On June 21, 2022 Verismo Therapeutics, a recent University of Pennsylvania spin-out company behind the novel KIR-CAR platform technology for CAR T-cells, reported that Penn and Verismo entered into a Sponsored Research Agreement (SRA) (Press release, Verismo Therapeutics, JUN 21, 2022, View Source [SID1234616143]). Under the SRA, Verismo is funding additional KIR-CAR T-cell focused preclinical research programs at Penn to advance new potential treatment options for solid tumor indications. The research funded under the SRA is expected to be conducted over four years, from 2021 to 2025, in the Penn laboratories of Michael C. Milone, MD, PhD, an associate professor of Pathology and Laboratory Medicine, and Donald L. Siegel, MD, PhD, a professor of Pathology and Laboratory Medicine.

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Dr. Milone, with Dr. Carl June, is the co-inventor of the CTL019 CAR T product that became the first FDA-approved CAR T cell therapy, and he is the lead inventor of the KIR-CAR technology. Under the SRA, Dr. Milone and his lab are working to advance the KIR-CAR platform engineering and are performing key preclinical research for the purpose of enabling an IND for future clinical studies involving the KIR-CAR platform.

Dr. Siegel is a leading innovator in phage display technology. Under the SRA, Dr. Siegel and his lab are utilizing this technology to generate novel antibodies to cancer targets, which will expand Verismo’s product pipeline and potentially enable the treatment of additional tumor indications.

"Our ongoing collaboration with Penn brings us closer to our goal to treat solid tumors. Dr. Milone and Dr. Siegel have a clear vision of what scientific advances are needed to advance our progress and pipelines. I am hopeful that the collaboration between Penn and Verismo will accelerate the development of the KIR-CAR therapy and ultimately bring a new much needed treatment option to patients with solid tumors," said Dr. Bryan Kim, CEO of Verismo.

Editor’s Note: Drs. June, Milone, Siegel, and Penn are equity holders in Verismo. Penn has licensed certain Penn-owned intellectual property to Verismo and Drs. June, Milone, and Siegel, along with Penn, may receive financial benefits under the license in the future. Penn’s Perelman School of Medicine receives sponsored research funding from Verismo to support certain research and development programs at Penn.

On June 21, 2022 G42 Healthcare, an Abu Dhabi-based leading health tech company and subsidiary of G42, an artificial intelligence and cloud computing company located in Abu Dhabi reported that it has signed a letter of intent (LOI) with global biopharmaceutical company, AstraZeneca, in presence of the Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the emirate of Abu Dhabi aiming to expand their collaboration into the domains of diagnostics and clinical research, providing access to innovative solutions and treatments for patients in the United Arab Emirates and beyond (Press release, AstraZeneca, JUN 21, 2022, View Source [SID1234616142]).

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Left to right – Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca, Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, Francesco Redivo Senior Director at G42 Healthcare
Left to right – Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca, Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, Francesco Redivo Senior Director at G42 Healthcare
Witnessed by Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca and Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, the agreement was signed by Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, and Francesco Redivo Senior Director at G42 Healthcare during the BIO International Convention held in San Diego, California.

G42 Healthcare and AstraZeneca initially signed a Declaration of Collaboration in December 2021. This agreement further expands on their partnership to build local research capabilities, conduct RWE / clinical trials in UAE and localize Oncology biomarkers testing in UAE.

Ashish Koshy, CEO of G42 Healthcare, said, "We value collaboration and believe the strategic partnership with AstraZeneca will yield incredible growth for the healthcare ecosystem. We are proud to align ourselves with these organizations to generate new treatments and technologies to solidify the UAE’s place as a global hub for life sciences, medical tourism and innovation."

Hicham Mirghani, Corporate Affairs Director GCC, AstraZeneca said, "We are excited about expanding our existing partnership with G42 Healthcare to further advance the healthcare sector in the country and region. There is no doubt that innovation is key to healthcare advancements, and we are eagerly looking forward to collaboratively exploring greater possibilities in clinical research and diagnostics, enabling us to together create a more patient-centric healthcare offering in the UAE."

On June 21, 2022 Brand Institute reported that having worked with Adello Biologics (acquired by Kashiv Biosciences in 2019) in developing the brand name FYLNETRA (pegfilgrastim-pbbk), for an injection used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (Press release, Brand Institute, JUN 21, 2022, View Source [SID1234616141]). In addition to working on the brand name, Brand Institute also partnered with Adello Biologics in developing the suffix "pbbk" for the non-proprietary name for FYLNETRA, pegfilgrastim-pbbk.

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FYLNETRA was developed by Kashiv Biosciences in collaboration with Amneal Pharmaceuticals. FYLNETRA is the most recent pegfilgrastim biosimilar approved by the FDA.

"The entire Brand Institute and Drug Safety Institute team congratulates Kashiv Biosciences and Amneal Pharmaceuticals on the FDA approval for FYLNETRA," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

On June 21, 2022 Nordic Nanovector ASA (OSE: NANOV) reported an update following its comprehensive review and independent data evaluation of PARADIGME, its ongoing Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, JUN 21, 2022, View Source [SID1234616140]).

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The independent expert panel reviewed the efficacy data collected to date. Betalutin, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile. While Betalutin showed signs of efficacy in this frail, elderly and difficult-to-treat patient population, the independent expert panel reported that the efficacy data are less promising than the data reported from the Phase 2a LYMRIT 37-01 trial. The Company intends to seek further guidance from the competent regulatory authorities, including the US Food and Drug Administration (FDA), regarding the way forward for PARADIGME. Pending regulatory feedback, the study will remain open for recruitment.

Following interaction with the regulatory authorities, the Company will provide an additional update, which is expected in August. The Company will not be commenting further until then. The Company’s Q2 results will be rescheduled to August and a new date will be confirmed in due course.

Given the continuing slow patient recruitment, Nordic Nanovector does now not expect to deliver preliminary top line data from PARADIGME in H2 2022.

On June 21, 2022 Rakuten Medical Taiwan, Inc. reported that their ASP-1929 Photoimmunotherapy Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05265013) has enrolled and treated its first patient (Press release, Rakuten Medical, JUN 21, 2022, View Source [SID1234616139]). This trial is using ASP-1929 photoimmunotherapy based on the Alluminox platform in combination with anti-PD1 therapy in head and neck squamous cell carcinoma to measure patient’s Objective Response Rate (ORR) . The trial will be conducted in 3 medical centers in North Taiwan and 2 medical centers in Central Taiwan.

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According to official cancer registration report, head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan, with an annual incremental of about 10,000 patients. Majority1 of the patients are males between the ages of 40 and 60. Local recurrence or metastasis is one of the leading causes of death in head and neck cancer patients2, and nearly one-half of recurrent or metastatic patients survive for less than one year3. After receiving treatment, about 40% of patients will still face in situ or local recurrence4.

Dr. Chun Wei Huang from Department of Otorhinolaryngology, Head and Neck Surgery of China Medical University Hospital, who participated in the trial, explained: "Currently patients have limited treatment options after recurrence. When surgery, chemotherapy combined with targeted therapy, radiotherapy, etc. fail to show obvious efficacy in treating head and neck cancer, not only the patients but the medical teams are disappointed. Patients are also prone to losing confidence for further treatment. In addition to this phase II clinical trial, Taiwan is also expected to join more clinical trials. The introduction of more clinical trials presents not only new chances for patients, but also new possibilities for head and neck cancer treatment."

"ASP-1929 has been conditionally approved by the MHLW in Japan and we are establishing more clinical evidence to help cancer patients around the world. The investment of this Phase 2 trial reiterates our long-term commitment in developing Taiwan as the foothold to Asia expansion. The enrollment of first patient also demonstrates the robust momentum and tight-knit collaboration of Rakuten Medical around the globe. We look forward to providing patients with impactful new treatment options as soon as possible," said Mickey Mikitani, Co-CEO of Rakuten Medical, Inc.

Reference
[1] Health Promotion Administration, Ministry of Health and Welfare, 2019 Cancer Registration Report
[2] A Novel CXCR4-Targeted Diphtheria Toxin Nanoparticle Inhibits Invasion and Metastatic Dissemination in a Head and Neck Squamous Cell Carcinoma Mouse Model. Pharmaceutics. 2022 Apr 18;14(4):887. doi:10.3390/pharmaceutics14040887
[3] Argiris A, Harrington KJ, Tahara M, Schulten J, Chomette P, Ferreira Castro A, Licitra L. Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2017 May 9;7:72. doi: 10.3389/fonc.2017.00072.
[4] Daniela Alterio, Giulia Marvaso, Annamaria Ferrari, Stefania Volpe, Roberto Orecchia, Barbara Alicja Jereczek-Fossa (2019.) Modern radiotherapy for head and neck cancer