On December 14, 2020 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by leveraging unparalleled insights into protein motion, reported it has entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of RLY-1971, a potent inhibitor of SHP2 (Press release, Relay Therapeutics, DEC 14, 2020, View Source [SID1234572797]). Under the collaboration, Genentech will assume development of RLY-1971 with the potential to expand into multiple combination studies including with Genentech’s investigational inhibitor of KRAS G12C, GDC-6036.

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"RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "Roche and Genentech’s global footprint and deep expertise in oncology makes them the perfect partner for us to execute the broad development and commercialization of RLY-1971."

"Genentech has a longstanding commitment to understanding the underlying biology of KRAS, the most commonly mutated oncogene and an important driver of cancer growth," said James Sabry, M.D., Ph.D., global head of pharma partnering, Roche. "We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors."

Under the terms of the agreement, Relay Therapeutics will receive $75 million in an upfront payment and is eligible to receive $25 million in additional near-term payments. Relay Therapeutics also has the right to opt in to a 50/50 U.S. profit/cost share on RLY-1971. If Relay elects to opt in, then Relay will be eligible to receive 50 percent of profits from U.S. sales and up to $410 million in additional ex-U.S. commercialization and sales-based milestone payments, as well as royalties on ex-U.S. net sales. If Relay Therapeutics elects not to opt in, then Relay will be eligible to receive up to $695 million in additional development, commercialization and sales-based milestones, as well as royalties on global net sales, anticipated to be in the low-to-mid-teens. In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, Relay Therapeutics is eligible to receive additional royalties. Relay Therapeutics retains the right to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3Kα programs.

With the execution of this collaboration, Relay Therapeutics anticipates it will have cash and investments to sustain its operations through 2024.

Conference Call Information

Relay Therapeutics will host a live webcast today beginning at 8:00 a.m. ET to discuss the collaboration. To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. A webcast of the conference call will be available under "News and Presentations" in the Investors & Media section of Relay Therapeutics’ website at View Source The archived webcast will be available on Relay Therapeutics’ website approximately two hours after the conference call and will be available for 30 days following the call.

About RLY-1971

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. Preclinically, RLY-1971 demonstrated significant anti-tumor activity as a monotherapy in cancers with specific alterations as well as in combination with other anti-tumor agents, potentially overcoming or delaying the onset of resistance to those therapies. RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinical trial of RLY-1971, please visit here.

On December 14, 2020 3SBio Inc. ("3SBio")’s subsidiary, Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. ("Sunshine Guojian") and Verseau Therapeutics, Inc. ("Verseau") reported the selection of a monoclonal antibody targeting VSIG4, as a licensed program under their partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, 3SBio, DEC 14, 2020, View Source [SID1234572834]). This is the second licensed program under the partnership agreement signed between the parties in 2019. The first licensed program was granted by Verseau to Sunshine Guojian for VTX-0811, a novel PSGL-1-targeted antibody in the field of immuno-oncology, on November 18, 2019.

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By targeting VSIG4, a type-I receptor from the B7-like family that is highly expressed on tumor-associated macrophages and dendritic cells across most tumor types, the antibody reprograms macrophages and dendritic cells to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Verseau’s anti-VSIG4 antibodies preclinically demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive tumors and non-responsive tumors. VSIG4 is the second unblinded target from Verseau’s pipeline of macrophage checkpoint modulators (MCMs). Verseau’s MCMs reprogram macrophages to be more inflammatory or more tolerogenic depending on the disease context.

"Since entering into a collaboration with 3SBio in 2019, we have made significant progress toward our goal to expand the potential of immunotherapy by developing a pipeline of first-in-class macrophage checkpoint modulators across a broad range of cancer types," said Dr. Tanya Novobrantseva, Chief Scientific Officer of Verseau. "With the selection of a monoclonal antibody targeting VSIG4 as a licensed program under our partnership, we now have two programs in co-development with 3SBio Group’s subsidiary, Sunshine Guojian and look forward to continuing our relationship as we expand our pipeline of both partnered and proprietary programs."

"Early data in patient-derived primary tumors suggest that VSIG4 antibodies could generate a greater anti-tumor inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors," said Dr. Jing Lou, Chairman of 3SBio. "By partnering with Verseau we are now at the forefront of one of the most promising areas of innovation within immuno-oncology, and are making timely progress toward our goal of bringing novel cancer therapies to patients in China."

Under the terms of the agreement, Sunshine Guojian received an exclusive license to develop and commercialize a select number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau retains global rights to all MCM programs outside of Greater China. Verseau is responsible for the discovery and optimization of MCM antibodies for each program. Sunshine Guojian will fund and conduct preclinical antibody development, GMP manufacturing, and commercialization in the Territory.

About VSIG4

VSIG4, a type-I receptor from the B7-like family, is highly expressed on tumor-associated macrophages and dendritic cells across most tumor types. The anti-VSIG4 antibody reprograms macrophages and dendritic cells to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. In patient-derived primary tumors, Verseau’s VSIG4 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumor samples. VSIG4 is the second unblinded target from Verseau’s pipeline of macrophage checkpoint modulators (MCMs). Verseau’s MCMs reprogram macrophages to be more inflammatory or more tolerogenic depending on the disease context.

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While many patients benefit from PD-1 inhibitor therapies, they are only effective in the ~25% of cancers that involve T cell infiltration. By targeting modulation of macrophages, which are present in ~75% of human cancers, Verseau aims to significantly expand the therapeutic benefit of immunotherapy. MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies.

On December 14, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response (Press release, Synlogic, DEC 14, 2020, View Source [SID1234572798]).

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SYNB1891 is being advanced due to acceptable safety at doses evaluated to date, intratumoral injection feasibility, successful escalation to clinically relevant dose levels, and evidence of target engagement and immune system upregulation.

"Our goal is to bring the benefits of immunotherapy to patients fighting cancer who do not have the option of immunotherapies today," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "Synlogic is designing Synthetic Biotic medicines that work uniquely inside the tumor microenvironment, boosting the patient’s immune response and promoting the body’s ability to detect and destroy cancer cells. The interim results of our monotherapy cohorts suggest SYNB1891 is working as designed, upregulating the immune system in the tumor microenvironment via the STING pathway. We are excited to move this study forward."

"The body of data validating our unique approach to immunomodulation with Synthetic Biotic medicines continues to grow," said Dr. Richard Riese, M.D., Synlogic’s Chief Medical Officer. "The investigation of SYNB1891 combined with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) is warranted by the encouraging and consistent results we have seen thus far across preclinical models, tumor response, and biomarkers of target engagement. We would like to thank the investigators, patients, and their families who continue to work closely with us as we advance this novel therapy."

SYNB1891 Highlights

SYNB1891 is being evaluated in a Phase 1, open-label, multicenter study administered by intratumoral injection to patients with advanced, metastatic solid tumors or lymphomas (NCT04167137).
The monotherapy arm of the study has enrolled four dose cohorts to date. A maximum tolerated dose has not been reached. Enrollment of additional monotherapy dose escalation cohorts will continue.
Study results to date across four dose cohorts of SYNB1891 monotherapy demonstrate:
SYNB1891 is safe and well-tolerated at currently evaluated dose levels, as an intratumoral injection in a heterogenous patient population with no dose limiting toxicities or infections to date.
Treatment with SYNB1891 demonstrates activation of the STING pathway and target engagement as assessed by:
Upregulation of IFN-stimulated genes, chemokines, cytokines, and T-cell response
Pharmacodynamic effects including increases in serum cytokines
Evidence of durable stable disease was observed in two patients being treated for metastatic melanoma and metastatic small cell lung cancer. Both patients experienced disease progression on immunotherapy with anti- PD-1/PDL-1 antibodies prior to enrollment in the study.
The combination arm of the study will combine escalating dose levels of SYNB1891 with a fixed dose of the PD-L1 checkpoint inhibitor atezolizumab, to establish a recommended Phase 2 dose for the combination regimen.
The study protocol has been amended to allow for the injection of visceral lesions in addition to cutaneous and subcutaneous lesions in both monotherapy and combination therapy cohorts.
Results of the SYNB1891 Phase 1 study will be presented at a future medical meeting.
The clinical development plan for SYNB1891 is based on compelling research from preclinical studies that demonstrate anti-tumor activity and generation of immunological memory by SYNB1891 in mouse models of cancer, as well as its robust activation of human antigen presenting cells (APCs) that are key to the generation of an anti-tumoral immune response. The Nature Communications publication titled, "Immunotherapy with an engineered bacteria by targeting the STING pathway for anti-tumor immunity," details the engineering and characterization of SYNB1891 (Leventhal, D.S., Sokolovska, A., Li, N. et al. Nature Communications 11, 2739 (2020)).

Learn more about Synlogic’s programs and pipeline by visiting View Source

About SYNB1891
SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic strain of E. coli Nissle that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway. This mechanism can play a critical role in the initiation of an anti-tumor immune response via activation of APCs and presentation of tumor antigens. The bacterial chassis of SYNB1891 also stimulates the innate immune system by several other mechanisms, including via Toll-like receptors (TLRs), potentially adding to the magnitude of the overall immune response. While SYNB1891 has been engineered with safety features that are designed to prevent its replication unless supplemented with specific nutrients, the bacteria remain active for several days within the injected tumor to stimulate a local immune response. SYNB1891 is being evaluated in a Phase 1 clinical trial.

On December 14, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases ("TG Therapeutics"), reported that it has commenced an underwritten public offering of $200,000,000 of its common stock (Press release, TG Therapeutics, DEC 14, 2020, View Source [SID1234572815]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of its common stock.

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TG Therapeutics intends to use the net proceeds of the public offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C., and Cantor Fitzgerald & Co. are acting as joint book-running managers for the proposed offering.

The public offering of common stock is being made pursuant to an automatically effective shelf registration statement previously filed with the SEC on September 5, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204, or email: [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Evercore Group L.L.C, Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: [email protected]; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 14, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that I-Mab’s American Depositary Shares (ADS) have been selected for inclusion in the NASDAQ Biotechnology Index (Nasdaq: NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020 (Press release, I-Mab Biopharma, DEC 14, 2020, View Source [SID1234572835]). The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

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Launched in 1993, the NBI is a modified market-cap weighted index 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 according to the Industry Classification Benchmark (ICB). The NBI, as a major global biotech equity index, is widely followed and tracked by many investors and Exchange Traded Funds (ETF) products worldwide.

Mr. Jielun Zhu, Director and Chief Financial Officer of I-Mab, said, "Since its IPO on Nasdaq in January 2020, I-Mab has successfully executed many important business milestones and significantly elevated its capital market profile. The inclusion in the NBI, following the first annual review by Nasdaq since our IPO, further validates I-Mab’s progress and potential in delivering value to shareholders. We look forward to sharing many more achievements in 2021 and beyond."

According to Nasdaq, the NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume. The index currently has 198 securities as its components. For more information about the NBI, please visit View Source