On February 13, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase I clinical trial of IBI101, a recombinant fully human anti-tumor necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody (Press release, Innovent Biologics, FEB 13, 2019, View Source [SID1234533290]).

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In this Phase I clinical study, the tolerance, safety and primary efficacy of IBI101, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody, will be evaluated. The study comprises two parts, namely a Phase Ia study with IBI101 as monotherapy and a Phase Ib study with IBI101 in combination with Tyvyt. Patients with advanced solid tumors who have failed standard treatments will be enrolled in the study.

"The Investigational New Drug (IND) application of IBI101, indicated for patients with advanced solid tumors, was approved by the U.S. Food & Drug Administration (FDA) on 5 Dec, 2018. The mechanism of IBI101 is different from that of anti-PD-1 antibodies. IBI101 stimulates the OX40 pathway so as to activate effector T cells, thus enhancing the anti-tumor immune reaction," commented Professor XU Ruihua, Director of Sun Yat-Sen University Cancer Hospital. "Worldwide clinical research on anti-OX40 antibodies is limited so far. We are looking forward to the study results of IBI101."

"Innovent, a China-based company, was established with an ambition to serve global patient needs. We are dedicated to exploring the most advanced research areas in cancer immunotherapy and providing innovative medicines that improve lives around the world. The initiation of Phase I study of IBI101 and dosing of first patient have again demonstrated our efforts and commitment. We truly anticipate further breakthroughs so that more patients will potentially benefit in the future," said Michael Yu, Founder, Chief Executive Officer and Chairman.

About IBI101

IBI101 is a recombinant fully human anti-OX40 monoclonal antibody developed by Innovent with independent intellectual property rights. Pre-clinical data confirms that IBI101 has a clear mechanism of action that enhances the activation of effector T cells and mediates the clearance of regulatory T cells, thus inhibiting the growth of tumor cells. The IND application of IBI101 was approved by the U.S. FDA on 5 Dec, 2018. Agonistic OX40 candidates are expected to be used in combination with our anti-PD-1 monoclonal antibody, Tyvyt (sintilimab injection), and other immunomodulating agents in our R&D pipeline to meet the unmet medical needs of cancer patients. At present, there are no approved monoclonal antibody therapeutics against the same target across the world.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been approved by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). Currently, more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on other solid tumors.

On February 13, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell receptor (TCR) therapies for patients suffering from cancer, reported the pricing of the Company’s initial public offering of 5,000,000 shares of common stock at a public offering price of $15.00 per share, for aggregate gross proceeds of $75.0 million, before deducting underwriting discounts and commissions and offering expenses (Press release, TCR2 Therapeutics, FEB 13, 2019, View Source [SID1234533289]). The Company has also granted the underwriters a 30-day option to purchase from the Company up to an additional 750,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. All of the shares are being offered by TCR2.

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The common stock is expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "TCRR" on February 14, 2019. The offering is expected to close on February 19, 2019, subject to customary closing conditions.

Jefferies, SVB Leerink and BMO Capital Markets are acting as joint book-running managers for the offering. Wedbush PacGrow and China Renaissance are acting as co-managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on February 13, 2019. The offering of these shares is being made only by means of a prospectus forming part of the effective registration statement relating to these shares. Copies of the prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by e-mail at [email protected], or by phone at (800) 808-7525, ext. 6132; or BMO Capital Markets Corp., Attn: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, tel: (800) 414-3627, 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 law of such state or jurisdiction.

On February 13, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that Terry Rosen, Ph.D., Chief Executive Officer, will participate in a fireside chat at the 8th Annual Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 at 11:30 am ET at the Lotte New York Palace, in New York, NY (Press release, Arcus Biosciences, FEB 13, 2019, View Source [SID1234533288]).

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To access the live audio webcast of the presentation, please visit the "Events & Presentations" section of the Arcus website at View Source A replay of the webcast will be available for 30 days following the live event.

On February 13, 2019 NanOlogy, a clinical-stage oncology company, reported that it will present an abstract at the 2019 Genitourinary Cancer Symposium, co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held February 14-16, 2019 in the Moscone West Building, San Francisco (Press release, NanOlogy, FEB 13, 2019, View Source [SID1234533287]).

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Data from preclinical studies of NanoDoce (submicron particle docetaxel suspension) administered via intratumoral injection will be presented showing prolonged, high concentration of drug at the tumor site and significant tumor regression in multiple xenograft animal models including clear cell renal carcinoma (768-O cell line), transitional cell bladder carcinoma (UM-UC-3 cell line), and prostate carcinoma (PC-3 cell line). Abstract title, location, and times follow:

Title: Evaluation of submicron particle docetaxel directly injected into uro-oncologic xenografts
Poster Session: B – Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers
Where: Board E17 Abstract #360, West Building Moscone, San Francisco
When: Friday, February 15, 2019, 12:15 to 1:45 PM and 5:15 to 6:15 PM
Data from the preclinical studies showed that tumor volume decreases with two and three intratumoral doses of NanoDoce were significantly greater than or similar to IV docetaxel. Immunohistochemistry evaluations for the renal and bladder cancer models revealed immune cell infiltration in NanoDoce-treated animals. Drug was detected in NanoDoce-treated tumor tissue up to 50 days after administration, and at levels far greater than IV-treated animals.

Persistent, therapeutic levels of docetaxel from intratumoral NanoDoce appear to kill tumor cells through direct and indirect means. NanoDoce is known to directly inhibit tumor cell mitosis, and its persistence results in prolonged release of tumor antigen, which appears to promote indirect immune cell-mediated tumor kill.

A clinical trial in high-risk non-muscle invasive (NMIBC) and muscle invasive bladder cancer (MIBC) will begin enrollment in the first quarter of this year. Following transurethral resection of bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with intravesical instillations of NanoDoce.

In addition, IND-enabling studies are nearing completion on NanoDoce for renal cell carcinoma to allow for a clinical trial via intratumoral injection in the second half of 2019. This work is part of an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, breast cancer, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036 in the US, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

On February 13, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that its Chief Scientific Officer, Mahiuddin Ahmed, PhD, will give a presentation titled "Past, Present and Future of Omburtamab for the Treatment of B7H3(+) tumors" at PEGS Boston on April 8, 2019 at 11:20 am EDT (Press release, Y-mAbs Therapeutics, FEB 13, 2019, View Source [SID1234533286]).

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