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Kangpu to Present Two Posters at the 2020 American Association for Cancer Research (AACR) Annual Meeting

On June 17, 2020 Kangpu Biopharmaceuticals, a clinical-stage company focused on the discovery and development of next-generation of immunomodulatory small molecules for the treatments of solid tumors, hematological malignancies, auto-immune diseases as well as inflammatory disorders, reported that two posters highlighting preclinical data of the company’s lead drug candidates, KPG-121 and KPG-818, will be presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II to be held from June 22-24, 2020 (Press release, Kangpu Biopharmaceuticals, JUN 17, 2020, View Source [SID1234561199]).

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Details of the e-poster presentations on June 22-24 are as follows:

Abstract Title: KPG-121, A Novel Cereblon Modulator, Potently Inhibits Growth of Metastatic Castration Resistant Prostate Cancer in Combination with Androgen Receptor Inhibitors Both In Vitro and In Vivo
Abstract Number: 5300
Poster Number: 5327
Poster Session: Novel Antitumor Agents 2

KPG-121 is a novel modulator of the Cerebron (CRBN) E3 ubiquitin ligase complex CRL4CRBN targeting rapid ubiquitination and degradation of casein kinase 1A1 (CK1α) and transcription factors Aiolos and Ikaros. KPG-121 promotes anti-proliferation and anti-angiogenesis activities and enhances immunomodulatory properties. KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including Enzalutamide, Abiraterone Acetate, Apalutamide, or Darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone. KPG-121 is currently being evaluated in a Phase I study in the US for the treatment of patients with metastatic and non-metastatic castration-resistant prostate cancer in combination with Enzalutamide, Abiraterone Acetate, or Apalutamide (NCT03569280 at www.clinicaltrials.gov).

Abstract Title: KPG-818, A Novel Cereblon Modulator, Inhibits Hematological Malignancies in Preclinical Models
Abstract Number: 5671
Poster Number: 6367
Poster Session: Novel Antitumor Agents 3

KPG-818 represents a novel generation of small molecule modulators of the CRBN E3 ubiquitin ligase complex CRL4CRBN and potently induces the ubiquitination and degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors critical in B-cell development. In preclinical studies, KPG-818 demonstrates outstanding in vitro anti-inflammatory properties and broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers. KPG-818 is currently being developed in a Phase I study for the treatment of patients with hematological malignancies in the US (NCT04283097 at www.clinicaltrials.gov).

Abstracts and full session details can be found at www.aacr.org.

RemeGen Co., Ltd. Announced New RC48-ADC Data in Patients with Advanced Gastric Cancer at ASCO

On June 17, 2020 RemeGen, Co., Ltd. reported positive results from its Phase II study of RC48 (disitamab vedotin) for the treatment of HER2-expressing advanced or metastatic gastric cancer in heavily treated patients at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which was held on May 29-31, 2020 (Press release, RemeGen, JUN 17, 2020, View Source [SID1234561198]). RC48 (disitamab vedotin) is a novel humanized anti-HER2 antibody drug conjugate (ADC) developed to treat several cancer diseases.

"For the third year in a row, we are pleased to showcase clinical progress of RC48 in a broad range of solid tumor treatments at ASCO (Free ASCO Whitepaper)," said Jianmin Fang, Ph.D., founder and CEO of RemeGen Co., Ltd., "We are encouraged to see positive data from the latest research, and we believe that RC48 has the potential to redefine treatment for patients with HER2-expressing advanced or metastatic gastric cancer."

The single-arm Phase II multicenter clinical study conducted in China was designed to evaluate the efficacy and safety of RC48. The study enrolled 127 patients (IHC2+ including FISH+ and FISH-, and IHC3+) with advanced or metastatic gastric cancer including gastric or gastroesophageal junction adenocarcinoma. The key endpoint of the study was the objective response rate (ORR) of the main efficacy index evaluated by the independent efficacy evaluation committee (IRC). The confirmed ORR was 23.6%, with a median progression free survival period (mPFS) of 4.1 months. The median overall survival time (mOS) was 7.5 months.

All patients evaluated in the study had received 2 or more lines of chemotherapy treatments with a subgroup of patients having received an additional line of systemic therapy treatment such as Herceptin. The study also included patients with low expressing HER2 (IHC2+ / FISH-) tumor, potentially widening the population of patients who may benefit from this therapy. The results of the study demonstrate RC48’s potential in addressing the urgent unmet medical need for this heavily treated patient population.

More information around these findings are found in the virtual scientific program of the ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #4560).

About RC48
RC48 was developed to treat HER2 expressing solid tumors. It has a novel antibody with a higher affinity to HER2 compared to standard of care, and superior anti-tumor activity compared to other treatments in animal models. RC48 was the first ADC drug approved for human clinical trials in China and favorable safety profile has been observed in clinical trials. It is currently being studied in multiple late-stage clinical trials across solid tumor types.

Centene Recommends Stockholders Reject "Mini-Tender" Offer by TRC Capital Investment Corporation

On June 17, 2020 Centene Corporation (NYSE: CNC) reported that it has been notified of an unsolicited "mini-tender" offer by TRC Capital Investment Corporation ("TRC Capital") to purchase up to 2,000,000 shares of Centene’s common stock at an offer price of $59.00 net per share in cash, which is an approximate 4.75% discount to the $61.94 per share closing price of Centene’s common stock on the New York Stock Exchange on June 12, 2020, the last trading day before the commencement of TRC Capital’s mini-tender offer, and an approximately 7.13% discount to the $63.53 per share closing price of Centene’s common stock on June 17, 2020, the day of this release (Press release, Centene , JUN 17, 2020, https://www.prnewswire.com/news-releases/centene-recommends-stockholders-reject-mini-tender-offer-by-trc-capital-investment-corporation-301079145.html [SID1234561197]).

Centene does not endorse TRC Capital’s mini-tender offer and is not associated in any way with TRC Capital, its mini-tender offer or its mini-tender offer documents.

Centene recommends that its stockholders reject the offer and not tender their shares in response to TRC Capital’s below-market offer. This mini-tender offer is at a price below the market price for Centene’s common stock (as of today’s close) and is subject to a number of conditions, including, among others, that there has not been a decrease in the market price of shares of Centene common stock and TRC Capital’s ability to obtain debt financing sufficient, together with cash on hand, to consummate the offer.

TRC Capital has made similar mini-tender offers for the shares of other companies. TRC Capital’s mini-tender offer seeks less than 5% of Centene’s outstanding common stock, thereby avoiding many disclosure requirements and procedural protections of the Securities and Exchange Commission ("SEC"). The SEC has cautioned investors about mini-tender offers in an investor alert, advising that some bidders make mini-tender offers at below-market prices "hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price." The SEC’s cautionary alert for investors regarding mini-tender offers is on its website at: View Source

Stockholders should obtain current market quotations for their shares of Centene common stock, consult with their broker or financial advisor, and exercise caution with respect to TRC Capital’s mini-tender offer. Stockholders who have already tendered shares are advised that they may withdraw their shares by providing the written notice described in the TRC Capital mini-tender offer documents prior to the expiration of the offer, currently scheduled for 12:01 a.m., New York City time, on Wednesday, July 15, 2020.

Centene encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at View Source

Centene requests that a copy of this press release be included with all distributions of materials relating to TRC Capital’s mini-tender offer for Centene common stock.

IDEAYA Announces Pricing of Public Offering of Common Stock

On June 17, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA) reported the pricing of an underwritten public offering of 6,666,667 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions (Press release, Ideaya Biosciences, JUN 17, 2020, View Source [SID1234561196]). In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be $100.0 million excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about June 22, 2020, subject to the satisfaction of customary closing conditions.

IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) preclinical and clinical development of IDE397, its MAT2A inhibitor development candidate, and other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, and a DNA Damage Target, or DDT, as well as its share of costs for targeting WRN under the previously announced Collaboration, Option and License Agreement with GSK, (ii) ongoing early clinical development of IDE196, its PKC inhibitor, and binimetinib, a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada, as combination therapy in metastatic uveal melanoma, or MUM and other solid tumors having GNAQ/11 hotspot mutations, as well as ongoing clinical trials evaluating IDE196 as monotherapy in such indications, (iii) biomarker research and development activities and (iv) working capital and other general corporate purposes.

J.P. Morgan, Citigroup and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected].

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

Nanobiotix Receives Feedback From US FDA to Advance Phase III Head and Neck Cancer Study Design and CMC Development Plan for NDA

On June 17, 2020 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) (Paris:NANO), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that the FDA has provided necessary feedback regarding the design of NANORAY-312, the Company’s pivotal phase III global registration trial in head and neck cancer (Press release, Nanobiotix, JUN 17, 2020, View Source [SID1234561195]). The FDA also agreed to the NBTXR3 chemistry, manufacturing, and controls (CMC) Development Plan to support the phase III trial and a future New Drug Application (NDA) for the product.

NANORAY-312: A Phase III Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma.

NANORAY-312 will be a phase III investigator’s choice, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy.

Patients in the control arm will receive radiation therapy with or without cetuximab (investigator’s choice), and patients in the treatment arm will receive NBTXR3 activated by radiation therapy with or without cetuximab (investigator’s choice).

The trial is expected to recruit approximately 500 patients. A futility analysis is expected 18 months after the first patient in the trial is randomized, and the interim analysis for progression-free survival (PFS) superiority is expected at 24-30 months. The final analysis will report on PFS and overall survival. Quality of Life will also be measured as a key secondary outcome. In the event of favorable data from the interim analysis, the FDA has advised that NBTXR3 could potentially qualify for accelerated approval.

In support of the phase III trial and a future NBTXR3 New Drug Application (NDA), Nanobiotix met with the FDA in a Type B end-of-phase I meeting on October 16, 2019. Following additional correspondence with the FDA, including written responses to the FDA’s recommendations, the Company received written FDA guidance on April 3, 2020. The Company expects to commence NANORAY-312 after making protocol refinements and securing the requisite financing to fund the trial.

Agreement to CMC Development Plan

The FDA’s written response regarding the CMC Development Plan does not raise any safety concerns for continued clinical development of NBTXR3, and the FDA agreed to the updated CMC Plan for NBTXR3 during an ongoing phase III clinical trial.

About NBTXR3
NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors.

NBTXR3 is actively being evaluated in clinical trials worldwide as a potential treatment in various cancer indications. The Company is prioritizing the development of NBTXR3 in the United States and the EU for the treatment of patients with locally advanced head and neck cancers ineligible for chemotherapy.

Nanobiotix is also running an Immuno-Oncology development program, evaluating NBTXR3 activated by radiotherapy as a primer of immune response in combination with checkpoint inhibitors. The Company has launched a phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in patients with locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) amenable to re-irradiation or with lung or liver metastasis (mets) from any primary cancer eligible for anti-PD-1 therapy.

Other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company has a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (initially expected to support nine new clinical trials in the United States) to evaluate NBTXR3 across several cancer types.