On November 30, 2021 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) to evaluate NKT2152, a small molecule that inhibits hypoxia inducible factor 2α (HIF2α), in combination with palbociclib, a CDK4/6 inhibitor, and sasanlimab, a subcutaneously administered PD-1 inhibitor for the treatment of advanced clear cell renal cell carcinoma (ccRCC) (Press release, NiKang Therapeutics, NOV 30, 2021, View Source [SID1234596285]). It will comprise two different combination regimens to treat ccRCC patients who have not responded to or relapsed from prior therapies. Under the terms of the agreement, NiKang will sponsor the study, and Pfizer will co-fund the trials and provide its drugs at no cost to NiKang. The two companies will form a Joint Development Committee to oversee this collaboration.

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"We are excited to work with Pfizer, a company that has been a leader in RCC drug development for nearly two decades, and appreciate its recognition of the potential for these important combination strategies in helping ccRCC patients in need. The scientific rationale of these novel combinations is compelling as they target different and complementary pathways," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "This clinical collaboration provides an excellent framework under which both companies pool their proprietary products and resources together to effectively explore the potential of these combination therapies."

NKT2152 is currently in a phase 1/2 dose escalation and expansion trial (NCT05119335). It is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced ccRCC. Once an appropriate dose is identified, combination studies including NKT2152 and Pfizer’s palbociclib and sasanlimab will commence.

On November 30, 2021 Jemincare, a leading pharmaceutical company from China, reported its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., had licensed exclusive worldwide ex-China rights to the Kras inhibitor, JMKX1899, to HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596302]). Jemincare will retain the relevant rights in greater China area.

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Kras is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of Kras in the switch-II region, which has made Kras druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare has filed the IND to NMPA in Oct. 2021. The parties will work closely to file IND in US FDA in 2021 to move towards clinical development.

Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program out-licensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage Kras inhibitor to our oncology pipeline especially to test in combination with our SHP inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."

On November 29, 2021 Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of cancer immunotherapies, reported that it has entered into a strategic multi-year research collaboration with Moffitt Cancer Center ("Moffitt") for pre-clinical development of investigational tumor-infiltrating lymphocyte ("TIL") therapies (Press release, Turnstone Biologics, NOV 29, 2021, View Source [SID1234596188]). The partnership will focus on new clinical candidates utilizing Turnstone’s next-generation selected TIL approach in multiple solid tumor types, in addition to IND submission of Turnstone’s lead TIL program, TIDAL-01.

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"Moffitt has established itself as a leader in the development of cutting-edge cell-based therapies," said Sammy Farah, Ph.D., MBA, President and CEO, Turnstone Biologics. "With Moffitt’s world leading researchers and unique capabilities to support translational research, we believe this collaboration will be crucial in bringing our transformative TIL therapies to people with cancer. We look forward to working closely with the team at Moffitt as we advance our innovative strategy in this field."

Under the terms of the agreement, Moffitt will collaborate on the development of Turnstone’s pipeline of selected TILs for the identification, enrichment and expansion of neoantigen reactive TILs in solid tumor indications, including melanoma, breast and colorectal cancers. Furthermore, Turnstone will transfer their proprietary TIL manufacturing process to Moffitt to produce cell products for upcoming clinical studies of Turnstone’s TIL product candidates. Turnstone will provide financial support for research and development at Moffitt over the multi-year collaboration.

"Turnstone’s strong commitment to support its novel TIL platform and pipeline aligns on Moffitt’s expertise and singular focus on developing truly life altering cancer treatments," said Shari Pilon-Thomas, Ph.D., Associate Member of the Immunology Department at Moffitt Cancer Center. "We are excited to collaborate with Turnstone to help propel the development of TIDAL-01 as well as progress investigation of multiple next-generation TIL immunotherapies with the potential to improve clinical outcomes for cancer patients."

Turnstone’s lead TIL therapy candidate, TIDAL-01, builds on the success of clinically validated treatment protocols while enriching for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients, with the ultimate goal of extending the benefit of TIL therapy across a wider range of solid tumor types. Turnstone aims to drive clinical efficacy in harder to treat, lower mutational burden cancer indications with its TIL platform. The TIDAL-01 program is expected to enter the clinic in early 2022.

On November 29, 2021 Vyant Bio, Inc. ("Vyant Bio", the "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Vyant Bio, NOV 29, 2021, View Source [SID1234596206]). Today, Vyant Bio announced that it will be participating in The Benchmark Company Discovery One-on-One Investor Conference. The event is being held virtually on Thursday, December 2, 2021.

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Conference Date: December 2, 2021 (Thursday)
1:1 Availability: 8:00am-4pmET
Vyant Bio’s Chief Executive Officer, Jay Roberts, will be discussing key highlights from the Third Quarter 2021, the recent addition of Chief Scientific Officer – Dr. Robert Fremeau, and the business and strategic outlook for the remainder of 2021 and into 2022.

If you are an investor and would like to schedule a one-on-one meeting with Vyant Bio during the Discovery One-on-One Investor Conference, please contact your Benchmark representative.

Vyant Bio will also be available for virtual outside 1:1 meetings after The Benchmark Company Discovery One-on-One Investor Conference. Please contact Jennifer K. Zimmons, Ph.D. at [email protected] or +1 917.214.3514 for scheduling.

On November 29, 2021 Quell Therapeutics (Quell) reported $156 million in oversubscribed Series B financing to advance its pioneering multi-modular engineered T Regulatory (Treg) cell therapy pipeline and platform (Press release, UCLB, NOV 29, 2021, View Source [SID1234596189]).

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The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC.

The biotechnology company and world leader in developing engineered (Treg) cell therapies, will use the proceeds raised to fund the clinical development of QEL-001 in liver transplantation, to accelerate development of its product pipeline across transplantation, neuroinflammatory and autoimmune diseases, and enhance its multi-modular engineered Treg platform and manufacturing footprint.

Quell builds on the expertise of leading academics within the Treg, cell engineering, solid organ transplantation and autoimmune disease fields from three world class institutions: UCL, Kings College London (KCL) and Hannover Medical School.

Formed in 2019 Quell provided the opportunity for UCL founders – Professors Hans Stauss and Emma Morris of the Institute of Immunity & Transplantation, to further develop their research and know-how, alongside counterparts at KCL and Hannover Medical School, in turn translating their expertise into medical impact.

"It’s fantastic to see Quell go from strength to strength as it moves a step closer towards generating real patient benefit through leading, cutting edge regulatory T cell expertise." Comments Barny Cox, the UCLB Senior Business Manager who supported Quell throughout its early formation. "Backed by this welcome injection of finance, I look forward to seeing the company grow, building upon its academic foundations as a fine example of the successful translation of pioneering, high-quality scientific research."