On July 24, 2024 Notable Labs, Ltd. (Nasdaq: NTBL) ("Notable", "Notable Labs" or the "Company"), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), reported progress for the Phase 2 volasertib program following receipt of "Clearance to Proceed" from the FDA and agreement on the dosing plan for its Phase 2 clinical trial (Press release, Notable Labs, JUL 24, 2024, View Source [SID1234645041]). With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollment in the Phase 2 study for PMP-enabled development of volasertib for relapsed refractory (R/R) acute myeloid leukemia (AML) in the coming months.

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"We are pleased to report positive progress in our clinical development program to evaluate the use of volasertib, in combination with decitabine, for patients with R/R AML. Receiving FDA’s clearance and agreement on a Phase 2 dosing plan positions us to move forward to activate study sites," said Thomas Bock, M.D., Chief Executive Officer of Notable. "AML remains a devastating and life-threatening unmet need, especially for patients whose disease has progressed after first-line treatment, and especially in those who have received venetoclax-based therapies. Advancing the volasertib program through the next Phase 2 implementation steps represents meaningful progress for the Company. We are excited about the potential of volasertib, our predictive platform, and our carefully designed clinical program to enhance patient clinical outcomes and tolerability. We look forward to updating our investors and key stakeholders as we proceed."

Glenn Michelson, M.D., Chief Medical Officer of Notable commented, "Our study design and enrollment strategy for volasertib has been informed by our robust clinical validation trials conducted at Stanford University, the University of Texas MD Anderson Cancer Center and other recognized institutions. In addition, our program incorporates learnings from the agent’s originator, Boehringer Ingelheim, and leverages their extensive post-hoc analysis of the initial Phase 3 AML study. These valuable data guided our decision to in-license volasertib and the overall development strategy. We are enthusiastic to advance a promising new treatment option for patents with R/R AML, building on our platform."

Amer Zeidan, MBBS, Associate Professor of Medicine (Hematology), Chief of Hematologic Malignancies at Yale Cancer Center and study co-chair shared, "As a clinical researcher with experience in acute myeloid leukemia, I am excited about the potential of volasertib, in combination with Notable’s platform and the enhanced trial design, to overcome some of the problems experienced in prior trials of this agent. This study will allow us to understand if volasertib could offer promise to advance care for patients with acute myeloid leukemia."

The Phase 2 study will begin with a dose optimization lead-in and incorporate body-surface area (BSA) dosing, prophylactic antibiotic treatment and best supportive care. The second part of the study is planned to enroll patients with R/R AML who are PMP-predicted responders. The Company is working towards initiating dosing of the first subjects in the Phase 2 trial. Based on our plan, Notable expects to have initial data from the dose optimization lead-in during the fourth quarter of 2024, initiate selective enrollment of PMP-predicted responders after that, and start to report initial efficacy results during H1 2025.

About Volasertib

Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize its PMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted Breakthrough Therapy designation by the FDA. Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.

On July 24, 2024 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported that it awarded inducement grants on July 22, 2024 to its Executive Vice President and Chief Financial Officer, Edward Dulac, under Intellia’s 2024 Inducement Plan as a material inducement to employment (Press release, Intellia, JUL 24, 2024, View Source [SID1234645040]).

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The inducement grants consisted of non-qualified stock options to purchase 96,219 shares of Intellia’s common stock with an exercise price of $25.33 per share, the closing price of Intellia’s common stock as reported by Nasdaq on July 22, 2024, with 33% of the options underlying the option award vesting on the first anniversary of the grant date and the remainder vesting monthly thereafter until fully vested on the third anniversary of the grant date; time-based restricted stock units ("RSUs") for 66,324 shares of Intellia’s common stock, with one-third of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the grant date; performance-based RSUs for 33,162 shares of Intellia’s common stock, with vesting criteria linked directly to Intellia’s total stockholder return over a three-year period compared to the companies comprising the Nasdaq Biotechnology Index at the beginning of the performance period; and performance-based RSUs for 30,000 shares (at target) of Intellia’s common stock, with vesting criteria linked directly to certain development milestones over a three-year period.

All equity vesting is subject to Mr. Dulac’s continued service as an employee of, or other service provider to, Intellia through the applicable vesting dates.

All of the above-described awards were granted outside of Intellia’s stockholder-approved equity incentive plans pursuant to Intellia’s 2024 Inducement Plan, which was adopted by the board of directors in June 2024. The awards were approved by a majority of the independent directors of Intellia’s board of directors as a material inducement to Mr. Dulac’s entering into employment with Intellia in accordance with Nasdaq Listing Rule 5635(c)(4).

On July 24, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported it will host a virtual key opinion leader (KOL) event on Friday, August 2 at 9:00 AM ET featuring J. Randolph Hecht, MD, (Professor, UCLA Gastrointestinal Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) who will discuss the unmet need and current treatment landscape for patients with metastatic microsatellite stable colorectal cancer (MSS-CRC) (Press release, Gritstone Bio, JUL 24, 2024, View Source [SID1234645039]).

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Gritstone management will also highlight the development of Gritstone’s personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically "cold" tumors including MSS-CRC. Mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC are expected in the third quarter of 2024.

A live Q&A session will follow the formal presentations.

About J. Randolph Hecht, MD
J. Randolph Hecht, MD is a Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA School of Medicine. He holds the Carol and Saul Rosenzweig Chair for Cancer Therapies Development and is the Director of the UCLA Gastrointestinal Oncology Program. Dr. Hecht attended medical school at Eastern Virginia Medical School. He took his internal medicine residency at Northwestern and completed fellowships in gastroenterology research at the University of Chicago, and in gastroenterology and medical oncology at UCLA. Dr. Hecht is an internationally known clinical and translational researcher in the field of gastrointestinal cancers. He has published widely on the molecular biology, early detection, and treatment of gastrointestinal malignancies. He has led and is currently directing small trials with new molecules as well as large international randomized trials. Current ongoing research includes preclinical models of therapy with biological agents, early studies with gene therapy vectors and tyrosine kinase inhibitors, and leading phase II and phase III trials with novel agents.

About Howard Brown
Howard Brown is a two-time Stage IV cancer patient, survivor, advocate, technology entrepreneur, husband, dad and avid basketball player. In 1989 at the age of 23, Howard was diagnosed with Stage IVe Non-Hodgkin’s Lymphoma. After failing three chemotherapy regimens, he had an allogeneic (from a donor) bone marrow transplant from his twin sister who was an exact HLA match. That, along with massive chemotherapy and full body radiation saved his life. Twenty-six years after achieving remission, Howard was diagnosed with Stage III Colon Cancer at age fifty via a standard colonoscopy. After two colon resection surgeries, intense chemotherapy and a failed clinical trial he turned metastatic Stage IV and discovered the cancer had spread to his liver, peritoneum, omentum and small bowel. After salvage second line chemotherapy showed some regression (shrinkage), Howard underwent Cytoreduction Surgery (debulking / removal of live and dead cancer cells) with Heated intra-peritoneal chemotherapy (hot chemo wash to kill micro cancer cells– (CRS HIPEC). Howard is currently considered No Evidence of Disease (NED) at this time after 9 consecutive CT scans. He serves as the Board Chair and President of Colontown, an organization that serves over 11,000 patients and caregivers with colorectal cancer. Howard is a proud graduate and past trustee of Babson College, #1 for entrepreneurship, and lives with his family in Birmingham, Michigan.

On July 24, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that its Canadian Nuclear Research Initiative Health ("CNRI-H") Program application was retained and approved by the Canadian Nuclear Laboratories ("CNL") to accelerate Defence’s radio-immuno-conjugates project (Press release, Defence Therapeutics, JUL 24, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-granted-cnri-h-from-the-canadian-nuclear-laboratories-to-accelerate-the-development-of-its-radio-immuno-conjugates-program [SID1234645036]).

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Defence’s CNRI-H project will focus on the synthesis and evaluation of novel constructs, variations of 111In-AccuTOX-Trastuzumab. The objective is to demonstrate that AccuTOX moiety is an essential modification to conventional 111In-Trastuzumab constructs to evade an endosome entrapment and ensure nuclear localization, where 111In will emit Auger Electrons ("AEs") to kill cancer cells, and providing a synergistic effect by unleashing AccuTOX immune-boosting power. It is expected that these constructs will be lethal to HER2-positive cancer cells specifically and will produce high potency.

Selected AccuTOX constructs, based on stability, solubility, and biochemical properties, will be conjugated to the trastuzumab antibody, followed by radiolabeled with 111In, and then characterized, in vitro and in vivo, for its efficacy in killing cancer. The main goal is to identify the biologically active 111In-AccuTOX-Trastuzumab molecule that will be more potent to treat solid tumor resistant to current HER2-targeting therapy such as therapeutic antibodies (e.g., trastuzumab alone) and antibody-drug conjugate (e.g., Kadcyla).

In summary, the aim of this CNRI-H collaborative project is:

1. To synthesize AccuTOX-Trastuzumab antibody conjugates, radiolabel with 111In, and characterize, including structure and cellular analysis (e.g. identification, drug-antibody ratio, specific activity), stability, and cytotoxic effects, in vitro.

2. To perform animal studies in rodents, in vivo, namely biodistribution, pharmacokinetic profile, and therapeutic potency, using selected 111In-AccuTOX-Trastuzumab constructs.

"We are proud to have this opportunity to collaborate with the Canadian Nuclear Laboratories and to advancing Defence’s radio-immuno-conjugates program for the benefit of the cancer’s patients. The CNL scientific team dedicated to our project is very strong and will definitely accelerate and reinforce Defence’s strength in this renowned and fast-growing radiopharmaceuticals field," said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

CNRI-H is a program developed by CNL to further the realization of its mission of contributing to the health of Canadians. Through CNRI-H, CNL provides financial support along with its expertise, experience, capabilities and makes this available and accessible to the healthcare community to advance new life saving radiopharmaceutical solutions. CNRI-H is a turnkey solution that integrates both funding and project execution in one award. The goal of the program is to accelerate the optimization of therapeutic isotopes production and the clinical translation of targeted radiopharmaceuticals for the benefit of Canadians whilst increasing the safety and efficacy of therapies that involve radiopharmaceuticals.

According to Allied Market Research, the global radiopharmaceuticals market was valued at $7.9 billion in 2023, and is projected to reach $21.8 billion by 2033, growing at a CAGR of 10.6% from 2024 to 2033. And according to Straits Research, the global radioligand therapy market size was valued at USD 12.55 billion in 2023, and it is anticipated to reach USD 21.55 billion by 2032 with a CAGR of 4.62%. The use of radioligands to treat specific cancers is a novel method. It delivers radiation to cancer cells with pinpoint accuracy and minimal side effects on healthy cells, resulting in higher treatment efficacy.

On July 24, 2024 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.120 billion during the second quarter of 2024, growing 14.5 percent on a reported basis, 16.1 percent on an operational1 basis and 14.7 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 24, 2024, View Source [SID1234645035]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $324 million or $0.22 per share (EPS), compared to $261 million or $0.18 per share a year ago, and achieved adjusted3 EPS of $0.62 for the period, compared to $0.53 a year ago.

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"We delivered a quarter marked by exceptional performance, reflecting our global team’s relentless pursuit of innovation that is supported by strong clinical evidence and investments aligned with our strategy of category leadership," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain excited about our plans for the future, and I am incredibly grateful for the commitment and winning spirit of our employees around the world."

Second quarter financial results and recent developments:

Reported net sales of $4.120 billion, representing an increase of 14.5 percent on a reported basis, compared to the company’s guidance range of 10.5 to 12.5 percent; 16.1 percent on an operational basis; and 14.7 percent on an organic basis, compared to the company’s guidance range of 10 to 12 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.22 per share, compared to the company’s guidance range of $0.35 to $0.37 per share, and achieved adjusted EPS of $0.62 per share, compared to the guidance range of $0.57 to $0.59 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 9.0 percent reported, 10.1 percent operational and 7.6 percent organic
Cardiovascular: 17.8 percent reported, 19.7 percent operational and 19.0 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 16.9 percent reported and operational
Europe, Middle East and Africa (EMEA): 13.7 percent reported and 16.1 percent operational
Asia-Pacific (APAC): 7.0 percent reported and 13.2 percent operational
Latin America and Canada (LACA): 15.3 percent reported and 15.7 percent operational
Emerging Markets4: 14.8 percent reported and 19.3 percent operational

Received National Medical Products Administration (NMPA) approval in China for the FARAPULSE Pulsed Field Ablation (PFA) System.

Presented the following clinical data at Heart Rhythm 2024:
Outcomes from a sub-analysis of the pivotal ADVENT clinical trial of the FARAPULSE PFA System, which demonstrated that treatment with the system resulted in an atrial arrhythmia burden (i.e., the total arrhythmia duration experienced by a patient) of less than 0.1% – a clinically meaningful threshold – in significantly more patients compared to thermal ablation.
Acute outcomes from the global FARADISE registry, which demonstrated favorable 30-day outcomes in more than 1,100 patients treated with the FARAPULSE PFA System, with no deaths or reports of coronary spasm, persistent phrenic nerve palsy, atrioesophageal fistula or pulmonary vein stenosis.
Positive results from the ongoing pivotal MODULAR ATP clinical trial of the Modular CRM (mCRM) System5 which met all pre-specified six-month safety and effectiveness endpoints. This is the first modular cardiac rhythm management (mCRM) system that consists of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER Leadless Pacemaker.

Initiated the U.S. launch of the AGENT Drug-Coated Balloon, indicated to treat in-stent restenosis in patients with coronary artery disease, and received NMPA approval for the device in China.

Announced agreement to acquire Silk Road Medical, Inc., (Nasdaq: SILK) a publicly traded medical technology company that commercialized a platform of products to prevent stroke in patients with carotid artery disease, subject to customary closing conditions.

Presented outcomes at the 2024 American Society of Pain & Neuroscience meeting from three follow-up studies of patients treated with the Intracept Intraosseous Nerve Ablation System, which demonstrated significant improvements in vertebrogenic pain with nearly one-third of patients 100% pain free after five years.

Elected to the company’s board of directors Dr. Cheryl Pegus, former partner at Morgan Health and former executive vice president of Health & Wellness at Walmart.

1. Operational net sales growth excludes the impact of foreign currency fluctuations.
2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.
3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.
4. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.
5. The EMPOWER Leadless Pacemaker is an investigational device and limited by U.S. law to investigational use only. It is not available for sale. Some device references are for informational purposes only and are pending CE Mark. Not available in the European Economic Area.

Net sales for the second quarter by business and region:

View News Release Full Screen

Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 676

$ 631

7.1 %

1.3 %

8.4 %

(0.5) %

7.9 %

Urology

525

485

8.2 %

0.9 %

9.1 %

— %

9.1 %

Neuromodulation

282

244

15.5 %

0.7 %

16.2 %

(12.5) %

3.7 %

MedSurg

1,483

1,360

9.0 %

1.0 %

10.1 %

(2.5) %

7.6 %

Cardiology

2,047

1,704

20.1 %

1.9 %

22.0 %

— %

22.0 %

Peripheral Interventions

590

535

10.2 %

2.1 %

12.3 %

(2.8) %

9.4 %

Cardiovascular

2,637

2,239

17.8 %

1.9 %

19.7 %

(0.7) %

19.0 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

(1.4) %

14.7 %

View News Release Full Screen

Increase/(Decrease)

Three Months Ended June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2024

2023

U.S.

$ 2,466

$ 2,110

16.9 %

— %

16.9 %

EMEA

822

723

13.7 %

2.5 %

16.1 %

APAC

670

626

7.0 %

6.2 %

13.2 %

LACA

162

140

15.3 %

0.4 %

15.7 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

Emerging Markets4

$ 680

$ 592

14.8 %

4.6 %

19.3 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared
in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2024

The company estimates net sales growth for the full year 2024, versus the prior year period, to be in range of approximately 13.5 to 14.5 percent on a reported basis, and 13 to 14 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.34 to $1.38 and estimates adjusted EPS, excluding certain charges (credits), of $2.38 to $2.42.

The company estimates net sales growth for the third quarter of 2024, versus the prior year period, to be in a range of approximately 13 to 15 percent on both a reported basis and organic basis. Third quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.36 to $0.38 and adjusted EPS, excluding certain charges (credits), of $0.57 to $0.59.

Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.