On October 16, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share research from studies evaluating BRUKINSA (zanubrutinib), Bruton tyrosine kinase (BTK) chimeric degradation activation compound (CDAC) degrader BGB-16673 and B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in patients with Waldenström’s macroglobulinemia at the 12th International Workshop on Waldenström’s Macroglobulinemia (IWWM) Oct. 17-19 in Prague, Czech Republic (Press release, BeiGene, OCT 16, 2024, View Source [SID1234647226]).

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BeiGene has seven presentations at IWWM 2024, and Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, will give the opening ceremony keynote, "Innovating for Impact: How BeiGene is Advancing Products and Pipeline to Address Waldenstrom’s Macroglobulinemia and Beyond."

"Waldenström’s macroglobulinemia is a rare and incurable cancer, and many patients face treatment failure after initial lines of therapy," Dr. Mobasher said. "Our BTK inhibitor BRUKINSA has become a standard of care for these patients and as shown through our long-term follow-up data at IWWM, continues to demonstrate deep and durable responses with favorable safety. Additional presentations demonstrate our continued commitment to developing and evaluating new treatment options for Waldenström’s macroglobulinemia patients and include results from Phase 1 studies of our BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax. We are encouraged by these results and look forward to advancing these assets to help more patients with WM."

During IWWM, BeiGene research will be shared in two invited talks, three oral presentations and two posters. Key presentations are outlined below.

IWWM Session
Title & Timing
(CEST)

Session
Type

Asset

Key Findings

BTK-Inhibitors in WM I

(Oct. 18, 11:30 a.m.-12:30 p.m.)

Oral presentation

BRUKINSA

Long-term safety and efficacy data from ASPEN LTE1, a long-term extension study evaluating ibrutinib-treated patients from ASPEN who switched to BRUKINSA, show that worsening of ibrutinib treatment-emergent AEs following transition to BRUKINSA was rare, as was the emergence of new events. The study also finds that efficacy is also maintained or improved in these patients.

BTK-I Intolerant and Resistant Disease

(Oct. 18, 2:30-3:30 p.m.)

Invited talk

BGB-16673

Preliminary safety and efficacy data from the phase 1 CaDAnCe-101 study demonstrates that BGB-16673 has a tolerable safety profile and shows promising antitumor activity in heavily pretreated patients with BTK inhibitor-exposed relapsed/refractory (R/R) WM, including those with BTK and CXCR4 mutations. BGB-16673 was recently granted Fast Track Designation by the U.S. Food and Drug Administration for R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

Invited talk

BRUKINSA

Updated results from a Phase 2 study of WM patients who switched to BRUKINSA after becoming intolerant to other BTK inhibitors, including ibrutinib and acalabrutinib, show that most adverse events (AEs) that led to intolerance did not recur after treatment with BRUKINSA. Additionally, efficacy was maintained or improved in these patients.

WM Poster Presentations & Reception

(Oct. 18, 4:30-6:30 p.m.)

Poster

BRUKINSA

An analysis of the Phase 3 ASPEN study demonstrates that peripheral neuropathy (PN) symptom resolution with BTK inhibitors correlates with depth of disease response, with faster symptom resolution with BRUKINSA than ibrutinib in patients achieving PN resolution.

Poster

N/A

Results of a UK-wide patient-centered experience survey demonstrate that active monitoring for asymptomatic patients with WM is highly variable, with more than half of participants stating their experience could be improved.

Plenary Session II

(Oct. 19, 9-10 a.m.)

Oral Presentation

Sonrotoclax

Results from the Phase 1 study show that sonrotoclax was generally well tolerated and the preliminary antitumor activity is encouraging in patients with heavily pretreated R/R WM.

Clinical Trials in Progress for WM II

(Oct. 19, 4-5 p.m.)

Oral presentation

Sonrotoclax

Trial-in-progress presentation provides an overview of a Phase 2 study of sonrotoclax in patients with R/R WM, who have been previously treated with a BTK inhibitor therapy or anti-CD20–based systemic therapy.

About Waldenström’s Macroglobulinemia (WM)

Waldenström’s macroglobulinemia (WM) is a rare B-cell lymphoma that occurs in less than 2% of patients with non-Hodgkin lymphomas.1 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.2 Typically, patients present between the ages of 60 and 70 years. For reasons that are unclear, WM is almost twice as common in men as in women and is more common in Caucasians than other ethnic groups.3 WM is a rare cancer seen only in approximately three to five per million people per year.2

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib)

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Waldenström’s macroglobulinemia (WM).
Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information including U.S. Patient Information.

This information is intended for a global audience. Product indications vary by region.

On October 16, 2024 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2024 (Press release, Abbott, OCT 16, 2024, View Source [SID1234647225]).

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Third-quarter GAAP diluted EPS of $0.94 and adjusted diluted EPS of $1.21, which excludes specified items.
Abbott maintains its full-year 2024 organic sales growth guidance range of 9.5% to 10.0%, excluding COVID-19 testing-related sales2.
Abbott now projects full-year diluted EPS on a GAAP basis of $3.34 to $3.40 and projects adjusted diluted EPS of $4.64 to $4.70, which represents an increase at the midpoint of the guidance range.
In October, Abbott’s board of directors authorized a new share repurchase program of up to $7 billion of the company’s common shares.
In August, Abbott announced a unique global partnership with Medtronic to collaborate on connecting Abbott’s world-leading continuous glucose monitoring (CGM) system with Medtronic’s insulin delivery devices.
In September, Abbott announced the U.S. launch of Lingo, the company’s first continuous glucose monitoring system available without a prescription and designed for people interested in improving their overall health and wellness.
In September, Abbott announced a partnership with the Big Ten Conference to conduct a nationwide blood donation competition to help increase the U.S. blood supply.
In September, Abbott completed enrollment ahead of schedule in its VOLT-AF IDE trial, which is designed to evaluate the Volt Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib).
"Our results this quarter demonstrate the strength of our diversified business model," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re well-positioned to achieve the upper end of our initial guidance ranges for the year and have great momentum heading into next year."

THIRD-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

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 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,202

950

1,032

—

2,216

International

6,433

1,116

1,380

1,406

2,531

Total reported

10,635

2,066

2,412

1,406

4,747

% Change vs. 3Q23

U.S.

10.1

10.4

1.8

n/a

14.2

International

1.7

(7.9)

(3.8)

2.7

9.6

Total reported

4.9

(0.3)

(1.5)

2.7

11.7

Impact of foreign exchange

(2.5)

(3.1)

(2.9)

(4.3)

(1.6)

Impact of business exit*

(0.2)

(0.6)

—

—

—

Organic

7.6

3.4

1.4

7.0

13.3

Impact of COVID-19 testing sales (3)

(0.6)

—

(1.9)

—

—

Organic (excluding COVID-19 tests)

8.2

3.4

3.3

7.0

13.3

U.S.

11.0

11.9

2.4

n/a

14.2

International

6.5

(2.6)

3.8

7.0

12.5

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

11,982

2,761

2,775

—

6,435

International

18,994

3,523

4,046

3,926

7,499

Total reported

30,976

6,284

6,821

3,926

13,934

% Change vs. 9M23

U.S.

4.2

8.1

(16.2)

n/a

14.3

International

3.4

(1.1)

(2.4)

2.1

10.1

Total reported

3.7

2.7

(8.5)

2.1

12.0

Impact of foreign exchange

(3.0)

(3.1)

(2.9)

(7.3)

(1.6)

Impact of business exit and acquisition*

0.1

(0.4)

—

—

0.4

Organic

6.6

6.2

(5.6)

9.4

13.2

Impact of COVID-19 testing sales (3)

(2.8)

—

(10.4)

—

—

Organic (excluding COVID-19 tests)

9.4

6.2

4.8

9.4

13.2

U.S.

10.0

9.0

3.0

n/a

13.3

International

9.0

4.2

5.9

9.4

13.1

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Quarter to date Sept. 30, 2024, reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024. Year to date Sept. 30, 2024, reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024 and the acquisition of CSI on April 27, 2023. Organic sales growth excludes the impact of the acquired business from January through April 2024.

Nutrition

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Pediatric

Adult

U.S.

950

568

382

International

1,116

387

729

Total reported

2,066

955

1,111

% Change vs. 3Q23

U.S.

10.4

12.2

7.9

International

(7.9)

(21.6)

1.5

Total reported

(0.3)

(4.5)

3.6

Impact of foreign exchange

(3.1)

(1.8)

(4.4)

Impact of business exit*

(0.6)

—

(1.1)

Organic

3.4

(2.7)

9.1

U.S.

11.9

12.2

11.5

International

(2.6)

(18.0)

8.0

Worldwide Nutrition sales decreased 0.3 percent on a reported basis and increased 3.4 percent on an organic basis in the third quarter, led by growth in Adult Nutrition.

In Adult Nutrition, global sales increased 3.6 percent on a reported basis and 9.1 percent on an organic basis, which was led by growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Pediatric

Adult

U.S.

2,761

1,646

1,115

International

3,523

1,377

2,146

Total reported

6,284

3,023

3,261

% Change vs. 9M23

U.S.

8.1

11.8

3.2

International

(1.1)

(6.8)

2.8

Total reported

2.7

2.5

3.0

Impact of foreign exchange

(3.1)

(1.6)

(4.4)

Impact of business exit*

(0.4)

—

(0.7)

Organic

6.2

4.1

8.1

U.S.

9.0

11.8

5.0

International

4.2

(3.6)

9.7

*Reflects the impact of discontinuing the ZonePerfect product line. This action was initiated in March 2024.

Diagnostics

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

1,032

332

37

103

560

International

1,380

982

91

43

264

Total reported

2,412

1,314

128

146

824

% Change vs. 3Q23

U.S.

1.8

4.5

(2.8)

6.0

(0.2)

International

(3.8)

(1.5)

(3.9)

0.7

(12.2)

Total reported

(1.5)

—

(3.6)

4.4

(4.4)

Impact of foreign exchange

(2.9)

(4.3)

(1.5)

(0.2)

(1.4)

Organic

1.4

4.3

(2.1)

4.6

(3.0)

Impact of COVID-19 testing sales (3)

(1.9)

(0.2)

(3.9)

—

(3.4)

Organic (excluding COVID-19 tests)

3.3

4.5

1.8

4.6

0.4

U.S.

2.4

4.8

4.5

6.0

(1.0)

International

3.8

4.4

0.8

1.3

2.8

As expected, Diagnostics sales growth in the third quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $265 million in the third quarter of 2024 compared to $305 million in the third quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 3.3 percent on an organic basis.

Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales grew 0.1 percent on a reported basis and increased 4.5 percent on an organic basis, led by continued adoption of Abbott’s Alinity family of diagnostics systems and testing portfolios.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

2,775

969

112

308

1,386

International

4,046

2,879

272

133

762

Total reported

6,821

3,848

384

441

2,148

% Change vs. 9M23

U.S.

(16.2)

5.6

(12.3)

6.6

(29.8)

International

(2.4)

0.3

(7.2)

4.8

(10.6)

Total reported

(8.5)

1.5

(8.7)

6.0

(24.0)

Impact of foreign exchange

(2.9)

(4.8)

(0.8)

(0.1)

(1.1)

Organic

(5.6)

6.3

(7.9)

6.1

(22.9)

Impact of COVID-19 testing sales (3)

(10.4)

(0.2)

(6.3)

—

(25.0)

Organic (excluding COVID-19 tests)

4.8

6.5

(1.6)

6.1

2.1

U.S.

3.0

5.9

(3.3)

6.6

(0.1)

International

5.9

6.7

(0.9)

5.1

5.7

Established Pharmaceuticals

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,406

994

412

Total reported

1,406

994

412

% Change vs. 3Q23

U.S.

n/a

n/a

n/a

International

2.7

0.7

8.1

Total reported

2.7

0.7

8.1

Impact of foreign exchange

(4.3)

(4.7)

(3.1)

Organic

7.0

5.4

11.2

U.S.

n/a

n/a

n/a

International

7.0

5.4

11.2

Established Pharmaceuticals sales increased 2.7 percent on a reported basis and 7.0 percent on an organic basis in the third 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 0.7 percent on a reported basis and increased 5.4 percent on an organic basis, led by growth in several geographies and therapeutic areas, including gastroenterology, cardiometabolic, and central nervous system/pain management.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

3,926

2,910

1,016

Total reported

3,926

2,910

1,016

% Change vs. 9M23

U.S.

n/a

n/a

n/a

International

2.1

0.7

6.4

Total reported

2.1

0.7

6.4

Impact of foreign exchange

(7.3)

(9.0)

(2.2)

Organic

9.4

9.7

8.6

U.S.

n/a

n/a

n/a

International

9.4

9.7

8.6

Medical Devices

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,216

288

285

252

258

270

190

673

International

2,531

309

325

70

441

288

46

1,052

Total reported

4,747

597

610

322

699

558

236

1,725

% Change vs. 3Q23

U.S.

14.2

6.0

15.8

16.7

2.8

21.1

0.8

23.6

International

9.6

5.7

9.2

5.2

4.5

9.2

17.8

13.3

Total reported

11.7

5.9

12.2

14.0

3.9

14.6

3.8

17.1

Impact of foreign exchange

(1.6)

(1.1)

(2.1)

(0.4)

(1.0)

(1.9)

(1.4)

(2.0)

Organic

13.3

7.0

14.3

14.4

4.9

16.5

5.2

19.1

U.S.

14.2

6.0

15.8

16.7

2.8

21.1

0.8

23.6

International

12.5

7.9

13.0

6.6

6.2

12.6

25.7

16.5

Worldwide Medical Devices sales increased 11.7 percent on a reported basis and 13.3 percent on an organic basis in the third quarter, including double-digit organic growth in both the U.S. and internationally.

Sales growth was led by double-digit growth in Diabetes Care, Structural Heart, Heart Failure, and Electrophysiology. Several products contributed to the strong performance, including FreeStyle Libre, Navitor, TriClip, Amplatzer Amulet, and AVEIR.

In Electrophysiology, sales grew 12.2 percent on a reported basis and 14.3 percent on an organic basis, which included double-digit growth in catheters and cardiac mapping-related products.

In Diabetes Care, sales of continuous glucose monitors exceeded $1.6 billion and grew 19.1 percent on a reported basis and 20.7 percent on an organic basis.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

6,435

851

841

733

787

761

563

1,899

International

7,499

915

983

215

1,325

876

142

3,043

Total reported

13,934

1,766

1,824

948

2,112

1,637

705

4,942

% Change vs. 9M23

U.S.

14.3

6.4

15.3

11.0

7.4

16.7

6.5

24.3

International

10.1

4.8

12.6

8.2

4.2

10.3

16.5

13.5

Total reported

12.0

5.6

13.8

10.4

5.4

13.2

8.4

17.4

Impact of foreign exchange

(1.6)

(1.2)

(2.6)

(0.1)

(1.3)

(1.9)

(1.5)

(1.9)

Impact of acquisition*

0.4

—

—

—

2.8

—

—

—

Organic

13.2

6.8

16.4

10.5

3.9

15.1

9.9

19.3

U.S.

13.3

6.4

15.3

11.0

0.1

16.7

6.5

24.3

International

13.1

7.1

17.4

8.9

6.0

13.7

24.6

16.5

*Abbott completed the acquisition of CSI on April 27, 2023. For purposes of calculating organic sales growth, the impact from this acquired business has been excluded from January through April 2024.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2024 diluted earnings per share under GAAP of $3.34 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.30 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.64 to $4.70 for the full-year 2024.

Abbott projects fourth-quarter 2024 diluted earnings per share under GAAP of $0.96 to $1.02. Abbott forecasts specified items for the fourth-quarter 2024 of $0.35 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $1.31 to $1.37 for the fourth quarter 2024.

ABBOTT DECLARES 403RD CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 19, 2024, the board of directors of Abbott declared the company’s quarterly dividend of $0.55 per share. Abbott’s cash dividend is payable Nov. 15, 2024, to shareholders of record at the close of business on Oct. 15, 2024.

Abbott has increased its dividend payout for 52 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 October 15, 2024 Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, reported its precision oncology development candidate ATV-1601, an orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers (Press release, Atavistik Bio, OCT 15, 2024, View Source [SID1234647394]). ATV-1601 was developed leveraging the company’s AMPSTM technology, which is seamlessly integrated with its AI-enabled drug discovery engine to rapidly advance programs from discovery into development.

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"ATV-1601’s nomination as our first oncology development candidate is a major milestone for the company, validating the capabilities of our proprietary platform to rapidly discover and advance novel precision allosteric therapeutics for targets that have historically been hard to drug. We anticipate significant progress in our portfolio in the upcoming year for high value oncology targets that address the unmet needs of large patient populations," said Bryan Stuart, Chief Executive Officer, Atavistik Bio. "We are working to quickly advance ATV-1601 to the clinic and to achieve early clinical proof of concept for this program. We believe our precision allosteric small molecule offers several advantages to target the difficult-to-drug AKT1 E17K mutation, with the potential to improve the lives of many cancer patients."

AKT1 E17K mutation is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers. In addition, early evidence indicates that the AKT1 E17K mutation appears to be an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. A selective allosteric AKT1 E17K inhibitor has the potential to be a transformative therapy against the validated AKT1 E17K oncogenic driver as well as resistance mutations emerging from PI3Kα-targeted therapies.

The only approved AKT-targeted therapy is a pan-AKT inhibitor that blocks all three isoforms of AKT (AKT1, AKT2, and AKT3). Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation. Additionally, pan-AKT inhibitors can cause significant adverse events, such as AKT2-driven hyperglycemia, rash, and diarrhea, which leads to treatment discontinuation or dose-reductions in a considerable subset of patients. ATV-1601, a selective allosteric AKT1 E17K inhibitor, has the potential to provide enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors for AKT1 E17K-driven cancers. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025.

"Behind ATV-1601, we have a robust pipeline of precision oncology programs derived from our AMPS platform, said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. "We look forward to advancing our internal pipeline with urgency while also broadening the reach of our platform through partnerships to discover important new allosteric therapeutics across other diseases."

Atavistik Bio EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium Data Presentation Details

Date: Wed., October 23, 2024
Time: 12.00 – 19.00 CET
Poster Session: New Drugs
Poster Title: ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1 E17K and Shows Profound and Durable Regressions in AKT1 E17K-Driven Patient-Derived Xenograft Models
Poster #: PB128

On October 17, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported a clinical engagement update of its pivotal Phase 3 study of Bria-IMT in combination with immune check point inhibitor in metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, OCT 15, 2024, View Source [SID1234647245]). The study will enroll up to 354 patients randomized 1:1 to the BriaCell combination regimen or physician’s choice and will include a small number (n=50) of patients randomized to Bria-IMT monotherapy.

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"We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT combination regimen in patients with metastatic breast cancer who failed approved therapies," stated Dr. William V. Williams, BriaCell’s President and CEO.

"Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet."

35 clinical sites (18 main and 17 satellite) are active and enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.

Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. Secondary analyses include comparison of the Bria-IMT combination regimen vs Bria-IMT monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

On October 15, 2024 Tolerance Bio, Inc., a biopharmaceutical company pioneering a novel approach to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, reported the closing of its oversubscribed $17.2 million seed financing round, led by Columbus Venture Partners, with participation from Criteria Bio Ventures, Sessa Capital, BioAdvance, Ben Franklin Technology Partners and individual biotechnology investors (Press release, Tolerance Bio, OCT 15, 2024, View Source [SID1234647220]).

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Tolerance Bio is developing an allogeneic, or "off the shelf," thymus induced pluripotent stem cell (iPSC)-based cell therapy platform as well as pharmacological thymus therapies to address immune-mediated diseases caused by abnormalities in immune tolerance, including cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies.

"Defeating immune diseases has been the lifelong quest of this exceptional team we have assembled, with patients and their families always front and center for us," said Francisco Leon, M.D., Ph.D., Co-Founder and Chief Executive Officer of Tolerance Bio. "We intend to rapidly advance and validate our pioneering concepts in a rare disease and then assess proof-of-concept in multiple major indications, advancing these novel therapeutics to target immune disease at its core."

The thymus, an organ in the chest, plays a crucial role in training T lymphocytes (T cells) to defend against threats such as infections and cancers while preventing autoimmunity. The T cell repertoire is developed in the first two years of life, and the thymus then declines with age, increasing the risk of immune diseases and mortality. Tolerance Bio’s technologies aim to delay and prevent thymic involution and restore thymic function if lost, ultimately addressing these immune diseases and potentially increasing longevity.

The iPSC technologies were initially developed at the University of Colorado and the University of Florida by Holger Russ, Ph.D., Scientific Co-Founder and Associate Professor, Department of Pharmacology and Therapeutics, Diabetes Institute at the University of Florida. The technologies were advanced alongside a proven team of drug and cell therapy developers, including Dr. Francisco Leon, former Co-Founder and Chief Scientific Officer of Provention Bio (acquired by Sanofi in 2023) and former Co-Founder, Chief Executive Officer, and Chief Medical Officer of Celimmune (acquired by Amgen in 2017).

"After pioneering the generation of bioengineered thymuses from iPSC in vitro and in vivo, I am very excited for the opportunity to advance this technology to benefit patients," said Dr. Holger Russ. "I couldn’t have found a more experienced and dynamic team to partner with than the cell and drug therapy experts at Tolerance Bio."

The Tolerance Bio team includes cell therapy experts such as Yeh-Chuin Poh, Ph.D., Vice President of Technical Operations, formerly with Semma Therapeutics (acquired by Vertex Pharmaceuticals in 2019) and Beam Therapeutics. The team also features experienced drug developers such as Justin Vogel, Chief Financial Officer; Phil Ball, Ph.D., Senior Vice President of Business Development and Operations; and Paul Dunford, Vice President of Translational Science. All three formerly worked at Provention Bio and each bring more than 20 years of biopharma experience from leading pharmaceutical companies such as Allergan, Janssen and Roche.

"The mission of Columbus Venture Partners is to support world-class teams to enable transformational technologies to become products and help people in need," said Damia Tormo, Managing Partner of Columbus Venture Partners. "With Tolerance Bio, we not only have the prospect of preventing and treating immune disease but also possibly extending longevity, a tremendously exciting opportunity."

Pablo Cironi, Ph.D., Director at Criteria Bio Ventures added, "We are excited to support Tolerance Bio in their mission to manipulate immune tolerance via thymus-based therapies, potentially transforming the landscape of immune-mediated diseases. The exceptional team at Tolerance Bio, with deep expertise across both cell and drug therapies, is uniquely positioned to bring these groundbreaking treatments to patients. Their combined experience from leading biopharmaceutical companies will be key in advancing these innovative therapies and addressing unmet medical needs in immune disease management."