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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On May 4, 2022 Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage biopharmaceutical company reported that it is presenting promising interim data from an ongoing Ph2 trial of Tenalisib in locally advanced or metastatic breast cancer patients, at the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting, in Berlin, Germany from May 3-5, 2022 (Press release, Rhizen Pharmaceuticals, MAY 4, 2022, View Source [SID1234613560]).

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This multi-center, randomized phase II study is being conducted in eastern Europe and is designed to assess Tenalisib’s anti-tumor activity (clinical benefit rate at the end of 6 months, disease control rate and overall response rates) and safety across two dose levels. The study also includes translational assessments intended to delineate the effect of Tenalisib’s multivalent mechanism on relevant cytokines/chemokine levels and gene expression changes within the tumor microenvironment.

The study included 40 enrolled patients (39 HR+/Her2- and 1 TNBC) presenting with stage IV A or IV B advanced or metastatic disease with majority of the patients having significant distal metastases to the bone, lymph nodes, lung and liver. The study population included patients with both primary resistance (~40%) and secondary resistance (~60%) to endocrine therapy and with ~50% of the patients undergoing prior chemotherapy treatment in a metastatic setting.

As of April 18th 2022, the initial results from the study showed that Tenalisib was well tolerated across dose levels with majority of reported adverse events being mild-to-moderate in severity. Discontinuations and dose reductions due to related AEs were minimal (5-7.5%). The median duration of treatment thus far was ~4 months (0.93 to 6.23+ months) with ~60% of patients continuing on the study. The median time to response was 1.8 months and preliminary efficacy results indicate an encouraging 67.5% DCR which is maintained across patients with primary endocrine resistance as well. Correlation of responses observed with gene expression profiles by RNA sequencing from tumor biopsy samples post treatment with Tenalisib and analysis of cytokine/chemokine levels post Tenalisib treatment are underway.

"We are encouraged by the early activity seen with Tenalisib in the advanced/metastatic disease setting where patients have limited treatment options once they have failed CDK inhibitors and endocrine therapies. As these results continue to translate into durable responses, we will be engaging with key opinion leaders and regulatory agencies to discuss the monotherapy and combination development plans and registration-enabling study designs." said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharma. Swaroop also added that "Given the relevance of Tenalisib’s multi-valent mechanism across solid tumors, we expect these results will pave the way Tenalisib’s development to be expanded into other solid tumors. We are designing Tenalisib’s clinical programme carefully to arrive at an optimized dose and also deploy randomized study designs to fully elucidate its efficacy and safety."

Rhizen indicated that Tenalisib, in addition to its selective dual PI3K δ/γ inhibitory activity, also has Salt-Inducible Kinase 3 (SIK3) activity via its principal metabolite, that could potentially contribute to its chemo-sensitization effect, especially in breast cancer. Rhizen hopes to establish the single agent activity of Tenalisib in this current study after which it plans to expand the assessment across additional solid tumor indications and combinations both with chemotherapeutic agents and with immune-checkpoint inhibitors.

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective, next-generation, orally active, dual PI3K δ/γ inhibitor with additional SIK3 activity, that is currently in phase II clinical development for solid tumors & haematological malignancies. Tenalisib has been granted US FDA Fast Track & Orphan-Drug Designations for treatment of r/r PTCL and CTCL and had recently published data from its phase II study evaluating Tenalisib both as monotherapy and in combination with Romidepsin in r/r PTCL & CTCL which showed robust responses of ~75% ORR in r/r PTCL and ~54% in r/r CTCL. The combination was well tolerated with no additional toxicities noted over & above those of the individual agents, confirming Tenalisib’s superior safety profile in its class. Overall, Tenalisib has been studied in ~200 patients across studies till now and has shown potentially better safety outcomes vis-à-vis other agents in the PI3K class.