On April 26, 2022 Symeres reported the acquisition of Organix, a US-based provider of high-quality organic chemistry services (Press release, Symeres, APR 26, 2022, View Source [SID1234612940]). The company is dedicated to the discovery and preclinical stage of the drug-discovery value chain, with a focus on lipids and small molecules. Organix has 47 employees, the majority of which have a PhD in chemistry, and is based in Woburn, in the Boston, MA, area. Its revenue is mainly generated from the sale of specialized and complex organic chemistry research services to biopharma clients.

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Symeres and Organix are highly complementary, and the combination unlocks significant strategic value. Organix represents a high-quality foothold into the US market, where Symeres already generates about 40% of its revenues. Furthermore, Organix broadens the Symeres drug-discovery offering into the fast-growing lipids market, addressing mRNA therapeutics and vaccines. Organix’s impressive client list includes some of the world’s leading biopharma companies, many based in the Boston biopharma community. Organix management will remain unchanged; the company is led by Dr. Anu Mahadevan, CEO, and Dr. Paul Blundell.

Symeres CEO Eelco Ebbers is very pleased to quickly integrate Organix into the Symeres group: "Organix is widely known as being highly innovative and an expert organic chemistry services provider that is able to solve complex projects for top-tier clients globally. Joining forces represents a fantastic opportunity for us to expand our drug-discovery-capability offering and provide an exceptional high-quality foothold into the US market."

As the majority shareholder in Symeres, Keensight Capital has worked together with the management team of the two companies to facilitate this combination. Amit Karna, Partner at Keensight Capital, comments: "We are delighted to support Symeres in this exciting acquisition of Organix. We are certain that the resulting business will create a truly differentiated transatlantic offering for the biopharma industry, with significant expertise in molecule design, synthesis, and early-stage clinical manufacturing. Moreover, the scientific and cultural fit of the two organizations could not be more perfect, and we are excited to see what the management teams will achieve together."

On April 26, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that Amgen, its collaboration partner for MP0310 (AMG 506), has informed the Company of their decision to return global rights of MP0310 to Molecular Partners following a strategic pipeline review (Press release, Molecular Partners, APR 26, 2022, View Source [SID1234612959]). Molecular Partners is presently conducting a phase 1 study of MP0310 and will look to present full phase 1 data at a scientific conference when available.

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"We would like to thank Amgen for a very fruitful collaboration which has led us to the initial clinical findings that an immunostimulatory receptor, such as 4-1BB, can be activated in a localized fashion," said Patrick Amstutz, Molecular Partners’ CEO. "This collaboration has enabled us to broaden our immuno-oncology expertise, DARPin platform knowledge, and clinical development capabilities which are now being applied across our portfolio. We continue to anticipate the full phase 1 dataset later this year, following which we can begin to explore potential collaborations for the program with new partners."

MP0310 is a dual-targeted compound, targeting both FAP and 4-1BB, that has the potential to activate T-cells and other immune cells, specifically in the tumor microenvironment, aiming to avoid systemic side effects associated with 4-1BB activation. Given this mode of action, future development will call for combination therapy trials. No additional clinical studies of MP0310 have been planned at this time. Following completion of the ongoing Phase 1 study, the Company will look to initiate discussions with potential collaborators.

The collaboration with Amgen was initiated in December 2018, providing an upfront payment of $50 million to Molecular Partners. Per the terms of the agreement, Molecular Partners is conducting the phase 1 clinical trial of MP310. Under the agreement with Amgen, following Phase 1 data, Amgen would have had the right to progress the program into later stage development, including into combination trials. The phase 1 clinical study was initiated in October 2019 in patients with solid tumors. Initial preliminary data from patient biopsies has demonstrated the potential of MP0310 to colocalize with FAP (fibroblast activation protein) and activate 4-1BB in the tumor microenvironment, after a first dose. A second part of the phase 1 clinical trial was initiated to optimize dosing and to demonstrate sustained activity at later time points. Data from the second part of the trial is pending. The remaining patient cohorts will be treated and followed, per the trial protocol, which is expected to be completed in the second half of 2022.

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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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.