On December 6, 2021 ITI reported that it will be attending the 2nd International Symposium on Merkel Cell Carcinoma (Press release, Immunomic Therapeutics, DEC 6, 2021, View Source [SID1234596484]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The focus of this symposium is to explore emerging data that may allow improvements in clinical guidelines, develop innovative approaches, and to understand the basic biology that drives this disease. We will include updates from the most recent clinical guidelines as well as emerging data highlighting MCC biology. This meeting will be partly in lecture format with talks from leaders in the field as well junior faculty and trainees. We will also include focused panel discussions and poster presentations to optimize real time feedback and collaboration. The educational purpose of this symposium is to disseminate emerging data and to advance MCC research by stimulating collaborative meeting.

On December 6, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that manufacturing and clinical updates on Phase III clinical trial FLAMINGO-01 (Press release, Greenwich LifeSciences, DEC 6, 2021, View Source [SID1234596500]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Over the past six months, the Company has been actively selecting and contracting partners to manufacture clinical and commercial lots of GP2 and to manage the Phase III clinical trial. An update on these activities follows:

Today, the Company ran its first commercial fill line of GP2 at its fill and finish partner’s production facility with sufficient scale to produce up to 80,000 doses of GP2 per lot. Three commercial lots of GP2 will be required to file a Biologics License Application (BLA) for GP2. The three lots combined should treat approximately 22,000 patients, and in the initial GP2 indication, approximately 17,000 new patients could be treated per year, saving up to 1,500 to 2,000 lives per year.
Clinical research organization (CRO) has been engaged to manage the Phase III clinical trial.
GP2 active ingredient manufacturer has been engaged to produce commercial scale GP2 lots.
Commercial testing laboratory has been engaged to release clinical and commercial GP2 lots and to manage GP2 stability program.
In addition to their operational role, these partners will play a key role in preparing the manufacturing and clinical information necessary to submit a BLA upon a successful interim analysis of the Phase III clinical trial.
Partners for HLA typing, blood test collection, GP2 storage and distribution, GM-CSF distribution, immune response testing, and blood sample storage have been selected to support the Phase III clinical trial.
CEO Snehal Patel commented, "Commencing commercial scale manufacturing is a major milestone for the Company. We are carefully selecting partners who are leaders in the industry with whom we hope to work with over the long term. At the same time, the Company is developing a back-up strategy by location and function to reduce risk and provide multiple options going forward. In addition, all of the various parties required to operate the Phase III clinical trial testing, storage, and distribution activities have been integrated well through our management team and CRO. The expertise of our partners has served to enhance the quality and accelerate the progress of our manufacturing and clinical plans."

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 6, 2021 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 17,486,364 shares of its common stock, which reflects the exercise in full by the underwriters of their option to purchase up to 5,850,000 additional shares of common stock, and pre-funded warrants to purchase 27,363,636 shares of its common stock (Press release, ImmunoGen, DEC 6, 2021, View Source [SID1234596517]). The shares of common stock were sold at a price of $6.60 per share and the pre-funded warrants were sold at a price of $6.59 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant, in each case before underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering were sold by ImmunoGen.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) were $295.7 million.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities acted as joint book-running managers for the offering. Canaccord Genuity acted as lead manager for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On December 6, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, reported the expansion of their agreement in order to support the development of a self-amplifying mRNA (SAM) vaccine designed to tackle the Omicron COVID-19 variant (Press release, Gritstone Oncology, DEC 6, 2021, View Source [SID1234596537]). CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine candidate in South Africa, where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is due to begin shortly. The SARS-CoV-2 T cell epitopes (TCEs) administered within Gritstone’s SAM COVID-19 vaccines are minimally impacted by mutations found within the Omicron variant, reinforcing the platform’s potential to address both Omicron and future variants of concern.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

CEPI is already funding up to $20.6 million to support preclinical studies, manufacturing process optimization, and a Phase 1 trial of Gritstone’s Beta variant vaccine candidate (containing beta-Spike plus additional TCEs), which will be initiated by South Africa’s University of the Witwatersrand in the coming weeks. The funding announced today will expand the Phase 1 trial to include additional arms to evaluate an Omicron-specific version of the vaccine (which contains omicron-Spike plus TCEs). Gritstone has commenced manufacturing its SAM vaccine to specifically target the Omicron variant, and the Omicron arms of the Phase 1 trial are expected to begin in Q2 2022, subject to regulatory approval.

The recently described Omicron variant, first identified in South Africa on November 9, 2021, was designated a variant of concern by the World Health Organization (WHO) on November 26, 2021. Early evidence suggests that Omicron carries an increased risk of re-infection, and sequence analysis has revealed many mutations in Spike, which may reduce clinical effectiveness of existing vaccines and/or therapeutic antibodies.

Enabling equitable access
CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone have agreed that this Omicron vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if it is proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.

Dr Richard Hatchett, CEO of CEPI, said: "While key questions are yet to be answered about Omicron, its transmissibility, and its potential ability to evade our current vaccines, the stakes are too high to delay developing Omicron-specific vaccine candidates. Given the uncertainties, we must accelerate crucial R&D so vaccines are available to tackle Omicron as soon as possible – just in case we need them. There is no time to lose, so I’m pleased that within 10 days of Omicron being declared a Variant of Concern by the WHO, CEPI is expanding its partnership with Gritstone to support a new Omicron vaccine candidate which can be made globally accessibly through COVAX."

"Our vaccine platforms are built on the premise that a best-in-class vaccine against a virus will drive strong neutralizing antibodies directed to surface antigens such as Spike, and strong cytotoxic T cell responses against other conserved viral antigens to eliminate virally infected cells. This broad immune response would, in principle, provide superior protection against a virus that is mutating its surface protein. Omicron is an example of a novel SARS-CoV-2 variant that may escape clinical protection conferred by vaccines that only afford narrow, Spike-specific immunity," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "Our SAM technology provides an innovative platform likely capable of delivering on the attractive concept of broad, durable immunity. We are thrilled to be quickly expanding our relationship with CEPI in our shared goal of finding new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks."

Self-amplifying mRNA vaccines
As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body.

However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself—the self-amplification machinery.

The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine. Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein and could potentially provide broad protection against other SARS-CoV-2 strains.

On December 6, 2021 ITI reported that it will be virutally attending The 40th Annual Health Care Conference that will take place on January 10-13, 2022 at the Westin St. Francis in San Francisco, CA (Press release, Immunomic Therapeutics, DEC 6, 2021, View Source [SID1234596485]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.