On March 24, 2022 Scenic Biotech reported Two independent studies were published this week on Scenic’s inflammation drug target QPCTL (Press release, Scenic Biotech, MAR 24, 2022, View Source [SID1234610883]). The studies were conducted by Genentech and Scenic’s SAB member Ton Schumacher at the Netherlands Cancer Institute. The publications provide proof of concept in preclinical models for the use of QPCTL inhibition in combination with other checkpoint inhibitors for the treatment of solid tumours.

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On March 24, 2022 Genagon Therapeutics reported that the European Patent Office has issued the Company European Patent No. 3568142, titled "Therapeutic Agents" (Press release, Genagon Therapeutics, MAR 24, 2022, View Source;utm_medium=rss&utm_campaign=patent-granted [SID1234610882]). The patent covers, among other things, the use of a polypeptide capable of binding to proteins in the TGFb superfamily. These claims protect inventions which are central to the Company’s programs for treating cancer and strengthen its main business focus.

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CEO Moa Fransson comments: "These claims protect inventions which are central to the Company’s programs for treating cancer and strengthen its main business focus".

On March 24, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer (Press release, Oncolytics Biotech, MAR 24, 2022, View Source [SID1234610881]). The trial’s first two cohorts have completed their dose escalation evaluation periods and indicated pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date.

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The dosing regimens for the bridging trial’s second and third cohorts are equivalent to those administered in Oncolytics’ randomized North American breast cancer trials, IND-213 and BRACELET-1, respectively. In IND-213, HR+/HER2- breast cancer patients treated with pelareorep and paclitaxel showed a statistically significant, near doubling of overall survival compared to those treated with paclitaxel alone. BRACELET-1, an ongoing phase 2 study evaluating pelareorep-paclitaxel combination therapy with and without a checkpoint inhibitor, is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States. Final results from the Chinese bridging trial are expected to accelerate pelareorep’s development in territories such as China, Hong Kong, and Macau, by allowing Adlai Nortye to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions.

"The territories covered by our partnership with Adlai Nortye represent an important component of our business development strategy, as China and the other areas in which Adlai Nortye anticipates commercializing pelareorep are among the largest in the world and growing rapidly," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "With the bridging trial entering its final cohort less than six months after dosing began, Adlai is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep’s development in China. The trial also continues to generate positive safety data, which will serve us well as we collaborate with Adlai Nortye to advance pelareorep towards approval in key global markets."

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 20201. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 20202.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

On March 24, 2022 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients one month to <18 years of age with localized, non-metastatic, solid tumors (Press release, Fennec Pharmaceuticals, MAR 24, 2022, View Source [SID1234610872]).

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"We appreciate the FDA’s comments during the resubmission process and look forward to working closing with the Agency during the NDA review," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "We are pleased to have reached this important step and Fennec remains committed to making PEDMARKTM available to reduce the risk of cisplatin induced ototoxicity in pediatric patients."

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

On March 24, 2022 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine sintilimab injection, a PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC) (Press release, Eli Lilly, MAR 24, 2022, View Source [SID1234610871]). Sintilimab is being developed by Innovent Biologics, Inc. (HKEX: 01801) and Lilly.

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The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February. The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.

Along with Innovent, Lilly is assessing next steps for the sintilimab program in the U.S.

About Sintilimab
Sintilimab, is an investigational PD-1 inhibitor developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab, marketed as TYVYT (sintilimab injection), has been approved for:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment.
Sintilimab was included in China’s National Reimbursement Drug List (NRDL) for all four approved indications (listed above), according to the latest announcement from the China National Healthcare Security Administration ("NHSA").