On September 1, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics (Shanghai) Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, reported that they have entered into an exclusive license agreement for the development and commercialization of GenFleet’s lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization (Press release, Innovent Biologics, SEP 1, 2021, View Source [SID1234587125]).

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GFH925, GenFleet’s lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies.

According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China.

GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets.

Dr. Yongjun Liu, President of Innovent said, stated, "GenFleet has rich experience in research and development and has built up a proprietary pipeline of large and small molecule assets. We are delighted to form this strategic collaboration with GenFleet. Innovent is deeply engaged in the oncology area having built up a robust oncology pipeline of 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of over 2000 people. KRAS G12C is an important mutation in multiple tumor types such lung cancer and solid tumors. Innovent has established a wide coverage on major tumor types including lung cancer. The collaboration on GFH925 will explore its potentials in clinical trials for both mono therapy and combination therapy such as combination with PD-1 which can further enhance our coverage in oncology area. By leveraging our synergy in clinical development and commercialization, we hope to expedite the development and launch of GFH925. Meanwhile, KRAS inhibitor has a promising global market potential. With the option-in rights for global development and commercialization, we look forward to bringing GFH925 as a new and more effective treatment option to patients both in China and globally.

Dr. Jiong Lan, CEO of GenFleet Therapeutics, stated, "We are pleased to announce our first major out-license collaboration with Innovent, an industry leading biopharmaceutical company which has demonstrated many successful track records of developing and commercializing novel anti-cancer therapies. RAS used to be an undruggable target and there was no KRAS G12C inhibitor moving into the clinics when GenFleet started the program, which highlights our "globally new" pipeline strategy that focuses on novel mechanisms of action. The partnership is not only a recognition of GFH925, a KRAS/G12C inhibitor with potential best-in-class differentiation, but also GenFleet’s internal discovery and development capability as well. The global scope of this collaboration will benefit not only patients in China, but also those throughout the world. In addition, we share the same vision of swiftly tackling unmet medical needs and the same culture of agile R&D in a biotech setting.

Professor Yilong Wu, Director of Guangdong Lung Cancer Institute, stated, "KRAS mutation is widespread among patients of non-small cell lung cancer, pancreatic cancer, colorectal cancer, etc. Preclinical data has shown that GFH925 is differentiated from other KRAS G12C inhibiting products, and we look forward to positive results of GFH925’s safety/tolerability and efficacy. Moreover, we will optimize our precision treatment plans and pave the way for the potential of combination therapies for patients with KRAS G12C gene mutation."

About GFH925 (KRAS G12C Inhibitor)

Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

On September 1, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the closing of an oversubscribed Series B financing, which raised $108 million (Press release, Asher Biotherapeutics, SEP 1, 2021, View Source [SID1234587090]). The financing was led by Wellington Management Company LLP, and included new investors RA Capital Management, Janus Henderson Investors, Logos Capital, Marshall Wace and Alexandria Venture Investments, and, along with existing investors Third Rock Ventures, Invus, Boxer Capital of Tavistock Group, Mission BioCapital, and other undisclosed institutional investors.

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"We are pleased to announce this Series B financing and we are tremendously grateful to our new and existing investors for their support and commitment to our goal of delivering a new class of biotherapeutics, with superior selectivity and broad applicability across multiple tumor types, as well as infectious and autoimmune diseases," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Since our founding, we have made significant progress validating the modularity and broad applicability of our cis-targeting platform, achieving preclinical proof-of-concept for our first three pipeline programs and building our team into a sustainable organization, with the depth and capabilities to exploit the full potential of our novel immunotherapies. This funding will enable us to accelerate the development of AB248, while continuing to drive our additional programs forward with urgency, as we aim to restore hope, health and happiness in the lives of patients."

Asher Bio aims to advance a portfolio of cis-targeted therapies derived from diverse cytokines and cell-types, each designed to address the challenge of pleiotropy that limits the efficacy and tolerability of many immunotherapies. By engaging two receptors on the same cell for activation, an immunomodulatory receptor for therapeutic action and a specific target receptor for directing the therapy to the desired cell type, Asher Bio’s cis-targeted immunotherapies seek to offer a new level of selectivity, with the potential to deliver superior clinical outcomes and an improved safety profile.

"We are encouraged by Asher Bio’s tremendous progress since launch, including the generation of new preclinical data that further validates the company’s unique cis-targeting approach," said Jeffrey Tong, Ph.D., Partner at Third Rock Ventures. "We believe cis-targeted immunotherapies may be able to overcome the selectivity challenges that prohibited first-generation cytokine immunotherapies from achieving their full therapeutic potential, ultimately providing better outcomes to patients by offering improvements in both efficacy and safety. We are pleased to continue supporting the Asher team as it applies its platform to address some of the most significant unmet needs in oncology, infectious and autoimmune diseases."

Proceeds from this financing will enable Asher Bio to fund its lead cis-targeted immunotherapy, AB248, through clinical proof-of-concept, while advancing a second program through investigational new drug (IND)-enabling studies and continuing to invest in its cis-targeting platform. Asher Bio expects to file an IND application for AB248 with the U.S. Food and Drug Administration in the third quarter of 2022. AB248 is an engineered interleukin-2 (IL-2) immunotherapy designed to specifically target CD8+ effector T cells. In preclinical and IND-enabling studies, AB248 has evidenced a highly differentiated profile, selectively expanding CD8+ T-cells, while avoiding immune cell subtypes associated with toxicities and immunosuppressive effects, resulting in enhanced anti-tumor efficacy and improved tolerability. The Series B funding will also support Asher Bio’s development of additional targeted immunotherapies, including a CD8+ T‑cell cis-targeted STAT3 cytokine and a CAR-T cis-targeted IL-2, both of which have demonstrated preclinical proof-of-concept.

"We designed our cis-targeting platform to leverage a systematic, modular process, which can be applied across an array of immunomodulatory molecules and cell types," said Ivana Djuretic, Ph.D., Co-Founder and Chief Scientific Officer of Asher Bio. "This enables us to continuously apply learnings from our research and development efforts across our earlier-stage portfolio, rapidly creating and de-risking additional programs. With this financing, we will be able to invest more aggressively in our next wave of novel therapeutic candidates, accelerating not only the development of AB248, but the advancement of our second program through IND-enabling studies."

On September 1, 2021 NuCana plc (NASDAQ: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will participate in three upcoming virtual investor conferences (Press release, Nucana BioPharmaceuticals, SEP 1, 2021, View Source [SID1234587108]).

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Event: Citi’s 16th Annual BioPharma Virtual Conference
Dates: September 8-10, 2021

Event: H.C. Wainwright 23rd Annual Global Investment Conference
Dates: September 13-15, 2021

Event: Oppenheimer’s Virtual Fall Healthcare Life Sciences & MedTech Summit
Presentation Date: Wednesday, September 22, 2021
Presentation Time: 9:05 AM ET

A pre-recorded webcast of the presentation at the H.C. Wainwright 23rd Annual Global Investment Conference will be made available on the Company’s website starting on Monday, September 13, 2021, at 7:00 AM ET. The presentation at the Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit will be webcast live. Both presentations will be available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On September 1, 2021 OncoQuest Pharmaceuticals Inc., ("OncoQuest") a clinical-stage biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer, reported the first patient enrolled in each of two investigator initiated clinical trials assessing the safety and efficacy of oregovomab in a previously treated recurrent ovarian cancer setting (Press release, OncoQuest, SEP 1, 2021, View Source [SID1234587126]).

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The first study, led byProf. Jung KH, is being conducted at three centres in Korea (Korea Anam Hospital, Seoul St. Mary’s Hospital and Seoul Asan Hospital). This is a Phase 1b/2 clinical trial evaluation of the safety and efficacy of oregovomab when used in combination with bevacizumab, paclitaxel, and carboplatin in subjects with platinum sensitive recurrent ovarian cancer. Oregovomab has previously been established to augment the activity of carboplatin and paclitaxel through immune stimulation, and bevacizumab augments the activity of carboplatin and paclitaxel by inhibiting angiogenesis. The study will establish the safety and compatibility of the combination of these agents as possible approaches in patient management(ClinicalTrials.gov Identifier: NCT04938583). This study is supported by Korean Government’s K-Master program (KM-21) under the guidance of Prof. Kim YH at the Korea University Anam Hospital and Professor Park KH at Korea University College of Medicine.

The second study (ORION-02), led by Clinical Assistant Professor Jack Chan, is being conducted at a single centre in Singapore (National Cancer Centre Singapore). This is a Phase 1/2 clinical trial evaluation of the safety and efficacy of platinum-based chemotherapy, oregovomab and the PD-1 blockade agent, nivolumab, in subjects with platinum sensitive recurrent epithelial cancer of ovarian, tubal, or peritoneal origin (ClinicalTrials.gov Identifier: NCT04620954). The safety of oregovomab in combination with nivolumab has already been established in the ORION-01 study (ClinicalTrials.gov Identifier: NCT03100006).

OncoQuest has completed a Phase II study using oregovomab in combination with a TLR-3 agonist (Hiltonol) in the recurrent ovarian cancer setting (ClinicalTrials.gov Identifier: NCT03162562). Oregovomab is currently being tested in a global Phase III study in 12 countries in combination with carboplatin and paclitaxel chemotherapy in the front-line ovarian cancer setting (ClinicalTrials.gov Identifier: NCT04498117).

"We are committed to continue to work with investigators to explore the potential of oregovomab in combination therapies for treating ovarian cancer in both front line and recurrent settings. Progress in this area began in collaboration with Dr. Alan Gordon (Gynecologic Oncology2004 94:340-351) that identified potential favourable interactions between oregovomab and both carboplatin and doxorubicin in the recurrent disease setting. Those initial results led eventually to the observations recently reported by Brewer et al (Gynecologic Oncology 2020 156:523-529) that combining oregovomab with carboplatin and paclitaxel in a front-line setting improves outcomes", said Dr. Madiyalakan, Chairman of OncoQuest. OncoQuest is also in the process of initiating a clinical trial using oregovomab with niraparib in the recurrent ovarian cancer setting. "These additional clinical studies will guide us to select the optimal combinations for treatment throughout the course of this difficult disease," added Dr. Madiyalakan.

About Oregovomab.

Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in this phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab demonstrated a highly clinically significant outcome for both progression-free and overall survival favoring the addition of oregovomab to a standard of care chemotherapy combination of carboplatin and paclitaxel. The risk of progression and of death was reduced by more than 50% when compared to placebo, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecologic Oncology (2020 156:523-529) and Cancer Immunology and Immunotherapy (2020 69: 383-397), respectively.

On September 1, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported that company management will participate in three virtual investor conferences in September 2021 (Press release, Shattuck Labs, SEP 1, 2021, View Source [SID1234591768]).

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Presentation Details

Conference: Citi 16th Annual BioPharma Virtual Conference
Format: Panel Discussion, "Framing the Tip of the Spear for Novel Antibodies and Protein Therapeutics"
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 9, 2021
Time: 1:25 p.m. EST

Conference: H.C. Wainwright 23rd Annual Global Investment Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 13, 2021
Time: 7:00 a.m. EST

Conference: Morgan Stanley 19th Annual Global Healthcare Conference
Format: Fireside Chat
Presenters: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer and Andrew Neill, M.B.A., Shattuck’s Chief Financial Officer
Date: September 15, 2021
Time: 11:45 a.m. EST

A live webcast of the panel discussion, corporate presentation, and fireside chat will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.