On September 1, 2021 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, and The University of Texas MD Anderson Cancer Center reported a global option and license agreement covering certain intellectual property and technology rights regarding Bellicum’s CaspaCIDe (inducible caspase-9, or iC9) safety switch and related technologies, and the use of rimiducid, an agent used to activate the safety switch (Press release, Bellicum Pharmaceuticals, SEP 1, 2021, View Source [SID1234587106]). Under this agreement, MD Anderson will have the option to incorporate CaspaCIDe into certain cellular therapy programs.

Bellicum’s CaspaCIDe safety switch may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next-generation higher potency cell therapy constructs.

"We are excited to expand our CaspaCIDe agreement with MD Anderson to include a broader set of programs to benefit cancer patients," said Rick Fair, President and CEO of Bellicum Pharmaceuticals. "We believe that our switch technology may enhance the benefit/risk profile of cell therapies. We intend to continue to pursue opportunities to expand its use via external collaborations with other leaders in the field."

Upon exercise of each option – typically expected to be upon out-license of an MD Anderson program that incorporates iC9 – Bellicum will receive an upfront payment and will be entitled to a percentage of certain consideration paid to MD Anderson by the third party. Bellicum also will receive a single-digit-percent royalty on global sales of the product. Additional details of the financial arrangements are not disclosed. Bellicum and MD Anderson have agreed on the first two programs for development concurrent with the execution of the agreement. This agreement expands upon a previous one, which covers the use of CaspaCIDe in a specific MD Anderson cell therapy program.

"The unique inducible caspase-9 technology covered by this agreement has the potential to reduce the risk of serious adverse events associated with cellular therapies and to improve patient outcomes," said Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. "We have successfully applied the technology to existing cell therapies, and we look forward to the potential future applications made possible by this agreement."

About CaspaCIDe

CaspaCIDe (inducible caspase-9, or iC9) is Bellicum’s chemical induction of dimerization (CID) safety switch technology designated to eliminate cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. Infusion of rimiducid is designed to trigger activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. In clinical studies, use of CaspaCIDe has resulted in clinical improvement in most patients as early as 24 hours after rimiducid administration. Further, because CaspaCIDe is designed to be permanently incorporated into Bellicum’s cellular therapies, the safety switch has the potential to be available for use when needed long after the initial therapy is delivered.

On September 1, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Bill Newell, Chief Executive Officer, will participate in the 2021 Wells Fargo Securities Healthcare Conference during a virtual fireside chat on Thursday, September 9, at 3:20 p.m. ET / 12:20 p.m. PT (Press release, Sutro Biopharma, SEP 1, 2021, View Source [SID1234587129]).

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A live webcast of the presentation will be accessible through the News and Events page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

On September 1, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that Ofer Haviv, Evogene’s President and CEO, will present at the H.C. Wainwright 23rd Annual Global Investment Conference, 2021, taking place from September 9-15, 2021 (Press release, Evogene, SEP 1, 2021, https://www.prnewswire.com/news-releases/evogene-to-present-at-hc-wainwright-23rd-annual-global-investment-conference—2021-301367032.html [SID1234587128]). Mr. Haviv’s presentation will focus on Evogene’s disruptive technologies, its tailor-made engines for product discovery and development and its fields of activity through its main subsidiaries, and will take place on Thursday September 9, 2021, at 07:30 am, EST.

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Investors attending the conference who wish to meet with Mr. Haviv, may contact Evogene’s Investor Relations team at [email protected] or through the conference’s online meeting platform.

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 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.