On September 28, 2020 Physicians’ Education Resource LLC (PER), a leading resource for continuing medical education, proudly reported it will present the International Society of Gastrointestinal Oncology (ISGIO) 17th Annual 2020 Gastrointestinal Oncology Conference, as a two-day continuing medical education (CME)-certified virtual, interactive meeting Oct. 2-3 (Press release, Physicians’ Education Resource, SEP 28, 2020, View Source [SID1234567694]).

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This year’s conference will be chaired by renowned expert Tanios S. Bekaii-Saab, M.D., professor, Mayo Clinic College of Medicine and Science, program leader, gastrointestinal cancer, Mayo Clinic Cancer Center and medical director, cancer clinical research office, Mayo Clinic.

"The ISGIO meeting has a long, rich history of providing quality CME-certified gastrointestinal (GI) cancer education to clinicians featuring some of the best minds in the field," said Phil Talamo, president of PER. "We look forward to utilizing our virtual interactive platforms, as well as expert speakers and resources, to deliver a highly engaging state-of-the-art two-day conference covering the hottest topics in GI cancer for 2020."

The 2020 Gastrointestinal Oncology Conference will provide the latest advances in the broad field of GI cancer research, as well as critical issues relevant to the care of persons with GI cancer. World-renowned thought leaders from different disciplines will educate clinicians using a combination of case-based learning, debates, panel discussions and didactic segments. Throughout the sessions, attendees will have the opportunity to interact with the faculty and ask questions via PER’s custom interactive platform.

Accredited by the Accreditation Council for Continuing Medical Education, this live activity will provide participants with the opportunity to earn 12.0AMA PRA Category 1 Credits.

On September 28, 2020 CureVac reported that Its focus is squarely on getting an mRNA vaccine against COVID-19 onto the market, but has bigger ambitions from its deep pipeline (Press release, CureVac, SEP 28, 2020, View Source [SID1234567807])

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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CEO: Franz-Werner Haas
Based: Tübingen, Germany
Founded: 2000
Clinical focus: Prophylactic vaccines, cancer immunotherapies and protein therapies

The scoop: CureVac, alongside BioNTech and Moderna, is one of the biotechs that put mRNA on the map. It suffered the field’s first big clinical setback when prostate cancer vaccine CV9104 flunked a phase 2b in 2017, only to bounce back through the progression of other programs and a significant infectious disease pact with Eli Lilly.

Then COVID-19 happened. As the coronavirus spread, CureVac received €300 million ($356 million) from the German government, struck a broad, big-ticket deal with GlaxoSmithKline, completed a Nasdaq IPO and briefly became a mainstream news story when President Donald Trump reportedly tried to buy it.

What makes CureVac Fierce: The biotech that emerged from the early months of the pandemic has a new CEO, Franz-Werner Haas, a new near-term focus, COVID-19, and, by extension, a radically revised outlook and strategy for the next year or two.

"[COVID-19] is really transforming the company," Haas said.

CureVac went into 2020 thinking it was still years away from bringing a product to market, meaning its focus was on running clinical trials and manufacturing materials for use in them. Now, CureVac is planning to bring a COVID-19 vaccine to market next year and lining up a contract to sell up to 405 million doses to the European Union.

The rapid acceleration of CureVac’s time to market has changed the focus of the leadership team. Today, Haas is occupied with questions about how to establish the expertise and scale CureVac will need to succeed as a commercial company. In January, those questions were distant concerns.

CureVac has a little more time to address the questions than some other developers of COVID-19 vaccine. While its peers were racing into the clinic, CureVac spent more time in preclinical doing the optimization work that it thinks will enable its vaccine to trigger balanced immune responses and be readily manufactured at scale. CureVac took a different approach to other mRNA vaccine developers.

"These other candidates, they’re building upon chemical modification of the RNA, which we don’t do. We are optimizing the RNA on the RNA level, so using the potency of the untranslated regions. That’s a differentiating factor," Haas said. One consequence of CureVac’s approach is the maximum dose in its first clinical trial is 8 µg. Moderna is testing a 100-µg dose in its phase 3.

The relatively small amount of mRNA used in its vaccine should enable CureVac to get more doses out of the manufacturing capacity it is adding. Infrastructure set up to support the COVID-19 vaccine could prove valuable as other assets get to market. CureVac’s rabies vaccine could come to market within the next five years. Perhaps more significantly, CureVac is retaining the commercialization rights in three European countries to the five candidates covered by its deal with GSK.

"These are big products, which need huge capacity in terms of manufacturing. And so there will be a kind of decision point: Where are these five projects? How can we bring these into the market? This is a transforming platform deal for us," Haas said.

Haas sees vaccines as the "sweet spot" for CureVac’s technology today as they are given at low doses in two-shot prime-boost regimens, rather than the repeated administration needed to treat disease. That is reflected in CureVac’s pipeline, which is led by vaccines against COVID-19 and rabies, but the biotech’s ambitions, like those of its mRNA rivals, extend well beyond prophylactics.

CureVac is testing its tumor microenvironment modulator CV8102 in cancer patients in combination with anti-PD-1 antibodies, and the Boehringer Ingelheim-partnered self-adjuvanting mRNA vaccine CV9202 is in early-phase development in non-small cell lung cancer. A third wing of the biotech is working on protein-based therapies, including in programs that pair its technology with the potentially complementary capabilities of CRISPR Therapeutics and Genmab.

Investors: Dievini Hopp BioTech holding, Kreditanstalt für Wiederaufbau and GlaxoSmithKline

On September 28, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present at Chardan’s Virtual 4th Annual Genetic Medicines Conference on Monday, October 5, 2020 at 9 a.m. ET (Press release, Intellia Therapeutics, SEP 28, 2020, View Source [SID1234567670]).

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A live webcast of Intellia’s presentation will be accessible through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com. To access the webcast, please log on approximately 15 minutes prior to the start time, to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Intellia’s website for approximately 14 days following the live event.

On September 28, 2020 -Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will participate in the Jefferies Virtual Cell Therapy Summit on Tuesday, October 6th (Press release, Legend Biotech, SEP 28, 2020, View Source [SID1234567695]). Ying Huang, interim-Chief Executive Officer and Chief Financial Officer, will represent the Company in a session scheduled at 11:20 a.m. (Eastern Time).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This webcast will be available to investors and other interested parties by accessing the Legend Biotech website at View Source

On September 28, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,772,907 (the ‘907 Patent) and allowed U.S. Patent Application No. 16/557,597 (the ‘597 Application), both entitled "Immune Modulation with TLR9 Agonists for Cancer Treatment" and each of which includes the Company’s investigational therapy tilsotolimod (Press release, Idera Pharmaceuticals, SEP 28, 2020, View Source [SID1234567671]).

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The new patent and allowed application each include 26 claims directed to methods of treating colorectal cancer (CRC) (the ‘907 Patent) and head and neck squamous cell carcinoma (HNSCC) (the ‘597 Application) with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies, including CTLA-4, PD-1 or PD-L1 proteins. This new coverage expands protection of the first tilsotolimod method-of-use patent, which was directed to methods of treating metastatic melanoma and was issued in November 2019. The patents and the allowed application provide exclusivity for certain uses of tilsotolimod through September 2037.

"The CRC patent and the soon-to-issue HNSCC patent fortify our ‘beyond melanoma’ strategy for tilsotolimod, which currently includes ongoing development in MSS-CRC via our ILLUMINATE-206 trial and in HNSCC via our collaboration with AbbVie," said Vincent Milano, Idera’s Chief Executive Officer. "These additional new intellectual property protections also demonstrate our commitment to tilsotolimod and to furthering its development potentially to address unmet need for patients living with cancer."

About MSS-CRC and ILLUMINATE-206

Colorectal cancer involves the abnormal growth of cells in the colon or rectum. This type of cancer is typically tested to determine its "MSI" status, which will inform treatment approach and prognosis. MSI stands for "microsatellite instable." MSI-High (MSI-H) means that there is a high amount of instability in a tumor, whereas MSS tumors are "microsatellite stable." According to the American Cancer Society and other references, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 deaths are attributed to CRC.

MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options. Given tilsotolimod’s mechanism of action of activating dendritic cells, it may serve a complementary function to Yervoy and Opdivo within the immunosuppressive tumor microenvironment of MSS-CRC patients.

ILLUMINATE-206 is a Phase 2, open-label, multi-center study to evaluate tilsotolimod in combination with Opdivo and Yervoy* in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC) patients. For more information on this trial, please visit ClinicalTrials.gov.

About HNSCC and the AbbVie Collaboration

Head and neck squamous cell carcinoma (HNSCC) develop in the flat, scale-like cells that form the lining of the mouth, nose, and throat. If HNSCC metastasizes to other parts of the body, such as the lymph nodes or lungs, the cancer has a worse prognosis and can be fatal. HNSCC is the seventh most common cancer worldwide. Each year, approximately 50,000 new cases are diagnosed and approximately 11,000 deaths are attributed to HNSCC in the United States.

In patients with relapsed or metastatic HNSCC, an overall survival benefit has been demonstrated for anti-PD-1 immune therapies versus standard of care chemotherapy. The challenge remains to increase the percentage of patients responding to these treatments, which currently ranges from 13% to 23%, depending on the line of therapy. Given tilsotolimod’s mechanism of action of activating dendritic cells, it may serve a complementary function to immune therapies within the tumor microenvironment of HNSCC patients.

For more information regarding Idera’s collaboration with AbbVie in HNSCC, see Idera’s September 2019 press release or visit ClinicalTrials.gov.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy. Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.