinical development (Press release, Sosei Heptares, JUN 10, 2019, View Source [SID1234552773]). Sosei Heptares will receive a $3 million milestone payment from Pfizer for this achievement. The first clinical candidate under this collaboration was nominated by Pfizer in May 2019.

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Dr. Malcolm Weir, Executive VP and Chief R&D Officer of Sosei Heptares, said: "We are very pleased to reach this development milestone for another candidate in our partnership with Pfizer so soon after nominating the first clinical candidate last month. The teams at Sosei Heptares and Pfizer have worked well together to generate and advance a novel molecule against a difficult GPCR target, highlighting again the power and potential of this approach and the combined capabilities being deployed."

The multi-target drug discovery collaboration between Sosei Heptares and Pfizer was signed in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

In an effort to address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering milestone payments from Pfizer, including the US$3 million announced today, as well as $3 million in May 2019, both resulting from the nomination of new clinical candidates. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a US$33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.

On June 10, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (OTCQB: GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, reported an update of the company’s drug development programs (Press release, GT Biopharma , JUN 10, 2019, View Source [SID1234539512]).

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GT Biopharma continues to move forward with its development of the HIV TriKE. On April 24th GT Biopharma announced the elimination of HIV infected cells using its Tri:Specific Killer Engagers (TriKEs) in Preclinical Testing at the University of Minnesota. Which could represent a possible cure to HIV which now has over 35 million infected people worldwide.

About the HIV TriKE

In preclinical testing led by Dr. Jeffrey Miller, M.D., Deputy Director Masonic Cancer Center and Dr. Timothy Schacker, M.D., Medical School and Director, Program in HIV Medicine, the research team designed a series of Bispecific and Trispecific Natural Killer Cell Engagers (BiKE and TriKE) constructs to direct Natural Killer cell mediated cytotoxicity against an HIV infected target. The data demonstrate that a BiKE construct can eliminate HIV infected targets expressing the HIV envelope on their surface. Based on the success of the BiKE data, GT Biopharma is planning to develop a TriKE version by incorporating IL-15 into the BiKE scFv construct to increase the level of NK cell killing of targeted HIV infected cells.

Additional TriKEs (Trispecific NK cell engagers) which target hematological malignancies (liquid tumors), and solid tumor cancers, are also progressing under the TriKE platform. The TriKE platform’s ability to expand into solid tumors (80% of the cancer market) allows for a much more economical and wider approach then CAR-T. Most recently KITE Pharma was bought by Gilead Sciences, Inc. for $12 Billion (NASDAQ: GILD) and Juno Therpeautics was accuried ($9 Billion) by Celegene Corporation (NASDAQ: CELG). These highly expensive cell therapies are limited to only liquid tumors (20% of the cancer market). The TriKE off the shelf technology is a protein (drug) version of CAR-T using the TriKE’s ability to employ NK (Natural Killer) cells from the immune system as the catalyst to target, attack and kill specific cancers.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE) product candidate being initially developed for the treatment AML. GTB-3550 (OXS-3550) is being readied to begin enrolling patients with advanced Acute Myeloid Leukemia (AML) in a Phase I/II expansion clinical trial starting mid- July 2019.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

GTB-1550 (DT2219) top-line Phase I/II expansion clinical trial results have been promising; two patients exhibited a complete remission (CR) with one patient currently disease-free at 50 months post completion of the study. A Phase 2 study is being planned.

About GTB-1550 Multi-Target Directed Bispecific Drug Conjugate

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented, "­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­We are pleased with the progress of our clinical development programs." The HIV TriKE’s possibility to kill the HIV virus would solve a massive economic burden as well as stop infected patients from spreading the disease. Mr. Cataldo also noted that the Company has two key platform technologies to attack cancer: the TriKE platform, and the Multi-Targeted Directed Bispecific Cytotoxic Payload platform. Mr. Cataldo stated, "We believe that these Platform technologies present first-in-class therapeutic opportunities for the Company, and will be the main focus going forward."

On June 10, 2019 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for patients with cancer, reported that it has completed a successful Type B Pre-Biologics License Application (BLA) meeting regarding the approval path for Vicinium for the treatment of patients with high-risk,Bacillus Calmette-Guérin(BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) (Press release, Xoma, JUN 10, 2019, View Source [SID1234539296]). The Company has reached alignment with the U.S. Food and Drug Administration (FDA) on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the Company expects to initiate submission of the BLA in the fourth quarter of 2019. The FDA also indicated that the nonclinical data, the clinical pharmacology data, and the safety database are sufficient to support a BLA submission, and that no additional clinical trials are necessary for a BLA submission.

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Rolling Review of the BLA enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. The final module submission for the BLA will be CMC, and Sesen Bio plans to meet with the FDA in the second half of 2019 to discuss the content and timing of that module.

"We have now had two successful meetings with the FDA over the last three weeks, which build on our long-term relationship with the Agency and make our regulatory path forward for Vicinium even more clear," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Gaining alignment with the FDA on an Accelerated Approval Pathway, in addition to a rolling review of the BLA, significantly increases our confidence in our regulatory pathway and our ability to bring a product to market that has the potential to save and improve the lives of patients."

On May 21, 2019Sesen Bio announced a positive outcome from its previous meeting with the FDA, a Type C CMC meeting, where Sesen Bio reached agreement with the FDA on the Analytical Comparability Plan, and confirmed, subject to final comparability data to be provided in the BLA submission, that no additional clinical trials were deemed necessary for comparability.

Sesen Bio plans to schedule two additional meetings with the FDA in the second half of 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, and a Type B CMC meeting to discuss the submission strategy of the CMC module.

Conference Call Information

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2958515. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium

Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On June 10, 2019 Oncologie, an innovative biopharmaceutical company using proprietary biomarkers to drive clinical development of next-generation oncology therapeutics, reported that it has closed an $80M Series B financing (Press release, Oncologie, JUN 10, 2019, View Source [SID1234536984]). Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined by a syndicate of new investors including Panacea Venture Healthcare and Korea Investment Partners.

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The funding will be used to advance Oncologie’s three clinical stage programs, as well as its proprietary biomarker platform and in-licensing activities. Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. Oncologie’s other programs include a TLR9 activator, lefitolimod, and a unique VEGF-targeting antibody, varisacumab. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic "driver" mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Company will also continue to leverage its platform to identify best-in-class assets for licensing and development.

"Expectations for precision medicine are increasing worldwide. By matching the right drug to the right patient, Oncologie’s innovative biomarker platform is designed to build value by narrowing patient populations, accelerating development timelines and reducing failure," said Laura E. Benjamin, PhD, Founder, President, and CEO. "This funding allows us to accelerate the development of our pipeline and platform, and grow our portfolio through partnering or acquisition."

"Over the past year, Oncologie has assembled an outstanding team of experienced professionals and a robust pipeline around a truly innovative biomarker platform," said Peter Bisgaard, Managing Director for NanFung Life Sciences and Managing Partner of Pivotal BioVenture Partners. "I am particularly excited by Oncologie’s biomarker strategy and approach, which leverages cutting-edge science to optimize patient selection in the challenging arena of the tumor microenvironment. This team has ambitious and strategic growth plan for building a leading oncology therapeutics company around this platform and around a pipeline of next-generation immunotherapies. "