On July 13, 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 financial results for the fiscal quarter ended May 31, 2023, and provided a corporate update (Press release, Nurix Therapeutics, JUL 13, 2023, View Source [SID1234633225]).

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"The expansion of our NX-2127 clinical trial in non-Hodgkin’s lymphomas provides an opportunity to identify clinical benefit in a significant patient population," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "In the second half of 2023, we expect to generate clinical data that will provide additional insight into the potential specific applications of both the NX-5948 and NX-2127 BTK degrader programs while we continue to advance our internal and partnered programs."

Recent Business Highlights

•Nurix announced the initiation of two additional Phase 1b expansion cohorts in the ongoing Phase 1a/1b trial of NX-2127: In June, Nurix announced the initiation of expansion cohorts in patients with diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The decision to expand was informed by evolving data from the Phase 1a portion of the trial including a rapid and sustained complete response in a patient with DLBCL, as previously reported.

•Nurix enhanced its cash position with the receipt of $20 million from Gilead: In April, Gilead exercised its option to exclusively license Nurix’s oral IRAK4 degrader, which has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. GS-6791/NX-0479 is the first development candidate resulting from the 2019 Nurix-Gilead collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation therapies. In addition to the $20 million license fee, Nurix could potentially receive up to an additional $425 million in clinical, regulatory and commercial milestone payments, as well as up to low double-digit tiered royalties on product net sales.

•Nurix presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting for its Bruton’s tyrosine kinase (BTK) Targeted Protein Degraders, NX-5948 and NX-2127: In April, Nurix presented preclinical data demonstrating the potent tumor cell-killing activity of Nurix’s BTK degraders, NX-5948 and NX-2127, against a broad range of acquired BTK inhibitor resistance mutations and their superiority compared with other reported BTK degraders. For NX-2127, the structure was disclosed to the broader oncology audience following its initial disclosure in an oral presentation at the American Chemical Society Spring 2023 meeting in March.

•Nurix presented additional data for NX-5948 and NX-2127 at the International Conference on Malignant Lymphoma (ICML): In June, Nurix presented early clinical PK/PD data from the Phase 1a trial of NX-5948 demonstrating rapid, robust and sustained BTK degradation and supporting ongoing investigation in B-cell malignancies and continuing dose escalation. Nurix also presented preclinical data demonstrating the potential utility of NX-5948 in addressing the unmet need in patients with central nervous system (CNS) lymphoma. For NX-2127, early clinical data, including a rapid and sustained complete response, informed Nurix’s Phase 1b dose expansion plans in that trial in patients with DLBCL and MCL.

Upcoming Program Highlights*

•NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory activity for the treatment of patients with relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1 clinical trial of NX-2127, which now includes three Phase 1b expansion cohorts in patients with chronic lymphocytic leukemia (CLL), DLBCL and MCL. Nurix anticipates presenting additional clinical results from this ongoing trial in the second half of 2023. Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

•NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable degrader of BTK designed without immunomodulatory activity. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to present initial clinical data from the Phase 1a portion of the study in the second half of 2023. In addition, Nurix expects to define a dose for Phase 1b cohort expansion. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).

•NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1a dose escalation trial in monotherapy and in a combination cohort utilizing Paclitaxel in adults in a range of oncology indications and expects to present clinical data from the Phase 1a portion of the study and to define a dose for Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

•NX-0479/GS-6791: GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s partner, Gilead, is responsible for conducting IND-enabling studies and advancing this program to clinical development.
•Continued advancement of strategic collaborations with Gilead Sciences and Sanofi: Nurix expects to continue to achieve substantial research collaboration milestones throughout 2023 from its collaborations with Gilead Sciences and Sanofi.
*Expected timing of events throughout this press release is based on calendar year quarters.
Fiscal Second Quarter 2023 Financial Results
Revenue for the three months ended May 31, 2023, was $30.7 million compared to $11.4 million for the three months ended May 31, 2022. The increase was primarily due to the receipt of $20 million related to the license option exercise payment from Gilead.

Research and development expenses for the three months ended May 31, 2023, were $45.8 million compared to $47.5 million for the three months ended May 31, 2022. The decrease was primarily related to a decrease in research related costs as we concluded certain studies and sponsored research agreements and a decrease in contract manufacturing as we stabilize the supply needed for our clinical trials, offset by an increase in compensation and related personnel costs and in non-cash stock-based compensation expense. There was also an increase in facility and other costs primarily driven by additional investments in information technology and expenses related to our leases of office and laboratory space.

General and administrative expenses for the three months ended May 31, 2023, were $11.7 million compared to $9.7 million for the three months ended May 31, 2022. The increase was primarily related to an increase in compensation related expenses and non-cash stock-based compensation expense and an increase in outside consulting and professional service costs.

Net loss for the three months ended May 31, 2023, was $24.3 million, or ($0.45) per share, compared to a net loss of $45.4 million for the three months ended May 31, 2022, or ($1.01) per share.
Cash, cash equivalents and marketable securities was $308.6 million as of May 31, 2023, compared to $325.6 million as of February 28, 2023.

On July 13, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the publication of data from its completed MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory AML (Press release, Moleculin, JUL 13, 2023, View Source [SID1234633223]). The manuscript titled, "Results of a Phase 1 Study of Liposomal Annamycin for the Treatment of Relapsed or Refractory AML Patients After Induction Therapy," was published in the peer-reviewed British Journal of Cancer Research.

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The authors of the published manuscript include Dr. Wolfram Dempke (Moleculin’s European Chief Medical Officer), Dr. John Paul Waymack (Moleculin’s Senior Chief Medical Officer) and Dr. Waldemar Priebe (Moleculin’s Chair – Scientific Advisory Board), as well as Polish investigators from the MB-105 trial.

"We are pleased to have the data from our successful MB-105 study published in this prestigious journal," commented Walter Klemp, Chairman and CEO of Moleculin. "This early data provided an important foundation for our AML program and was informative for guiding our clinical development strategy for Annamycin in combination with Cytarabine for the treatment of AML. We continue to be very optimistic about Annamycin’s potential to provide a non-cardiotoxic treatment option for patients."

MB-105 is the Company’s completed multicenter, open-label, dose-escalation study which was conducted to determine the maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Annamycin as a single agent for the treatment of patients with AML after induction therapy. A total of 20 subjects with the age range of 24-76 years with a median age of 64.5 were enrolled across five clinical trial sites in Europe. The median number of prior therapies for all subjects was 4 (range 1-18). Of the 20 subjects enrolled, 17 received the full 3 consecutive days of dosing per protocol.

As previously announced, the final MB-105 results aligned with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally, as detailed in the paper, among the eight subjects treated in the final dosing cohort (240 mg/m2) five were evaluable for efficacy and there were one PRs (Partial Response) and three CRi (complete response with incomplete recovery of peripheral blood count) among these five subjects, representing an 80% overall response rate (ORR) in the last cohort.

For purposes of this clinical trial, a CR means that the subject’s bone marrow blasts reduced to 5% or less (with CRi meaning a CR where there was incomplete recovery of white blood cell and/or platelet counts), and a PR means the subject’s bone marrow blasts reduced by 50% and resulted in a blast count of 25% or less.

Annamycin again demonstrated no evidence of cardiotoxicity based on review of cardiotoxicity biomarkers, LVEF, and ECHO GLS evaluation. These properties differentiate Annamycin from all other anthracyclines that have shown limited or no cardiotoxicity to date and highlight it as a very promising anticancer agent and it retains the ability to poison TOPO-IIα (topoisomerase II) and can also overcome mdr-1-related resistance mechanisms in leukaemic blasts, as shown in its parent compound.

As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial. Based on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, Moleculin commenced its ongoing Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106) clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.

On July 13, 2023 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies ("ETBs"), to create novel therapies with potent differentiated mechanisms of action for cancer, reported that it has entered into a definitive securities purchase agreement with certain healthcare investors that will provide up to $40 million in gross proceeds to MTEM through a private placement in two tranches (Press release, Molecular Templates, JUL 13, 2023, View Source [SID1234633222]). The financing is being led by existing investor BVF Partners LP and includes existing investors BB Biotech AG and Adage Capital Management, and other leading institutional investors.

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The purchase is comprised of an initial tranche of $20 million in exchange for 42.6 million shares of common stock (or pre-funded warrants in lieu thereof) for a purchase price per common share of $0.47, the closing price of the common stock on July 12, 2023, and up to an additional $20 million in a mandatory second tranche if certain stock price and trading levels are achieved within a 12 month period, as described below. The first tranche is expected to close on July 17, 2023, subject to the satisfaction of customary closing conditions.

The second tranche of $20 million, consisting of the sale of an additional 42.6 million shares of common stock (or pre-funded warrants in lieu thereof) on the same pricing terms, would close if the following conditions are met: within a 12 month measurement period defined in the stock purchase agreement, MTEM’s common stock trades for a 10-day volume weighted average price of at least $1.41 per share with aggregate trading volume during the same 10-day period of at least 10 million shares, and other customary closing conditions are satisfied. In addition, upon such second tranche closing, MTEM will issue to the investors common stock warrants representing the right to purchase an additional 85.2 million shares of MTEM common stock at an exercise price of $0.47 per share, in exchange for the payment of $0.125 per warrant. In the aggregate, these warrants would represent 100% warrant coverage of the number of shares of common stock (or pre funded warrants) sold in the initial and second tranche, and would have a term of five years.

Stifel is acting as the sole placement agent in connection with the financing.

MTEM intends to use the net proceeds from the private placement to fund its ongoing clinical studies, working capital and for general corporate purposes and to continue its collaboration activities with BMS.

The securities sold in the private placement, including the common shares underlying the warrants, are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. As part of the securities purchase agreement, MTEM has agreed to file two separate resale registration statements with the Securities and Exchange Commission registering the resale of the securities following the closing of each of the initial and second tranches, respectively.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.

On July 13, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported the closing of an underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $7.50 per share (Press release, Iovance Biotherapeutics, JUL 13, 2023, View Source [SID1234633221]). The shares of common stock issued and sold in the offering include 3,000,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discounts and commissions. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are $172.5 million.

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Iovance intends to use the proceeds from this offering to fund preparations for the commercial launch of lifileucel (if approved), including continuing to prepare the Iovance Cell Therapy Center, the Company’s manufacturing facility in Philadelphia, to support ongoing clinical programs including its NSCLC registration-directed study and its frontline advanced melanoma Phase 3 confirmatory trial, to expand the combination of TIL and immune checkpoint inhibitors ("ICIs") in ICI naïve patient cohorts, to support the continued development of our pipeline candidates, to support Proleukin integration activities and for other general corporate purposes.

Goldman Sachs & Co. LLC and Jefferies LLC acted as joint lead book-running managers for the offering.

The shares of common stock described above were offered by Iovance pursuant to its shelf registration statement on Form S-3 that became automatically effective upon filing with the Securities and Exchange Commission on June 16, 2023. The offering was made by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York, 10022, by telephone at (877) 547-6340, or by email at [email protected].

This press release shall not constitute an offer to sell or a 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 July 13, 2023 Invectys, Inc., a clinical-stage immuno-oncology company developing novel therapies for the treatment of advanced cancers, reported that it has initiated the clinical trial of its lead CAR-T program, IVS-3001, in solid tumors (Press release, Invectys, JUL 13, 2023, View Source [SID1234633220]). The Company also announces the appointment of Dr. Jake Kushner, M.D., as its new CEO.

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About the IVS-3001 clinical trial

IVS-3001 is Invectys’ cutting-edge CAR-T cell therapy, targeting the rarely exploited immune checkpoint and tumor specific antigen known as HLA-G. Normally expressed only during pregnancy, this checkpoint molecule protects the fetus from the mother’s immune system, which would otherwise recognize it as foreign, by shutting down the immune system’s response to its presence. In cancer, this mechanism is often highjacked by tumors to create a protective microenvironment, preventing the patient’s defenses from killing the cancer cells.
Having won the MATWIN "Best Project" award in 2019 and the Cancer Prevention and Research Institute of Texas (CPRIT) Award in 2020, IVS-3001 is now entering the next phase of its development. A Phase I/2a clinical trial (NCT05672459) was initiated at The University of Texas MD Anderson Cancer Center on June 21, 2023, in HLA-G-positive solid tumor patients, particularly those with kidney and ovarian cancers. The co-Principle Investigators on the trial are Aung Naing, M.D. FACP, Professor of Investigational Cancer Therapeutics, and Samer Srour, MB ChB, MS, Assistant Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.
"This is a great step towards bringing new solutions to patients," comments Julien Caumartin, CSO. "There are currently far too few reliable solutions on the market for solid tumor cancer patients, due to the complexity of solid tumors. Our vision is to provide broad-ranging solutions to the patients, and we are eager to carry our CAR-T cells to the clinic and challenge the paradigm of CAR-Ts in solid tumors."

About the appointment of Jake Kushner, M.D. as CEO

Now in the clinical stage, the Company is also announcing the appointment of Jake Kushner, M.D., as the new Chief Executive Officer (CEO), responsible for leading the transformative efforts in both the Houston and Paris offices of Invectys. As CEO, Dr. Kushner will be building on his previous role as executive advisor and close collaborator to the Invectys management team and board.
Dr. Kushner is a renowned endocrinologist who also serves as the Medical Director for McNair Interests where he evaluates and manages medical investments in support of scientific and entrepreneurial solutions for those who suffer from chronic disease. He previously served as Chief of Pediatric Diabetes and Endocrinology at Baylor College of Medicine and Texas Children’s Hospital.
"Invectys is entering a new, thrilling phase of its development," said Dr. Kushner. "CAR-T cells have delivered stunning results in blood cancers, but their promise in solid tumors has yet to be fulfilled. Invectys has the potential to turn this promise into a reality and breathe new hope into the cancer care field. I am honored and humbled the Board has entrusted me with leading this bold and visionary Company."