On April 24, 2024 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) ("Intra-Cellular Therapies"), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported that it has completed the sale of an additional 1,027,397 shares of its common stock at a public offering price of $73.00 per share on April 24, 2024, pursuant to the full exercise of the option granted by Intra-Cellular Therapies to the underwriters in connection with its previously announced public offering of 6,849,316 shares of common stock, which closed on April 22, 2024 (Press release, Intra-Cellular Therapies, APR 24, 2024, View Source [SID1234642286]).

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All of the shares in the public offering, including the full exercise of the underwriters’ option, were sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies of approximately $575 million, before deducting underwriting discounts and commissions and offering expenses.

J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley and RBC Capital Markets acted as joint book-running managers for the offering. Cantor, Mizuho, Canaccord Genuity and Needham & Company acted as co-managers for the offering.

The public offering was made pursuant to a shelf registration statement on Form S-3 (including a base prospectus) that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website located at View Source, and may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, (800) 808-7525 ext. 6105, [email protected]; BofA Securities, Inc., NC1-022-02-25, 201 North Tryon Street, Charlotte, NC, 28255-0001, Attn: Prospectus Department, Email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by email: [email protected]; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by emailing [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On April 24, 2024 IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting, taking place May 7 – 11, 2024, in Baltimore, MD and virtually (Press release, In8bio, APR 24, 2024, View Source [SID1234642285]).

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Details of the oral presentation are as follows:

Title: Healthy Donor vs Patient Manufactured Autologous Deltex DRI Product; Immunophenotyping Gene Expression

Session Type: In-Person Oral Presentation

Session Title: Novel Production Platforms

Abstract Number: 282

Location: Ballroom 2

Presentation Date/Time: Friday, May 10th at 3:45 pm – 4:00 pm ET

Abstracts are available at View Source The data are embargoed until 6:00 a.m. ET on the presentation day, Wednesday May 10, 2024. A copy of the presentation will be available at View Source once the presentation concludes.

On April 24, 2024 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO and Dr Tim Franklin, COO, will be attending BIO-Equity (Press release, ImmuPharma, APR 24, 2024, View Source [SID1234642284]). The event will be held from 12-14 May 2024, in San Sebastian, Spain.

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BIO-Equity is an annual premier partnering event, designed to provide biotechnology companies with the opportunity to present to and connect with investors together with the global biopharma community. This event provides an important continuum for ImmuPharma to facilitate ongoing discussions regarding potential global partnering deals across its pipeline portfolio.

Commenting on the event, Tim McCarthy, CEO of ImmuPharma said: "Further to our clinical progress with P140 in SLE and CIDP, attending BIO-Equity 2024 offers the opportunity to continue discussions on our unique portfolio with specific bioPharma companies and investment specialists, particularly in relation to SLE, CIDP and potentially other autoimmune diseases within our P140 technology platform. Our focus remains on track to establish global partnering opportunities across all our programs."

On April 24, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that it will present Phase 1 expansion data for brenetafusp (IMC-F106C), the first off-the-shelf ImmTAC therapy targeting PRAME, in patients with late-line cutaneous melanoma, all previously treated with anti-PD1 and the vast majority having received ipilimumab, at the 2024 American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting commencing on 31 May (Press release, Immunocore, APR 24, 2024, View Source [SID1234642283]).

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The Company will also present four posters, including one trial-in-progress poster of the Phase 3 PRISM-MEL301 trial with brenetafusp in combination with nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with first-line advanced melanoma, and three posters sharing clinical and translational data about KIMMTRAK in metastatic uveal melanoma.

Presentation and poster details

Title: Phase 1 safety and efficacy of IMC-F106C, a PRAME×CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma
Presenting author: Omid Hamid
Session: Oral Abstract Session – Melanoma/Skin Cancers, Friday 31 May 2024; 2:45-5:45 p.m. CT / 1:45-4:45 p.m. ET

Title: A Phase 3 trial of IMC-F106C (PRAME × CD3) plus nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with previously untreated advanced melanoma (PRISM-MEL-301)
Presenting author: Georgina Long
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Stable disease with confirmed tumor reduction has a similar clinical outcome as RECIST partial response for tebentafusp in metastatic uveal melanoma
Presenting author: Alexandra Ikeguchi
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Association between clinical and disease characteristics and detectable or undetectable baseline ctDNA in patients with metastatic uveal melanoma
Presenting author: Paul Nathan
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Baseline and serial ctDNA dynamics predicts outcomes in patients treated with first-line tebentafusp including those who were and were not treated beyond progression
Presenting author: Ryan Sullivan
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Conference Call
Immunocore will host an investor and analyst event and webcasted conference call on Friday 31 May 2024 at 6:15 p.m. CT with Dr. Diwakar Davar. The webcast will be available under ‘News & Events’ in the Investor Relations section of Immunocore Holdings’ website at www.immunocore.com.

On April 24, 2024 ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, reported positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy to be discussed during the upcoming conference call (Press release, ImmunityBio, APR 24, 2024, View Source [SID1234642282]). The results continue to reinforce ImmunityBio’s belief in the unique mechanism of action of ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

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In NSCLC patients who relapsed or were refractory to checkpoint inhibitors, ANKTIVA was administered together with the same checkpoint inhibitor. The addition of ANKTIVA resulted in the rescue of the checkpoint therapy efficacy, with significant prolongation of overall survival. These positive results were noted regardless of the patient’s PD-L1 status, consistent with the mechanism of action of ANKTIVA in activating and proliferating natural killer cells, and stimulating CD8+ Killer Memory T cells. This prolongation of survival in NSCLC following checkpoint failure is consistent with ImmunityBio’s findings of durable complete responses following BCG failure in NMIBC.

A meeting with the FDA has been scheduled for June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available.

The positive overall survival data of patients enrolled in QUILT 3.055, a basket trial across multiple tumor types, in which checkpoint inhibitors failed will be discussed, along with the status of launch readiness for ANKTIVA for its recently approved indication in NMIBC on an investor conference call Friday, April 26 at 8 am PDT/11 am EDT.

"The results we noted with the completion of the QUILT 3.055 basket trial across multiple tumor types in patients with late-stage cancers for whom standard of care plus checkpoints failed, validates our hypothesis that orchestration of NK cells with killer T cells and memory T cells could result in meaningful clinical improvements to current standards of care. We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or of tumor location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance, "said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "QUILT 3.055 was the initial and seminal study of our Cancer Moonshot program launched in January 2016 (see related video here). The findings of a significant extension of overall survival in 2nd- and 3rd-line lung cancer affirms that combination therapy, with the orchestration of the innate and adaptive immune system, could potentially lead to the evolution of immunotherapy beyond T cells for all cancer patients. We are excited that these results continue to demonstrate the broad potential for ANKTIVA across multiple tumor types and its role as the next-generation immunotherapy. We are committed to pursuing additional indications for ANKTIVA in our pipeline with a mission to deliver new hope to patients with serious, advanced cancers where standard therapies have failed."

The QUILT trials initiated since the launch of the Cancer Moonshot program across multiple tumor types can be found on ImmunityBio.com and is summarized in the figure accompanying this announcement. As can be seen ANKTIVA (N-803) serves as the backbone to the immunotherapy vaccine across multiple tumor types at late-stage with exploratory evidence of complete remissions. Updates to this figure denoting the QUILT trials at the time of publication in 2021 will be forthcoming.

According to the American Cancer Society, lung cancer is the second most common cancer in the U.S. In 2023, it is estimated that 238,340 new cases of lung cancer will be diagnosed in the U.S. and 127,070 deaths will be attributed to the disease. NSCLC accounts for about 80% to 85% of all lung cancers diagnoses and there are very few successful treatment options for these patients once the cancer spreads beyond the lungs.

The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient response may be short lived, due to late response and/or progression after achieving an initial response. Historical and real-world experience (RWE) data show that the median overall survival rates in these patients range from 7 to 9 months.

In addition, the company will provide information about the status of launch readiness of ANKTIVA for NMIBC. Presentations by the company on ANKTIVA data in NMIBC are scheduled at the upcoming American Urological Association (AUA) conference in San Antonio, Texas from May 3-6, 2024. It is anticipated the first vials of ANKTIVA will be available for shipment the week of May 6, 2024.

Further details regarding ANKTIVA as the backbone of ImmunityBio’s late-stage clinical pipeline across multiple solid and liquid tumor types will be discussed during the conference call, along with commercial launch readiness details, and the corporate financial position to support launch of ANKTIVA for the U.S. market.

Conference call details:

Investors may access the live audio webcast of the call via this weblink. A replay of the webcast will be available at View Source All participants may join the call by dialing (800) 579-2543 (U.S. and Canada Toll-Free) or (785) 424-1789 and using the access code ANKTIVA.