On July 20, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star"), operating through its subsidiary, F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported that it has entered into a license agreement with Takeda (Press release, F-star, JUL 20, 2022, View Source [SID1234616796]).

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Under the terms of the agreement, F-star will grant Takeda a worldwide, exclusive royalty-bearing license to research, develop, and commercialize a bispecific antibody against an immuno-oncology target using F-star’s proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development, and commercialization activities under the agreement. F-star will receive an upfront license fee of $1 million. F-star is also eligible to receive future development and commercialization milestone payments up to approximately $40 million over the course of the agreement if all milestones are achieved, plus single-digit percentage royalties on annual net sales.

Neil Brewis, Ph.D., Chief Scientific Officer of F-star said, "At F-star, we are committed to working towards a cancer-free future and are delighted to partner with Takeda towards a shared goal of developing immunotherapeutics so that more people with cancer can live longer with improved lives. We believe there is enormous potential for our mAb2 platform to produce multiple next-generation bispecific antibody therapeutics beyond our current proprietary pipeline and this agreement with Takeda represents F-star’s long-term commitment to realising this potential through partnerships."

Kathy Seidl, Ph.D., Head of Oncology Drug Discovery Unit at Takeda said, "We have an opportunity at Takeda to lead the discovery and development of novel cancer therapies that leverage the power of the innate immune system. We are eager to build on our relationship with F-star and apply their Fcab technology to diversify and accelerate our gamma delta (γδ) T cell engager portfolio in support of our collective pursuit of life-transforming medicines for patients with cancer."

On July 20, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a corporate and financial update for the second quarter of 2022 on Wednesday, August 3, 2022, at 8:30 a.m. ET (Press release, G1 Therapeutics, JUL 20, 2022, View Source [SID1234616795]).

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Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On July 20, 2022 ADC Therapeutics SA (NYSE: ADCT) reported the first patient has been dosed in LOTIS-9, a Phase 2 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in unfit and frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, JUL 20, 2022, View Source [SID1234616790]).

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The initial exploratory stage of the LOTIS-9 open-label Phase 2 trial is evaluating the efficacy and tolerability of Lonca-R in approximately 80 unfit or frail patients aged 80 years or older with previously untreated DLBCL. The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living, instrumental activities of daily living and the Cumulative Illness Rating Scale for Geriatrics. Trial participants will be assigned to either Cohort A (unfit) or Cohort B (frail) using the sGA. For more information about the LOTIS-9 trial, please visit www.clinicaltrials.gov (identifier NCT05144009).

About LOTIS-9

The LOTIS-9 Phase 2 clinical trial is evaluating loncastuximab tesirine-lpyl in combination with rituximab (Lonca-R) in previously untreated unfit/frail participants with DLBCL. The primary objectives of the Phase 2 clinical trial are to assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL and to assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL who are ineligible for standard R-mini-CHOP.

The first arm of this study will examine participants who are unfit and who will receive Lonca-R for three cycles. Participants who achieve a complete response will receive Lonca-R for one additional cycle. Participants who receive a partial response will receive Lonca-R for three additional cycles. The second arm of this study will examine participants who are frail or participants with cardiac comorbidities. These participants will receive Lonca-R for three cycles. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On July 20, 2022 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2022 (Press release, Abbott, JUL 20, 2022, View Source [SID1234616789]).

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Second-quarter sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis, which excludes the impact of foreign exchange.
GAAP diluted EPS1 was $1.14 in the second quarter. Excluding specified items, adjusted diluted EPS was $1.43, which reflects growth of 22.2 percent compared to the prior year.
Global COVID-19 testing-related sales were $2.3 billion in the second quarter.
Abbott is raising its full-year 2022 EPS guidance. Abbott projects full-year diluted EPS on a GAAP basis of at least $3.50 and projected adjusted diluted EPS of at least $4.90.
2022 guidance includes projected COVID-19 testing-related sales of $6.1 billion, which includes sales of $5.6 billion through June 2022 and projected sales of $500 million over the next few months.
In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of its Aveir single-chamber (VR) leadless pacemaker for the treatment of patients with slow heart rhythms. Aveir VR is the world’s only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placement and was specifically designed to be expandable and retrievable when therapy needs evolve or the device needs to be replaced.
In May, Abbott announced U.S. FDA clearance of its FreeStyle Libre 3 system, which automatically delivers up-to-the-minute glucose readings and unsurpassed 14-day accuracy2 in the world’s smallest and thinnest3 wearable sensor.
In June, Abbott announced breakthrough device designation from the U.S. FDA for its first-of-its-kind glucose-ketone biowearable sensor development program, which will enable people with diabetes to continuously monitor glucose and ketones in one sensor, helping those at risk for developing a life-threatening complication called diabetic ketoacidosis.
"We achieved another quarter of strong growth and are raising our full-year EPS guidance," said Robert B. Ford, chairman and chief executive officer, Abbott. "Our new product pipeline has remained highly productive, and our diversified business has continued to be resilient in a challenging macro environment."

SECOND-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.

Second-quarter 2022 worldwide sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis.

Worldwide sales, excluding COVID-19 testing-related sales, decreased 0.3 percent on a reported basis and increased 4.1 percent on an organic basis in the quarter.4 Worldwide sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott’s U.S. plants. Excluding COVID-19 testing-related sales and the U.S. sales associated with the recalled products in the current and prior years, total worldwide sales increased 1.6 percent on a reported basis and 6.2 percent on an organic basis in the second quarter. 5

Worldwide Nutrition sales decreased 7.4 percent on a reported basis and 4.5 percent on an organic basis in the second quarter. Total worldwide Nutrition and Pediatric Nutrition sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott’s U.S. plants. On July 1, Abbott restarted partial production at the facility. Excluding the U.S. sales associated with these products in the current and prior years, total worldwide Nutrition sales increased 0.5 percent on a reported basis and 3.8 percent on an organic basis in the second quarter.6

In Adult Nutrition, Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global sales growth of 1.2 percent on a reported basis and 5.2 percent on an organic basis.

Worldwide Diagnostics sales increased 33.1 percent on a reported basis and 36.9 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $2.3 billion in the quarter, led by sales of testing products in Rapid Diagnostics.

Sales in Core Laboratory and Molecular Diagnostics were impacted by year-over-year declines in COVID-19 testing-related sales in these businesses. Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales decreased 3.1 percent on a reported basis and increased 2.3 percent on an organic basis and Molecular Diagnostics sales increased 17.9 percent on a reported basis and 22.3 percent on an organic basis in the second quarter.7

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 9.2 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 1.8 percent on a reported basis and 7.1 percent on an organic basis, led by double-digit growth on a reported and organic basis in several geographies and therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Other sales increased 10.3 percent on a reported basis and 16.7 percent on an organic basis in the quarter.

Worldwide Medical Devices sales increased 2.5 percent on a reported basis and 7.5 percent on an organic basis in the second quarter. Sales growth was negatively impacted by reduced cardiovascular and neuromodulation procedure volumes as a result of recent surges of COVID-19 in several geographies, healthcare staffing challenges and lockdowns in China that were implemented to control the spread of the virus.

In Diabetes Care, FreeStyle Libre sales were approximately $1.1 billion in the quarter, which represents sales growth of 18.7 percent on a reported basis and 25.6 percent on an organic basis.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott is raising its projected full-year 2022 diluted earnings per share under GAAP to at least $3.50. Abbott forecasts specified items for the full-year 2022 of $1.40 per share primarily related to intangible amortization, costs related to a voluntary recall, expenses associated with acquisitions, restructurings and cost reduction initiatives and other net expenses. Excluding specified items, Abbott is raising its projected adjusted diluted earnings per share to at least $4.90 for the full-year 2022.

ABBOTT DECLARES 394TH CONSECUTIVE QUARTERLY DIVIDEND
On June 10, 2022, the board of directors of Abbott declared the company’s quarterly dividend of $0.47 per share. Abbott’s cash dividend is payable Aug. 15, 2022, to shareholders of record at the close of business on July 15, 2022.

Abbott has increased its dividend payout for 50 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.

On July 20, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported new regulatory designations for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) investigational compound being studied for the treatment of myelodysplastic syndromes (MDS): (i) the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk MDS; (ii) the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion to designate eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU) (Press release, Karyopharm, JUL 20, 2022, View Source [SID1234616787]). Karyopharm also received orphan drug designation from the FDA in January 2022. MDS are a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function with a risk of progression to acute myeloid leukemia.

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Karyopharm is currently investigating eltanexor in an ongoing open-label Phase 1/2 study in patients with relapsed/refractory MDS. Previously, Karyopharm reported initial data from the Phase 1 portion of this study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS.

Approximately 15,000 people in the U.S.1 and 14,000 people in the EU2 are expected to be diagnosed with intermediate-to-high risk MDS in 2022. HMAs are the current standard of care for newly diagnosed, higher-risk MDS patients. However, only 40-60% of patients respond, with these responses typically lasting less than two years.3 The prognosis in HMA-refractory disease is poor, with a median overall survival of four to six months.4,5 There are currently no approved therapies for HMA- refractory MDS.

"These recent designations from the FDA and EC reinforce eltanexor’s potential to improve clinical outcomes for patients with relapsed/refractory MDS," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are dedicated to advancing our ongoing clinical trials and remain committed to bringing eltanexor to these patients and their families as a new treatment option."

Fast track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process.

Orphan Medicinal Product Designation is granted by the EC to promote the development of drugs that target rare (less than 5 in 100,000 people across the EU), seriously debilitating and/or life-threatening diseases, and are expected to provide a significant benefit over existing authorized treatments. Orphan designation qualifies a company for certain incentives that apply across all stages of drug development, including the potential for ten years of market exclusivity following marketing approval, fee reductions, and eligibility for orphan drug grants.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure than is possible with selinexor.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration or any other regulatory agency.