On April 26, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it will host a conference call on May 12, 2022 at 4:30 PM Eastern Time to discuss results for its first quarter ended March 31, 2022 (Press release, Panbela Therapeutics, APR 26, 2022, View Source [SID1234612975]).

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Conference Call Information

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About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On April 26, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported financial results for the full year ended December 31, 2021 (Press release, Ambrx, APR 26, 2022, View Source [SID1234612992]).

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"We have made great progress in advancing our engineered precision biologics and clinical pipeline in recent months. We continue to transition preclinical candidates into the clinic and anticipate submitting another IND to the U.S. FDA in 2022. Ambrx has several potential key milestones coming up in the mid-year and into the second half of this year including initiating two clinical trials of ARX788 for Her2+ breast cancer in the neoadjuvant setting, a single agent and a combination trial with an anti-PD-1 agent, and a clinical trial of ARX305 in renal cell carcinoma (RCC) and other cancers," commented Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "Ambrx has truly positioned itself as a leader in the antibody drug conjugate and precision biologics space, working together with our partners, demonstrating promising data from its ongoing trials. I look forward to furthering our clinical development throughout 2022, bringing value to stakeholders and patients alike."

2H 2021 and Subsequent Clinical Highlights

ARX788 Included in Quantum Leap’s I-SPY 2.2 Phase 2 Clinical Trial in Breast Cancer. In April 2022, Ambrx announced the inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s I-SPY 2.2 Phase 2 clinical trials in patients with HER2-positive breast cancer. ARX788 will be evaluated as a monotherapy and in combination with cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting.
Acceptance of an Investigational New Drug Application (IND) for ARX305 to the U.S. Food and Drug Administration (FDA). In February 2022, Ambrx announced that the FDA had accepted the company’s IND for ARX305 for the treatment of solid and hematological tumors and provided a "Study May Proceed" letter. The acceptance allows Ambrx to prepare a first in human, Phase 1 clinical trial of ARX305.
Positive Data on ARX788 for the Treatment of HER2+ Metastatic Breast Cancer Presented at SABCS. In December 2021, Ambrx presented positive data from the ACE-Breast-01 Phase 1 clinical trial of ARX788 for the treatment of HER+ positive metastatic breast cancer in patients whose disease is resistant/refractory to HER2 targeted agents including trastuzumab, ADCs, TKIs (tyrosine kinase inhibitors) and bispecific antibodies. At 1.5 mg/kg every three weeks, ARX788 demonstrated robust treatment effect with a disease control rate of 100% in 29 evaluable patients.
First Patient Dosed in Phase 2 ACE-Breast-03 Clinical Trial of ARX788. In November 2021, the company announced that the first patient had been dosed in its global ACE-Breast-03 Phase 2 clinical trial of ARX788 in patients with HER2+ metastatic breast cancer. The Phase 2 trial will measure the objective response rate in patients whose HER2+ metastatic breast cancer is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regiments.
Positive Data on ARX788 for the Treatment of HER2+ Gastric Cancer Presented at CSCO. In October 2021, NovoCodex Pharmaceuticals Ltd., Ambrx’s partner in China, presented positive interim data from the ACE-Gastric-01 Phase 1 clinical trial of ARX788 for the treatment of HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer.
First Patient Dosed in a Phase 1 Trial for ARX517. In August 2021, Ambrx announced that the first patient had been dosed in a Phase 1, multicenter, dose-escalation, and dose expansion trial to evaluate the safety, pharmacokinetics, and anti-tumor activity of ARX517, an ADC being developed to treat subjects with prostate specific membrane antigen (PSMA) expressing tumors.
2H 2021 and Subsequent Corporate Highlights

Strengthened Board of Directors. In February 2022, Ambrx appointed Paul Maier to its Board of Directors and as Chair of the Audit Committee. Mr. Maier joins Ambrx’s Board with more than 25 years in senior operational, international and financial management experience in rapid growth biotechnology companies.
Anticipated Near-Term Milestones

Topline Phase 3 data in ACE-Breast-02 by the end of 2022
Additional Phase 1 data in ACE-Pan Tumor-01 in 2H 2022
Interim Phase 1 safety data in ARX517 for PSMA in 2H 2022
Initiate Phase 1 trial in ARX305 for RCC and other cancers in 2H 2022
Submit IND to FDA for ARX102 in 2H 2022
Financial Highlights

Cash and Cash Equivalents: Cash and cash equivalents were $170.1 million as of December 31, 2021, compared to $167.2 million for the first half ended June 30, 2021.
Revenue: Revenue was $2.4 million and $7.5 million for the six months and full year ended December 31, 2021, respectively, as compared to $7.2 million and $13.7 million for the six months and full year ended December 31, 2020, respectively. The decrease was primarily driven by less revenue recognized in connection with our R&D and license agreements including a cumulative catch-up adjustment, partially offset by increased third party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $32.7 million and $54.8 million for the six months and full year ended December 31, 2021, respectively, as compared to $10.5 million and $20.4 million for the six months and full year ended December 31, 2020, respectively. The increase year over year of $34.4 million was mainly due to increased costs related to clinical trial program spend primarily driven by our ARX788 clinical trials and related manufacturing and outside services costs as well as personnel related costs including stock-based compensation expense.
General and administrative (G&A) expenses: G&A expenses were $8.7 million and $17.1 million for the six months and full year ended December 31, 2021, respectively, as compared to $3.8 million and $6.4 million for the six months and full year ended December 31, 2020, respectively. The increase year over year of $10.7 million was mainly attributable to professional services and fees in connection with preparing for Ambrx’s IPO and operating as a public company, expenses associated with the corporate structure reorganization, and personnel related costs including stock-based compensation expense.
Other expenses: Other expense, net, for the six months and full year ended December 31, 2021 was zero and $3.9 million, respectively, as compared to $4.7 million for the six months and full year ended December 31, 2020.
Net loss: Net loss for the six months and full year ended December 31, 2021 was $39.1 million and $68.1 million, respectively, as compared to $11.1 million and $16.5 million for the six months and full year ended December 31, 2020, respectively.

On April 26, 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 that it intends to offer and sell $150,000,000 of shares of its common stock and pre-funded warrants to purchase shares of its common stock in an underwritten public offering (Press release, Deciphera Pharmaceuticals, APR 26, 2022, View Source [SID1234612960]). In addition, Deciphera intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of common stock offered in the public offering. All of the shares and pre-funded warrants are being offered by Deciphera. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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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 TGCT 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 the Company’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 the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering 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 26, 2022, Cyteir Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, Cyteir Therapeutics, APR 26, 2022, View Source [SID1234612976]).

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On April 26, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has filed a clinical trial application with the Human Research Ethics Committee (HREC) in Australia in order to initiate the Phase I ATRIUM trial of ATG-018 in patients with advanced solid tumors and hematologic malignancies (Press release, Antengene, APR 26, 2022, View Source [SID1234612993]).

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The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as monotherapy to determine the appropriate dose for Phase II studies and assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018.

ATG-018 is an orally available, potent, selective small molecule ATR inhibitor. ATG-018 inhibits the ATR (ataxia telangiectasia mutated and Rad3-related) kinase, thus limiting cancer cells’ ability to repair damaged DNA, in a mechanism also known as synthetic lethality.

Dr. Bo Shan, Chief Scientific Officer of Antengene commented, "ATG-018, one of Antengene’s first in-house programs to reach the clinic, targets the DDR pathway that is deregulated in many cancers. DDR inhibitors represent a promising area of drug development and clinical research in oncology, especially in resistant or advanced diseases. The differentiated profile of ATG-018 may enable it to be used as monotherapy and open the door for novel collaborations and combination regimens that could benefit cancer patients around the world."

Dr. Kevin Lynch, Chief Medical Officer of Antengene continued, "Antengene is very excited to submit the ATG-018 Phase I protocol for HREC review, based on its solid preclinical data package including efficacy as a monotherapy in solid tumor models, oral bio-availability and potential biomarkers. The use of biomarker-informed studies may facilitate clinical trial enrollment and provide an additional tool to monitor patients during the trial. As we prepare for the start of this important study, I want to thank all of the investigator sites for their support and enthusiasm, and everyone in Antengene’s R&D organization for their dedication in the preparation for this study."

About the ATRIUM Trial

The ATRIUM trial is a Phase I multi-center, open-label, dose finding study of ATG-018 monotherapy in patients with advanced solid tumors or hematologic malignancies. The primary objective of the study is to evaluate the safety and tolerability of ATG-018 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and/or biologically effective dose of ATG-018 monotherapy and preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018. As a Phase I study, there will be intensive safety monitoring throughout the trial.

About ATG-018

Developed by the internal R&D Team at Antengene, ATG-018 is an oral, potent, selective small molecule inhibitor targeting ataxia telangiectasia and Rad3-related (ATR) kinase. ATR kinase belongs to the phosphoinositide 3 kinase-related family. Inhibiting ATR kinase leads to increased accumulation of single-strand DNA breaks, particularly meaningful for tumor cells which rely on DNA damage repair (DDR). Preclinical studies have demonstrated that ATR inhibitor monotherapy or combination with other drugs (including DDR agents) could be promising therapeutic strategies for solid tumors (including gastric, esophageal, squamous cell carcinoma) and hematologic malignancies (chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma [DLBCL] and multiple myeloma [MM]).

According to a preclinical poster presented at AACR (Free AACR Whitepaper) 2022, ATG-018 has demonstrated potent in vitro and in vivo monotherapy efficacy in solid tumor/hematologic cancer models with certain homologous recombination deficiencies. These data were supported by a series of genetic alterations that correlated with ATG-018 sensitivity and could be potential predictive biomarkers. Taken together, these data suggest that ATG-018 could be a promising therapeutic agent for patients with such homologous recombination deficiencies/genetic alterations.

ATG-018 is a development stage product candidate and is not approved by any regulatory agency. Antengene has global rights to ATG-018.