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Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukaemia in AMPLIFY Phase III trial

On July 29, 2024 Astrazeneca reported positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL) (Press release, AstraZeneca, JUL 29, 2024, View Source [SID1234645124]).

For the secondary endpoint of overall survival (OS), a trend was observed in favour of Calquence in combination with venetoclax, with or without obinutuzumab, versus standard-of-care chemoimmunotherapy. The OS data were not mature at the time of this analysis and the trial will continue to assess OS as a key secondary endpoint.

CLL is caused by the abnormal production of white blood cells and is the most prevalent type of leukaemia in adults worldwide, with numbers anticipated to grow.1-3 In the first-line setting, approximately 40,000 patients are treated with the current standard of care.4 Although CLL is considered an incurable cancer, patients often live with the disease for many years, and may remain on continuous treatment.5

Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the trial, said: "The AMPLIFY results demonstrate the potential of acalabrutinib and venetoclax with or without obinutuzumab to be effective and well-tolerated fixed-duration treatment options for patients with chronic lymphocytic leukaemia. This is an important advance in this setting as fixed-duration regimens allow those living with this chronic disease to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance and improving quality of life."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The progression-free survival and overall survival results from the AMPLIFY Phase III trial demonstrate the potential of including a BTK inhibitor in a fixed-duration regimen and reinforce our leadership in advancing science for patients with chronic lymphocytic leukaemia. If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers."

The safety and tolerability were consistent with the known safety profile of each medicine. No new safety signals were identified, with low rates of cardiac toxicity observed.

The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Notes

CLL
In CLL, there is an accumulation of abnormal lymphocytes within the bone marrow and in blood and lymph nodes.1 Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.6 As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets. This could result in anaemia, infection and bleeding.1 B-cell receptor signalling through BTK is one of the essential survival pathways for CLL.

AMPLIFY
AMPLIFY is a randomised, global, multi-centre, open-label Phase III trial evaluating the efficacy and safety of Calquence in combination with venetoclax with and without obinutuzumab compared to investigator’s choice of chemoimmunotherapy in adult patients with previously untreated CLL without del(17p) or TP53 mutation.7 Patients were randomised 1:1:1 to receive either Calquence in combination with venetoclax, Calquence in combination with venetoclax plus obinutuzumab for a fixed duration or standard-of-care chemoimmunotherapy.7

The primary endpoint is PFS in the Calquence and venetoclax arm as assessed by an Independent Review Committee (IRC) and PFS in this arm assessed by investigators (INV) is a key secondary endpoint. IRC and INV assessed PFS in the Calquence, venetoclax and obinutuzumab arm as a key secondary endpoint. Other key secondary endpoints include OS, event-free survival, overall response rate, duration of response and time to next treatment.7 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.7

The AMPLIFY trial enrolled patients from 2019 to 2021, continuing through the COVID-19 pandemic.7 Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalisation and death compared to the general population.8

Calquence
Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.9 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence has been used to treat more than 80,000 patients worldwide10 and is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. Calquence is also approved in the US, China and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is not currently approved for the treatment of MCL in Japan or the EU.

As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

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Anixa Biosciences Announces Presentation on its Ovarian Cancer CAR-T Clinical Trial at the International Gynecologic Cancer Society 2024 Annual Meeting

On July 29, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported a presentation on its ovarian cancer CAR-T therapy clinical trial at the International Gynecologic Cancer Society (IGCS) 2024 Annual Global Meeting being held October 16-18, 2024, in Dublin, Ireland (Press release, Anixa Biosciences, JUL 29, 2024, View Source [SID1234645123]).

The presentation, titled "Phase I Clinical Trial of Autologous T-cells Genetically Engineered with a Chimeric Receptor to Target the Follicle Stimulating Hormone Receptor (FSHR) in Recurrent Ovarian Cancer (OVCA)," will be presented by the study’s principal investigator, Dr. Robert Wenham, Chair of Gynecologic Oncology at Moffitt Cancer Center, Anixa’s collaboration partner.

About Anixa’s CAR-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T. Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

Rakovina Therapeutics Closes Previously Announced Over-subscribed Private Placement

On July 26, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV) (the "Company"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private placement (the "Private Placement") for gross proceeds to the Company of $2 million (Press release, Rakovina Therapeutics, JUL 27, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-closes-previously-announced-over-subscribed-private-placement [SID1234645110]).

In connection with the Private Placement, the Company issued 19,950,000 units (each, a "Unit") at a purchase price of $0.10 per Unit. Each Unit is comprised of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange (the "TSXV") is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.

According to Executive Chairman Jeffrey Bacha, the funds will be used to further the company’s Artificial Intelligence (AI) fueled drug candidate research. Bacha said, "We are continuing activities under our AI collaboration to screen billions of drug candidates against DNA-damage response targets. We anticipate having initial output from this effort in the form of recommended molecular structures for validation in our laboratories at the University of British Columbia in early fall, which puts us on track to have initial data from validating in vivo models later this year."

Defects on our natural DNA-damage response mechanism are involved in the formation and growth of approximately three out of every four cancers. First generation DDR-inhibitors, called PARP-inhibitors, currently generate approximately $3 billion in annual sales and have provided significant benefit to patients diagnosed with certain types of breast, ovarian, and prostate cancer. Rakovina Therapeutics’ goal is to advance one or more next-generation DDR drug candidates into human clinical trials in collaboration with pharmaceutical partners.

In connection with the Private Placement, the Company paid a cash finder’s fee to Hampton Securities Limited totaling $1,200 and issued 12,000 finder’s warrants (each, a "Finder’s Warrant"). Each Finder’s Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance, subject to acceleration on the same terms as the Warrants issued in connection with the Private Placement.

The Private Placement is subject to the final acceptance of the TSX-V and all securities issuable in connection with the Private Placement are subject to resale restrictions for a period of four months plus one day from the date of issuance.

Half-year results reflect the deteriorated situation in Niger in an otherwise favorable dynamic 2024 financial outlook confirmed

On July 26, 2024 Orano reported Half-year results reflect the deteriorated situation in Niger in an otherwise favorable dynamic 2024 financial outlook confirmed (Presentation, Orano, JUL 26, 2024, View Source;orano-2024-half-year-results.pdf?sfvrsn=a29c3931_6 [SID1234647176]).

Q2 2024 Results

On July 26, 2024 Bristol-Myers Squibb reported second quarter 2024 results (Presentation, Bristol-Myers Squibb, JUL 26, 2024, View Source [SID1234646907]).