On December 12, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported updated results from the ongoing Phase 1 trial evaluating INB-100, an allogeneic, gamma-delta T cell therapy, in patients with hematologic malignancies undergoing haploidentical stem cell transplantation (HSCT) (Press release, In8bio, DEC 12, 2022, View Source [SID1234625124]). The data, featured in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting and Exposition, demonstrate the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia (AML) and other hematologic malignancies.

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"While haploidentical stem cell transplantation provides a pathway towards leukemic cures, 50% of transplant patients relapse after one year, with many succumbing to the disease," said Dr. Joseph McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director of Hematological Malignancies and Cellular Therapeutics and Medical Director, Blood and Marrow Transplant at The University of Kansas Cancer Center and the Principal Investigator on the study. "The long-term durable responses, in conjunction with a manageable safety profile, observed in Cohort 1 are very meaningful and highlight the potential of INB-100 to increase the cure rates in patients with AML."

The poster presented at ASH (Free ASH Whitepaper) included efficacy and safety data from Cohort 1 of the ongoing study as of the data cutoff of November 11, 2022. As of December 9, 2022, four patients have received the first dose level (DL) of INB-100 (1 x 106 cells/kg) and remain on study and in remission. Three DL1 patients with at least approximately 18 months and one patient with 3.5 months of follow-up

all remain in morphologic complete remission (CR); two patients have remained progression free for more than two years, at 31.9 months and 29.5 months respectively, and a third for nearly a year and a half at 17.8 months. A fourth DL1 patient remains relapse free in CR at 3.5 months and continues to be monitored. Immune system reconstitution through the first 100-days post-treatment demonstrates continued normal function, including observed elevations in T cells, B cells, and gamma-delta T cells.

"These results are encouraging, and reinforce our conviction that INB-100, a one-time allogeneic gamma-delta T cell therapy, has the potential to provide meaningful clinical benefit to patients with AML who face a significant risk of relapse," said Trishna Goswami, M.D., Chief Medical Officer of IN8bio. "We are excited about the early signals of durable relapse-free survival observed in Cohort 1 in this high-risk patient population and look forward to gaining further insights as we enroll additional patients in Cohort 2 and evaluate INB-100 at a higher dose."

No DLTs, treatment-related ≥ grade 3 adverse events (AEs) or cytokine release syndrome (CRS) have been observed. Steroid-responsive cutaneous acute Grade 1/2 graft-versus-host disease (GvHD) has been observed in all patients, with one patient experiencing Grade 2 intestinal GvHD. The most common AEs were constipation, cytomegalovirus (CMV) reactivation, emesis, fatigue, and hypomagnesaemia, the majority of which were Grade 1/2.

Two patients have been enrolled and dosed in Cohort 2, evaluating INB-100 at a dose level of 3 x 106 cells/kg. The Company expects to share additional clinical updates from the Phase 1 study of INB-100 in 2Q 2023.

Conference Call Details

IN8bio will host a conference call and webcast today, December 12, 2022, at 8:30 a.m. ET to review the data from the ASH (Free ASH Whitepaper) presentation, as well as recent clinical updates. The webcast can be accessed by clicking the link: View Source and can also be accessed on the Events & Presentations page of the Company’s website.

About the INB-100 Phase 1 Trial

The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

On December 12, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has executed financing to provide further working capital and support its ongoing business operations (Press release, ImmunityBio, DEC 12, 2022, View Source [SID1234625123]).

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The Company entered into a securities purchase agreement for a registered direct offering with a single institutional investor, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $50 million before deducting any offering-related expenses. If fully exercised the warrants could result in additional gross proceeds of up to $60 million.

Contemporaneously with the offering, the Company will issue additional debt in an aggregate principal amount of $50 million to Nant Capital, LLC, an entity affiliated with Dr. Patrick Soon-Shiong, ImmunityBio’s Executive Chairman and Global Chief Scientific and Medical Officer. Another entity affiliated with Dr. Soon-Shiong, NantWorks LLC, will also convert approximately $56.6 million of existing debt into the Company’s common stock at a conversion price of $5.67 per share, in accordance with the terms of that existing tranche of fixed-rate debt.

In the registered direct offering, ImmunityBio agreed to sell 9,090,909 shares of its common stock and to issue accompanying warrants to purchase 9,090,909 shares of common stock with an exercise price of $6.60 per share, for a purchase price of $5.50 per share and accompanying warrant. The warrants will become immediately exercisable at any time after they are issued and expire two years after the initial issuance date. The closing of the offering is expected to occur on or about December 14, 2022, subject to the satisfaction of customary closing conditions.

Piper Sandler & Co. is acting as the exclusive placement agent for the registered direct offering.

The securities to be sold by the Company in the registered direct offering are offered under its shelf registration statement on Form S-3, as amended (Registration No. 333-255699). The shares of common stock and warrants to purchase common stock will be issued as separate securities. A final prospectus supplement, which contains additional information relating to the offering, has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924, or by email at [email protected].

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety.

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

On December 12, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that it has completed release testing and shipped Good Manufacturing Practice ("GMP") process manufactured batches of IMX-110 for clinical trial patient dosing (Press release, Immix Biopharma, DEC 12, 2022, View Source [SID1234625121]). IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 clinical trials: IMX-110 monotherapy and combination IMX-110 + BeiGene/Novartis anti-PD-1 tislelizumab clinical trial in advanced solid tumors.

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"Completing release testing and shipping GMP IMX-110 manufactured with our new scaled-up, proprietary process for patient dosing is a pivotal milestone," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We are looking forward to releasing clinical data in our IMX-110 monotherapy and IMX-110 plus BeiGene/Novartis anti-PD-1 tislelizumab combination clinical trial."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease designation ("RPDD") for IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

On December 12, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with essential thrombocythemia (ET) who have failed at least one standard of care (Press release, Imago BioSciences, DEC 12, 2022, View Source [SID1234625118]).

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The data were presented in an oral presentation session during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) taking place 10-13 December 2022. A Phase 2 data set with a cut-off date of 29 April 2022 was previously presented at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and congress (EHA) (Free EHA Whitepaper) in June 2022.

Updated Highlights (available data as of 18 October 2022)

Of the 62 Patients treated with bomedemstat for more than 24 weeks:
100% (62/62) achieved platelet count reduction to ≤ 400 x 109/L.
95% (59/62) achieved platelet count reduction to ≤ 400 x 109/L in the absence of thromboembolic events.
89% (25/28) of the 28 patients treated with bomedemstat for at least 48 weeks achieved a durable response by week 48, defined as platelet count of ≤ 400 x 109/L for ≥ 12 weeks.
Of the 12 patients with baseline Total Symptom Scores (TSS) greater than 20:
75% (9/12) showed a decrease in TSS.
67% (8/12) showed improvements ≥ 10 points.
Platelet response rate was 100% across all genotypes identified in the study (JAK2V617F, CALR, MPL, triple negative and no mutations). Further, 67% (20/30) patients demonstrated a net decrease in mutation allele frequencies including both CALR and JAK2.
100% (5/5) patients with baseline loss of heterozygosity and follow-up samples demonstrated a reduction in homozygous mutant granulocytes and mutant allele frequencies.
"We are delighted to share the most recent data from our ongoing Phase 2 study of bomedemstat in patients with ET, which has notably achieved platelet count reductions to below 400 x 109/L in every patient treated for at least 24 weeks," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "We are intrigued by the observation in granulocytes that patients homozygous for a driver mutation at baseline showed at follow-up a significant reduction in the proportion of homozygous cells, some reduced to the limit of detection, regardless of the driver mutation. The impact of bomedemstat on mutant stem cell population is currently being assayed. Additionally, we recently conducted an End-of-Phase 2 meeting with the FDA where we aligned on a strategy for the bomedemstat Phase 3 registrational program in ET."

Safety and Tolerability

Bomedemstat was generally well-tolerated with no safety signals identified per the Safety Advisory Board.
The most common adverse events (AEs)(>20%) regardless of causality were dysgeusia, constipation, thrombocytopenia, arthralgia, fatigue, contusion and diarrhea.
There were 38 reported serious adverse events (SAEs), 7 of which were deemed drug-related by the investigator in 5% (4/73) of patients.
20 patients have discontinued treatment, with 10 due to AEs, 1 death from aspiration pneumonia unrelated to bomedemstat, 7 due to withdrawal of consent, 1 due to investigator decision, and 1 due to disease progression.
Details on the Imago ASH (Free ASH Whitepaper) Oral Presentation

Oral Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Essential Thrombocythemia (ET)"
Session Name: Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies and Surrogate Endpoints in ET and PV
Presentation Date/Time: Monday, December 12, 2022, at 11:45 AM ET
Location: Ernest N. Morial Convention Center, 217-219
Presenting Author: Harinder Gill, Queen Mary Hospital University of Hong Kong

On December 12, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with advanced myelofibrosis (MF) (Press release, Imago BioSciences, DEC 12, 2022, View Source [SID1234625117]).

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The data were presented in a poster presentation session during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) taking place 10-13 December 2022. A Phase 2 data set with a cut-off date of 29 April 2022 was previously presented at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and congress (EHA) (Free EHA Whitepaper) in June 2022.

Updated Highlights (available data as of 18 October 2022)

Of evaluable patients at 24 weeks:
65% (17/26) showed a decrease in Total Symptom Score (TSS).
19% (5/26) showed a ≥ 50% decrease in TSS.
66% (33/50) showed spleen volume reductions from baseline.
28% (14/50) showed a ≥ 20% spleen volume reduction.
The majority of patients had a decrease in mutant allele frequencies (MAF) including driver mutations (e.g., JAK2) and high molecular risk (HMR) mutations (e.g., ASXL1).
90% (37/41) of transfusion-independent patients had stable (19/41) or improved (18/41) hemoglobin at Week 12.
85% (50/59) of patients had an improved (19/59) or stable (31/59) bone marrow fibrosis score post-baseline.
No new mutations or transformations to acute myeloid leukemia (AML) while on treatment, even in patients with a high-risk of progression.
"Bomedemstat continues to demonstrate its potential as a monotherapy for patients suffering from advanced myelofibrosis, highlighted by the data presented at ASH (Free ASH Whitepaper) showing improvements in patient symptom scores, spleen volumes, fibrosis, and anemia," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "I am also delighted we continue to see the majority of patients experience a decrease in mutant allele frequencies and no progression to AML, even in patients with ASXL1 mutations known to confer a high-risk of transformation. We are further exploring the use of bomedemstat in myelofibrosis in an investigator-sponsored Phase 2 combination study with ruxolitinib; patients are currently being screened."

Safety and Tolerability

Bomedemstat was generally safe and well-tolerated in patients with myelofibrosis.
The most common non-hematologic adverse event (AE) related to bomedemstat was dysgeusia (altered taste), which occurred in 33% (30/90) of patients and led to discontinuation of the study in 1 patient.
There were 44 patients who reported a total of 86 serious adverse events (SAEs), 16% of which were deemed drug-related by the investigator.
Details on the Imago ASH (Free ASH Whitepaper) Poster Presentation

Poster Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Advanced Myelofibrosis (MF): Updated Results and Genomic Analyses"
Session Name: Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Presentation Date/Time: Monday, December 12, 2022, at 7:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D
Presenting Author: Kristen Pettit, University of Michigan