Leo Lens Pharma Excited to Have Its Lead Asset Ready for Human Clinical Evaluation

Leo Lens Pharma | June 23, 2020

Today, Leo Lens Pharma, an emerging San Diego-based pharmaceutical company focused on helping protect sight, is pleased to announce that its lead asset, LL-BMT1, is ready for IND submission and human clinical evaluation. LL-BMT1 is a therapeutic contact lens that delivers preservative-free bimatoprost to the eye to treat glaucoma for one week. After a productive Pre-IND meeting with the FDA, Leo Lens has now successfully completed GLP biocompatibility studies required by the FDA, secured a clinical research organization to oversee the initial human clinical trial, secured the clinical site, and executed an agreement with a contract manufacturing organization for cGMP manufacturing of the clinical test articles. The company plans to submit an IND in the coming months and proceed to Phase 2a clinical evaluation of LL-BMT1 in 2020.

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PHARMA TECH

Lantheus Acquires Cerveau Technologies

Lantheus | February 07, 2023

On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau). Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease. Alzheimer's disease is a neurodegenerative condition that causes a steady and gradual deterioration in cognition and function. Alzheimer's disease affects an estimated 6.5 million people in the United States. As the population ages, the frequency of this disease is expected to climb further, and by 2050, the number of persons 65 and older with Alzheimer's disease may reach 12.7 million. MK-6240 is a clinical-stage PET development candidate that is designed to identify Tau protein that accumulates as neurofibrillary tangles in the brains of individuals suffering or suspected of Alzheimer's disease. MK-6240 has the potential to help in Alzheimer's disease diagnosis, staging, treatment selection and response to therapy. Despite being in clinical development, MK-6240 is now being employed in over 60 academic and industrial clinical studies worldwide for various late-stage Alzheimer's disease therapeutic candidates, being explored by more than 16 pharmaceutical firms. Following the terms of the agreement, Lantheus will make an upfront payment as well as potential further development and commercial milestone payments. It will also pay double-digit royalties on research revenue and commercial sales. In addition, the deal, which is structured as a stock acquisition, stipulates, among other things, that the seller would offer transition and clinical development services for a specified period after the conclusion of the transaction. In this transaction, Chestnut Partners, Inc. served as the exclusive financial advisor to Cerveau. At the same time, Lantheus was advised by Foley Hoag LLP in connection with the acquisition. About Lantheus Founded in 1956, Lantheus offers novel diagnostics, targeted medicines, and artificial intelligence (AI) solutions to help clinicians Find, Fight, and Follow® diseases. It has been delivering life-changing research to patients and clinicians for over 60 years, going above and beyond to enhance lives and outcomes. Lantheus Holdings is the parent company of Progenics Pharmaceuticals, Lantheus Medical Imaging, Inc., Inc. and EXINI Diagnostics AB. Headquartered in North Billerica, Massachusetts, the company has offices in New Jersey, Canada and Sweden.

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BUSINESS INSIGHTS, PHARMA TECH

Innate Pharma Announces Preclinical Data Publication in Nature Biotechnology

Innate Pharma | January 17, 2023

On January 16, 2023, Innate Pharma SA announced the publication of preclinical findings demonstrating the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 in the scientific journal Nature Biotechnology. Innate and Sanofi conducted the experiments, which were published in Nature Biotechnology on January 12, 2023. This study demonstrates that CD64 expression on AML blasts imparts resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and that redirecting NK cells against cancer targets by binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE primarily target NK cells and have substantial antitumor activity against primary AML blasts; they stimulate NK cell activation and cytokine secretion exclusively in AML cells' presence. In vivo, its antitumor activity observed in a mouse tumor model surpasses that of the anti-CD123 antibody used as the comparator. Furthermore, in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates, the efficacy of CD123-NKCE was associated with the induction of low pro-inflammatory cytokine release and the absence of toxicity. These results support CD123-NKCE clinical development. IPH6101/SAR'579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, is currently being evaluated in a Phase 1/2 clinical trial by Sanofi in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS). About Innate Pharma Headquartered in Marseille (France), Innate Pharma SA is a global, clinical-stage oncology-focused biotech firm dedicated to enhancing patient treatment and clinical outcomes using therapeutic antibodies that employ the immune system to combat cancer. Its extensive antibody pipeline has numerous potentially first-in-class clinical and preclinical candidates for cancers with a high unmet medical need. In addition, Innate has been a pioneer in the study of natural killer cell (NK cell) biology and developed its expertise in tumor antigens, tumor microenvironment, and antibody engineering. This innovative strategy has resulted in a varied proprietary portfolio and substantial alliances with biopharmaceutical industry leaders, including Sanofi, Bristol-Myers Squibb, Novo Nordisk A/S, and a multi-product collaboration with AstraZeneca.

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BUSINESS INSIGHTS, PHARMACY MARKET

Shields Health Solutions Increases Specialty Pharmacy Services Nationwide

Shields Health Solutions | January 12, 2023

Shields Health Solutions (ShieldsRx), one of the leading specialty pharmacy accelerators, informed that the company has now collaborated with more than 850 hospitals at over 75 health systems after adding four more health systems. ShieldsRx health system partners are well-positioned to improve therapy management and care coordination for critical patients, improving outcomes through high-quality care. Its health systems serve 1 million patients in 44 states. Matt Conway, Chief Commercial Growth Officer of ShieldsRx stated, "As the foremost expert in health system specialty pharmacy, Shields has proven successful in partnering with health system leaders to develop integrated programs that deliver superior experiences and outcomes for complex patients." He further stated, "Not only do these programs deliver measurable clinical results but integrating specialty pharmacy within the health system also creates the net operating income health systems need to succeed. These proven clinical and financial results are why so many leading health systems trust Shields to elevate access, outcomes and growth within specialty pharmacy." (Source- PRNewswire) ShieldsRx's expansion with new health system partnerships includes MyMichigan Health: Midland-based MyMichigan Health serves 25 counties. Its urgent care, home health, virtual care, and medical offices offer a broad spectrum of care in over 30 specialties and subspecialties. Nemours Children's Health: Nemours Children's Health, the nation's most extensive multistate pediatric health system, has two free-standing children's hospitals and over 70 general and specialized care practices. Solution Health: Phoenix Children's Care Network, Arizona's leading children's hospital, offers over 1,175 pediatric primary care professionals and specialists in over 75 subspecialties. Traditional specialty pharmacy patients had to tackle administrative difficulties like prior authorization and expensive medical bills alone. Shields' expansion facilitated value-based reimbursement. About Shields Health Solutions Shields Health Solutions is a leading specialized pharmacy accelerator. Its Performance Platform is designed to improve payer and drug access for specialty pharmacies, improve health outcomes for complex patients, and promote growth across the entire health system. The company has access to over 80% of limited distribution medications (LDDs) and major health insurance payers in the U.S. along with a clinical strategy that lowers the total cost of treatment by 13%. ShieldsRx has collaborated with more than 70 health systems to deliver measurable clinical and financial benefits.

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