On August 25, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported second quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, AUG 25, 2022, View Source [SID1234618700]).

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"We have made significant progress by gaining conditional FDA approval, whose conditions have since been satisfied, for our pivotal trial IDE in SCC as well as treating our first patient in a prostate cancer feasibility trial. We’ve seen overwhelming interest from leading clinical sites across the U.S. in participating in our upcoming pivotal trial in SCC, and look forward to initiating that trial shortly. While making clinical progress, we are thoughtfully expanding our pipeline from superficial cancers that only require a temporary Alpha DaRT implant, to more invasive internal tumors like liver and prostate, and then finally to ones such as pancreatic cancer and GBM with the greatest unmet need. We’ve made great strides in GBM in large animal studies, on the back of receipt of Breakthrough Device Designation for recurrent GBM from the FDA," said Alpha Tau CEO Uzi Sofer. "In tandem, we have been preparing for global commercialization efforts by expanding our manufacturing capabilities alongside our expanded radioactive licenses in Israel and in the U.S., as well as educating the medical community on our technology via hands-on experience in our trials."

Recent Corporate Highlights:

Approval by the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application to initiate our multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (SCC) using the Alpha DaRT. The clinical study has been approved to enroll up to 86 patients at up to 20 institutions in the U.S., in addition to any sites that may be added outside the U.S., and will focus on patients with recurrent cutaneous SCC who have failed at least first line standard of care therapy and are not indicated for another curative standard of care therapy.

First patient treated in a feasibility study evaluating the Alpha DaRT as a neoadjuvant therapy in patients with prostate cancer. This is the Company’s first patient treated with Alpha DaRT in an internal organ.

Alpha Tau was granted an active radioactive license for use and possession of Thorium-228 and Radium-224, radioactive materials which are utilized in the production of the Alpha DaRT sources, in the main manufacturing floor of the Company’s production facility in Jerusalem by the Israeli Ministry of Environmental Protection. This license should enable the Company to achieve a nearly 3x increase in production capacity, to yield approximately 90,000 Alpha DaRT sources per year.

First patients treated with Alpha DaRT in a French multicenter trial for skin cancer, which is currently being conducted at six cancer centers in France, on patients with malignant cutaneous lesions (including SCC, BCC, lentigo maligna melanoma, and carcinosarcoma), and is evaluating two cohorts: (1) newly diagnosed patients (up to 49 subjects), and (2) patients with locally recurrent disease (36 subjects). The primary effectiveness endpoint is the assessment of the overall response rate using RECIST criteria, 9 to 11 weeks after Alpha DaRT source insertion. Dr. Pascal Pommier is the principal investigator of this study.

Held an investor KOL event featuring Professor Michael Zelefsky and Dr. Mark D’Andrea to review clinical data and user experience with Alpha DaRT and to preview potential new indications for the technology. The event was held in New York on July 18, 2022 and a replay is available here and on the Alpha Tau website in the Investors section.
Upcoming Anticipated 2022 Milestones

Expecting first patient treated in U.S. multi-center pivotal trial in recurrent cutaneous SCC in the second half of 2022.
Targeting recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the fourth quarter of 2022.
Planned submission of Alpha DaRT pivotal trial results in head and neck SCC to Japan’s regulatory authority, PMDA, in the coming months for marketing approval.
Targeting Health Canada approval for initiation of liver cancer feasibility trial by the end of 2022.
Financial results for the second quarter ended June 30, 2022

R&D expenses for the quarter ended June 30, 2022 were $5.4 million, compared to $3.0 million for the same period in 2021, primarily due to increased R&D headcount, costs associated with our U.S. multi-center pivotal study and other clinical studies, and increased share-based compensation costs.

Marketing expenses for the quarter ended June 30, 2022 were $0.1 million, compared to $0.1 million for the same period in 2021.

G&A expenses for the quarter ended June 30, 2022 were $2.4 million, compared to $0.4 million for the same period in 2021, primarily due to increased professional fees (including D&O insurance), share-based compensation, and costs (including bonuses) associated with our financing transaction in the first quarter of 2022.

Financial income, net, for the quarter ended June 30, 2022 was $6.0 million, compared to financial expense, net of $3.5 million for the same period in 2021, primarily due to the remeasurement of warrants.

For the quarter ended June 30, 2022, the Company had a net loss of $2.0 million, or ($0.03) per share, compared to a loss of $7.0 million, or ($0.17) per share, in the same period in 2021.

Balance Sheet Highlights

As of June 30, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $112.8 million, compared to $31.9 million on December 31, 2021. The Company expects that this cash balance will be sufficient to fund operations for at least two years.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On August 25, 2022 Lytix Biopharma, a Norwegian immune-oncology company, reported its second quarter and first half 2022 results – New encouraging clinical data (Press release, Lytix Biopharma, AUG 25, 2022, View Source [SID1234618687]).

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"The first six months of 2022 have been fueled by clinical development and clinical data presentations across international conferences alongside seeing our partner Verrica Pharmaceuticals advance its Phase II study evaluating LTX-315 for basal cell carcinoma. For Lytix, the most significant clinical trial development was the completion of the Phase II study evaluating LTX-315 in combination with adoptive therapy (ACT) in soft tissue sarcoma patients. This combination treatment provided meaningful clinical benefit for patients with progressive metastatic soft tissue sarcoma and clearly shows the potential of using LTX-315 in combination with ACT to generate a high number of tumor-specific T cells", says Dr. Øystein Rekdal, CEO of Lytix Biopharma.

Highlights from the first quarter 2022:

Data from the Phase II ATLAS-IT-04 trial evaluating LTX-315 in sarcoma patients demonstrated proof-of-concept by showing that the compound improved the outcome of adoptive cell transfer treatment by stabilizing the disease in patients with progressive metastatic soft tissue sarcoma.
In April, Verrica Pharmaceuticals dosed the first patient in its Phase II study evaluating LTX-315 in basal cell carcinoma (BCC), triggering an initial milestone payment to Lytix.
Regulatory process is initiated and ongoing to expand the site network for the ATLAS-IT-05 study to highly recognized sites with intratumoral immunotherapy expertise in three European countries.
The preclinical safety testing for LTX-401 has been completed demonstrating a favorable safety profile. Preparations for a Phase I clinical study are progressing according to plan.
In April, Lytix received a USD 1 million milestone payment from Verrica following first patient dosed in its Phase II study of LTX-315 for the treatment of basal cell carcinoma.
Total operating expenses for the six months ended 30 June 2022 ended at NOK 36.6 million, which is in line with last year’s figures of NOK 36.1 million.
Key figures (unaudited):

The full report and a presentation is linked to this press release (and available at View Source).

The results will be presented in a webcast with CEO Øystein Rekdal, CDO Graeme Currie and CFO Gjest Breistein at 14:30 CEST.

The presentation and subsequent Q&A session will be held in English and may be viewed live. Please register for the presentation at Lytix Biopharma Q2 webcast 25.08.22

A recording of the presentation will be made available on View Source after the presentation.

On August 25, 2022 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases reported 2022 interim results and major company updates (Press release, Innovent Biologics, AUG 25, 2022, View Source [SID1234618686]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "This year was a watershed year of Innovent for next decade of development. For the past decade, Innovent has developed itself with an established platform foundation, sustained strong execution and favorable financial position. In 2022 to date, we continue to make remarkable progress in commercialization, product development, business collaboration and CMC under adherence to our long-term strategy of global innovation. Meanwhile, as one of China’s leading innovative biopharmaceutical start-ups, Innovent made a pioneering deployment to explore and develop a more sustainable business model via optimizing organizational structure and enhancing refined management capabilities, with aim to support our company’s long-term strategies more efficiently. We will continue to enhance drug R&D capability, expand global R&D team and promote global innovation and development, meanwhile expanding our commercial portfolio and improving business benefits and performance to create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

For the first half of 2022: RMB2,240million total revenue, including RMB2,041million product revenue at 10.0% growth compared with the same period of prior year
– Commercial portfolio increased to seven products; new approvals of additional indications and in new territories attained for marketed products.
– TYVYT is successfully included in the updated National Reimbursement Drug List (NRDL) for three additional first-line indication for major types of cancer in beginning of 2022; and is approved for first-line treatment of two additional indications, i.e. esophageal cancer (ESCC) and gastric cancer (GC) in June 2022.
Upgrading commercial model and platform to 2.0 stage, actively seek to establish a more agile and lean organization with more refined, systematic and scientific management, aiming to further increase output and improve efficiency.
Unleashing the platform value and unique competitive advantages, solicit more in-depth strategic collaborations with global pharmaceutical companies such as Lilly and Sanofi to accelerate the pace of innovation.
Insisting on global innovation strategy with acceleration of clinical development and data readout
– 7 molecules at NDA or late clinical stage
– Oncology pipeline achieved preliminary positive Proof of Concept (PoC) data readouts for multiple global innovative molecules
– The non-oncology field entered into the harvest period with encouraging Phase 2 studies data readouts and registraitional clinical trials in plan for two potentially Best-in-Class molecules
Commercial – Product Sales Volume Fast Ramp-up and Commercial Platform Upgraded

Expansion of commercial portfolio into seven approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, NAILIKE and CYRAMZA.
Product revenue RMB2,041 million in H1 2022: an increase of 10.0% compared with the same period of the prior year with fast ramp-up of product volume and synergic value unleashing.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 people.
Upgraded commercial model and platform to 2.0 stage:
– Upgraded the commercialized business structure, operated in a more professional and precise BU model, and gradually established a more efficient marketing system.
– Created a good operational capability and model, which will effectively increase the sales scale while improving efficiency and revenue, thereby better supporting the company’s long-term sustainable business development.
Pipeline – 34 Valuable Assets, Data Readout for High-Potential Molecules

Valuable pipeline consisted of 7 products approved for marketing in China, 3 assets under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 molecules in clinical studies

Oncology: Robust pipeline with 25 assets covering broad cancer types

TYVYT as leading brand in PD-(L)1 market:
– 3 additional indications successfully included in the NRDL, including non-squamous non-small cell lung cancer (NSCLC), squamous NSCLC, and hepatocellular carcinoma (HCC).
– 2 additional indications approved for 1L ESCC and 1L GC.
Two NDA stage and multiple pivotal stage assets:
– Retsevmo (selpercatinib), NDA accepted
– IBI-326 (BCMA CAR-T), NDA accepted
– IBI-310 (CTLA-4)
– IBI-344 (ROS1/NTRK)
– IBI-376 (PI3Kδ)
– IBI-126 (CEACAM5 ADC)
Multiple global innovative molecules rolled out preliminary positive data:
– IBI-110 (LAG3): 1L sqNSCLC, 1L GC
– IBI-188 (CD47): 1L MDS
– IBI-351 (KRASG12C): NSCLC, CRC
– IBI-344 (ROS1/NTRK): NSCLC
Non-Oncology: Differentiated 9 molecules represents long-term growth potential

One NDA accepted and expected to be the second non-oncology product:
– IBI-306 (PCSK9), NDA accepted
Robust Phase 2 studies data readout and registrational trials in plan for two potential Best-in-Class molecules:
– IBI-362 (GLP-1/GCGR): Phase 2 studies data readout in obesity and type 2 diabetes, showing robust efficacy in weight loss, blood glucose lowering and multiple metabolic benefits. Plan to initiate Phase 3 studies for both indications in late 2022 to early 2023.
– IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential and long dosing interval convenience. Plan to initiate Phase 3 study in the second half of 2022.
R&D: Global Innovation Continues as Long-term Strategy

Innovent US and global product development team enhancement:
– Full operation of Innovent US: 300 Scientists of Innovent Academy based in China and the US work closely in the preclinical research project with focus on global innovation and cutting edge technologies, sustainably providing novel molecules into clinical development stage.
– Full-function overseas development and registration team established: as important part of the company’s global product development platform, the team join and undertake the long-term strategy of global pipeline development.
Continue to progress global clinical development projects:
– First-in-human clinical studies to initiate in Australia for IBI-363 (PD-1/IL2) and IBI-343 (CLDN18.2 ADC) in H2 2022
– IND approved by the US FDA for the Phase 1 platform study for the treatment of melanoma
Breakthrough achievement for oversea market access:
– BYVASDA (Indonesian trademark: Bevagen) was approved by the Indonesian Food and Drug Administration (BPOM) and is expected to be the first Chinese anti-body drug to be commercialized and locally manufactured in Southeast Asia markets.
BD: Unique Competitive Advantages to Solicit More In-Depth Strategic Cooperation

Entered into strategic collaboration with Sanofi to benefit more patients in China and initial equity investment of EUR300 million made by Sanofi in Innovent. Both companies are committed to accelerating the development and commercialization of clinical Phase 3 stage SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody drug conjugates) and clinical Phase 2 stage SAR444245 (non-alpha IL-2) in China.
Expanded oncology strategic partnership with Lilly: Innovent obtained the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib) in Mainland China, and the right of the priority negotiation for future commercialization of Pirtobrutinib (BTK inhibitor) in Mainland China.
CMC: High-Quality and Scalable Manufacturing Capabilities

60,000L production capacity which is currently the largest stainless steel production capacity in China with more capacity construction in plan
Quality compliance to GMP and cost advantage further strengthen market competitiveness
Financial Highlights for H1 2022

Total revenue was RMB 2,240 million, an increase of 15.3% compared to the same period of the prior year.
R&D expenses were RMB1,078 million, an increase of 22.5% compared to the same period of the prior year.
Loss for the year was RMB1,085 million, mainly due to continuous investment in R&D.
Cash on hand and short-term financial assets was approximately USD1.5 billion, which enables strategical focus on the long-term development.[1]

On August 25, 2022 CDx Diagnostics, Inc. reported that the WATS3D diagnostic platform has been incorporated in the American Gastroenterological Association (AGA) Clinical Practice Update (CPU) on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review, published in Clinical Gastroenterology and Hepatology (Press release, CDx Diagnostics, AUG 25, 2022, View Source [SID1234618685]). WATS3D uses a unique wide-area sampling instrument, proprietary 3D imaging with AI analysis, and expert pathologists to reliably identify abnormal cells to help physicians prevent esophageal cancer.

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"The CPU is based on a thorough review of the existing clinical literature and expert opinion. It includes several Best Practice Advice statements intended to provide gastroenterologists with real-world, actionable, practical advice on the management of BE," said Vivek Kaul, MD, FACG, FASGE, AGAF, Segal-Watson Professor of Medicine, Division of Gastroenterology, University of Rochester Medical Center. "The inclusion of WATS3D in this update is an important addition and presents an opportunity for clinicians to potentially increase their detection of BE and esophageal dysplasia, both endoscopically treatable precursors to one of the fastest growing and most fatal cancers in the United States."

WATS3D technology helps overcome the limitations associated with traditional upper endoscopy screening and surveillance methods. The CPU highlights some WATS3D clinical evidence, which demonstrated an increased yield for dysplasia detection, and that pathologic interpretation of these specimens has been shown to have significantly higher interobserver agreement, with a kappa of 0.86.

"CDx is committed to providing physicians with an AI-based diagnostic solution that empowers them to prevent esophageal cancer," said Bill Huffnagle, CEO of CDx Diagnostics. "The clinical value of adding WATS3D to the upper endoscopy screening and surveillance protocol has now been recognized by 4 major medical societies (AGA, ASGE, AFS, and SAGES). This is a significant accomplishment for CDx which underscores the clinical value of WATS3D and its continued role in preempting this potentially life-threatening disease, one patient at a time."

On August 25, 2022 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) reported development of a novel immunotherapy for treatment of solid tumors (Press release, Regen BioPharma, AUG 25, 2022, View Source [SID1234618684]). Current cellular approaches to kill cancer involve administration of a specific type of modified T cell called "chimeric antigen receptor" (CAR) T cell . Despite significant progress being made in using CAR-T cells to treat leukemia, little progress has been made in solid tumors such as those found in lung, brain, breast, prostate and colon. It is believed that solid tumors possess an abnormal "microenvironment" which physically prevents T cells from entering the tumor, as well as inactivating T cells that do manage to enter. The microenvironment consists of surrounding blood vessels, immune cells, fibroblasts, signaling molecules and an extracellular matrix. The solid tumor is surrounded by its microenvironment and constantly interacts with it.

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The current approach developed by the Company, for which a provisional patent application has been submitted, involves initial treatment of the tumor microenvironment with cells of the innate immune system called CAR-M and CAR-NK cells. These cells, which also begin to attack the tumor, are able to "normalize" the tumor microenvironment, thus allowing CAR-T cells to enter and attack the tumor.

"The company believes that taking this two-step approach – first softening up the target with CAR-M and CAR-NK cells and then bringing in the heavy artillery (CAR-T cells) will allow solid tumors to be successfully targeted by these cell therapies, thus greatly expanding the CAR-T market and ultimately saving people’s lives," said Dr. David Koos, CEO and Chairman of the Company.