On June 18, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will participate in a fireside chat as part of the virtual BofA Securities Napa Biopharma Conference on Wednesday, June 24, 2020 at 3:30 PM EDT / 12:30 PM PDT (Press release, Exelixis, JUN 18, 2020, View Source [SID1234561225]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On June 18, 2020 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX), reported the closing of its underwritten public offering of 15,384,614 shares (including 2,006,688 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares) of its common stock, par value $0.001 per share (Press release, Celldex Therapeutics, JUN 18, 2020, View Source [SID1234561224]).

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All of the common stock was sold at a public offering price of $9.75 per share for total gross proceeds to Celldex of approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses.

With the closing of this offering, Celldex believes that the cash, cash equivalents and marketable securities at June 18, 2020 are sufficient to meet estimated working capital requirements and fund currently planned operations through 2023.

Cantor Fitzgerald & Co. acted as the sole book running manager for the offering. H.C. Wainwright & Co. acted as co-manager for the offering.

The securities described above were offered and sold by Celldex pursuant to a final prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File Nos. 333-235399 and 333-239199), which was declared effective by the Securities and Exchange Commission ("SEC") on June 12, 2020, which are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On June 18, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported dosing of the first patient in a phase 1 clinical trial evaluating investigational agent SEA-TGT, also known as SGN-TGT, an anti-TIGIT antibody for patients with solid tumors and lymphomas. TIGIT (T-cell immune receptor with Ig and ITIM domains) is an inhibitory immune receptor that is emerging as a clinically relevant immuno-oncology target (Press release, Seattle Genetics, JUN 18, 2020, View Source [SID1234561223]). SEA-TGT is a nonfucosylated human IgG1 antibody that uses the Company’s proprietary Sugar Engineered Antibody (SEA) technology. The Company also announced the dosing of the first patient in a phase 1 clinical trial evaluating investigational agent SGN-B6A, an antibody-drug conjugate (ADC) targeting integrin beta-6, which is overexpressed in numerous solid tumors and has been demonstrated to be a negative prognostic indicator across a diverse range of cancers.

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Preclinical data indicate that SEA-TGT has enhanced effector function enabled by the Company’s SEA technology. These data indicate that SEA-TGT may have best-in-class potential through enhanced depletion of TIGIT-positive regulatory T-cells (Tregs), distinct immune changes including amplified naïve and memory T-cell responses, and induction of innate immune cell activation. Curative anti-tumor activity in preclinical models was observed as a single agent and in combination with a PD-1 checkpoint inhibitor. These data support potential for improved monotherapy and combinatorial clinical activity as compared to a non-enhanced TIGIT antibody.

SGN-B6A is an ADC targeting integrin beta-6 to deliver the clinically validated payload monomethyl auristatin E (MMAE). In preclinical research, this ADC has demonstrated in vivo activity in models spanning a range of antigen expression levels and tumor types.

"We believe that anti-TIGIT antibodies may have an important therapeutic role in the evolving immuno-oncology landscape," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "SEA-TGT utilizes our novel SEA technology, which in preclinical research has demonstrated enhanced effector function that potentially differentiates it from other TIGIT antibodies in the clinic. The initiation of clinical trials for both SEA-TGT and the ADC, SGN-B6A, underscore our commitment to advancing novel drug candidates from our pipeline into clinical testing."

SEA-TGT Phase 1 Trial

The phase 1 trial of SEA-TGT will evaluate the safety and anti-tumor activity of SEA-TGT as a single agent as well as in combination with the anti-PD-1 antibody, pembrolizumab. The phase 1 trial will evaluate SEA-TGT in advanced solid tumors and lymphomas, including non-small cell lung cancer, gastric carcinoma, Hodgkin and selected non-Hodgkin lymphomas. The study is currently open in multiple sites in the United States and is expected to enroll approximately 111 participants. More information about the study of SEA-TGT is available at clinicaltrials.gov.

SGN-B6A Phase 1 Trial

SGN-B6A is an ADC targeting integrin beta-6 to deliver the clinically validated payload MMAE. The phase 1 trial will evaluate SGN-B6A in solid tumors, including non-small cell lung cancer, head and neck squamous cell cancer, breast, esophageal, ovarian, bladder, cervical and gastric cancers. The study is currently open in multiple sites in the United States and is expected to enroll approximately 235 participants. More information about the study of SGN-B6A is available at clinicaltrials.gov.

On June 18, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the pricing of its initial public offering of 13,882,352 shares of common stock at a public offering price of $20.00 per share (Press release, Forma Therapeutics, JUN 18, 2020, View Source [SID1234561222]). All of the shares are being offered by Forma. The shares are expected to begin trading on the Nasdaq Global Market on June 19, 2020 under the ticker symbol "FMTX." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Forma, are expected to be approximately $277.6 million. The offering is expected to close on June 23, 2020, subject to the satisfaction of customary closing conditions. In addition, Forma has granted the underwriters a 30-day option to purchase up to an additional 2,082,352 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering.

Registration statements relating to these securities became effective on June 18, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone 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 telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected].

On June 18, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma’s, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML) (Press release, Ascentage Pharma, JUN 18, 2020, View Source [SID1234561220]). This is Ascentage Pharma’s first NDA submission since its inception. If approved, HQP1351 will become the first third-generation BCR-ABL inhibitor therapeutics in China.

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Ascentage Pharma recently engaged in pre-NDA discussions with the CDE regarding the NDA based on results from two pivotal studies in patients with T315I-mutant CP-AML and AP-CML. The CDE has agreed that the company should proceed to submit the NDA for those two indications.

CML is a hematologic malignancy of the white blood cells. BCR-ABL tyrosine kinase inhibitors (TKI) have significantly improved the clinical management of CML. However, despite clinical benefits offered by the first-generation BCR-ABL inhibitor imatinib (GLEEVEC), and several second-generation TKIs, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for effective treatment.

HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. In July 2019, HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. In May 2020, HQP1351 was granted an Orphan Drug Designation and a Fast Track Designation by the US FDA.

"As Ascentage Pharma’s first NDA and one that may lead to the market authorization of the first third-generation BCR-ABL inhibitor in China, this submission marks a major milestone for our company," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "For patients with CML who cannot be effectively treated by currently available TKIs, there remains an urgent unmet medical need for safer and more effective therapies. We hope that HQP1351 will bring a breakthrough to the current conundrum and benefit more patients."