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Kura Oncology to Participate in JMP Securities Life Sciences Conference

On June 10, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the JMP Securities Life Sciences Conference (Press release, Kura Oncology, JUN 10, 2021, View Source [SID1234583823]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present in a virtual fireside chat at 3:00 p.m. ET / 12:00 p.m. PT on Thursday, June 17, 2021.

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

Targovax’s ONCOS-102 mesothelioma 24-month data shows class-leading median overall survival

On June 10, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that mOS between 21.9 and 25.0 months from the randomized phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, JUN 10, 2021, View Source [SID1234583822]).

The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (or later) line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The trial has now completed the 24-month follow-up.

At the 24-month follow-up, it was determined that the final mOS will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous MPM clinical trials have reported mOS in the range of 12–16 months for patients receiving the same SoC chemotherapy treatment[1].

Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 36). The tumor tissue analyses revealed broad and powerful ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. Notably, this activity was associated with both tumor responses and survival outcomes, indicating that the immune activation generated by ONCOS-102 is driving the clinical benefit for patients.

Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the Hospital Doce de Octubre, Madrid and Principal Investigator of the trial, said: "Mesothelioma remains a challenging disease with a generally poor prognosis, and there is a large unmet medical need for new, innovative treatments such as ONCOS-102. Although the number of patients in this trial is small, the overall survial is very encouraging, particularly since the outcomes can be linked to ONCOS-102-induced immuno-modulation. These early results clearly support further clinical development, and we look forward to participating in future trials with ONCOS-102 in mesothelioma."

Recently, the double checkpoint inhibitor (CPI) combination of Opdivo and Yervoy (nivolumab and ipilimumab) was approved by the U.S. Food and Drug Administration (October 2020) and the European Medicines Agency (April 2021) for the first-line treatment of MPM, based on a phase 3 trial showing mOS of 18.1 months compared with 14.1 months in the SoC control group (pemetrexed/cisplatin). The Opdivo/Yervoy combination is seeing rapid uptake among clinicians in both the USA and Europe and is becoming the new preferred first-line Standard of Care. Given the class-leading activity ONCOS-102 has demonstrated in CPI-refractory melanoma (see link here), Targovax believes there is a strong scientific rationale for testing ONCOS-102 in the CPI-refractory setting also in MPM. This opportunity is now being discussed with key opinion leaders.

Øystein Soug, CEO of Targovax, commented: "We are very pleased to see ONCOS-102 generating robust immune activation in a tumor type with low immunogenicity and delivering meaningful survival benefit for patients with high medical need. With the recent approval of the Opdivo/Yervoy combination, the power of immunotherapy is now making its way into mesothelioma and is already improving patient outcomes. ONCOS-102 is ideally positioned for combination with checkpoint inhibitors and, as demonstrated in our melanoma trial, to reactivate checkpoint resistant tumors. Therefore, we are now evaluating the potential opportunity in the emerging checkpoint resistant mesothelioma population, thereby expanding on the demonstrated ability of ONCOS-102 to bring benefit to the majority of patients who still progress after checkpoint inhibitor treatment."

[1] 1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC (Free SITC Whitepaper) 2020 poster

Cardinal Health™ Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK® Pediatric Indication

On June 10, 2021 Cardinal Health (NYSE: CAH) reported that LYMPHOSEEK (technetium Tc 99m tilmanocept) injection – the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) – has been approved for pediatric use by the U.S. Food and Drug Administration (FDA) (Press release, Cardinal Health, JUN 10, 2021, View Source;Precision-Health-Solutions-Receives-U.S.-Food-and-Drug-Administration-Approval-for-New-LYMPHOSEEK-Pediatric-Indication/default.aspx [SID1234583821]).

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"This new indication opens the door for physicians, oncologists and nuclear medicine specialists to more accurately stage the spread of disease using lymphatic mapping in pediatric cancer patients," said Tiffany Olson, President of Nuclear & Precision Health Solutions at Cardinal Health. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

In addition to adult use, this new indication will provide accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma (RMS) or other types of solid tumors. This will offer physicians, oncologists and nuclear medicine specialists an efficient, accurate and safe option to enhance lymphatic mapping and SLNB in pediatric melanoma cases, the most common skin cancer in children, which results in around 500 new cases per year [1].

Approximately the same number of pediatric cases of RMS, a rare type of cancer that forms in soft tissues, such as eyes, occurs each year in the United States. RMS is most often diagnosed in children and teens, with more than half of diagnoses in children younger than 10 years old [2].

LYMPHOSEEK is a radioactive diagnostic agent. A clinical study to evaluate LYMPHOSEEK in pediatric patients has shown that the radiopharmaceutical is safe and effective for patients one month and older. Less than one percent of patients reported injection site irritation and/or pain in clinical trials, with no serious adverse reactions to the drug being reported.

With the largest national pharmacy network and the industry’s most comprehensive portfolio of radiopharmaceuticals – with best-in-class service, accuracy and reliability to deliver on-demand prescriptions across the country – Cardinal Health Nuclear & Precision Health Solutions is helping shape the future of precision healthcare.

Werewolf Therapeutics Reports First Quarter 2021 Financial Results

On June 10, 2021 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (NASDAQ: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the quarter ended March 31, 2021 (Press release, Werewolf Therapeutics, JUN 10, 2021, View Source [SID1234583820]).

"Our recently completed IPO will help us advance our two lead programs to the clinic and will enable us to continue to build our immuno-oncology R&D organization," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Despite important recent advances in the treatment of cancer, using the body’s immune system without eliciting off-target side effects remains a challenge. We are leveraging our novel PREDATOR platform to engineer conditionally activated proinflammatory immunomodulators, or INDUKINE molecules, which are delivered systemically but activated only in the tumor microenvironment, with the goal of generating potent anti-tumor response while minimizing toxicities."

Successful Initial Public Offering Completed: On May 4, 2021, Werewolf completed its initial public offering (IPO). In connection with the offering, the Company issued and sold 7,500,000 shares of common stock at a public offering price of $16.00 per share, resulting in net proceeds of approximately $108.9 million.

First Quarter 2021 Financial Highlights

Cash position: As of March 31, 2021, cash and cash equivalents decreased to $84.6 million, compared to $92.6 million as of December 31, 2020. The Company expects that its existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operations for at least the next twenty-four months.
Research and development expenses: Research and development expenses were $4.8 million for the first quarter of 2021, compared to $2.8 million for the same period in 2020. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613 and increased employee compensation costs related to increased headcount.
General and administrative expenses: General and administrative expenses were $2.6 million for the first quarter of 2021, compared to $1.1 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased personnel, consulting and recruiting costs in preparation for increased requirements of operating as a public company.
Net loss: Net loss was $7.4 million for the first quarter of 2021, compared to $3.8 million for the same period in 2020.

Post-ASCO 2021 Investor & Analyst Event: Zandelisib in Focus

On June 10, 2021 MEI Pharma Presented the Corporate Presentation (Press release, MEI Pharma, JUN 10, 2021, file:///C:/Users/komal/Downloads/ASCO.2021.IR_Webcast.FINAL%20(3).pdf [SID1234583819])