On December 12, 2022 Regeneron Pharmaceuticals reorted positive initial data from a pivotal Phase 2 expansion cohort evaluating investigational linvoseltamab (formerly REGN5458) at the 200 mg dose recommended for further development in patients with heavily pre-treated, relapsed/refractory (R/R) multiple myeloma (Press release, Regeneron, DEC 12, 2022, View Source [SID1234625126]). The results were part of a broader presentation of new and updated data from a Phase 1/2 trial and were shared at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in New Orleans, LA. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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"The need for innovative medicines is critical for patients with multiple myeloma who inevitably face a downward spiral of relapses, reduced responses to subsequent therapies, and increasingly shorter remissions," said Naresh Bumma, M.D., Hematologist and Assistant Professor in the Division of Hematology at Ohio State University, and a trial investigator. "At the recommended 200 mg dose in a pivotal Phase 2 trial, linvoseltamab demonstrated early, deep and durable responses in patients living with multiple myeloma who had been on at least three prior therapies, including those with higher risk and high disease burden. These clinically meaningful outcomes at 12 weeks reinforce the positive linvoseltamab results seen in the Phase 1 dose escalation portion, and we look forward to seeing data from more patients and longer follow-up."

As presented at ASH (Free ASH Whitepaper), out of 252 patients treated in the Phase 1/2 trial, 81% of patients were triple-refractory to existing therapeutic options, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. Additionally, 37% had bone marrow plasma cells ≥50%, and the median soluble BCMA was 0.43 mg/L, representing a patient population with a higher disease burden than those enrolled in similar trials. Of the 87 patients in the 200 mg cohort, 58 were evaluated for efficacy. With a median follow-up of 3 months (range: 0 to 30 months), efficacy results were as follows:

64% objective response rate (ORR), with 45% achieving a very good partial response or better, as determined by an independent review committee. Based on earlier results, responses may increase with longer follow-up.
Median time to response was <1 month (range: <1 to 5 months).
79% probability of maintaining a response at 6 months (95% confidence interval: 50% to 92%), per Kaplan-Meier estimates.
Among the 87 patients treated in the 200 mg cohort assessed for safety, adverse events (AEs) occurred in 95% of patients, with 66% being ≥Grade 3. The most common AEs occurring in ≥20% of patients were cytokine release syndrome (CRS; 37%), fatigue (32%), anemia (28%), diarrhea, cough, headache (23% each) and neutropenia (20%). Discontinuations due to an AE occurred in 6% of patients. When CRS occurred, in 32 out of 87 patients, 23 of those patients experienced Grade 1, 8 experienced Grade 2, there was 1 transient Grade 3 case, and none were ≥Grade 4.

Among the overall patient population across different dose levels (n=252), the median time to first CRS onset was 11 hours (range: 0-47 hours) and all cases resolved, with a median time to resolution of 15 hours (range: 0-377 hours). Deaths due to AEs in the overall population were reported in 14 patients, including sepsis/bacterial infection (n=6), COVID-19 (n=4) or other causes (n=4). None of the deaths were considered related to treatment per the treating physician.

Linvoseltamab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

On December 12, 2022 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported the receipt of the €25 million payment under the first tranche of the unsecured loan agreement executed with the European Investment Bank ("EIB") on May 16, 2022 with a maturity date of December 2026 (the "Finance Contract") (Press release, Inventiva Pharma, DEC 12, 2022, View Source [SID1234625125]).

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Jean Volatier, Chief Financial Officer of Inventiva, stated: "We are pleased to see that our long-term partnership with the EIB is bearing fruit. This payment of the first tranche of €25 million, triggered by the progress made on our NATiV3 Phase III trial and the completion of the cash injections condition precedent for this tranche, will further support the development of lanifibranor. We remain strongly focused on the recruitment of patients in our Phase III trial and are hoping to satisfy all conditions for the disbursement of the second tranche of €25 million from the EIB."

As previously announced, the Finance Contract provides funding in two tranches of €25 million each, which are both subject to the completion of certain conditions precedent. Any drawings under the terms of the Finance Contract that have not been disbursed within 36 months from the signing of the Finance Contract, (i.e., before May 16, 2025), cannot be completed at a later date. There is no assurance that the Company will be able to satisfy the conditions precedent for the drawing of the second tranche2.

The disbursement of the first tranche (with 8% interest capitalized annually, a maturity of 4 years and a repayment in fine) was subject to, among other conditions, (i) the Company issuing warrants to EIB in accordance with the terms and conditions of the warrants agreements entered into July 1, 2022, and (ii) the Company’s receipt from the date of the Finance Contract of an aggregate amount of €18 million, paid either in exchange for new shares of the Company or through the receipt of upfront or milestone payments.

On June 15, 2022, the Company raised €9.3 million through a capital increase under its ATM program. On November 4, 2022, the Company received an upfront payment of $12 million under its collaboration agreement with Sino Biopharm.

On November 28, 2022, the Company issued 2,266,023 warrants to EIB, in accordance of the terms of the 25th resolution of the combined general meeting of shareholders of May 19, 2022 and Article L.225-138 of the French Commercial Code, as a condition to the financing of the first tranche, representing approximately 5.4% of the Company’s share capital outstanding as of the date hereof.

The exercise price of the warrants is equal to €4.0152 and corresponds to 95% of the volume-weighted average price of the Company’s shares on the regulated market of Euronext Paris during the last trading session preceding the decision to issue the warrants.

As previously announced, the warrants have a maturity of twelve years and shall be exercisable following the earliest to occur of (i) the maturity date of the first tranche (i.e. on December 8, 2026), (ii) a change of control event, (iii) an event of default under the Finance Contract, or (iv) a repayment demand by EIB under the Finance Contract. The warrants will automatically be deemed null and void if not exercised within the twelve-year period.

EIB has a put option which may require the Company to repurchase all or part of the unexercised warrants then exercisable at their intrinsic value (subject to a cap equal to the amount drawn under the Finance Contract) under certain circumstances (for example, in the event of a change of control or on the maturity date of the first tranche or in the event of default). The Company (or a substitute third party) has a call option to require EIB to sell all shares and other securities of the Company, including the warrants, to the Company, subject to certain terms and conditions. In addition, the Company has a right of first refusal to buy-back all warrants offered for sale to a third party, subject to certain terms and conditions.

On the basis of the 2,266,023 new shares of the Company issuable upon exercise of all the warrants at a price of €4.0152 per new share, the Company could potentially receive gross proceeds of up to €9,098,535. There is no assurance that EIB will exercise any or all of the warrants or that the Company will receive any proceeds from the exercise of the warrants.

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