On January 10, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported a corporate update and highlighted key 2022 milestones in anticipation of its presentation at the 40th Annual J.P. Morgan Healthcare Conference being held virtually January 10 – 13, 2022 (Press release, Nuvation Bio, JAN 10, 2022, View Source [SID1234598552]).

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"We are proud of the significant strides Nuvation Bio made in 2021, including the ongoing progress of our Phase 1/2 study of NUV-422 in patients with high-grade glioma, hormone receptor-positive metastatic breast cancer, and metastatic castration-resistant prostate cancer. Since the trial initiated, the FDA has cleared three INDs for NUV-422 and granted it Fast Track Designation for the treatment of high-grade glioma, demonstrating the therapy’s broad potential to address the significant unmet needs of patients with a variety of cancer types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We look forward to building upon this momentum in 2022 with advancements across our deep pipeline of treatments for the most difficult-to-treat cancers."

In 2022, Nuvation Bio seeks to achieve the following milestones across its broad pipeline of potential product candidates:

NUV-422, CDK 2/4/6: High-grade glioma, aBC, mCRPC

Identify a recommended Phase 2 dose and initiate Phase 2 monotherapy dose expansion cohorts for NUV-422 in glioblastoma multiforme, advanced breast cancer (aBC), and metastatic castration-resistant prostate cancer (mCRPC)
Initiate Phase 1b combination studies for NUV-422 in aBC and mCRPC
Present safety data from NUV-422 Phase 1 dose escalation study
NUV-868, BD2 Selective BETi: Solid tumors

Receive clearance from U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application for NUV-868 and initiate a Phase 1 study in patients with advanced solid tumors
NUV-569, Wee1i: Solid tumors

File an IND for NUV-569 with the FDA for the treatment of patients with solid tumors
A2A and DDC Programs

Select clinical candidates
Presentation at J.P. Morgan Healthcare Conference

David Hung, M.D., founder, president, and chief executive officer, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 7:30 a.m. ET. The presentation will be webcast live and can be accessed under "Events & Presentations" in the "Investors" section of Nuvation Bio’s website at www.nuvationbio.com.

On January 10, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported that it will be hosting a conference call and webcast to discuss updated data from its lead clinical program in KRAS-mutated metastatic colorectal cancer on Tuesday, January 18, 2022, at 5:00 PM ET (Press release, Cardiff Oncology, JAN 10, 2022, https://www.prnewswire.com/news-releases/cardiff-oncology-to-host-conference-call-and-webcast-to-discuss-updated-data-from-lead-clinical-program-in-kras-mutated-metastatic-colorectal-cancer-being-presented-at-the-2022-american-society-of-clinical-oncology-gastrointestina-301456944.html [SID1234598551]).

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The conference call and webcast will include data that will be featured in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI). ASCO (Free ASCO Whitepaper)-GI is taking place January 20-22, 2022, both virtually and in-person at the Moscone West Building in San Francisco, California.

On January 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), reported it will participate in a study pursuant to a clinical trial collaboration between Gilead and MSD (Merck & Co., Inc., Kenilworth, NJ., USA) to evaluate the combination of the Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) and MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC) (Press release, Everest Medicines, JAN 10, 2022, View Source [SID1234598550]). As part of the collaboration, MSD will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Everest Medicines will participate in the global Phase 3 study in Asia through its existing collaboration agreement with Gilead.

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"We look forward to participating in a study pursuant to a clinical collaboration between Gilead and MSD to evaluate Trodelvy in combination with KEYTRUDA in first-line NSCLC patients," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis. Although there has been significant progress in recent years in the treatment of the disease, there is a still a major unmet need for patients with only 25% of patients surviving beyond five years.

Trodelvy is an antibody-drug conjugate that targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could potentially provide a new treatment option for a broader set of patients with first-line metastatic NSCLC.

In the United States, Trodelvy is approved for the treatment of second-line metastatic triple-negative breast cancer (TNBC), and has additionally been approved under the accelerated approval pathway for the treatment of metastatic urothelial cancer (UC) in adults who have received prior therapy. Everest is closely coordinating with regulatory bodies in Greater China, Singapore and South Korea to review its applications for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. The use of Trodelvy for the treatment of NSCLC is investigational, and this use has not been approved by any regulatory agency globally.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer (including both NSCLC and small-cell lung cancer (SCLC)) is the second most common cancer in both men and women and is the leading cause of cancer death, making up approximately 25% of all cancer deaths. NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis, and the relative five-year survival rate is 25%.

About Sacituzumab Govitecan

Sacituzumab govitecan (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the TROP-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. SG is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland under the trade name Trodelvy. Review is also underway in Greater China, South Korea and Singapore through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On January 10, 2022 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported preliminary financial results for the fourth quarter and full fiscal year ended December 31, 2021 (Press release, ViewRay, JAN 10, 2022, View Source [SID1234598549]). The preliminary results have not been audited and are subject to change.

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Selected Fourth Quarter and Full Year 2021 Preliminary Results and Other Data (Unaudited)

Received seven new orders for MRIdian systems totaling approximately $41 million, compared to five new orders, including one upgrade, totaling approximately $24 million in the fourth quarter of 2020. A total of 28 orders were received for the twelve months ended December 31, 2021, representing a 65% growth over 17 total orders for the twelve months ended December 31, 2020.
Total backlog increased to approximately $313 million as of December 31, 2021, compared to approximately $241 million as of December 31, 2020.
Total revenue for the fourth quarter 2021 was approximately $20 million, primarily from three revenue units, compared to approximately $18 million, primarily from three revenue units including one system upgrade, in the fourth quarter of 2020.
Full year 2021 revenue was approximately $70 million, primarily from ten revenue units, compared to 2020 revenue of approximately $57 million, primarily from nine revenue units including two system upgrades.
Cash and cash equivalents was approximately $220 million as of December 31, 2021. Cash usage in the fourth quarter of 2021 was approximately $7 million excluding net proceeds from the November 2021 public offering of approximately $75 million.
"Our team delivered another solid set of results in Q4. Our clinical, innovation and commercial pipelines are stronger than ever. We are well positioned for a drumbeat of clinical data, new product launches, and increased therapy adoption in 2022," said Scott Drake, President and CEO. "I am pleased with our performance especially in light of the ongoing challenges from the pandemic and look forward to an exciting new year."

Our estimated unaudited financial results and certain business metrics as of and for the fourth quarter and full fiscal year ended December 31, 2021 presented above are preliminary and are subject to the close of the quarter and year, completion of our quarter-end and year-end closing procedures and further financial review. Our independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information. Our actual results may differ from these estimates as a result of the completion of our quarter-end and year-end closing procedures, review adjustments and other developments that may arise between now and the time our financial results for the fourth quarter and year are finalized.

On January 10, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CT041 for the treatment of patients who have advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor (Press release, Carsgen Therapeutics, JAN 10, 2022, View Source [SID1234598548]). CT041 is the first CAR T-cell product candidate against solid tumor with RMAT designation*, according to public resources.

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With the RMAT designation, CT041 enjoys all the benefits of Fast Track and Breakthrough Therapy designations including early and intensive FDA guidance on efficient product candidate development and eligibility for rolling review and priority review. Products granted RMAT designation may also be eligible for accelerated approval.

CT041 is an autologous CAR T-cell product candidate developed by CARsgen, which has the potential to be the first-in-class globally. As of the date of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with investigational new drug (IND) or clinical trial application approvals from the FDA, the NMPA, and Health Canada.

In October 2019, CARsgen’s CT053 CAR T-cell product candidate was first granted RMAT designation by the FDA for the treatment of relapsed and/or refractory multiple myeloma. CT041 is CARsgen’s second product candidate with RMAT designation.

CARsgen currently has 11 in-house developed product candidates and obtained 8 IND approvals for CAR T-cell therapies. In addition to the existing clinical pipeline product candidates, CARsgen continues to develop innovative technologies, such as CycloCAR technology to enhance efficacy of CAR T cells against solid tumors, and allogeneic THANK-uCAR technology to reduce costs and increase affordability. As of December 31, 2021, CARsgen owns over 300 patent applications and 65 issued patents in more than 19 countries and regions, including the United States, Europe, China, and Japan.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, stated that, "The RMAT designation indicates that CT041 has the potential to solve the unmet medical needs of patients with GC/GEJ. RMAT is not only important for accelerating product development and the review of the biologics license application, but also helps patients obtain this advanced therapy as soon as possible. We hope that the RMAT and PRIME designations obtained by CT041 will enable us to work closely with the FDA and the EMA, to obtain approvals from regulatory agencies globally, and thus benefit patients worldwide as soon as possible."

About CT041

CT041 is an autologous CAR T-cell product candidate developed by CARsgen. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CT041 has the potential to become a backbone therapy for GC/GEJ and PC and benefit a large population of patients worldwide.

According to the results of the investigator-initiated trial of CT041 that was orally presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (ESMO 2021), 18 patients with GC/GEJ who failed at least two prior lines of therapy (including 8 [44%] patients exposed to an anti-PD-1 or PD-L1 antibody) at the dose of 2.5×108 CAR T cells achieved an objective response rate (ORR) of 61.1%. Historical data shows that for patients with GC/GEJ who fail at least two prior lines of therapy, the efficacy rate of chemotherapy is about 4% to 8%, and the efficacy rate of anti-PD-1 antibody is about 11%. Therefore, compared with other treatments for patients with GC/GEJ who fail at least two prior lines of therapy, CT041 shows a significant improvement in ORR.

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

In 2020 and 2021, CT041 received Orphan Drug designation from the FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the European Medicines Agency (EMA) for the treatment of advanced gastric cancer. In November 2021, CT041 was granted Priority Medicines (PRIME) eligibility by the EMA for the treatment of advanced gastric cancer.

About Regenerative Medicine Advanced Therapy Designation

The RMAT designation program is intended to help the FDA facilitate an efficient development program for any drug that (1) qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products; (2) is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) has preliminary clinical evidence to indicate the drug has the potential to address unmet medical needs for such a disease or condition.