On June 30, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ), Nitto Denko Corporation (TSE: 6988, President: Hideo Takasaki, "Nitto"), and M. Heart Co., Ltd. (President and CEO: Yoshimi Mizunuma, "M. Heart") reported that the three companies have entered into an agreement for a sales pilot of disposable Holter ECG device "EG HolterTM" for the Japan market (Press release, Astellas, JUN 30, 2022, View Source [SID1234616392]). Based on this agreement, Astellas has established an e-commerce site for healthcare professionals and will start the sales pilot of the device today.

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This is Astellas’ first initiative in Rx+ program to promote a product through an e-commerce site. After verifying the business model through the sales pilot, Astellas will move to full-scale marketing of the product.

EG Holter is a holter electrocardiograph designed and developed by Nitto. Because it is a disposable device, it is hygienic and does not require maintenance. It is 6 mm thick,11 g in weight, has no cords, and is water resistance (IPX4). It is easy to attach and remove.

Data obtained by EG Holter will be analyzed by "MYHOLTER II", which is software for the holter analyzer jointly developed by Astellas and M. Heart. MYHOLTER II is a program that analyzes holter ECG data with a proprietary analytical algorithm using artificial intelligence (AI). M. Heart has obtained cerification for EG Holter and MYHOLTER II as medical device (Class II).

Astellas, Nitto and M. Heart have come together to create a simple, convenient, patient-centered solution for patients and medical institutions.

Medical costs for heart diseases and other cardiovascular diseases in Japan exceed 6 trillion yen per year―the highest of any disease category1. Of particular concern is cardiogenic cerebral embolism, which occurs when a thrombus that formed in the heart blocks an artery in the brain or neck. This has a high mortality rate (20%) and often results in severe sequelae, such as a bedridden state (40%)2. Atrial fibrillation is said to be the cause of cardiogenic cerebral embolism in 3 out of 4 cases2. Early detection of atrial fibrillation is an important social issue.

By providing a total solution that involves combining convenient ECG testing using the EG Holter and the data analysis using MYHOLTER II, Astellas, Nitto, and M. Heart propose to enable early detection and appropriate treatment of atrial fibrillation, a condition estimated to affect approximately 700,000 patients in Japan2, and contribute to the prolongation of healthy life expectancy.

On June 30, 2022, Immatics N.V. (the "Company") Presented the investor presentation (Presentation, Immatics, JUN 30, 2022, View Source [SID1234616409]).

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On June 30, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), reported that the U.S. Food and Drug Administration (FDA) has cleared the initial IND for its first-in-class drug candidate AsiDNA (Press release, Onxeo, JUN 30, 2022, View Source [SID1234616410]). This is the first US IND Onxeo filed since the US team came on board in April 2022.

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This FDA decision enables the Company to initiate a Phase 1b/2 multicenter, basket trial to assess the safety and efficacy of AsiDNA in combination with the PARP inhibitor Olaparib in patients with epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated progression on previous PARP inhibitor therapy. The Company plans to initiate the trial in the second half of 2022 at 3-5 potential clinical sites across the United States.

"I am very proud that our team has been able to file and obtain FDA clearance of its first US IND in a very short period. We are now ready to start our first clinical trial with AsiDNA in the US, with the full support of our clinical and regulatory teams," said Dr. Shefali Agarwal, Chairwoman of the Board of Directors and CEO. "We believe that our drug candidate has the potential to meaningfully impact the lives of patients with recurrent solid tumors who have progressed on an initial treatment with a PARP inhibitor. This is consistent with the preclinical findings of AsiDNA, which increased our understanding of its potential against acquired resistance to PARP inhibitors and which formed the basis for our first-in-human study."

On June 30, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo to treat patients with solid and hematologic malignancies, reported that the company will participate in two Hanson Wade summits taking place in July in Boston (Press release, Umoja Biopharma, JUN 30, 2022, View Source [SID1234616411]). Details can be found below.

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In Vivo Engineering of Therapeutic Cells Summit held July 12-14, 2022

Umoja’s participation will begin on July 13:

Participation: Panel
Title: Applying In Vivo CAR-T Cell Therapy for Oncology and Beyond
Umoja Speaker: Shon Green, Ph.D., Senior Director, Translational R&D (In-Vivo)
Details: The panel will address how in vivo CAR T-cell therapy obviates current ex vivo bottlenecks including access, efficacy, and toxicity as well as achieving transient versus longer-term effects for different indications.
Time: 12:30 PM ET

Participation: Poster
Title: Preclinical development of UB-VV100, a novel platform for in vivo engineering of therapeutic anti-CD19 CAR T cells
Umoja Speaker: Susana Hernandez Lopez, Scientist
Time: 3:00 PM ET

Umoja’s participation will continue July 14:

Participation: Fireside Chat
Title: In Vivo Engineering of Therapeutic Cells as the Future of Cell and Gene Therapy
Umoja Speaker: Andy Scharenberg, M.D., Co-founder and CEO
Details: The fireside chat will evaluate what has inspired the industry to move from ex vivo to in vivo therapies, outline the advantages and opportunities that in vivo cell and gene therapies offer over current generations, and discuss the next steps to streamline pre-clinical development to fast-track in vivo therapies to the clinic.
Time: 9:15 AM ET

Participation: Oral Presentation
Title: In Vivo Approaches to Generate CAR T Cells Engineered to Mediate Durable Antitumor Responses
Umoja Speaker: Ryan Larson, Ph.D., Vice President, Head of Immunology
Details: The presentation will cover how manufacturing complexities limit patient access to autologous CAR T-cell products, the ability of Umoja’s VivoVec off-the-shelf lentiviral vector platform to enable efficient generation of functional CAR T-cells in vivo, and how the approach can be applied to target both hematological and solid tumor cancers.
Time: 11:30 AM ET

iPSC Manufacturing Summit from July 26-28, 2022

Umoja’s participation will begin on July 28:

Participation: Oral Presentation
Title: Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up
Umoja Speaker: Teisha Rowland, Ph.D., Principal Scientist, iPSC Team Lead
Details: The presentation will cover how iPSCs can more efficiently be differentiated into functional, persistent immune cell types by genetically engineering iPSCs to express a synthetic cytokine receptor, how differentiation can be performed in suspension to make it compatible with efficient scale-up production, and how the overall approach may be used in a manufacturing setting to drive high-purity immune cell production.
Time: 11:45 AM ET

On June 30, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported an update on recent progress with its two pipeline assets, paxalisib and EVT801, and on recent corporate financing activity (Press release, Kazia Therapeutics, JUN 30, 2022, View Source [SID1234616396]).

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Key Points

EVT801 phase I study protocol has cleared third dose level and is recruiting well.

GBM AGILE pivotal study has opened in France, the fourth country to commence recruitment to the paxalisib arm.

Phase I study of paxalisib in combination with radiotherapy for treatment of brain metastases at Memorial Sloan Kettering Cancer Center has been accepted for presentation at an upcoming academic conference in Q3 CY2022.

ATM financing facility has realized gross proceeds of US$ 2,956,036 for the period ending June 2022, at an average price of $6.08 (approximately AU$ 0.88 per share).

Kazia CEO, Dr James Garner, commented, "Despite a challenging first half equity market for biotech companies, Kazia has continued to make good progress. The GBM AGILE pivotal study is progressing well, and appears on track for data in 2H CY2023, as anticipated. We have been pleased in the first half to see new data presented and milestones delivered from several projects, and we expect that pace to continue and increase during the second half."

EVT801 Phase I Study

The phase I study of EVT801 in patients with advanced cancer continues to recruit well. The drug has recently completed the third of a potential eight dose levels and is anticipated to open recruitment to the fourth dose cohort in the near future. To date, the drug appears generally well-tolerated. Depending on how many dose cohorts are required to establish a maximum tolerated dose (MTD), interim data from the study is anticipated in 2H CY2022 or 1H CY2023.

GBM AGILE

More than forty sites are currently open to the paxalisib arm of GBM AGILE. The first site to commence recruitment to the paxalisib arm in France opened in June 2022, making France the fourth country to join the study, alongside the United States, Canada, and Switzerland.

In January 2022, the Global Coalition for Adaptive Research (GCAR), the sponsor of GBM AGILE, stated that over a thousand patients had been screened to the study, with enrolment rates approximating 0.75 to 1.00 patients per site per month, which is around four times higher than would generally be expected in a clinical study of glioblastoma.

Kazia continues to work closely with GCAR and Simcere Pharmaceutical to open the study in China. Public health measures in some Chinese cities relating to the ongoing COVID pandemic have had a modest impact on operational activities, but it is currently anticipated that the study will open in China during 3Q CY2022.

Paxalisib in Brain Metastases

In June 2022, the company announced that a multi-drug, genomically-guided study in brain metastases run by the Alliance for Clinical Trials in Oncology had seen the paxalisib arm graduate to an expansion cohort in patients with breast cancer brain metastases, having seen positive efficacy signals in the initial exploratory cohort. Paxalisib continues to recruit to the exploratory cohort in two other patient subgroups.

Interim data from a phase I study of paxalisib in combination with radiotherapy for patients with brain metastases run by Memorial Sloan Kettering Cancer Center has been accepted for an oral presentation at an upcoming international conference in Q3 CY2022. Kazia looks forward to sharing data from this presentation as soon as it is available.

Financing

In May 2022, Kazia established a NASDAQ-based at-the-market financing facility with Oppenheimer and Company. For the period ending June 30, 2022, the company has issued 486,281 American Depository Shares (ADSs) under this facility, at an average price of $6.08, for total gross proceeds of US$ 2,956,036 (approximately AU$ 4,256,691). Of note, these shares have been issued at no discount, with no warrant coverage, and with transaction fees approximately half of those associated with traditional financing.