On October 14, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has initiated dosing in a 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, OCT 14, 2021, View Source [SID1234591225]).

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Results from the bridging trial are expected to allow Adlai Nortye to include data from Oncolytics’ North American metastatic breast cancer trials in a future submission to Chinese regulators. The first of Oncolytics’ randomized phase 2 trials, IND-213, showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone. Oncolytics’ second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.

"Adlai’s bridging trial is an important step forward for pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareorep towards registration in major 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 2020.1 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 2020.2
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 October 14, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported an investigator-presented case series from the Cancer Molecular Screening and Therapeutics (MoST) study at the Australasian Gastro-Intestinal Trials Group (AGITG) 2021 Annual Scientific Meeting, taking place virtually October 12-15, 2021 (Press release, Elevation Oncology, OCT 14, 2021, View Source;utm_medium=rss&utm_campaign=elevation-oncologys-seribantumab-included-as-part-of-a-case-series-presentation-at-the-australasian-gastro-intestinal-trials-group-2021-annual-scientific-meeting [SID1234591224]). The presentation was selected as one of four "Best of the Best" at the meeting and provides a select case series of patients treated on the MoST program, which uses genomic profiling to characterize molecular changes in tumors from patients with treatment-refractory advanced cancers and matches those patients with targeted oncology agents.

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A patient with treatment-refractory metastatic pancreatic cancer had their tumor genomically profiled through the MoST program, was found to harbor an NRG1 fusion, and subsequently received treatment with seribantumab through a compassionate use program provided by Elevation Oncology. As of the data cut-off for the presentation, treatment with seribantumab resulted in durable clinical benefit for over 9 months, an approximately 90% reduction in the cancer biomarker CA19-9, and an ongoing 3 month confirmed partial response per RECIST criteria with a maximum tumor reduction of over 50%.

"The MoST program is focused on exploring the importance of matching therapeutics to patients based upon genomic evaluation of their individual tumors," said Dr Subotheni Thavaneswaran, Medical Oncologist at The Kinghorn Cancer Centre and a research fellow and principal investigator of the MoST program, Garvan Institute of Medical Research and NHMRC Clinical Trials Centre. "We are pleased to have been able to gain access to an investigational treatment option for this patient, following identification of an NRG1 fusion. Compassionate early access to seribantumab following three prior lines of therapy resulted in a clinical benefit for this individual patient, and is an important reminder of the potential for matching specific therapeutics to genomic tumor profiling results."

The full presentation from AGITG can be accessed here.

The details for the AGITG 2021 poster presentation are as follows:

Title: Comprehensive genomic profiling reveals novel opportunities for treatment-refractory gastrointestinal cancers
Authors: Wei Yen Chan1, Subotheni Thavaneswaran1,2,3, Frank Lin2,3, Lucille Sebastian3, Mandy Ballinger2, John Grady2, Maya Kansara2, Anthony Joshua1,2, Rasha Cosman1, John Simes3, David Thomas1,2
1 The Kinghorn Cancer Centre St Vincent’s Hospital Sydney; 2 Garvan Institute of Medical Research, Faculty of Medicine, UNSW; 3 NHMRC Clinical Trials Centre, University of Sydney
Presenter: Wei Yen Chan, The Kinghorn Cancer Centre, St. Vincent’s Hospital, Sydney
Session: Best of the Best
Date and time: Thursday, October 14, 2021; 11:15 to 12:15 AEDT

Distinct from the compassionate use program through which this patient was treated, seribantumab is currently being investigated by Elevation Oncology in the company-sponsored Phase 2 CRESTONE study, a tumor-agnostic "basket trial" in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The CRESTONE study is currently enrolling across the U.S. at over 26 active clinical sites and is anticipated to expand to other global regions. Elevation Oncology expects to report clinical data from an interim analysis of the CRESTONE study in mid-2022.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins." The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States. For more information visit www.NRG1fusion.com.

On October 14, 2021 OncoNano Medicine, Inc. reported that results from a Phase 2 study of its lead clinical development candidate, pegsitacianine, presented as a late- breaking oral presentation at the 2021 World Molecular Imaging Congress (WMIC) (Press release, OncoNano Medicine, OCT 14, 2021, View Source [SID1234591223]). This late- breaking oral presentation by Dr. Jason Newman of the University of Pennsylvania Health System revealed the fluorescent nanoprobe, pegsitacianine, provided real-time surgical imaging in a tumor-agnostic manner for the accurate identification of malignant tissue in the operating room.

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Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark ( "Off") state at physiological pH but transitions rapidly to a fluorescently "On" state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in a Phase 1 clinical trial where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

"The Phase 2 study results for pegsitacianine presented at the recent World Molecular Imaging Congress indicate this fluorescent nanoprobe has the potential to change the current surgical paradigm," said Dr. Newman. "With the real-time feedback that pegsitacianine provides, we could now have a tool that offers real-time surgical imaging on margin status and provides a greater degree of confidence in achieving complete tumor resection. Given the unique activation mechanism of targeting a universally dysregulated tumor metabolic signature, pegsitacianine could be beneficial in aiding surgical oncologists across multiple tumor disciplines."

The recently completed Phase 2 study (NCT03735680) was a non-randomized, open-label, multi-center study being conducted at three U.S. sites. This exploratory study further confirmed the selected dose-schedule, expanded upon the drug’s safety profile and increased the number of tumor types in which pegsitacianine imaging was shown to be feasible. Together, the results demonstrated that pegsitacianine is well-tolerated in patients and provides the surgeon with accurate, real-time feedback in the operating room. Intraoperative imaging observations demonstrated a high correlation with the pathological assessments of collected tissues, and imaging can be reliably performed using multiple FDA-cleared NIR imaging devices. Results from evaluable patients demonstrated favorable sensitivity (100%) and specificity (92%) values, as well as a strong negative predictive value (100%) for detecting histologically normal tissue that was collected as part of standard of care surgery.

"The high sensitivity and specificity valuesfrom the Phase 2 trial not only corroborated our Phase 1 observations to further support the use of OncoNano’s ON-BOARDTM platform in surgical imaging, but also highlight the potential benefit of this pH-activatable platform for tumor-targeted delivery of therapeutic payloads with an increased therapeutic window," commented Jinming Gao, PhD, OncoNano’s Chief Scientific Officer.

On October 14, 2021 Purple Biotech Ltd. (the "Registrant" or the "Company") reported that the Company entered into a settlement agreement with Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc. (collectively, "Lupin"), resolving the Company’s patent litigation against Lupin (Press release, Purple Biotech, OCT 14, 2021, View Source [SID1234591220]). The litigation concerned Lupin’s filing of an Abbreviated New Drug Application (ANDA) seeking approval from the U.S. Food and Drug Administration (FDA) to market a generic version of the Company’s commercial drug CONSENSI. This agreement with Lupin allows Lupin to enter the market on March 1, 2030 and earlier, under certain circumstances.

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On October 14, 2021 Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., reported a new study of real world data showing higher response rates than previously seen in people living with cutaneous T-cell lymphoma (CTCL) treated with POTELIGEO (mogamulizumab) (Press release, Kyowa Hakko Kirin, OCT 14, 2021, View Source [SID1234591218]). The findings, from a retrospective observational study of French CTCL patients, showed that the best overall response rate in the real-life study was 58.5 per cent, compared to 35 per cent seen in the MAVORIC trial.1,2 The MAVORIC study was the pivotal Phase 3 trial that investigated treatment with POTELIGEO compared to an active comparatora in previously treated adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

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Professor Martine Bagot of Saint-Louis Hospital, Université de Paris, France said: "The purpose of the study was to assess, for the first time, the efficacy and safety of mogamulizumab in a real-life setting. We saw a higher response in the real-life study compared to the MAVORIC trial results. The increase was also seen in both the MF and SS patient groups, compared to MAVORIC. As both the real world data and MAVORIC recruited a broadly similar set of patients, this new data underlines the value of mogamulizumab in treating these CTCL patients, whose disease causes a severe impact on their functioning, emotional and social wellbeing."

Data was collected and analysed from medical records of 124 MF and SS patients treated with POTELIGEO between February 2014 and March 2020, from 14 specialist treatment centres in France. The best overall response rate (ORR) seen in the real-life study was 47.0% in MF patients and 68.3% in SS patients. In contrast, the ORRb in MAVORIC was 21% and 37%, respectively.1,2 Of the 124 patients who received POTELIGEO treatment in the study, 44% were MF patients and 56% were SS patients. This compares to 56% and 44% in MAVORIC, respectively. In the real-life study, 49.6% of patients were at disease stage IVA1, compared to 39% in MAVORIC.1,2

POTELIGEO was also shown to have a favourable safety profile, in the real life study the most common drug-related treatment-emergent adverse events (TEAEs) were lymphopenia and asthenia. Commonly occurring TEAEs seen in both the real life study and MAVORIC were rash and infusion-related reactions.1,2

Abdul Mullick, President of Kyowa Kirin International, said: "Kyowa Kirin is committed to improving outcomes for patients with rare diseases, whose needs are often underserved. It’s heartening to see this new real world data, which reinforces what we’ve seen previously in clinical trials. Kyowa Kirin is dedicated to improve the lives of patients with CTCL, which is a chronic, debilitating disease and to deliver on our purpose, to make people smile."

MF and SS are subtypes of CTCL, a rare type of non-Hodgkin’s lymphoma that can affect the skin, blood, lymph nodes and internal organs.3 It is associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.4

The new data was presented at a poster session at the EORTC meeting in Marseille, France, which is being held on 14-16 October 2021.

a The comparator in the MAVORIC trial was vorinostat, a histone deacetylase inhibitor (HDACi) and FDA-approved standard of care option for treatment of CTCL that is licensed in the US for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies. Vorinostat is not licensed for use in Europe.

b MAVORIC ORR included only those patients with confirmed global response at two (or more) successive evaluations at least 8 weeks apart).

About Mycosis Fungoides (MF) and Sézary syndrome (SS)

Cutaneous T-cell lymphoma (CTCL) is a cancer of white blood cells (lymphocytes) that presents in the skin.5 CTCLs are rare, serious and potentially life-threatening forms of non-Hodgkin lymphoma (NHL).2 Malignant T cells in CTCL circulate in the blood and migrate to the skin6 causing lesions and itching.7

The annual incidence of CTCL in Europe is around 5.2 new cases per 100,000 population8 and it affects around 240 people per million in the region at any one time.5 The two best-studied types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS).9 Together, MF and SS account for around two thirds of all CTCLs.10,11

MF accounts for approximately 60% of all CTCLs,10 is typically indolent and is characterised by skin symptoms including patches or plaques, skin redness and tumours.12
SS is much rarer, accounting for around 5% of CTCLs,6 and is more aggressive13 with high levels of blood involvement by definition.10 It causes very severe itching, total body redness (erythroderma), intense scaling of the skin and frequent hair loss. 7
It can typically take between three and six years from CTCL disease onset for a patient to be diagnosed, in some cases it can take decades.10,12 This is sometimes due to the fact that CTCL presents very similarly to other benign skin conditions (e.g. eczema and psoriasis)7; this can mean many patients experience a long, frustrating journey before diagnosis.

CTCL can be very distressing for patients and has a significant negative life-long impact upon many aspects of a patient’s life.12,14 CTCL causes chronic skin impairment with itching, pain, recurrent infections, and disfiguring skin lesions, as well as sleep disturbance and psychosocial problems.9,12 Even in the early stages of CTCL, the disease can affect patients’ ability to meet the needs of their family, interfere with their job, and limit normal daily activities.14

About POTELIGEO (mogamulizumab) and the MAVORIC Trial

Malignant T lymphocytes in MF and SS, consistently express a molecule called CC chemokine receptor 4 (CCR4).2 POTELIGEO is a humanised monoclonal antibody that selectively binds to CCR4-expressing cells15 and helps destroy them by harnessing the body’s immune system.2 POTELIGEO is a systemic therapy, administered by intravenous infusion weekly for the first five weeks, then subsequently every two weeks.15 The registrational Phase 3 MAVORIC trial was the largest randomised study of systemic therapy in CTCL. It evaluated the safety and efficacy of POTELIGEO versus vorinostat in patients who had failed at least one previous systemic therapy.2

Following a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission (EC) granted marketing authorisation for POTELIGEO in November 2018 for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.15

Important Prescribing information and Safety Information

Refer to the full Summary of Product Characteristics (SmPC) for prescribing information and the full safety information: View Source