On May 4, 2022 Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported the first patient dosing in the United States of its multi-regional phase II clinical trial (NCT05178043) of ALK-1 antibody (GT90001) and Nivolumab (Opdivo) combination therapy for the treatment of advanced Hepatocellular Carcinoma (HCC) on 2 May 2022 (Press release, Suzhou Kintor Pharmaceuticals, MAY 4, 2022, View Source [SID1234613576]).

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According to Global Cancer Statistics 2020, primary liver cancer is the sixth most commonly diagnosed cancer and the third leading cause of cancer death worldwide, with approximately 906,000 new cases and 830,000 deaths[1]. HCC is the most common form of liver cancer in adults, accounting for about 75%-85% of all liver cancers.[2] Overall, the treatment and prognosis of liver cancer are relatively poor, and the overall survival of liver cancer needs to be further improved with better treatment options.

In recent years, innovative therapies have increased options for patients with advanced liver cancers. In 2020, the combination treatment of Atezolizumab (TECENTRIQ) and Bevacizumab (AVASTIN) ("T+A") was approved in the US to replace Sorafenib (NEXAVAR) or Lenvatinib (LENVIMA) as the first-line standard of care ("SOC") for advanced HCC, following by approval in many other countries and regions. There has been huge unmet needs for a second-line treatment for patients who failed treatment with or did not tolerate T+A.

Dr. Tong Youzhi, founder, Chairman, and CEO of Kintor Pharma, commented, "We are delighted to complete the first patient dosing in the phase II multi-regional clinical trial of GT90001 combined with Nivolumab for the treatment of advanced HCC. We expect this phase II MRCT study would position GT90001 well as a combination candidate with I/O for the second-line treatment of HCC. We are also selecting clinical strategies for GT90001 in other solid tumors and hope to bring more innovative treatment options for patients with unmet needs."

About the Study

This phase II clinical trial was greenlighted by the FDA on February 11, 2021. This is an open label, multi-regional study designed to evaluate the efficacy and safety of GT90001 in combination with Nivolumab in patients with advanced HCC who were intolerant of, or had progressed after first-line treatment with Immune Checkpoint Inhibitors (ICI) such as Atezolizumab and/or Bevacizumab, or ICI plus Tyrosine Kinase Inhibitor (TKI). This study will enroll a total of 105 patients to receive a combination therapy of Nivolumab and GT90001. The proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, infusion every two weeks. The primary endpoint is to assess the overall response rate (ORR) as evaluated by an independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

About ALK-1 Antibody

ALK-1 antibody is a potential first-in-class, fully human IgG2 neutralizing monoclonal antibody that inhibits BMP9, TGFβ through ALK-1 receptor-mediated signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for ALK-1antibody from Pfizer, Inc., in February 2018.

In January 2021, the preliminary data of the ongoing Taiwan phase II clinical trial for advanced HCC was released at ASCO (Free ASCO Whitepaper) GI 2021 and showed positive efficacy and good safety results. The overall response rate ("ORR") was 40 percent.

In February 2021, the U.S. Food & Drug Administration (FDA) granted Kintor Pharma an investigational new drug ("IND") application for ALK-1 antibody as a second-line treatment for HCC. In October 2021, the clinical trial of combination therapy of ALK-1 antibody for the treatment of advanced HCC was approved by the National Medical Products Administration (NMPA) of China.

On May 4, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported first quarter 2022 financial results and highlighted recent achievements and developments (Press release, Oncorus, MAY 4, 2022, View Source [SID1234613476]).

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"Early 2022 has been focused on clinical and operational execution as we work toward operational completion of our manufacturing facility, as well as extending our cash runway to support our dual platform approach to next-generation viral immunotherapies. We plan to share additional ONCR-177 Phase 1 data from the surface lesion monotherapy expansion and the initial combination expansion data with KEYTRUDA in the second half of 2022, while we continue to advance our vRNA drug candidates and LNP capabilities in parallel," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We recently presented exciting preclinical data from our selectively self-amplifying vRNA/LNP immunotherapy platform at AACR (Free AACR Whitepaper) demonstrating the full potential of our IV-administered viral immunotherapy candidates, ONCR-021 and ONCR-788, in overcoming well-established limitations of RNA-based therapeutics. We look forward to further positioning Oncorus for growth driven by our dual-platform pipeline of product candidates targeting cancers with significant unmet need, which is enabled by our wholly owned GMP-compliant manufacturing infrastructure."

First Quarter 2022 and Recent Business Highlights

On track to report additional ONCR-177 monotherapy and combination data in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of its Phase 1 open-label, multi-center trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The Company continues to enroll patients in the combination cohort with future data readouts expected in the second half of 2022. Data readouts are expected to include both additional surface lesion monotherapy expansion data for ONCR-177 and initial surface lesion combination expansion data for ONCR-177 administered with KEYTRUDA.
Presented preclinical data for ONCR-021 and ONCR-788 supporting the company’s selectively self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. In April 2022, Oncorus presented preclinical data for both ONCR-021 and ONCR-788 in two e-posters at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating robust preclinical anti-tumor efficacy in multiple tumor models while avoiding the challenges seen in previous studies that incorporate IV administration of RNA-based oncology therapeutics. Oncorus plans to submit an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration (FDA) in mid-2023 and a subsequent IND submission for ONCR-788.
Announced debt capital facility with K2 HealthVentures (K2HV); $20 million funded at closing: In April 2022, Oncorus entered into a loan and security agreement with K2HV, a healthcare-focused specialty finance company. The term loan facility provides Oncorus with up to $45 million available in multiple tranches upon the achievement of certain time-based, clinical and regulatory milestones, with the initial tranche of $20 million funded at closing. Oncorus intends to use the proceeds of the initial tranche of the loan facility to complete the buildout of its Andover facility and to continue the advancement of its pipeline of next generation viral immunotherapies for cancer and LNP technologies.
Announced relocation of all operations to Andover, Massachusetts facility in fourth quarter of 2022 to increase operational efficiency: In April 2022, Oncorus announced plans to relocate all operations to its facility in Andover, Massachusetts in the fourth quarter of 2022, allowing research, process development and Good Manufacturing Practice (GMP)-compliant manufacturing to occur all in one facility.
First Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $98.7 million as of March 31, 2022 compared to $123.9 million as of December 31, 2021.

Research and development expenses for the quarter ended March 31, 2022 were $12.5 million compared to $8.4 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, which was driven by increased headcount and increased stock-based compensation, increased development costs related to the Company’s nominated candidates, as well as increased rent expense related to the Company’s manufacturing facility.

General and administrative expenses for the quarter ended March 31, 2022 were $5.3 million compared to $4.2 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, including higher stock-based compensation, increased headcount and increased salary and related expenses.

Net loss for the quarter ended March 31, 2022 was $17.8 million, or $0.69 per share, as compared to a net loss of $12.7 million, or $0.53 per share for the corresponding quarter in 2021. The increase in net loss was due to increased expenses associated with the Company’s preclinical development costs of its nominated candidates.
Financial Guidance

As a result of the debt capital facility and operations relocation, as well as other initiatives to increase operational efficiency, Oncorus now expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.

On May 4, 2022 Fresenius Kabi reported that closed the acquisition in March of Ivenix, Inc. ("Ivenix"), a specialized infusion therapy company (Press release, Fresenius, MAY 4, 2022, View Source [SID1234613508]). Ivenix adds a next-generation infusion therapy platform for the significant U.S. market to Fresenius Kabi’s portfolio and provides the company with key capabilities in hospital connectivity. The combination of Ivenix’s leading hardware and software products with Fresenius Kabi’s offering in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space. The purchase price is a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

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On May 4, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, Prime Market of TSE) reported that the companies have entered into an exclusive licensing agreement under which Jazz has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma’s investigational DSP-0187, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders. Jazz has designated this molecule JZP441 (Press release, Jazz Pharmaceuticals, MAY 4, 2022, View Source [SID1234613524]).

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Sumitomo Pharma initiated a Phase 1 trial in Japan of DSP-0187 in November 2021 to evaluate safety, tolerability and pharmacokinetics in healthy volunteers. Jazz expects to rapidly advance development of DSP-0187 based on these clinical findings.

"Orexin agonism is an exciting area of sleep disorder research and an approach that may be complementary to oxybate therapy. We believe that DSP-0187 has the potential to advance the treatment of narcolepsy and other sleep disorders based on its profile," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "As a leader in sleep medicine, we are committed to delivering innovative therapies to people who are living with debilitating sleep disorders. We look forward to leveraging our expertise in sleep disorders to rapidly advance this promising therapy into clinical trials in the U.S. and Europe. This agreement exemplifies both our ability to identify promising compounds that have the potential to improve patient care and our corporate objective of making strategic, value-creating investments in our pipeline."

"DSP-0187 is a potent, highly selective oral orexin-2 receptor agonist, which is a novel small molecule compound originally created by Sumitomo Pharma by utilizing our advanced expertise in drug discovery for central nervous system disorders. We are pleased to partner with Jazz on DSP-0187 given their strong track record of development success and commercial execution in sleep disorders and long-term commitment to advancing therapies to improve the lives of people with sleep disorders," said Toru Kimura, Representative Director, Executive Vice President of Sumitomo Pharma. "Jazz’s accomplishments in sleep medicine make the company an ideal partner for us as DSP-0187 enters its next phase of development."

Orexins are neuropeptides that play an important role in the regulation of sleep and wakefulness. DSP-0187 is a potent, highly selective orexin-2 receptor agonist designed to activate orexin signaling. DSP-0187 is initially planned to be evaluated in patients with narcolepsy, a debilitating sleep disorder which can manifest clinically with cataplexy, excessive daytime sleepiness (EDS), disrupted nighttime sleep (DNS), sleep paralysis and other symptoms. There is also potential for DSP-0187 to treat other sleep disorders.

Transaction Terms

Under the terms of the agreement, Jazz will receive an exclusive license to develop and commercialize DSP-0187 throughout the world except for Japan, China and certain other Asia/Pacific countries and regions, where Sumitomo Pharma will retain all development and commercialization rights. Sumitomo Pharma will receive an upfront payment of $50 million, and is eligible to receive development, regulatory and commercial milestone payments of up to $1.09 billion. Pending approval, Sumitomo Pharma is eligible to receive a tiered, low double-digit royalty on Jazz’s net sales of DSP-0187.

On May 4, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the quarter March 31, 2022 on Monday, May 9, 2022, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, MAY 4, 2022, View Source [SID1234613541]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, May 10, 2022, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; and Sue Smith, Chief Commercial Officer.

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