On December 16, 2021 InveniAI LLC, a global leader in applying Artificial Intelligence (AI) and Machine Learning (ML) to transform drug discovery and development, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that expanded their longstanding relationship with a new, multiple drug discovery agreement (Press release, Kyowa Hakko Kirin, DEC 16, 2021, View Source [SID1234597306]). The collaboration will provide Kyowa Kirin with access to InveniAI’s AI Innovation Lab and AI Technology Platform, AlphaMeld, to expand the scope of Kyowa Kirin’s drug discovery programs.

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The agreement builds on an ongoing partnership between InveniAI and Kyowa Kirin that began in 2018. The collaboration enables Kyowa Kirin to access InveniAI’s AI technology platform, AlphaMeld, its AI Innovation Lab, and a dedicated team of experts to drive drug discovery efforts across Kyowa Kirin’s therapeutic areas, platforms, and modalities. InveniAI and Kyowa Kirin are now standing at the intersection of state-of-the-art biotechnology and digital technology. Both scientists will work together more interactively to generate innovative drug candidates.

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin, said, "We are excited about the strategic expansion of our partnership, as it is designed to seamlessly integrate InveniAI’s AI capabilities with our therapeutic platforms to facilitate the discovery of valuable new therapies for patients. Our collaboration, to date, is a testament to the importance of a data-driven approach, and through our partnership with InveniAI, we are embracing the undeniable advantage of technology-aided drug discovery and development."

"We are pleased to expand our collaboration with Kyowa Kirin, with whom we share a common philosophy of leveraging data and technology to de-risk drug development and deliver better therapies to patients more efficiently. By leveraging our longstanding relationship and combined capabilities – including drug discovery and development infrastructure, and a proven AI platform –we believe we can rapidly achieve this objective," said Krishnan Nandabalan, Ph.D., President and CEO, InveniAI LLC. "InveniAI is the only AI company with a track record that includes an AI-identified candidate that has undergone successful Phase 3 trials and an NDA submission, in addition to ten other programs at various stages of development. We remain excited about harnessing the potential of this platform for both industry partnerships and our internal drug portfolio."

Under the terms of the collaboration, InveniAI will receive a committed annual research funding fee for the duration of the collaboration term and obtain rights to receive milestone payments and royalties on sales from Kyowa Kirin.

About AlphaMeld
AlphaMeld is an AI-based platform powered by machine learning algorithms that accelerates innovation by identifying alpha signals for targets, drugs, and healthcare products and technologies. The platform generates testable hypotheses by leveraging the TranslationalEdge and ModalityFit AI tools we have developed that take into account an ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations. AlphaMeld operates in real-time and in a rapidly changing and diverse data environment.

On December 16, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported dose administration for the first patient in KURRENT, the Company’s Phase 1/2 clinical trial of tipifarnib in combination with alpelisib in patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) (Press release, Kura Oncology, DEC 16, 2021, View Source [SID1234597305]).

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"Despite the approval of immunotherapy, the treatment of recurrent and metastatic HNSCC remains a significant unmet need," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The KURRENT trial builds on the impressive clinical activity reported for tipifarnib as a monotherapy in HRAS mutant HNSCC and represents an opportunity to significantly expand the potential patient population and target mechanisms of drug resistance."

Tipifarnib is Kura’s farnesyl transferase inhibitor drug candidate currently in a registration-directed trial as a monotherapy in patients with HRAS mutant HNSCC. Novartis’ alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against the PI3Kα isoform. Preclinical data suggests that HRAS and PI3kα are co-dependent oncogenes in HNSCC, and that combining tipifarnib with a PI3Kα inhibitor has the potential to provide meaningfully greater antitumor activity, relative to inhibiting either target alone.

Earlier this year, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and alpelisib in patients with HNSCC whose tumors have HRAS overexpression or PIK3CA mutation and/or amplification. Under the collaboration, Kura maintains global development and commercial rights to tipifarnib.

About KURRENT

The KURRENT trial is a biomarker-defined cohort study designed to evaluate the safety, determine the recommended combination dosing and assess early anti-tumor activity of tipifarnib and alpelisib for the treatment of HNSCC patients whose tumors are dependent on HRAS and/or PI3Kα pathways. These patients account for approximately 50% of HNSCC, according to The Cancer Genome Atlas (TCGA). The initial cohort in the trial is comprised of patients who have PIK3CA-dependent HNSCC. For more information about the trial, refer to www.kuraoncology.com/kurrent/.

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

About Tipifarnib

Tipifarnib is a potent, selective and orally bioavailable inhibitor of farnesyl transferase, which has been granted Breakthrough Therapy and Fast Track Designations by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

On December 16, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that it has been selected for addition to the NASDAQ Biotechnology Index ("NBI") (Press release, Kinnate Biopharma, DEC 16, 2021, View Source [SID1234597304]). Kinnate’s addition to the NBI will become effective prior to market open on Monday, December 20, 2021.

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The NBI is designed to track the performance of a set of securities listed on The NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical companies, and is a modified market capitalization weighted index. The NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume, among other criteria.

"We are pleased to be added to the NASDAQ Biotechnology Index and see it as reflection of the progress we have made this year," said Nima Farzan, Chief Executive Officer of Kinnate. "2021 has been transformative for Kinnate and the inclusion in this index will enable greater awareness about Kinnate’s mission and pipeline."

On December 16, 2021 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported an update from the ongoing Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT) (Press release, In8bio, DEC 16, 2021, View Source [SID1234597303]). The three patients with relapsed acute myeloid leukemia (AML) treated to date demonstrate that allogeneic gamma-delta T cell therapy has a manageable toxicity profile with the potential for durable responses in high-risk patients. Haploidentical HSCT patients have high relapse rates of up to 50% at one-year post-treatment. All three of the INB-100 treated patients remain in remission with two patients in remission at 18 and 20 months, respectively. No treatment-related grade 3 or greater adverse events, infusion reactions or dose-limiting toxicities were observed. The trial continues to track these patients and enroll additional patients.

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"We believe that the encouraging early data from the first patients dosed in this clinical trial suggest the potential of gamma-delta T cells to offer a novel treatment option for patients with aggressive hematologic malignancies," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "Multiple complete responses with durability greater than 1.5 years is especially promising for patients with high-risk leukemias, who have high rates of post-HSCT relapse. The absence of grade 3 or greater graft versus host disease (GvHD) 100 days post gamma-delta T cell infusion is also encouraging for an allogeneic therapy. We continue to enroll patients in this Phase 1 clinical trial and look forward to reporting additional data from this program in 2022."

This Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic, or donor-derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date, including patients with trisomy 8, del7 mutations. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.

The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.

On December 16, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will hire and deploy an additional 20 salespeople, bringing the total number of oncology sales representatives to 34 (Press release, G1 Therapeutics, DEC 16, 2021, View Source [SID1234597302]). The expansion will allow G1 to target all accounts to accelerate sales activities and help maximize the adoption of COSELA (trilaciclib). G1 and Boehringer Ingelheim have mutually agreed to end the co-promotion agreement for COSELA, effective March 2022.

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"We want to thank Boehringer Ingelheim for their support in laying the early commercial groundwork during the first year of COSELA’s availability in the U.S.," said Andrew Perry, Chief Commercial Officer of G1 Therapeutics. "We are well along in the process of hiring our COSELA-focused sales force; these experienced oncology sales professionals have existing relationships at target organizations and are prioritizing prescriber access, which is the key to execution and adoption of new therapies like COSELA. Our goal is to drive as quick an impact as possible from this effort, and as such we are hiring, training, and deploying these individuals into the field as they arrive. We have already hired 13 of these field-based professionals, deployed seven, and expect to have the full team of 34 in place and deployed by mid-February 2022."

Under the terms of the termination agreement, Boehringer Ingelheim and G1 will work together on transitioning promotional activities by March 2022. After that point, Boehringer Ingelheim will receive reduced payments based on net sales of COSELA for patients with ES-SCLC in the U.S. until March 2024. There are no payments due by either party beyond March 2024. The Co-Promotion Agreement does not extend to additional indications that G1 may pursue for trilaciclib.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to discuss the expansion of the COSELA sales force. The live call may be accessed by dialing (866) 763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 8549816. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source