On February 24, 2021 Vividion Therapeutics, Inc., a biotechnology company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, reported the completion of a $135 million Series C financing, co-led by new investors, Logos Capital and Boxer Capital of Tavistock Group (Press release, Vividion Therapeutics, FEB 24, 2021, View Source [SID1234575504]). Additional new investors in the raise include SoftBank Investment Advisers, Avoro Capital Advisors, funds and accounts managed by BlackRock, RA Capital Management, funds and accounts advised by T. Rowe Price Associates, Inc., Surveyor Capital (a Citadel company), Woodline Partners LP, Acuta Capital and Driehaus Capital Management, alongside existing investors ARCH Venture Partners, BVF Partners L.P., Casdin Capital, Mubadala Capital, Nextech Invest and Versant Ventures.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Vividion has made significant progress advancing drug discovery beyond the traditional boundaries of druggability. By leveraging our unique platform technologies, we are building a robust pipeline of precision oncology and immunology programs," said Jeffrey Hatfield, chief executive officer of Vividion. "We’re excited to have attracted such a distinguished group of healthcare investors, whose support will be instrumental in fueling the continued maturation of our broad pipeline, with the intention of beginning to advance programs into the clinic next year."

Vividion has integrated multiple emerging technologies in its platform that enable the company to discover and develop potential therapies for well-known but previously undruggable targets. The platform conveys the unique ability to: find unknown or cryptic functional pockets on high value targets; interact with those pockets using its first-in-kind, proteome-trained covalent chemistry library; and ensure precise selectivity across the entire proteome with its industrial scale chemoproteomics capabilities. Leveraging this platform, Vividion is advancing a pipeline of potent and selective small molecule therapies across a range of oncology and immunology indications. The company’s initial wave of wholly owned assets includes programs targeting the KEAP1-NRF2 axis, with antagonists for the treatment of NRF2 mutant and NRF2 addicted cancers, as well as agonists for the treatment of inflammatory diseases. Also in the initial wave, and in partnership with Bristol Myers Squibb, the company is advancing a program against a highly pursued yet unsolved transcription factor for the treatment of both oncology and immunology indications.

"The science behind Vividion’s approach to drugging the undruggable space and accessing some of the world’s most highly sought-after targets has the potential to solve a wide range of devastating cancer and immune disorders," said Arsani William, M.D., M.B.A. and Graham Walmsley, M.D., Ph.D. of Logos Capital. "Our investment philosophy at Logos is centered upon propelling innovation that meaningfully advances the standard of care for patients. The combination of a leading-edge platform, robust pipeline, strategic partnerships with leading pharmaceutical companies BMS and Roche, and a deeply experienced team sets Vividion apart. We are honored to support the team’s efforts in both the near- and longer-term."

Aaron Davis, chief executive officer of Boxer Capital, LLC, added, "We believe this company is building a remarkable early pipeline of precision oncology and immunology therapies that can have transformative value for patients in traditionally unserved or vastly underserved disease indications. At Boxer, our mission is to enable the most innovative biotechnology companies to drastically improve medicine, and we are delighted to help Vividion accelerate into the next phase of its evolution and toward achieving that goal."

On February 23, 2021 Graviton Bioscience Corporation ("Graviton"), a privately held early-stage drug development company founded by Dr. Samuel Waksal, and Beijing Tide Pharmaceutical Co., Ltd. (Beijing Tide) a subsidiary of Sino Biopharmaceutical Limited (HKG:1177), reported the signing of an exclusive license agreement for TDI01 (Press release, Graviton Bioscience, FEB 23, 2021, View Source [SID1234576629]). The agreement grants development and commercialization rights for TDI01 to Graviton in all territories, excluding China. Under the terms of the agreement, Graviton will make an upfront payment and additional amounts for development, regulatory and sales milestone payments for all programs, as well as royalties on net sales and an option for a revenue-sharing arrangement for certain developed products. The aggregate amount of upfront, development, regulatory and sales milestone payments is up to USD 517.5 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

TDI01 is a targeted inhibitor of Rho/Rho containing protein kinase 2 (ROCK2). In 2020, an Investigational New Drug application for evaluation of TDI01 in fibrosis was cleared by the FDA, and a clinical trial application for the treatment of fibrosis was filed and accepted by the Center for Drug Evaluation of the People’s Republic of China. A Phase I clinical trial of the drug candidate in idiopathic pulmonary fibrosis is currently ongoing in the United States. Graviton expects to develop this novel therapeutic for the treatment of various serious diseases, including exploration of TDI01’s ability to penetrate the central nervous system, and the translation of efficacy demonstrated in certain preclinical cancer models as well as models of certain viral diseases.

"There remains a tremendous unmet need for novel, safe and effective therapies against a broad spectrum of diseases globally," said Dr. Waksal, Founder of Graviton. "Having pioneered the field in targeting ROCK2 mediated disease, I believe that the extraordinarily high selectivity and potency engineered by Beijing Tide in developing TDI01 offers great potential in advancing the next-generation of ROCK2 therapeutics. We look forward to moving TDI01 into different clinical studies in the U.S. as quickly as possible, and to begin elucidating this potential in the coming quarters."

"TDI01 is the first innovative small molecule in the clinical phase developed by Beijing Tide, and it shows great potential in treating a variety of diseases," said Sino Biopharmaceutical Limited’s Chairlady Theresa Tse. "We believe that collaborating with the experienced scientific team at Graviton would not only maximize the value of TDI01, but also accelerate the clinical development in both China and US. We look forward to initiating multiple clinical studies for different indications very soon."

On February 23, 2021 Graviton Bioscience Corporation ("Graviton"), a privately held early-stage drug development company founded by Dr. Samuel Waksal, and Beijing Tide Pharmaceutical Co., Ltd. (Beijing Tide) a subsidiary of Sino Biopharmaceutical Limited (HKG:1177), reported the signing of an exclusive license agreement for TDI01 (Press release, Graviton Bioscience, FEB 23, 2021, View Source [SID1234576625]). The agreement grants development and commercialization rights for TDI01 to Graviton in all territories, excluding China. Under the terms of the agreement, Graviton will make an upfront payment and additional amounts for development, regulatory and sales milestone payments for all programs, as well as royalties on net sales and an option for a revenue-sharing arrangement for certain developed products. The aggregate amount of upfront, development, regulatory and sales milestone payments is up to USD 517.5 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

TDI01 is a targeted inhibitor of Rho/Rho containing protein kinase 2 (ROCK2). In 2020, an Investigational New Drug application for evaluation of TDI01 in fibrosis was cleared by the FDA, and a clinical trial application for the treatment of fibrosis was filed and accepted by the Center for Drug Evaluation of the People’s Republic of China. A Phase I clinical trial of the drug candidate in idiopathic pulmonary fibrosis is currently ongoing in the United States. Graviton expects to develop this novel therapeutic for the treatment of various serious diseases, including exploration of TDI01’s ability to penetrate the central nervous system, and the translation of efficacy demonstrated in certain preclinical cancer models as well as models of certain viral diseases.

"There remains a tremendous unmet need for novel, safe and effective therapies against a broad spectrum of diseases globally," said Dr. Waksal, Founder of Graviton. "Having pioneered the field in targeting ROCK2 mediated disease, I believe that the extraordinarily high selectivity and potency engineered by Beijing Tide in developing TDI01 offers great potential in advancing the next-generation of ROCK2 therapeutics. We look forward to moving TDI01 into different clinical studies in the U.S. as quickly as possible, and to begin elucidating this potential in the coming quarters."

"TDI01 is the first innovative small molecule in the clinical phase developed by Beijing Tide, and it shows great potential in treating a variety of diseases," said Sino Biopharmaceutical Limited’s Chairlady Theresa Tse. "We believe that collaborating with the experienced scientific team at Graviton would not only maximize the value of TDI01, but also accelerate the clinical development in both China and US. We look forward to initiating multiple clinical studies for different indications very soon."

On February 23, 2021 Race Oncology Limited (ASX: RAC) reported to share further interim results of our continuing collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, FEB 23, 2021, View Source [SID1234576448]). Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute is leading the project .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The aim of this recent preclinical research program is to explore Bisantrene efficacy in ovarian cancer. Bisantrene was the subject of two-Phase II clinical trials in the USA in advanced ovarian cancer patients in the 1980s. These trials showed that Bisantrene was able to induce a clinical response in heavily pre-treated ovarian cancer patients, including those resistant to doxorubicin and other standard of care drugs of the period.

Early results show Bisantrene to be an effective chemotherapeutic agent in patient- derived ovarian cancer cell lines. Bisantrene was able to kill these cancer cells that were resistant to the current standard of care ovarian drugs, cisplatin, 5-fluorouracil and chlorambucil.

Race’s CSO Dr Daniel Tillett commented "These initial results from Nikki’s team further highlight Bisantrene’s potential use in ovarian cancer patients as a safer alternative to the commonly used anthracyclines which can be very dangerous to the hearts of patients. It is highly encouraging that bisantrene is able to kill ovarian cancer cells resistant to currently used treatments and these findings support further exploration of the use of Bisantrene in ovarian cancer patients."

Race’s CEO Mr Phillip Lynch added, "We continue to generate results reconfirming the historical positives for Bisantrene, in this case in ovarian cancer, the 5th most common form of cancer in women. Race Oncology has a broad range of opportunities, ovarian cancer included. This program is further evidence of Race delivering against the Three Pillar strategy, taking counsel, and completing feasibility assessments with a view to mapping promising yet attainable clinical paths for Bisantrene."

On February 23, 2021 AbbVie and Caribou Biosciences, Inc reported that the companies have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR) T-cell therapeutics (Press release, Caribou Biosciences, FEB 23, 2021, View Source [SID1234575782]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The terms of the multi-year agreement will allow AbbVie to utilize Caribou’s next-generation Cas12a clusters of regularly interspaced short palindromic repeats (CRISPR) hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to research and develop 2 new CAR T-cell therapies. AbbVie will be given exclusive rights to Cas12a for the targets of their choosing. Caribou will perform certain pre-clinical research, development, and manufacturing activities for the collaboration programs, while AbbVie will handle development, commercialization, and other manufacturing efforts.1,2

A $40 million upfront cash payment and equity investment will be directed to Caribou, as well as up to $300 million in future development, regulatory, and launch milestones. Additionally, there will be the potential for Caribou to receive additional payments for commercial milestones and global tiered royalties. AbbVie has the option to expand the collaboration to include an additional 2 CAR T -cell therapies for a fee.1

"Caribou’s next-generation CRISPR genome editing technologies hold broad promise for new therapy development," Rachel Haurwitz, PhD, president and CEO of Caribou said in an interview with OncLive. "A partnership with AbbVie allows Caribou to increase the number of targets and diseases addressable by these technologies. It’s an important opportunity to expand upon what we hope to do for patients. The collaboration is also an important validation of Caribou’s differentiated next-generation CRISPR genome editing technologies."

CRISPR gene editing technology utilizes modular, biological tools to induce DNA changes in living cells. The 2 basic components of CRISPR systems are the nuclease proteins and the RNA molecules. The nuclease proteins cut DNA while the RNA molecules guide the nuclease to generate a site-specific, double-stranded break, which result in editing at the targeted genomic site. CRISPR systems are differentiated by the presence of a class 1 multiprotein effector complex or a class 2 single effector protein.2,3

CRISPR systems have been shown to achieve several different types of genetic modifications in different types of cells. CRISPR techniques have achieved recombination, engineered immunity, mutagenesis, and donor-mediated gene disruption in bacteria, yeast, and filamentous fungi cells. The technique has also been used to achieve RNA-guided gene editing in multiple human cell lines with high specify and efficiencies of up to approximately 50%.3,4

CRISPR systems can sometimes unintentionally edit certain genomic sites, leading to harmful effects on cellular function. Caribou’s chRDNAs are highly specific RNA-DNA hybrid guides that are used in combination with CRISPR to direct more precise genome editing.2

"Caribou utilizes CRISPR hybrid RNA-DNA guides that contain both DNA and RNA nucleotides," Haurwitz explained. "These hybrid guides drive much more specific genome editing than all RNA guides. Caribou uses chRDNA guides in concert with a CRISPR enzyme to develop complex immune cell therapies."

By using CRISPR technology to engineer CAR T-cells to withstand host immune attack, Caribou hopes to develop "off-the-shelf" cellular therapies aimed at benefitting a broad patient population. The company is currently focusing on genome-edited off-the-shelf allogenic CAR T-cell and natural killer cell therapies for the treatment of patients with intractable malignancies.5

Current programs in the discovery phase include CB-011 and CB-012 which use T cells to target BCMA and CD371 for patients with hematologic malignancies, respectively. Another product, CB-020, focuses on using natural killer cells therapies for an undisclosed target for patients with solid tumors. The CB-010 program, currently in phase 1 exploration, uses T cells to target CD19 and for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.5

"I am excited about the opportunity for our companies to collaboratively develop 2 additional CAR T- [cell products], expanding upon the total number of therapies Caribou’s technologies underpin," Haurwitz concluded.