On September 23, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing and commercializing next-generation vaccines for serious infectious diseases, reported that it will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Novavax, SEP 23, 2021, View Source [SID1234590233]). Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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Fireside chat details:

Date:

Wednesday, September 29, 2021

Time:

8:40 – 9:10 a.m. Eastern Daylight Time (EDT)

Moderator:

Charles C. Duncan, Ph.D.

Novavax participants:

Gregory M. Glenn, M.D., President, Research and Development and John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

A replay of the recorded fireside session will be available through the events page of the Company’s website at ir.novavax.com for 90 days.

On September 23, 2021 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, reported the publication of two case studies of adult patients with desmoid tumors treated with AL101 in Current Oncology (Press release, Ayala Pharmaceuticals, SEP 23, 2021, View Source [SID1234594000]). This publication highlights the potential of a gamma secretase inhibitor for the treatment of desmoid tumors.

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The data included in the case study are based on earlier Phase 1 results and compassionate use of AL101 in desmoid tumors. Both patients showcased in these case studies, Case One and Case Two, presented with significant tumor burden and symptomatic and life-threatening disease due to disease bulk and location. Both patients achieved long-lasting partial responses (PR) with AL101 treatment with a maximal decrease in tumor size from baseline of 41% after approximately 1 year (55 weeks) of treatment in Case One, and a maximal decrease in tumor size from baseline of 60% after about 1.6 years (82 weeks) of treatment in Case Two. With continued monitoring, one patient was able to discontinue AL101 after 4.6 years of treatment, while maintaining a PR, and the other patient has maintained a PR at a reduced AL101 dose.

"Both of these patients’ case studies represent additional evidence to support the development of our gamma secretase inhibitor, AL102 for the treatment of desmoid tumors. The body of data conducted by BMS in patients with desmoid tumors implicating the role of gamma secretase inhibition furthers our hypothesis for treating desmoid tumors through AL102’s mechanism of action," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Desmoid tumors continue to be an area of high unmet medical with a significant impact to patients’ quality of life, and we are pleased to have initiated our pivotal Phase 2/3 RINGISDE trial of AL102 to potentially address this gap in the existing treatment paradigm."

The pivotal Phase 2/3 RINGSIDE trial is designed to evaluate the efficacy, safety and tolerability of AL102 in adult and adolescent patients with desmoid tumors. Part 1 of the study is open label and will enroll up to 36 patients with progressive desmoid tumors in three study arms across three doses of AL102: 1.2 mg daily (QD), 2 mg twice weekly (QIW) and 4mg twice weekly (QIW) with initial follow up of safety, tolerability and tumor volume by MRI after 16 weeks in order to determine the optimal dose. At the end of part 1, all patients will be eligible to enroll into an open label extension study at the selected dose where long-term efficacy and safety will be monitored.

Part 2 of the study will start immediately after dose selection from part 1 and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo. The study’s primary endpoint will be progression free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR) and patient reported Quality of Life (QOL) measures.

About Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

On September 23, 2021 Lion TCR Pte Ltd, a clinical-stage biotech company specialized in T Cell Receptor (TCR) T cell therapy reported that it has received clearance from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR (Press release, Lion TCR, SEP 23, 2021, View Source [SID1234590234]).

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Lion TCR intends to initiate a Phase 1b/2 multi-center study for its lead investigational product, LioCyx-M004, for patients with advanced Hepatitis B Virus (HBV)-related hepatocellular carcinoma (HCC). This will be the first Phase 1b/2 study that uses specific T cell receptor (TCR)-T cell therapy to target HBV-related HCC.

In 2020, there are more than 900,000 new cases with liver cancer worldwide, of which 90% been hepatocellular carcinoma (HCC). In Asia, HBV is an important inducer of HCC, for example, 80% – 90% of HCC is related to HBV infection in China. The use of LioCyx-M004 has been tested in Phase 1 study in primary HBV-related HCC. LioCyx-M004 infusions were well-tolerated with no occurrence of cytokine release syndrome (CRS) nor neurotoxicity. Disease control rate was 60% and partial response (PR) as per RECIST 1.1 was observed with a duration of response of 27.7 months. Median overall survival (OS) was 33.1 months.

The upcoming study aims to evaluate LioCyx-M004 as a monotherapy treatment and the safety and efficacy of LioCyx-M004 in combination with lenvatinib. Considering lenvatinib as a well-established first-line treatment for advanced HCC and its potential to revert the immunosuppressive tumor microenvironment towards an immune-supportive profile, the combination of lenvatinib and LioCyx-M004 treatment is expected to further improve clinical outcome.

"LioCyx-M004, with its unique mechanism of action and its excellent safety profile and radiological tumor response, has the potential to become a first-in-class TCR T cell therapy for HCC. We also have a strong scientific rationale for the use of our TCR-T therapy in combination with other therapies to extend its effectiveness. We are proud of our significant progress in recent years and look forward to initiating the Phase 1b/2 study in the upcoming weeks for the benefits of HCC patient refractory or relapsed to current systemic treatment. Patient recruitment for this study will begin at City of Hope Comprehensive Cancer Center in United States, a leading research and treatment center for cancer," said Dr Tina Tingting Wang, COO and CMO of Lion TCR.

"This Phase 1b/2 IND clearance is a very important milestone for Lion TCR! We will continue our dedication to be the world leading biotech company using cutting-edge TCR-T immunotherapy to provide innovative therapeutic options for patients in need. Lion TCR has developed various TCR-T technology platform including TCR discovery platform, autologous and allogeneic TCR platform incorporating with gene editing technologies. With the potential of our revolutionary TCR-T cell immunotherapy, we aim to be the pioneer company for benchmarking in the field of liver cancer treatment," said Dr Peng Xiaoming, Managing Director & CEO of Lion TCR.

On September 23, 2021 Global Coalition for Adaptive Research (GCAR) reported a new clinical trial initiative, Ovarian CanceRx (Press release, Global Coalition for Adaptive Research, SEP 23, 2021, View Source [SID1234590253]). This innovative trial, referred to as an adaptive platform trial, is designed to test multiple drugs simultaneously against the standard of care treatments to rapidly test and deliver new therapies to patients with advanced ovarian cancer or recurrent platinum-resistant disease.

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The Ovarian CanceRx platform trial is designed to be more efficient and reduce the development time of testing new investigational drugs, while providing a more patient-centric approach that increases access to new potentially life-changing therapeutic options for women with ovarian cancer.

"As a clinician and researcher driven to bring better treatment options to my patients, efforts like Ovarian CanceRx are essential to rapidly advance new treatments that can improve patient survival," said Beth Karlan, Chair of the Ovarian CanceRx Steering Committee. "Working in collaboration with key members of the research, clinical and patient advocacy communities, Ovarian CanceRx capitalizes on novel drug development to give ovarian cancer patients access to potentially beneficial treatments at a time when they need them most – now!"

Ovarian cancer is less common than breast cancer, although it is more deadly. There are nearly 300,000 new cases diagnosed each year worldwide making ovarian cancer the fifth leading cause of cancer-related deaths in women. While there are numerous randomized control trials in ovarian cancer, there are still significant unmet clinical needs in this field. Patients with ovarian cancer have not benefited from new therapeutics the same way other cancer patients have for a number of reasons including a lack of innovative clinical research approaches that can rapidly adapt and evaluate new therapies as they become available. Additionally, there are challenges to recruiting enough patients to participate in trials given that ovarian cancer is a relatively uncommon disease. While the traditional randomized control trial remains the gold standard, it can often be inefficient and very expensive and may not be equipped to accommodate the complexities of the diverse ovarian cancer subtypes.

To address these hurdles, Professor Andrew W. Lo from the Laboratory for Financial Engineering at Massachusetts Institute of Technology (MIT) organized a series of meetings to bring together a committed group of scientists, clinicians, patient advocates, investors, philanthropists, and industry representatives to discuss opportunities in therapeutics and diagnostics and improved financial models for ovarian cancer focusing on innovations in clinical research. With a generous $1 million donation, GCAR, a non-profit organization with extensive experience in developing and executing master protocol and platform trials, has taken the reins to develop Ovarian CanceRx as an efficient, cost-effective and advanced model for drug development and improved patient outcomes.

"Given the challenges of the traditional trials, platform trials, provide a unique opportunity to accelerate advancements in ovarian cancer research," shared Meredith Buxton, CEO, GCAR. "Ovarian CanceRx will help to identify science-driven treatment options for women with advanced ovarian cancer or recurrent platinum-resistant disease. GCAR is excited to provide seed funding, support the work of foremost experts in ovarian cancer clinical care and research, and sponsor this important effort. Ovarian CanceRx represents innovation, efficiency and a patient-centric approach to clinical research."

A key stakeholder in the effort is Ovarian Cancer Research Alliance (OCRA), the world’s largest ovarian cancer charity. OCRA provides funding for research, advocates on Capitol Hill, and supports patients and their families. OCRA has served as an essential partner, providing the voice of the patient, since Ovarian CanceRx efforts initiated.

"We are delighted to partner with GCAR, the gynecologic oncology clinical and research community, and patients on this important effort to identify better treatment options for those with ovarian cancer," stated Audra Moran, President and CEO, Ovarian Cancer Research Alliance. "Collaborating on Ovarian CanceRx fits squarely into one of the cornerstones of our mission to support the most promising scientific research, seek out better treatments, and hasten desperately needed breakthroughs."

The Clearity Foundation, a non-profit science-based advocacy organization for women and families impacted by ovarian cancer, recently joined Ovarian CanceRx to provide clinical trial resources and patient education as well as treatment decision and psychosocial support.

"We believe that all women deserve the best possible therapies for their unique disease as well as personalized emotional support for their particular life challenges," said Hillary Theakston, Executive Director Clearity. "Through GCAR’s Ovarian CanceRx partnership we are gratified to support an innovative clinical trial design that will improve treatment for women with ovarian cancer."

On September 23, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30th at 9:20 a.m. ET (Press release, ADC Therapeutics, SEP 23, 2021, View Source [SID1234590195]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.