On October 21, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported the pricing of an underwritten public offering of 7,576,000 shares of its common stock at a price to the public of $19.80 per share (Press release, Crinetics Pharmaceuticals, OCT 21, 2021, View Source [SID1234591685]). All of the shares to be sold in the offering are to be sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $150.0 million. In addition, Crinetics has granted the underwriters a 30-day option to purchase up to an additional 1,136,400 shares of common stock. The offering is expected to close on or about October 25, 2021, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the offering to fund the development of paltusotine, CRN04894, CRN04777 and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink, Evercore ISI and Cantor are acting as joint bookrunning managers for the offering. H.C. Wainwright & Co. is acting as lead manager and JonesTrading is acting as co-manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to this offering has been filed with the SEC and a final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]; from: Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On October 21, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has entered into a Research Collaboration and License Option Agreement with LegoChem Biosciences, Inc. ("LCB", KOSDAQ: 141080) for new antibody-drug conjugates (ADCs) (Press release, Antengene, OCT 21, 2021, View Source;license-option-agreement-with-legochem-biosciences-for-new-antibody-drug-conjugate-candidates-301405417.html [SID1234591684]).

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Under this agreement, the two parties will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next generation ADC technology platform. Antengene will have an exclusive option to license global rights for the development and commercialization of the resulting ADC candidates. When the option is exercised, LCB will be eligible to receive upfront and milestone payments, as well as tiered royalties. In addition, LCB is eligible to receive a prespecified percentage of any sublicensing income received by Antengene.

ConjuAll is a next-generation ADC platform technology utilizing novel linker chemistry combined with site-specific conjugation. LCB’s platform provides solutions for site-specific conjugation enabling high-purity final ADCs with defined Drug-to-Antibody Ratio (DAR), plasma stability, and tumor-selective efficient payload release which are major unmet needs in ADC development.

"It is our pleasure to collaborate with LCB, a company with an industry-leading ADC technology platform," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. " This further complements our existing in-house discovery efforts and our deep experience in developing novel oncology medicines globally. Utilizing LCB’s next generation ADC platform, we aim to accelerate the discovery and development of innovative ADC candidates, furthering our vision of treating patients beyond borders worldwide."

"LCB and Antengene will team up to accelerate the development of new therapies that combine Antengene’s expertise in oncology with LCB’s clinically validated ADC technology platform." said Dr. Yong-Zu Kim, CEO & President of LCB.

On October 21, 2021 Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, reported its two lead conditional inhibitor programs: an inhibitor of TEAD for the treatment of solid tumors, such as mesothelioma and certain squamous cell carcinomas; and a highly selective inhibitor of CDK2 for the treatment of multiple tumor types, including CDK4/6-resistant breast cancer, ovarian, uterine, stomach, and esophageal cancers (Press release, Cedilla Therapeutics, OCT 21, 2021, View Source [SID1234591683]). Both programs are wholly owned by Cedilla. In addition, Cedilla is pursuing discovery research efforts against a portfolio of high value cancer targets.

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"Over the past three years, we have built an integrated suite of capabilities that enable us to understand the relevant functional states of important yet elusive cancer targets, and identify previously unrecognized small molecule binding sites," said Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics. "Today, we are excited to announce our two lead programs from our internal efforts to discover conditional inhibitors: an inhibitor of TEAD and a highly selective inhibitor of CDK2. We look forward to advancing these programs closer to the clinic and creating novel medicines with the potential to deliver profound benefit to patients."

The discovery of both programs was enabled by Cedilla’s novel approach to developing small molecule conditional inhibitors. Cedilla recognizes proteins as dynamic entities, whose function is orchestrated by inter-molecular associations and post-translational tailoring. By accounting for the native full-length protein with relevant post-translational modifications, protein-protein interactions and sub-cellular localization, Cedilla is able to understand proteins in their functional state to discover new ways to access key cancer drivers that have been considered undruggable.

"Since our founding, we have worked to develop a deep understanding of high-value, historically inaccessible targets, and to identify new vulnerabilities that may enable us to drug them more effectively, delivering superior clinical benefit," said Brian Jones, Ph.D., Chief Scientific Officer. "Based on preclinical data, I believe our TEAD and CDK2 programs have clear advantages relative to historical approaches, offering the opportunity for preferential clinical utility, in terms of targeted efficacy or combinability with other therapeutic mechanisms. We look forward to advancing both programs into IND-enabling studies next year."

About Cedilla’s TEAD Program

TEAD (transcriptional enhanced associate domain) is a key component of the Hippo signaling pathway that is aberrantly regulated in solid tumors such as mesothelioma and certain squamous cell carcinomas. TEAD is also increasingly implicated in resistance to targeted therapies, including those for the treatment of EGFR-mutated and KRAS-mutated lung cancer.

Cedilla’s program is designed to inhibit the function of TEAD by preventing a post-translational modification required for full function. The company’s portfolio of TEAD inhibitors encompasses multiple chemotypes with different effects on TEAD isoforms and cofactors, providing Cedilla a range of starting points for selecting a candidate with an optimal profile for effective and combinable TEAD inhibition. Cedilla plans to be conducting investigational new drug (IND) application-enabling studies in the first half of 2022.

About Cedilla’s CDK2 Program

CDK2 (cyclin dependent kinase 2) has been a major target of interest for cancer indications driven by amplification or high levels of Cyclin E, including in roughly half of patients with CDK4/6-resistant breast cancer. In addition, Cyclin E amplification drives genetically defined subsets of ovarian, uterine, stomach and esophageal cancers. The CDK2-Cyclin E cancer node has remained inaccessible due to challenges achieving selectivity over other CDKs (cyclin dependent kinases), particularly CDK1, and Cyclin E isoforms.

Cedilla has developed a unique series of inhibitors that bind to a previously unreported site on the CDK2-Cyclin E complex with unprecedented selectivity, potentially offering a substantial advance over two decades of industry efforts. Preclinical characterization suggests that the exquisite selectivity of Cedilla’s inhibitor could result in a better safety profile compared to traditional kinase inhibitors, particularly with respect to dose-limiting hematological toxicities. Cedilla plans to be conducting IND application-enabling studies in the second half of 2022. In addition, based on its unique insights into Cyclin biology, Cedilla has the potential to pursue additional drug discovery programs against related targets.

On October 21, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported the first patient has been treated in an investigator-initiated, open-label Phase 2 study with lead asset plinabulin in combination with nivolumab + ipilimumab in patients with 3rd line recurrent small-cell lung cancer (SCLC) who failed checkpoint inhibitors and platinum-based chemotherapy. Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer (Press release, BeyondSpring Pharmaceuticals, OCT 21, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-first-patient-treated-in-phase-2-study-with-plinabulin-combined-with-nivolumab-ipilimumab-in-patients-in-3rd-line-recurrent-small-cell-lung-cancer-patients-who-failed-checkpoi [SID1234591682]). This Phase 2 study, to be conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers, comes after the successful completion of the Phase 1 dose escalation study portion of this Phase 1/2 study.

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"For patients with extensive stage SCLC who failed chemo and checkpoint inhibitors, effective treatment options are limited. By exploring this novel immunotherapy combination and expanding on the encouraging Phase 1 data, there is an opportunity to address this unmet medical need," commented Jyoti Malhotra, M.D., M.P.H., Principal Investigator, medical oncologist at Rutgers Cancer Institute of New Jersey. "In the Phase 1 study, the addition of plinabulin to nivolumab + ipilimumab was able to induce tumor responses in patients who failed chemotherapy and checkpoint inhibitors with ORR at 43%, double the ORR of nivolumab + ipilimumab in Checkmate 032. An added bonus is the marked reduction in Grade 3/4 IR-AEs from historical 37% to 12.5%; IR-SAE typically leads to permanent discontinuation of PD-1 and CTLA-4 combination. The ability to both enhance the anti-cancer effects and reduce the Grade 3/4 IR-AEs of PD-1 and CTLA-4 inhibitors makes plinabulin an ideal addition to these checkpoint inhibitors for establishing the concept of a ‘chemo-free’ therapeutic strategy for cancer patients."

In this Phase 2 study, up to 26 patients with histological or cytological confirmed extensive-stage SCLC who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors will receive the triple combination of plinabulin + nivolumab + ipilimumab. Patients in the Phase 2 study will continue treatment until disease progression, development of unacceptable toxicity, or one of the protocol-defined reasons for treatment discontinuation occurs.

Dr. Ramon Mohanlal, BeyondSpring’s Executive VP of R&D and Chief Medical Officer added, "Confirmation of the positive Phase 1 data in Phase 2 will open the doors for adding plinabulin to PD-1 and CTLA-4 inhibitors as a ‘chemo-free’ triple combination therapeutic strategy in the cancer types wherein plinabulin has single agent activity, which include bladder cancer, TNBC, CNS cancers, gastric cancers and sarcoma. We firmly believe that plinabulin’s differentiated immune MOA, as a SIMBA, provides the basis for its potential broad applicability as an anti-cancer agent in multiple cancer indications. The recent success of Dublin-3 showing plinabulin’s durable anti-cancer benefit in long term survivals in NSCLC patients is our first step towards this goal. We’re also very thankful to be working with experts at the Big Ten Research Consortium who realized the potential for plinabulin and chose it to be the subject of this combination therapy clinical trial."

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA-stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

SCLC Phase 1 IIT Study (Big Ten Consortium)

In the Phase 1 dose escalation study evaluating 20 mg/m2 and 30 mg/m2 doses of plinabulin combined with nivolumab and ipilimumab in 16 patients, the 30 mg/m2 dose was selected for the Phase 2 trial. All 16 patients were evaluated for safety, and 13 patients were evaluated for efficacy.

The combination demonstrated favorable safety and tolerability. There were no Grade 4 events in the 16 patients studied, and 12.5% experienced Grade 3 IR-AEs, compared to 37% Grade 3/4 IR-AEs reported with nivolumab + ipilimumab in SCLC. ORR was 50% for the six patients receiving the triple IO combination as second line therapy after platinum. Three patients had partial responses (PR), with best tumor reduction at target lesions of 100%, 53% and 45%, respectively. ORR was 43% for the seven patients receiving the triple IO combination as third line therapy, who had either failed or had not responded to platinum and PD-1/PD-L1 inhibitors. Three patients had PRs, with best tumor reductions at target lesions of 78%, 75% and 52%, respectively. Duration of therapy for these 3 PR patients was 18 months, five months (still on treatment) and three months, respectively.

On October 21, 2021 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will provide a corporate and financial update for the third quarter 2021, on Friday, November 5, 2021, before the market opens (Press release, Athenex, OCT 21, 2021, View Source [SID1234591681]). Athenex’s management team will host a conference call and live audio webcast at 8:00am Eastern Time.

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To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations," located at View Source