On December 11, 2023 Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, reported a private placement that the Company estimates will result in gross proceeds of approximately $25 million before deducting estimated offering expenses payable by the Company (Press release, Prelude Therapeutics, DEC 11, 2023, View Source [SID1234638435]). Proceeds from the private placement will be used to primarily fund the continued advancement of its SMARCA2 portfolio, for working capital and general corporate purposes.

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The proceeds from this private placement, combined with current cash and cash equivalents, are expected to be sufficient to fund the Company’s current operating plan into 2026.

Dr. Kris Vaddi, CEO of Prelude stated, "This additional funding allows us to further resource our SMARCA2 portfolio by rigorously advancing the clinical development of our IV molecule, PRT3789, and progressing the oral program into the clinic. We look forward to providing initial clinical results from PRT3789 and initiating clinical development of our oral program in the second half of 2024."

Terms of the private placement, with certain institutional accredited investors, include an agreement to purchase pre-funded warrants of 7,936,759 shares of Prelude’s common stock at a price of $3.1499 per warrant, each with an exercise price of $0.0001 per share. The volume-weighted average trading price of the Company’s common stock over the last five trading days is $3.04. Prelude will pay no placement fees in connection with the financing. The closing of the private placement is subject to customary closing conditions and is expected to occur on or about December 13, 2023.

The securities in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to certain registration rights related to the resale of the shares of common stock issuable upon the exercise of the pre-funded warrants purchased in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 11, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported initial data from the ongoing ORIC-533 Phase 1 dose escalation trial in patients with relapsed/refractory multiple myeloma at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (poster here) (Press release, ORIC Pharmaceuticals, DEC 11, 2023, View Source [SID1234638434]).

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"ORIC-533 demonstrated an exceptionally well-tolerated safety profile and preliminary evidence of clinical antimyeloma activity in heavily pretreated relapsed/refractory multiple myeloma patients, which to our knowledge is the first reported single agent activity for a CD73 inhibitor in any oncology indication," said Pratik Multani, MD, chief medical officer. "We believe the Phase 1 data presented today position ORIC-533 as an ideal candidate for combinations with other immune-based antimyeloma therapies, including bispecific anti-BCMA-CD3 antibodies, CAR-T therapies, and anti-CD38 antibodies."

"We’re excited that multiple ORIC programs have achieved preliminary proof of concept that justify advancement into later stage studies. Given our desire to advance both ORIC-114, our EGFR/HER2 exon 20 inhibitor for lung cancer, and ORIC-944, our PRC2 inhibitor for prostate cancer, into Phase 2 and beyond, those two programs will require a level of focus from our team that necessitates the prioritization of our clinical pipeline," said Jacob M. Chacko, MD, chief executive officer. "As such, we intend to complete the single agent dose escalation for ORIC-533 in the coming months, and then combination studies will only be pursued with the operational and financial backing of a future partner for that program. This prioritization extends our projected cash runway into 2026, even with the increased expenses associated with moving ORIC-114 and -944 towards registrational studies."

ORIC-533 Phase 1 Study Design

ORIC-533 is being evaluated in a Phase 1 dose escalation trial in patients with relapsed/refractory multiple myeloma. The primary objectives of the trial are safety and determination of the recommended Phase 2 dose (RP2D). Additional objectives include characterization of the pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.

ORIC-533 Phase 1 Dose Escalation Data

As of November 28, 2023, a total of 23 patients with multiple myeloma received doses ranging from 400 mg to 2400 mg once daily. The study included a heavily pretreated patient population where 100% of patients were triple-class refractory, 91% were penta-refractory, and 57% also received prior anti-BCMA bispecific antibody and/or CAR-T therapy.

ORIC-533 demonstrated a favorable pharmacokinetic profile with an estimated plasma half-life of ~24 hours, which supports QD dosing. ORIC-533 clinical exposures achieved concentrations associated with efficacy in ex vivo models. ORIC-533 also demonstrated strong inhibition of soluble CD73 enzymatic activity across all dose levels, highlighting good target engagement, including in the bone marrow.

ORIC-533 was well tolerated with only Grade 1 and 2 treatment-related adverse events (TRAEs), without any specific recurrent toxicity. There were no dose limiting toxicities, dose reductions or treatment-related serious adverse events.

ORIC-533 exhibited clear evidence of immune activation in the majority of patients dosed at ≥ 1200 mg, as evidenced by an increased abundance and fraction of activated CD8+ T cells and NK cells. At the 1600 mg dose, there were notable reductions in soluble BCMA levels in serum, indicating that ORIC-533 was having a measurable antimyeloma effect. Soluble BCMA levels have been reported to correlate with clinical response on treatment and predict progression free survival of various therapies. Finally, there were multiple examples of clinical activity, including a confirmed minor response in a patient with penta-refractory myeloma who had progressed on an anti-BCMA bispecific antibody 3 months before study entry.

Next Steps

The company intends to complete dose escalation for ORIC-533 in the first quarter of 2024. Given the overall profile of ORIC-533, it is an ideal candidate for development in combination with other immune-based antimyeloma therapies, and the company intends to evaluate strategic partnerships to enable such development.

Conference Call and Webcast Details

To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

About ORIC-533

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, as well as other small molecule inhibitors of CD73 and adenosine receptor antagonists. Preclinical data demonstrated that ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment, reflective of AMP levels observed in tumors. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, as well as in ex vivo bone marrow aspirates from relapsed or refractory multiple myeloma patients.

On December 11, 2023 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, reported positive clinical data from its orally available degraders of BTK, NX-5948 and NX-2127, which are being evaluated in separate Phase 1a/1b clinical trials in patients with relapsed or refractory (r/r) B-cell malignancies, including CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), primary CNS lymphoma (PCNS), and Waldenström’s macroglobulinemia (WM) (Press release, Nurix Therapeutics, DEC 11, 2023, View Source [SID1234638433]). These data were presented in two posters at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is being held in San Diego, California.

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"Targeting BTK is an established treatment paradigm for patients with CLL and other B-cell malignancies. BTK degraders represent a novel next generation therapy for these patients," said Alexey Danilov, M.D., Ph.D. Professor and Co-Director, Toni Stephenson Lymphoma Center, City of Hope National Medical Center and an investigator on both studies. "CLL patients whose disease progresses on or after treatment with BTK inhibitors, most often due to the development of resistance, have no effective treatment options. The oral availability of BTK degraders, their ability to target BTK mutations, and their acceptable tolerability highlight the potential for these agents in the refractory CLL treatment landscape and potentially in earlier lines of therapy."

"The emerging efficacy and safety finding from our differentiated BTK degraders, NX-5948 and NX-2127, highlight the potential of degraders to become the next dominant class of agents in the valuable BTK-targeted therapy market," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "This first clinical disclosure for NX-5948 supports our strategy to broadly develop NX-5948 in CLL and other non-Hodgkin lymphoma conditions."

Nurix reported data from the dose escalation stage of its Phase 1a/1b clinical trial evaluating daily oral dosing of BTK degrader NX-5948 in patients with r/r B-cell malignancies. These data were from 26 patients enrolled in cohorts 1-5 (50-450 mg) who had received a median of four prior therapies (range 2-10, including BTKi, BCL2i, bispecific antibody or CAR-T therapy) and included patients with acquired mutations associated with drug resistance. Dose-dependent pharmacokinetics (PK) were observed, resulting in rapid, robust, and sustained BTK degradation in all patients treated once daily with oral NX-5948. In the CLL population that received doses ranging from 50 to 200 mg, six of seven patients demonstrated clinical benefit with three partial responses (PR) that were all ongoing as of the October 17, 2023 data cut, including one over nine months and three showing stable disease (SD), with treatment ongoing in two patients. In NHL patients (n= 19) who were treated with doses from 50 to 450 mg, durable responses were seen across indications, with almost half the patients continuing to receive treatment as of the cut-off date. NX-5948 was well-tolerated across all doses tested (50-450 mg) with no dose limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) and no treatment emergent adverse events (TEAEs) that resulted in drug discontinuation. Importantly, there were no incidences of atrial fibrillation or hypertension. Dose escalation continues across all indications and the study is actively enrolling patients in the United States, the United Kingdom, and the Netherlands. Additional data with higher dose levels and longer treatment duration are expected in 2024.

Data from the Phase 1a dose escalation and Phase 1b dose expansion cohorts (CLL, MCL and DLBCL) of Nurix’s clinical trial of NX-2127, an orally available degrader of both BTK and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3) were reported in a second poster presentation. The presentation included data from 54 patients with r/r B-cell malignancies treated once daily with NX-2127 at doses that ranged from 100 to 300 mg. The patient population had a median age of 72.5 years (range 50-92 years) and had received a median of four prior lines of therapy (range 2-11, including BTKi, BCL2i, IMiDs, bispecific antibodies, or CAR-T therapy). Among the patients with CLL, 36% had acquired BTK mutations associated with BTK inhibitor drug resistance prior to entry in the study. NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically-relevant degradation of Ikaros. Treatment with NX-2127 resulted in encouraging rapid and durable responses in this heavily pre-treated patient population with complete responses (CR) reported in two (MCL and DLBCL) of the 17 evaluable NHL patients. These responses were durable for over one year. Two PRs in other NHL patients (MZL and FL) were also reported. Among the 27 evaluable patients with CLL, 11 experienced a PR for an overall response rate (ORR) of 40.7%. This compares favorably to earlier results presented at ASH (Free ASH Whitepaper) 2022 showing a preliminary 33% ORR.

NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies. The most common grade ≥3 TEAEs were neutropenia, which showed evidence of dose response, hypertension and anemia. Atrial fibrillation was observed in six patients (11.1%, down from 17% reported previously), with three patients (5.6%) having grade ≥3 events. Twenty-one patients (38.9%) had serious TEAEs, of which eight (14.8%) had serious adverse events considered related to NX-2127 treatment. Two patients experienced DLTs (cognitive disturbance; neutropenia), and 13 patients developed TEAEs that resulted in discontinuation of NX-2127. As of the September 15, 2023 cutoff date, treatment was ongoing in 13 patients.

Webcast details
The live webcast KOL event, which will begin at 8:30 p.m. PT (11:30 p.m. ET) on Monday, December 11, 2023, and the subsequent replay, will be available in the Investors section of the Nurix website under Events and Presentations.

About NX-5948
NX-5948 is an investigational, orally bioavailable, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

About NX-2127
NX-2127 is a novel bifunctional molecule that degrades BTK and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). NX-2127 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

On December 11, 2023 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported updated encouraging safety and efficacy data from Mustang’s multicenter Phase 1/2 clinical trial of MB-106, a CD20-targeted, 3rd-generation autologous CAR T-cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL") (Press release, Mustang Bio, DEC 11, 2023, View Source [SID1234638432]). The data were presented during a poster session on December 9th (Abstract #2102) at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting and build upon previously reported data from a single-institution Phase 1/2 clinical trial conducted at Fred Hutchinson Cancer Center ("Fred Hutch"). MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

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"All nine patients have responded clinically to treatment in this multicenter trial and the safety and efficacy profile of MB-106 appears to be consistent with the original single-institution trial. It is especially encouraging that complete responses were observed in all patients with follicular lymphoma in this multicenter trial," said Mazyar Shadman, M.D., M.P.H., Study Chair, Innovators Network Endowed Chair at Fred Hutch, Associate Professor and physician at Fred Hutch and University of Washington. "One patient with follicular lymphoma who had six prior treatments including CD19-targeted CAR T-cell therapy experienced a complete response for the first time with no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)."

Highlights from the data include:

o All patients responded clinically to treatment with MB-106 (n=9); 100% overall response rate for patients with follicular lymphoma ("FL") and Waldenstrom macroglobulinemia ("WM")
o 100% of patients with FL (n=5) had a complete response; 1 very good partial response and 2 partial responses were observed in WM patients (n=3); and the hairy cell leukemia variant ("HCL-v") patient experienced stable disease, with prolonged, ongoing independence from blood transfusions
o Complete responses observed in patients previously treated with CD19-targeted CAR T-cell therapy
o MB-106 has a tolerable safety profile in patients with indolent NHL, with no occurrence of CRS above grade 1, and no ICANS of any grade, despite not using prophylactic tocilizumab or dexamethasone
o Outpatient administration was allowed and found to be feasible
o MB-106 CAR T-cell expansion and persistence in patients was demonstrated

Efficacy (combined results for dose level 1 & 2)

Best Responses to Date1

Follicular Lymphoma
(n=5)

Waldenstrom
Macroglobulinemia
(n=3)

Overall response rate (ORR),2 n (%)

5 (100%)

3 (100%)

Complete response (CR), n (%)

5 (100%)

0

Very good partial response (VGPR),3 n (%)

N/A

1 (33%)

Partial response (PR), n (%)

0

2 (67%)

Minor response,3 n (%)

N/A

0

Stable disease (SD)

0

0

1. In WM patients, responses are evaluated using the 11th International Workshop on WM (IWWM) criteria (Treon, 2023). In lymphoma patients, PET-CT-based responses are evaluated using the Lugano Classification (Cheson, 2014).
2. ORR is the rate of PR or better in follicular lymphoma. ORR is the rate of minor response or better in WM.
3. VGPR and minor response are WM-specific response categories.
N/A = Not applicable

Safety

CRS and ICANS (combined results for dose level 1 & 2)

Grade 1

Grade 2

Grade 3

Grade 4

CRS, n (%)

5 (56%)

0

0

0

ICANS

0

0

0

0

● CRS = Cytokine release syndrome
● ICANS = Immune effector cell-associated neurotoxicity syndrome
● No related serious adverse events (SAEs) reported, apart from Grade 1 CRS.
● No prophylactic tocilizumab or dexamethasone was administered.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Given the favorable data presented from the multicenter Mustang trial at ASH (Free ASH Whitepaper) and from the original single-institutional Fred Hutch trial, we anticipate finalizing a recommended Phase 2 dose level in early 2024 and moving ahead with the first ever registrational CAR-T trial focused on relapsed or refractory WM. As we plan for an End-of-Phase 1 meeting with the FDA in the first half of 2024 to solicit approval for the design of this trial, we are especially encouraged by the safety of the higher dose level of 1.0×107 CAR T-cells/kg which so far is indistinguishable from the safety of the lower dose level and which we have manufactured successfully for all 5 patients enrolled to date at the higher dose level. Following that meeting, we anticipate initiating a trial enrolling 58 patients across 20 sites in North America, with top-line data expected as early as mid-2026."

The data reported on nine patients from the indolent lymphoma arm of the multicenter clinical trial, including five patients with follicular lymphoma, three patients with Waldenstrom macroglobulinemia, and one patient with transfusion-dependent hairy cell leukemia variant. The patients had been treated with a median of 4 lines of prior therapy (range: 1-9), including 2 patients who had received prior CD19-directed CAR T-cell therapy and 1 patient who had received prior autologous stem cell transplant. The patients received one of two dose levels: dose level 1, 3.3×106 CAR T-cells/kg body weight, or dose level 2, 1.0×107 CAR T-cells/kg.

A link to the poster can be found on the Publications page of the Mustang Bio website here.

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

On December 11, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported the presentation of preliminary efficacy findings from the Company’s ongoing European Phase 1B/2 clinical trial evaluating Annamycin for the treatment of acute myeloid leukemia or AML (MB-106) to key opinion leaders and current investigators at a meeting held in conjunction with the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (ASH) (Free ASH Whitepaper) in San Diego on December 10, 2023 (Press release, Moleculin, DEC 11, 2023, View Source [SID1234638431]). Additionally, the Company will have a paper published on its MB-106 clinical trial as part of ASH (Free ASH Whitepaper). A link will be provided on the Company’s website once this publication is available online.

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The KOL presentation included an update to the positive preliminary efficacy findings previously reported on MB-106. To date, among patients who had an evaluable post treatment bone marrow biopsy, or who dropped out due to an adverse event (AE), there have been 4 complete responses (CR’s) or 36% of the intent to treat (ITT) subjects (n=11) and 44% of the subjects treated (dosed with Annamycin) (n=9). Two subjects experienced adverse events and were not dosed with one being an allergic reaction to Annamycin, the first the Company has seen in over 70 subjects dosed in the Company’s multiple Annamycin clinical trials; the second dropout was due to an allergic reaction to cytarabine. There continues to be no evidence of cardiotoxicity as measured by ejection fraction, strain analyses, ECGs, and cardiac biomarkers including Troponin-I and T in MB-106.

"We believe that our growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML continues to be highly encouraging and bolsters our confidence in its potential to be a meaningful option for patients," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "While still preliminary, the complete response rate we are seeing continues to reflect what we believe is an efficacy level greater than we need for eventual approval of Annamycin. Our recruitment rate continues to exceed expectations and we are optimistic that we will be fully recruited within the next few months."

Currently, the median age of subjects in MB-106 is 69 years with a median number of prior therapies for AML of one. While two of the Company’s complete responders are too recent to measure durability, the Company is seeing durability as high as 8 months and climbing, and the Company has yet to see any relapses of CR’s experienced to date in the trial. The Company has recruited 16 subjects to date with 2 subjects withdrawing from the trial due to adverse events and 3 other subjects having received treatment and not having the bone marrow aspirate fully evaluated.

Additionally, one of the subjects treated but not evaluated experienced a grade 4 serious adverse event (SAE) with septic shock caused by Escherichia coli (E. coli) and was reported on a Suspect Adverse Reaction Report to the appropriate regulatory bodies and ethics committees. The subject was treated for the infection, the SAE is still reported as "ongoing," and the subject is recovering. This subject will be evaluated until resolution of the SAE and will be assessed for efficacy per protocol.

The presentation to the KOL’s mentioned above will be posted on the Company’s website and filed on Form 8-K with the Securities and Exchange Commission.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. For more information about the MB-106 Phase 1B/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple early-stage human clinical trials, including ongoing trials for the treatment of AML and STS lung metastases. For that reason, although additional data will be necessary, the Company believes Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently approved anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes the drug may have the potential to treat additional indications.

About "Complete Remission"

Per the American Cancer Society, the goal of treatment for acute myeloid leukemia is to put the leukemia into complete remission (the bone marrow and blood cell counts return to normal), preferably a complete molecular remission (no signs of leukemia in the bone marrow, even using sensitive lab tests), and to keep it that way. Source: View Source