On October 20, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported the appointment of Dr. Erik Digman Wiklund as Chief Executive Officer (CEO) (Press release, Targovax, OCT 20, 2021, View Source [SID1234591574]). Dr. Wiklund has intimate knowledge of the company and its technology having served as Chief Business Officer (CBO) and Chief Financial Officer (CFO) of Targovax since 2017.

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Dr. Erik Digman Wiklund said: "I am very excited to be entrusted with the opportunity to lead Targovax into the next stage of development. The ONCOS-102 program has set us up with a unique, clinically validated platform system, and I believe we are in a great position to expand beyond ONCOS-102 to build a pipeline of novel, cutting edge product candidates. I am especially excited to explore the potential for utilizing ONCOS as a delivery tool for novel RNA concepts, where we intend to move into the emerging space of circular RNA that has recently attracted significant interest from both industry and investors. In parallel, we continue planning for the ONCOS-102 platform trial in anti-PD1refractory melanoma, and we are in active discussions with prospective collaboration partners who have complementary therapeutics that may act synergistically with ONCOS-102".

Targovax’s current CEO, Øystein Soug, will remain with the company following the appointment of Dr. Wiklund. Mr. Soug will act as a special advisor and also serve as interim CFO providing important strategic and management continuum for the company.

Damian Marron, Chairman of the Board, commented the transition: "Øystein Soug has effectively led the company through an important period executing the phase 1/2 development program of ONCOS-102, and we would like to place on record our profound thanks for Øystein´s leadership and contribution to Targovax. Øystein´s tenure has culminated in a strong data package for the lead asset ONCOS-102 demonstrating promising clinical efficacy and powerful immune activation in several cancer forms and treatment combinations. We believe that these data confirm the tremendous potential of ONCOS as a versatile delivery vector for targeted anti-cancer payloads, and we wish to pursue this opportunity by expanding our pipeline repertoire. With his deep scientific expertise and intimate knowledge of Targovax and our technology, Erik is the ideal CEO to capture this opportunity and lead the company into the future".

The Board of Directors of Targovax has initiated a search process for a new CFO, a position Øystein Soug will fill in the interim period. Mr. Soug was the CFO of Targovax in 2015-2016, before he was appointed CEO, and has previously held the position as CFO of Algeta ASA.

Øystein Soug commented: "It has been a privilege to lead Targovax through an exciting and rewarding period. I fully support the Board’s decision to increase the scientific focus and expand our pipeline to fully exploit the potential in the ONCOS platform, and I am delighted that Erik has accepted to take over as CEO to execute this vision. In my view, Erik, with his blend of deep scientific competence and commercial experience, is the best candidate to lead Targovax into the future."

On October 20, 2021 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported four presentations at the upcoming 2021 International Oncolytic Virus Conference (IOVC) being held November 5-7, 2021, both virtually and in Sedona, Ariz (Press release, OncoMyx Therapeutics, OCT 20, 2021, View Source [SID1234591591]). The company plans to present recent preclinical data demonstrating oncolytic activity, transgene production, immunomodulatory mechanisms of action, and efficacy of intratumoral (IT) and intravenous (IV) administration of OncoMyx’s multi-armed myxoma virotherapy for the treatment of cancer.

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OncoMyx Talk and Poster Info

Session 1: Novel Payloads and Mechanisms of Action 1 with Leslie Sharp, PhD, CSO, will happen Friday, Nov. 5th from 8:55am – 9:20am MST
Poster Presentation (Virtual) with Lina Franco, PhD, Scientist II, is available on demand Friday, Nov. 5th – Sunday, Nov. 7th
A Special Session with Steve Potts, PhD, MBA, CEO and cofounder, entitled "Benefits of a systemic-delivered, multi-armed non-human pathogen, myxoma virus, against solid and heme cancers" will take place Saturday, Nov. 6th from 8:44pm – 8:56pm MST.
A Live Q&A for the poster presentation with Dr. Franco will be held Sunday, Nov. 7th from 1:00pm – 3:30pm MST.
The poster will be available on OncoMyx’s website on November 5th.

About Oncolytic Immunotherapy and Myxoma Virus

Oncolytic viruses (OV) selectively replicate in and lyse tumor cells and provide stimulation to the immune system, representing a promising therapeutic option in development to treat cancers that do not respond well to treatment with immune checkpoint inhibitors. Myxoma virus (MYXV) is a member of the Pox family of double stranded DNA viruses. The natural host of MYXV is a subset of rabbits and hares, but MYXV is able to infect cancer cell lines of humans and other species. The genome of MYXV is relatively large and is amenable to engineering for expression of transgenic proteins, making it an excellent oncolytic virus for introduction of immunomodulatory proteins.

On October 20, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress (Press release, Fusion Pharmaceuticals, OCT 20, 2021, View Source [SID1234591611]). These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1.

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"These data demonstrate the broad potential of our TAT platform across multiple validated targets overexpressed in a variety of solid tumors," said Chief Executive Officer John Valliant, Ph.D. "We are pleased to share preclinical efficacy and tumor uptake data resulting from the administration of FPI-1966, and we believe strongly that this data will translate into meaningful results for patients with solid tumors overexpressing FGFR3 – a population with high unmet medical need. We look forward to initiating the Phase 1 study around the end of this year."

Data from preclinical studies of FPI-1966, a TAT designed to target and deliver actinium-225 to cancer cells expressing FGFR3, were presented in an oral presentation titled, "FGFR3 Targeted Alpha Therapeutic [225Ac]-FPI-1966 induces regression in preclinical bladder xenograft model". Outcomes demonstrated that FPI-1966 when administered with vofatamab results in high tumor delivery and low off-target uptake. Further, the data showed therapeutic efficacy of FPI-1966 at both single and multiple doses in a preclinical bladder cancer xenograft model.

Data from preclinical studies of FPI-2059, a TAT designed to target and deliver actinium-225 to cancer cells expressing neurotensin receptor 1 (NTSR1), were presented in an oral presentation titled "NTSR1 Targeted Alpha Therapeutic [225Ac]-FPI-2059 induces regression in preclinical colorectal xenograft model". The study results include a head-to-head comparison of therapeutic efficacy obtained from FPI-2059, which delivers an alpha emitting isotope, with [177Lu]-IPN-1087, which delivers a beta emitting isotope on the same targeting molecule. Results demonstrate superior efficacy with [225Ac]-FPI-2059 in a mouse xenograft model of colorectal cancer.

Dr. Valliant continued, "Our science is based on the belief that alpha-emitting isotopes can provide significant therapeutic advantages compared to other commonly used radioisotopes. Preclinical results from our FPI-2059 product candidate provide further validation of this belief and support the diversification of our product portfolio to comprise multiple targeting vehicle types, including small molecules. We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022."

About FPI-1966
[225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated. FPI-1966 is advancing to a Phase 1 study following the recent investigational new drug (IND) clearance

About FPI-2059
FPI-2059 is a targeted alpha therapy combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1. Fusion expects to submit an IND for FPI-2059 in the first half of 2022.

On October 20, 2021 AstraZeneca reported that it has paused an active phase 1 trial of AZD5991, a direct inhibitor of MCL-1, citing the need to suss out a potential safety issue (Press release, AstraZeneca, OCT 20, 2021, View Source [SID1234591820]).

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The trial suspension, noted only through ClinicalTrials.gov, came Oct. 19: "The study has been put on hold to allow further evaluation of safety related information," the brief update said. AstraZeneca did not immediately respond to a request for comment on the trial’s suspension.

The trial was assessing the drug, known as AZD5991, either alone or combined with AbbVie/Roche’s approved blood cancer medicine Venetoclax in relapsed or refractory hematologic malignancies. The drug works by targeting apoptosis, the process of programmed cell death, specifically in blood cancer.

RELATED: Amgen shares hit after analysts expose buried FDA trial halt

This class has seen safety issues before: Back in 2019, Amgen’s oral small-molecule MCL-1 inhibitor AMG 397 was hit with an FDA halt given a "safety signal for cardiac toxicity."

And that’s not all: After AMG 397 showed some potential safety issues, Amgen then voluntarily halted enrollment for another early-stage test for AMG 176, given that it too is an MCL-1 inhibitor. Enrollment was, however, then opened back up.

Back in February, work on AMG 397 was stopped, and the focus shifted to AMG 176, which is now in phase 1 for blood cancers and uses an intravenous route of administration.

On October 20, 2021 Abbott (NYSE: ABT) reported that financial results for the third quarter ended Sept. 30, 2021 (Press release, Abbott, OCT 20, 2021, View Source [SID1234591576]).

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Third-quarter sales of $10.9 billion increased 23.4 percent on a reported basis and 22.4 percent on an organic basis, which excludes the impact of foreign exchange.
Third-quarter GAAP diluted EPS was $1.17 and adjusted diluted EPS, which excludes specified items, was $1.40, reflecting 42.9 percent growth versus the prior year.1
Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of $3.55 to $3.65 and full-year adjusted diluted EPS from continuing operations of $5.00 to $5.10, reflecting growth of 38.4 percent at the mid-point versus prior year.2
In August, Abbott announced U.S. FDA approval of its Amplatzer Amulet device, which offers immediate closure of the left atrial appendage – an area in the heart where blood clots can form.
In August, Abbott announced results of the company’s GUIDE-HF clinical trial, which showed Abbott’s CardioMEMS remote monitoring system can improve care for more patients living with heart failure. Abbott filed a Premarket Approval (PMA) supplement with the FDA for consideration of an expanded indication for CardioMEMS.
In September, Abbott announced U.S. FDA approval of its Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
During the third quarter, Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.
"We achieved another quarter of strong growth overall and across all four of our major business areas," said Robert B. Ford, president and chief executive officer, Abbott. "We’re particularly pleased with the continued advancements of our new product pipeline, including several recent launches in large, high-growth markets."

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the third quarter 2021:

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average
foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2021 worldwide sales of $10.9 billion increased 23.4 percent on a reported basis and 22.4 percent on an organic basis.

Compared to pre-pandemic sales in 2019, worldwide sales, excluding COVID-19 testing-related sales3, increased 11.7 percent on both a reported and organic basis in the third quarter.

Worldwide Nutrition sales increased 9.6 percent on a reported basis and 8.9 percent on an organic basis in the third quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 9.8 percent on a reported basis and 9.3 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 9.4 percent on a reported basis and 8.6 percent on an organic basis. Strong performance of Abbott’s market-leading oral hydration brand, Pedialyte, and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 20.2 percent.

Worldwide Diagnostics sales increased 48.2 percent on a reported basis in the third quarter and increased 46.8 percent on an organic basis. Global COVID-19 testing-related sales were $1.9 billion in the third quarter, led by combined sales of $1.6 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms. Excluding COVID-19 testing-related sales, worldwide diagnostics sales increased 14.1 percent on a reported basis in the third quarter and 12.5 percent on an organic basis.4

Compared to the pre-pandemic 2019 baseline, sales in Core Laboratory and Molecular Diagnostics, excluding COVID-19 testing-related sales, grew 5.8 percent and 14.9 percent, respectively, on a reported basis in the third quarter and grew 4.9 percent and 13.6 percent, respectively, on an organic basis.5

Established Pharmaceuticals sales increased 15.1 percent on a reported basis in the third quarter and increased 15.3 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 17.1 percent on a reported basis in the quarter and increased 17.9 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including China, Russia and India.

Other sales increased 9.7 percent on a reported basis in the quarter and increased 8.5 percent on an organic basis.

Worldwide Medical Devices sales increased 14.6 percent on a reported basis in the third quarter and increased 13.1 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic and strong growth in Diabetes Care.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 18.5 percent on a reported basis and 16.1 percent on an organic basis in the third quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.6

In Diabetes Care, FreeStyle Libre and Libre Sense sales were $968 million in the quarter, which represents sales growth of 41.6 percent on a reported basis and 38.8 percent on an organic basis.

During the quarter, Abbott continued to strengthen its Medical Devices portfolio with several new products, including:

U.S. FDA approval of Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who are at risk of ischemic stroke.
U.S. FDA approval of Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high risk for open-heart surgery.
U.S. FDA approval of Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke.
Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.
ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under GAAP of $3.55 to $3.65. Abbott forecasts specified items for the full-year 2021 of $1.45 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, including expenses to align its COVID-19 testing-related business with changes during the year in current and projected testing demand, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $5.00 to $5.10 for full-year 2021.

ABBOTT DECLARES 391ST CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 15, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s 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 annually increased their dividend for at least 25 consecutive years.