On August 29, 2022 ZAP Surgical Systems, Inc. reported that Denver-based Neurosurgery One became the first provider in the Rocky Mountain region to treat patients using the ZAP-X Gyroscopic Radiosurgery platform (Press release, ZAP Surgical Systems, AUG 29, 2022, View Source [SID1234618743]). ZAP-X is the latest advancement in completely non-invasive brain tumor treatment and aims to set new standards in patient safety, comfort, convenience, and treatment accuracy. Neurosurgery One doctors are now performing stereotactic radiosurgery (SRS) using ZAP-X in an outpatient facility in the south Denver metro area of Littleton, Colorado.

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The first patient, a male in his 50s who has lived in Colorado for forty-five years, was treated for an acoustic neuroma (also known as vestibular schwannoma), a benign tumor of the nervous system. Acoustic neuromas are known to cause hearing loss, in addition to pain, dizziness and balance problems.

"As an electrical contractor with a passion for kiteboarding, windsurfing, skiing and foiling, I live a very active lifestyle, so maintaining my quality of life is extremely important," said Bill Lawson, the first ZAP-X patient treated at Neurosurgery One. "I am excited to be the first ZAP-X patient in Colorado. Knowing that I was treated by the most modern, cutting-edge technology with an excellent team behind the treatment is very rewarding."

"Our neurosurgeons have treated patients for decades with stereotactic radiosurgery as a precise non-surgical option for cranial conditions, including brain tumors, meningiomas, trigeminal neuralgia, and vestibular schwannomas," said Dr. J. Adair Prall, MD, FAANS, senior partner and CEO of Neurosurgery One in Denver. "Having the ZAP-X system now allows us to treat our patients with the latest SRS technology and provide world-class care in a convenient and easy-to-access location."

Stereotactic Radiosurgery is a well-established procedure to non-invasively treat many primary and metastatic brain tumors with high-intensity radiation, and often provides equivalent or superior clinical outcomes to surgery. When compared to historical whole brain radiotherapy (WBRT), which often requires many weeks of radiation treatment, SRS minimizes healthy brain tissue exposure and has demonstrated improved preservation of patient cognitive function.

"Unlike multi-purpose, full-body radiotherapy systems, ZAP-X was purpose-built without compromise for treating the brain with SRS," said Dr. Darlene Bugoci, radiation oncologist in Littleton. "This focused approach supports the clinical objective of reducing radiation exposure to healthy brain tissue and mitigating the risks of potential neuro-cognitive deficit and related complications."

Being the first and only "vault-free" radiation delivery technology, ZAP-X also eliminates the long-standing practice of prolonged patient isolation in a two-to-three-million-pound concrete bunker during treatment. This pioneering approach also now allows the clinical team, and in some instances, family members to be adjacent to the patient during treatment, with the goal of creating a more comfortable and confident patient experience.

On August 29, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 29, 2022, View Source [SID1234618742]):

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Wells Fargo Healthcare Conference on Thursday, September 8 at 10:25am Eastern Time

Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 13 at 10:35am Eastern Time

Baird Global Healthcare Conference on Wednesday, September 14 at 9:40am Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On August 29, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported financial results for the first half of 2022 (Press release, Ambrx, AUG 29, 2022, View Source [SID1234618741]).

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"I am very grateful for all that Tian accomplished during his tenure leading Ambrx, from spearheading the development of the company’s research and development programs to the transition to a public company last year," said Kate Hermans, Interim Chief Executive Officer of Ambrx. "While the Board conducts a search for a permanent CEO, we will review the company’s pipeline to focus on Ambrx’s strongest commercial opportunities and further extend our cash runway. Additionally, I would like to congratulate NovoCodex for their recent successful Series B financing and am thankful for the relationship we have built. Our strong partnerships will remain a priority for us. We remain confident in our platform to deliver on the promise of precision medicine and I look forward to having the opportunity to lead Ambrx during this transition."

1H 2022 and Subsequent Highlights

Appointed Kate Hermans as Interim Chief Executive Officer. In August, Ambrx announced the appointment of Kate Hermans as Interim Chief Executive Officer (CEO), replacing Feng Tian, Ph.D. Ms. Hermans has more than two decades of commercial and operational experience in the healthcare industry, previously serving in executive leadership roles at companies including Radius Health, Bristol Myers Squibb and Pfizer. Ambrx’s Board has commenced a search for a permanent CEO. Dr. Tian has agreed to continue with Ambrx in an advisory capacity.
Received a "Study May Proceed" letter from the FDA related to an IND application for ARX305. In February, Ambrx announced that the FDA accepted the company’s IND and provided a "Study May Proceed" letter for ARX305 for the treatment of solid and hematological tumors. ARX305 is the third antibody drug conjugate (ADC) developed by Ambrx on its proprietary EPB platform to receive IND clearance. In July, Ambrx’s partner in China, NovoCodex, announced that it had received drug clinical trial approval notice for ARX305 and intends to initiate a Phase 1 trial in China in the second half of 2022.
Announced Inclusion of ARX788 in a Quantum Leap’s I-SPY 2.2 Phase 2 Clinical Trial. In April, the company announced the inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting. Sponsored by Quantum Leap, I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. The first patient was dosed with ARX788 in August 2022.
Appointed Janice Lu, M.D., Ph.D., as Chief Medical Officer. In May, Janice Lu, M.D., Ph.D., joined Ambrx as its Chief Medical Officer. Dr. Lu is a distinguished clinical professor of medicine who has more than 18 years of experience in leading clinical trials and breast cancer drug development. Dr. Lu, a board-certified medical oncologist, was on the faculty in Hematology and Oncology at UCLA, and most recently served as Clinical Professor of Medicine and Medical Director of the Breast Oncology Program at the USC Keck School of Medicine.
Strengthened Board of Directors. In August, Ambrx announced the appointment of Katrin Rupalla, Ph.D. to Chair of the Board of Directors. Since the start of 2022, Ambrx has appointed Paul V. Maier, Janet Loesberg, Pharm. D., Edward Hu and Kate Hermans to its Board.
Financial Highlights

Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $129.7 million as of June 30, 2022, of which $64.1 million are marketable securities, compared to $170.1 million in cash and cash equivalents as of December 31, 2021.
Revenue: Revenue was $2.9 million for the six months ended June 30, 2022, as compared to $5.1 million for the six months ended June 30, 2021. The decrease was primarily driven by less revenue recognized in connection with our R&D and license agreements, partially offset by increased third party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $32.8 million for the six months ended June 30, 2022, as compared to $22.1 million for the six months ended June 30, 2021. The increase was mainly due to increased costs related to our clinical trial programs, primarily driven by our lead product candidate ARX788, and related manufacturing costs, partially offset by lower stock-based compensation expense.
Impairment loss on intangible assets: The loss of $9.7 million for the six months ended June 30, 2022 was driven by the impairment of intangible assets related to assets that were in development with a collaboration partner.
General and administrative (G&A) expenses: G&A expenses were $9.4 million for the six months ended June 30, 2022, as compared to $8.4 million for the six months ended June 30, 2021. The increase was mainly attributable to professional services and fees in connection with operating as a public company including directors & officer insurance.
Other expenses, net: Other expense, net, for the six months ended June 30, 2022 were $0.9 million, as compared to $3.9 million for the six month ended June 20, 2021. The current period expense is mainly related to fees and interest incurred related to a promissory note settlement and capital reduction related to Ambrx Shanghai.
Net loss: Net loss for the six months ended June 30, 2022 was $51.5 million, as compared to $29.0 million for the six months ended June 30, 2021.

On August 29, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will be participating in the upcoming Morgan Stanley Global Healthcare Conference in New York City, New York (Press release, Guardant Health, AUG 29, 2022, View Source [SID1234618740]).

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Guardant Health’s management is scheduled to participate in a fireside chat on Monday, September 12th at 8:10 a.m. Eastern Time / 5:10 a.m. Pacific Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On August 29, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy (Press release, Biocytogen, AUG 29, 2022, View Source [SID1234618739]).

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The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and assess the safety and efficacy of the combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

"YH001 was discovered using Biocytogen’s evidence-based in vivo drug efficacy screening platform and has demonstrated a favorable safety profile and promising anti-tumor activity in combination with a PD-1 antibody in an earlier phase 1 clinical study," said Rong Chen, M.D., Ph.D., VP of Biocytogen, CEO and CMO of Eucure Biopharma. "As an antibody targeting the validated checkpoint CTLA-4, YH001 is expected to play a very important role in immune-oncology therapy. We are glad to learn that the combination therapy of YH001 + envafolimab and doxorubicin received IND approval by the FDA."

"We are pleased to receive approval from the FDA to initiate our triplet combination therapy study in sarcoma, which includes our potentially best-in-class CTLA-4 antibody YH001 and the only subcutaneous checkpoint inhibitor approved anywhere in the world, envafolimab," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We look forward to enrolling patients in this study and giving patients additional options for their sarcoma treatment."

About YH001
YH001 is an IgG1 antibody targeting CTLA-4 that was invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON. YH001 has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro when compared with ipilimumab. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab as a single agent and when combined with a PD-(L)1 antibody in human transgenic mouse tumor models. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).