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."

On June 18, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported the publication of four abstracts on developmental therapeutics for immunotherapy, molecularly targeted agents and tumor biology during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, NantHealth, JUN 18, 2020, View Source [SID1234561219]).

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The program, held virtually from May 29-31, 2020, gathered oncology physicians, biotechnology executives, researchers, patient advocates, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology, and to gain insights for improving cancer care.

Alongside ImmunityBio, LLC, and others, Dr. Sandeep K. Reddy, Chief Medical Officer at NantHealth, and Christopher Szeto, Director of Machine Learning at NantHealth, presented the data gathered from NantHealth’s database which was used to advance findings in developmental therapeutics.

The details of NantHealth’s ASCO (Free ASCO Whitepaper) posters are as follows:

Title: "Effect of chemokine signaling signatures on resolving discrepancy between TMB and checkpoint expression"
Authors: Saihitha Veerapaneni, Rahul Parulkar, Sandeep K. Reddy, Shahrooz Rabizadeh, Stephen Charles Benz and Christopher Szeto; ImmunityBio, LLC, Culver City, CA; NantHealth, Culver City, CA
Abstract Number: 3131
Session Title: Developmental Therapeutics—Immunotherapy

"In this study, 1,395 clinical samples from the NantHealth database with matched tumor normal whole exomes and deep whole-transcriptomic sequencing were analyzed to confirm previous findings that Tumor Mutation Burden (TMB) and PDL1 mRNA were not correlated," said Dr. Sandeep K. Reddy, Chief Medical Officer, NantHealth. "However, chemokine activity may be an alternative to TMB and PDL1 to identify patients appropriate for immunotherapy and can help resolve discordant cases."

Title: "Targetable immune checkpoint molecules may be significantly differentially expressed in minority ethnicities"
Authors: Jacob J. Adashek, Christopher Szeto, J. Zack Sanborn, Sandeep K. Reddy, Amir A. Toor, Stamatina Danielides, Steven Smith, Steven R. Grossman, Charles V Clevenger, Anthony Faber, Andrea Ferreira-Gonzalez, Sosipatros Alexandros Boikos; University of South Florida, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; NantHealth, Culver City, CA
Abstract Number: 3576
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

"The Cancer Genome Atlas (TCGA) data for 7,087 patients and about 2,700 patients in the NantHealth database were used to identify differential patterns of checkpoint gene expression across different ethnic groups," said Dr. Sandeep K. Reddy, Chief Medical Officer, NantHealth. "White breast cancer patients might be anticipated to exhibit reduced sensitivity to PD1/CTLA4 blockade, while Black colon cancer patients may exhibit reduced sensitivity to IDO1 therapies, such as epacadostat. Ethnicity may represent a significant factor for efficacy checkpoint blockade therapies."

Title: "Highly accurate automated tissue classification using deep learning on digital pathology images: A novel tool for resolving conflicts in diagnosis"
Authors: Liudmila Beziaeva, Mustafa Jaber, Stephen Charles Benz, Shahrooz Rabizadeh, and Christopher Szeto, ImmunityBio, LLC, Culver City, CA; NantHealth, Culver City, CA
Abstract Number: 3578
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

"NantHealth combined whole slide imaging with deep neural networks to develop a tool which can identify which of 24 primary tumor types a sample is derived from with 94.6 percent accuracy," said Christopher Szeto, Director of Machine Learning, NantHealth. "This accuracy, which approaches that of a human pathologist, is achieved by focusing machine-vision attention on just tumor regions within bulk samples. Used in conjunction with molecular profiling, rates of Cancers of Unknown Primary (CUP) or misdiagnosis can feasibly be minimized to improve patient care."

Title: "High correlation between TMB, expressed TMB, and neoantigen load using tumor: Normal whole exome DNA and matched whole transcriptome RNA sequencing"
Authors: Christopher Szeto, Mrinal M. Gounder, Rahul Parulkar, Andrew Nguyen, Shahrooz Rabizadeh, Sandeep K. Reddy; Memorial Sloan Kettering Cancer Center, New York, NY; ImmunityBio, LLC, Culver City, CA; NantHealth, Culver City, CA
Abstract Number: e15238
Session Title: Publication Only: Developmental Therapeutics—Immunotherapy

"Surprisingly, we see minimal difference between the various biomarkers derived from mutational burden," said Christopher Szeto, Director of Machine Learning, NantHealth. "Tissue-specific TMB thresholds may be useful in patient with Sarcoma and Pancreatic cancers. Otherwise, additional data inputs such as microbiome, chemokine expression, and TME cell phenotyping may be required to improve upon TMB as a biomarker of immunotherapy response."