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Alpine Immune Sciences Announces $91 Million Private Placement

On September 15, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of common stock and prefunded warrants, as described below, in a private placement with certain institutional and other accredited investors for gross proceeds to Alpine of approximately $91 million, before deducting offering expenses (Press release, Alpine Immune Sciences, SEP 15, 2021, View Source [SID1234587730]). The private placement is being led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.

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"As a long-term backer of Alpine, we are impressed by the company’s progress and their emergence as a leader in both immunology and immuno-oncology," said James Topper, M.D., Ph.D, Managing General Partner of Frazier’s Life Sciences team. "This financing will help the company to pursue a focused and rapid development plan for ALPN-303, a potentially best-in-class inhibitor of the BAFF and APRIL pathways, and will also support the ongoing development of ALPN-202 as it enters monotherapy expansion cohorts next year and expands its development efforts in combination with Keytruda. We are pleased to lead this syndicate of strong investors and look forward to supporting the company in this next phase of growth."

Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue approximately 6.5 million shares of common stock and approximately 3.2 million prefunded warrants to purchase the same number of shares of common stock. Both the common stock and prefunded warrants will be sold at a price of $9.40 per share or prefunded warrant, respectively. The prefunded warrants will have a per share exercise price of $0.001 and will be exercisable at any time on or after the closing date. The price of the common stock and prefunded warrants is at a 4.4% premium to the closing price of $9.00 per share of Alpine’s common stock on the Nasdaq Global Market on September 14, 2021.

The private placement is expected to close on or about September 17, 2021, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to support the expansion of its pipeline, including the development of ALPN-303 in lupus and other B cell-mediated inflammatory diseases. In addition, net proceeds will be used to support the further clinical development of ALPN-202 as well as Alpine’s discovery programs and general corporate purposes.

In connection with the entry into the securities purchase agreement, an affiliate of Frazier Life Sciences Public Fund entered into an exchange agreement with Alpine, pursuant to which Alpine will exchange an aggregate of 1.2 million shares of common stock currently held by the affiliate of Frazier Life Sciences Public Fund for prefunded warrants to purchase an aggregate of 1.2 million shares of common stock, which prefunded warrants have identical terms to the prefunded warrants sold pursuant to the securities purchase agreement. After giving effect to the exchange of 1.2 million shares of common stock and the issuance of the approximately 6.5 million shares pursuant to the securities purchase agreement, the number of shares of Alpine’s outstanding common stock immediately after this offering would be approximately 29.2 million as of July 30, 2021. The closing of the exchange is subject to customary closing conditions and is contingent upon and will occur immediately following the closing of the private placement.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the prefunded warrants.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Abbott Declares 391st Consecutive Quarterly Dividend

On September 15, 2021 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 45 cents per share (Press release, Abbott, SEP 15, 2021, View Source [SID1234587729]).

This marks the 391st consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Nov. 15, 2021, to shareholders of record at the close of business on Oct. 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

Patrys demonstrates potential for deoxmabs in antibody drug conjugates (ADCs)

On September 15, 2021 Today Patrys reported that new data from a successful preclinical study highlighting the potential for using our deoxymab antibodies as targeting agents in antibody drug conjugates (ADCs) (Press release, Patrys, SEP 15, 2021, View Source [SID1234587728]).

ADCs harness the targeting attributes of antibodies to deliver payloads specifically to the sites of disease, and are one of the most active areas of drug development

The study data confirms that it is possible to conjugate the anticancer drug monomethyl auristatin E (MMAE) to Patrys’ full-sized IgG deoxymab, PAT-DX3. MMAE conjugated to PAT-DX3 was shown to inhibit tumour growth by 99.7% in mice implanted with human breast cancer cells, showing that deoxymabs can be used to effectively target delivery to tumours in animals.

According to Patrys CEO and Managing Director, Dr James Campbell:

"We are very excited by the potential of using our deoxymabs as the basis for new ADCs. This work has shown that deoxymabs can be used to target cancers and, by using a potent and validated ADC payload, deliver a drug. As with the therapeutic applications we are working on, the ability of our deoxymab antibodies to target multiple types of cancer, enter the cell and cell nucleus, and transit the blood brain barrier provides some really novel ways for using them as targeting agents for ADCs.

"This study has clearly demonstrated the proof of concept and is expected to open up a range of potential development or partnering opportunities for the Company."

PsiOxus to Present Positive Biomarker Data at ESMO 2021 Demonstrating the Potential of Their Novel Tumor-Selective T SIGn® vector, NG-350A, to Re-Engineer Advanced Cancers

On September 15, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus), a tumor re-engineering company, reported that they will present key safety and translational data from their first-in-human phase 1 FORTITUDE clinical study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 this week. Data from the completed monotherapy dose-escalation part of the FORTITUDE study, initiated in 2019 to assess the safety and tolerability of the NG-350A T-SIGn vector, will be presented on Friday 16th September 2021, with the poster available in full at www.psioxus.com shortly afterwards.

NG-350A is a T-SIGn vector designed to re-engineer cancers by selectively expressing a CD40 agonist monoclonal antibody, a potent activator of immuno-inflammatory responses, within the tumour microenvironment. PsiOxus is developing this agent as one of several products within its T-SIGn portfolio of vectors that combine systemic delivery with localized production of powerful transgene payloads to allow the selective re-engineering of both primary and metastatic tumors.

The data to be presented at the ESMO (Free ESMO Whitepaper) Congress show that IV delivery of NG-350A results in sustained elevations of inflammatory cytokines in the phase 1 FORTITUDE trial. In particular, marked and persistent dose-dependent increases in both IL-12 and IFNγ were observed after a single 1-week course of NG-350A, indicative of robust activation of antigen presenting cells via CD40 agonism generated within the tumor. Expansion of new T cell clones, a high proportion of which were new clones, was also observed following a single cycle of NG-350A. Safety data from the 25 patients treated with NG-350A as part of the now completed monotherapy dose-escalation part of FORTITUDE demonstrated that NG‑350A was well-tolerated, with few of the adverse events associated with systemic delivery of anti-CD40 agonists observed.

Together, these data suggest NG-350A contributes to the re-programming of the tumour microenvironment while avoiding the toxicity associated with systemic non-localized dosing of anti-CD40 antibodies.

"The headline data shared at the ESMO (Free ESMO Whitepaper) Congress confirms previous findings that our T-SIGn vector replicates selectively in primary tumor cells and metastases and persists for several months after intravenous delivery. Even more importantly, the biomarker data indicates that ongoing vector replication in tumors effectively translates into sustained production of the transgene payload, in this case a CD40 agonistic antibody. This translational data is a first in class demonstration of a downstream effect of tumor re-engineering, using T-SIGn vectors to turn the patient’s tumor cells into small drug factories," said Tom Lille, M.D., Ph.D., Chief Medical Officer, PsiOxus.

Based on these highly promising data, NG-350A will be assessed in combination with an anti–PD-1 checkpoint inhibitor in Part B of FORTITUDE.

Magenta Therapeutics Announces IND Clearance for MGTA-117 Targeted Conditioning Clinical Trial

On September 15, 2021 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that its Investigational New Drug (IND) application for MGTA-117 is active with the U.S. Food and Drug Administration (FDA) (Press release, Magenta Therapeutics, SEP 15, 2021, View Source [SID1234587726]). The company expects to open the Phase 1/2 clinical trial in Q4 2021 to evaluate its MGTA-117 antibody-drug conjugate (ADC) targeted conditioning program.

"We are very pleased that our collaboration with the FDA has resulted in the clearance of the MGTA-117 IND. We have addressed the FDA’s request for a bioassay to be incorporated into the clinical trial protocol," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "Improving conditioning treatments is essential for broadening patient accessibility to the curative potential of stem cell transplant and gene therapies. We have designed MGTA-117 specifically to replace toxic radiation and chemotherapy-based conditioning agents used in current medical practice. This program holds significant potential for patients across several disease areas."

The multi-center, open label Phase 1/2 clinical trial with single-dose escalating cohorts will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MGTA-117 as a single agent in relapsed/refractory AML and MDS patients. Magenta will continue to engage with the FDA to transition the trial to the intended primary target population of hematopoietic stem cell transplant-eligible AML and MDS patients. In addition, Magenta has planned gene therapy clinical trial collaborations with AVROBIO and Beam Therapeutics to evaluate the potential utility of MGTA-117 for conditioning gene therapy patients without the use of non-selective busulfan or other toxic chemotherapies.

About MGTA-117

Magenta’s MGTA-117 program is the company’s lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to selectively deplete hematopoietic stem cells (HSCs) from patients prior to transplant or HSC-based gene therapy to reduce the need for high-dose or high-intensity chemotherapeutic agents or, in the case of gene therapy applications, to potentially eliminate the need for chemotherapeutic agents altogether. MGTA-117 targets the CD117 receptor, which is highly expressed on the cell surface of HSCs and leukemia cells, making it a promising target for conditioning across broad sets of diseases, including certain blood cancers, hemoglobinopathies (sickle cell disease and beta thalassemia) and inherited metabolic disorders.