On April 27, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the acceptance of an abstract for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Onconova, APR 27, 2022, View Source [SID1234613058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details on the abstract are provided below.

Abstract Title: Narazaciclib’s kinase inhibitory activity is differentiated from approved CDK4/6 inhibitors in preclinical models

Abstract Number: e15096

Publication Date and Time: May 26, 2022, at 5:00 p.m. ET

On April 27, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported presentations from the Company’s global clinical development programs in hematologic malignancies and solid tumors at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) being held on June 3-7, 2022 (Press release, BeiGene, APR 27, 2022, View Source [SID1234613074]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

"We have more than 800 oncology researchers at BeiGene, and these data presentations highlight our important work to deliver potential new therapies to patients worldwide," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

BeiGene presentation highlights:

ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia.
ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial.
RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer.
BeiGene Poster and Oral Presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title and Number

Session

Date and Time
(all times CDT)

Presenting Author

Hematologic Malignancies Clinical Data

Zanubrutinib plus obinutuzumab (Z-O) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): primary analysis of the phase 2 randomized ROSEWOOD trial

Abstract Number: 7510

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM
and
3:00 PM – 4:30 PM

Pier L. Zinzani, M.D., Ph.D.

ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) vs ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM)

Abstract Number: 7521

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4

3:00 PM – 4:30 PM
and

8:00 AM – 11:00 AM

Constantine S. Tam, M.D.

Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a phase 2 study

Abstract Number: 7552

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM

Emmanuel Bachy. M.D., Ph.D.

Solid Tumor Clinical Data

RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Abstract Number: 384950

Plenary Session

Sunday, June 5
1:00 PM – 4:00 PM

Li Zhang, M.D.

Clinical outcomes associated with tislelizumab in patients (pts) with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (SOR) or lenvatinib (LEN) in RATIONALE-208.

Abstract Number: 4072

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Julien Edeline, M.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study.

Abstract Number: 1031

Poster session – Breast Cancer – Metastatic

Monday, June 6
8:00 AM – 11:00 AM

Keun Seok Lee, M.D., M.S., Ph.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) and tislelizumab (TIS) as first line (1L) therapy for patients (pts) with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC): Preliminary results from a Phase 1b/2 study.

Abstract Number: 4032

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Keun-Wook Lee, M.D., M.S., Ph.D.

AdvanTIG-206: Anti-TIGIT monoclonal antibody (mAb) ociperlimab (BGB-A1217; OCI) plus anti-programmed cell death protein 1 (PD-1) mAb tislelizumab (TIS) plus BAT1706 versus TIS plus BAT1706 as first-line (1L) treatment for advanced hepatocellular carcinoma (HCC)

Abstract Number: TPS4172

Poster session – Gastrointestinal cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Jia Fan, M.D.

BeiGene Online Only Abstracts at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title

Abstract Number

Lead Author

Hematologic Malignancies Clinical Data

A phase 2 expanded access study of zanubrutinib (ZANU) in patients (pts) with Waldenström Macroglobulinemia (WM)

e19522

Jorge J. Castillo, M.D.

Solid Tumor Clinical Data

Clinical outcomes in patients (pts) with previously treated advanced hepatocellular carcinoma (HCC) experiencing hepatitis B virus (HBV) DNA increases during tislelizumab (TIS) treatment in RATIONALE-208.

e16181

Ann-Lii Cheng, M.D.

RATIONALE 302 PRO (encore): Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life

e16095

Eric Van Cutsem, M.D., Ph.D.

Randomized, Phase 3 study of second-line tislelizumab versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (ESCC), RATIONALE 302: Asia subgroup.

e16107

Kuaile Zhao, M.D.

Updated analysis from a Phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.

e14556

Jian Li, M.D., Ph.D

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab is currently in regulatory review in first line recurrent/metastatic nasopharyngeal cancer in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S. and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe, and Japan.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On April 27, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported the pricing of an underwritten public offering of 5,251,239 shares of its common stock at a public offering price of $10.00 per share (Press release, Deciphera Pharmaceuticals, APR 27, 2022, View Source [SID1234613007]). In addition, in lieu of common stock to certain investors, Deciphera is offering pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The aggregate gross proceeds to Deciphera from this offering are expected to be approximately $150 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In addition, Deciphera has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock at the public offering price per share of the common stock, less underwriting discounts and commissions. The offering is expected to close on April 29, 2022, subject to the satisfaction of customary closing conditions. All of the shares of common stock and pre-funded warrants are being offered by Deciphera.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Deciphera intends to use the net proceeds from the offering to continue to fund the development of vimseltinib including in its pivotal Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor patients currently underway, additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material and pre-commercial and medical affairs capabilities related to vimseltinib; to fund the development of DCC-3116 including multiple Phase 1b combination studies and potential Phase 2 expansion combination cohorts in multiple tumor types as well as clinical research outsourcing and manufacturing of clinical trial material; to fund the research and development of Deciphera’s pan-RAF program and other new research activities for potential drug candidates from its proprietary kinase switch control inhibitor platform; and the remainder for working capital purposes, including general operating expenses.

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

The securities described above are being offered by Deciphera pursuant to a shelf registration statement on Form S-3 (No. 333-236389) that was declared effective by the Securities and Exchange Commission (SEC) on March 10, 2022. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on April 26, 2022, and is available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204, or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 laws of that state or jurisdiction.

On April 27, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that a poster describing the design of the Phase 1/2 trial of AU-007 will be presented during a Trials in Progress session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Aulos Bioscience, APR 27, 2022, View Source [SID1234613026]). AU-007 is a monoclonal antibody computationally designed by Biolojic Design that is highly selective for the CD25-binding portion of IL-2. The ASCO (Free ASCO Whitepaper) meeting will take place virtually and at McCormick Place in Chicago, Illinois, from June 3-7, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the Aulos poster presentation are as follows:

Title: Trial in progress: A phase 1-2, first-in-human, open label, dose escalation and expansion study of AU-007, a monoclonal antibody that binds to IL-2 and inhibits IL-2Rα binding, in patients with advanced solid tumors.

Abstract: TPS2671

Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 a.m.-11:00 a.m. CDT

Presenter: Jim Vasselli, M.D., Chief Medical Officer, Aulos Bioscience

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. To learn more about the clinical trial program, visit ClinicalTrials.gov (NCT05267626).

On April 27, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported, in conjunction with its Asia Pacific partner BeiGene, the acceptance of two abstracts for poster presentations at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting taking place virtually and in Chicago, IL from June 3 – 7, 2022 (Press release, Zymeworks, APR 27, 2022, View Source [SID1234613042]). The presentations will provide new clinical data from two early-stage studies of zanidatamab in first-line oncology settings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first poster, scheduled for presentation on Saturday, June 4, highlights Phase 1b/2 data of zanidatamab in combination with the CAPOX regimen of chemotherapy and the PD-1 inhibitor tislelizumab, for first-line treatment of HER2-positive advanced/metastatic gastric and gastroesophageal junction adenocarcinoma (GEA). This is the first clinical data presentation of zanidatamab in combination with chemotherapy and a PD-1 inhibitor. The regimen evaluated in this study is also being used in one of the treatment arms of the ongoing Phase 3 HERIZON-GEA-01 study (NCT05152147).

The second poster, scheduled for presentation on Monday, June 6, includes preliminary Phase 1b/2 data of zanidatamab in combination with docetaxel, for first-line treatment of advanced/metastatic HER2-positive breast cancer. This will be the first clinical data presentation of zanidatamab in a first-line setting of advanced/metastatic HER2-positive breast cancer.

The poster presentations will be available on their respective presentation dates on the conference website as well as the Zymeworks website.

Presentation Details

Title: Zanidatamab, a HER2-targeted bispecific antibody, in combination with chemotherapy and tislelizumab as first-line therapy for patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GJEC): Preliminary results from a Phase 1b/2 study

Abstract: 4032

Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Date: Saturday June 4, 2022

Time: 08:00 –11:00 am CDT

Title: Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study

Abstract: 1031

Session Title: Breast Cancer – Metastatic

Date: Monday June 6, 2022

Time: 08:00 –11:00 am CDT

Zymeworks plans to host a webcast to discuss the clinical results presented at ASCO (Free ASCO Whitepaper) as well as an update on the Company’s clinical development strategy for zanidatamab. Call details and presentation materials will be available on the Zymeworks website at View Source