On January 27, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the fourth quarter and fiscal year ended November 30, 2021 and provided a corporate update (Press release, Nurix Therapeutics, JAN 27, 2022, View Source [SID1234607439]).

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"2021 was a remarkable year for Nurix with the advancement of four wholly owned drug candidates into clinical development. We are very encouraged by our early clinical results having obtained positive proof-of-mechanism data from all patients treated in the first two cohorts with advanced B-cell malignancies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to an exciting year as we advance our proprietary protein modulation portfolio for patients with significant unmet medical need in both solid tumors and hematologic malignancies."

Recent Business Highlights

Initiated Phase 1 clinical development for four wholly owned and internally developed drug candidates: Nurix proprietary protein modulation clinical programs include two targeted protein degraders of Bruton’s tyrosine kinase (BTK), NX-2127 and NX-5948, for the treatment of relapsed and refractory B-cell malignancies, a first-in-class oral E3 ligase inhibitor, NX-1607, for the treatment of a variety of solid tumors and hematologic malignancies, and a first-in-class cell therapy program, DeTIL-0255, that combines tumor infiltrating lymphocytes (TIL) with a small molecule E3 ligase inhibitor with the aim of generating a superior T-cell product with enhanced efficacy.
Presented initial data from its first-in-human, Phase 1 dose-escalation trial of NX-2127 in adults with relapsed or refractory B-cell malignancies: In October 2021, Nurix reported initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the first six patients in its Phase 1a clinical trial of NX-2127, including completed cohorts 1 and 2 treated at 100 mg and 200 mg once daily. The data showed BTK levels in peripheral blood significantly decreased in all patients in the trial starting on day 1 and remained suppressed throughout the dosing period. BTK degradation exceeded 80% at steady state in the first dose cohort and exceeded 90% in the second dose cohort. Such levels of BTK degradation have been associated with anti-tumor effects in preclinical animal models. Clinical observations were presented for the one patient in cohort 1, a 78-year-old man with chronic lymphocytic leukemia (CLL) and significant mutations in the BTK gene associated with resistance to standard of care BTK inhibitors, who achieved a partial remission with lymphocytosis.
Strengthened financial position: In March 2021, Nurix completed an underwritten public offering of 5,175,000 shares of its common stock, at a public offering price of $31.00 per share, which included 675,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock. The net proceeds to Nurix from the offering were approximately $150.2 million, after deducting underwriting discounts, commissions and offering expenses. Combined with additional capital from partners in 2021, Nurix ended fiscal year 2021 with $432.9 million in cash and equivalents compared to $372.0 million as of November 30, 2020.
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 drug (IMiD) activity. Nurix plans to initiate the Phase 1b expansion phase of its ongoing Phase 1a/1b clinical trial of NX-2127 in adults with relapsed or refractory B-cell malignancies in mid-2022 and to present additional data from Phase 1a in the second half of 2022. 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 BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to begin dosing at multiple clinical centers in the United Kingdom in the first half of 2022 and to have initial safety and PK/PD data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107739).
Fiscal Fourth Quarter and Full Year 2021 Financial Results

Collaboration revenue for the three months and twelve months ended November 30, 2021 was $7.4 million and $29.8 million, respectively, compared with $6.7 million and $17.8 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily due to the continued scale up of internal resources and external spending for Nurix’s collaborations with Sanofi and Gilead as compared to the prior year, resulting in a higher percentage of completion in the current year. The increase was also due to partial revenue recognized during the year ended November 30, 2021 for the achievement of certain preclinical milestones under Nurix’s collaborations with Gilead and Sanofi.

Research and development expenses for the three months and twelve months ended November 30, 2021 were $36.5 million and $116.4 million, respectively, compared with $20.4 million and $66.5 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to an increase in compensation and personnel costs attributable to an increase in headcount; increases in supplies and contract research, preclinical activities and contract manufacturing costs attributable to an increase in Nurix’s preclinical development activities and drug discovery research and preparation for upcoming clinical programs for its lead drug candidates; an increase in clinical costs due to ongoing clinical trial startup and patient enrollment; an increase in non-cash stock-based compensation expense; and an increase in facility and other costs primarily due to the expansion of leased premises and investments in information technology.

General and administrative expenses for the three months and twelve months ended November 30, 2021 were $8.8 million and $31.2 million, respectively, compared with $6.3 million and $16.3 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to non-cash stock-based compensation expense, compensation related expenses attributable to higher headcount, and consultant and other professional services costs primarily related to becoming a public company.

Net loss for the three months and twelve months ended November 30, 2021 was $37.7 million or ($0.85) per share and $117.2 million or ($2.73) per share, respectively, compared with $19.9 million or ($0.51) per share and $43.2 million or ($2.76) per share for the three and twelve months ended November 30, 2020, respectively.

Cash, cash equivalents and investments: As of November 30, 2021, Nurix had cash, cash equivalents and investments of $432.9 million, compared with $372.0 million as of November 30, 2020.

On January 27, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its collaborators published positive preclinical data for the use of Genprex’s ONCOPREX Nanoparticle Delivery System for delivery of a FAS DNA plasmid to treat metastatic colorectal cancer. Published in the journal Cancers1, the preclinical study found that tumor selective ONCOPREX nanoparticles carrying FAS DNA plasmids suppress human colon tumor growth in vivo in mouse models, indicating that this may be an effective therapy for human colorectal cancer (Press release, Genprex, JAN 27, 2022, View Source [SID1234607437]).

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The manuscript, "Restoring FAS Expression via Lipid-Encapsulated FAS DNA Nanoparticle Delivery Is Sufficient to Suppress Colon Tumor Growth In Vivo," provides data indicating that complete loss of FAS expression is often observed in metastatic human colorectal tumors. Using Genprex’s ONCOPREX system to deliver the FAS gene, the researchers found that overexpression of codon usage-optimized FAS in metastatic mouse colon-tumor cells enabled FASL-induced elimination of FAS positive tumor cells in vitro, suppressed colon tumor growth, and increased the survival of tumor-bearing mice in vivo.

"These positive preclinical data validate that the ONCOPREX Nanoparticle Delivery System can be used to deliver tumor suppressor genes other than TUSC2, which we are using in lung cancer studies with REQORSA, to address multiple types of cancer," said Mark S. Berger, MD, Chief Medical Officer at Genprex. "The data also provide early support for FAS as a tumor suppressor gene in colorectal cancer. With this compelling data, Genprex is positioned to expand its oncology programs in the future and to further explore use of its delivery system for other therapeutic genes, alone or in combination with other approved cancer therapies, to provide new therapeutic approaches for patients with serious medical conditions and unmet medical needs. We will continue to evaluate FAS using our ONCOPREX delivery platform as a potential pipeline addition within our oncology program."

Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in humans.

The ONCOPREX delivery system is used to deliver TUSC2 plasmid DNA in Genprex’s REQORSA immunogene therapy. REQORSA is being combined with Tagrisso (by AstraZeneca) in the Company’s Acclaim-1 clinical trial and is being combined with Keytruda (by Merck & Co.) in the Company’s Acclaim-2 clinical trial, both targeting progressing lung cancers.

In 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for non-small cell lung cancer (NSCLC) in combination therapy with Tagrisso (osimertinib) for late-stage patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Keytruda (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.

The ONCOPREX Nanoparticle Delivery System is designed to deliver tumor suppressor genes, which are encapsulated in lipid nanoparticles. The nanoparticles are then administered intravenously and taken up by tumor cells where the encapsulated gene is translated to express proteins that are missing or depleted in cancer cells. Genprex has treated more than 50 NSCLC patients in clinical trials with REQORSA, the Company’s lead drug candidate that uses the ONCOPREX Nanoparticle Delivery System to deliver the TUSC2 gene.

A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

1Cancers 2022, 14(2), 361; View Source

On January 27, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer (Press release, Oncolytics Biotech, JAN 27, 2022, View Source [SID1234607436]). Dosing in the trial’s first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

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"Initiation of the bridging trial’s second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep’s potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep’s development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact."

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics’ randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.

The first of Oncolytics’ randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics’ second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep’s path to a registrational study in metastatic breast cancer in the United States.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 20201. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 20202.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

On January 27, 2022 Case Western Reserve University reported that About 1.2 million people with HIV in the United States live relatively normal lives with uncompromised immune systems and the virus medically controlled (Press release, Case Western Reserve University, JAN 27, 2022, View Source [SID1234607435]).

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But there are two rising concerns, said Ge Jin, a professor in the Department of Biological Sciences at the Case Western Reserve University School of Dental Medicine.

"One, they are aging and will develop all the diseases or illnesses of the general population, like you or me," he said. "The other problem—those morbidities, like cancer or co-infection with other viruses, happen at an earlier stage, occur at a higher rate and are more severe (for people with HIV)."

With two new research grants totaling $3.7 million from the National Institutes of Health (NIH), Jin and his co-investigators hope to learn why.

The new grants will focus on identifying the reasons for higher rates of cancers in the head and neck within this population, as well as co-infection with the herpes virus (Kaposi sarcoma herpesvirus or KSHV).

Jin, also a member of the Case Comprehensive Cancer Center’s Molecular Oncology Program, received:

A five-year, $3.3 million grant from the National Cancer Institute at NIH to investigate the mechanisms underlying transmission of KSHV in the oral cavity in people living with HIV.
KSHV causes Kaposi sarcoma (KS), one of the most common malignancies in people living with HIV. While the oral cavity contains the highest levels of infectious KSHV—and saliva is the most common way to transmit the infection—how that happens isn’t understood.

Jonathan Karn, professor and chair of the Department of Molecular Biology and Microbiology at the School of Medicine and director of the Case Center for AIDS Research, is co-investigator on this project.

A related $401,000 grant from the National Institute of Dental and Craniofacial Research at NIH to study why cases of oral diseases, like lesions that could develop into oral cancers, are increasing as people with HIV age—and then identify new therapies. Michael Lederman, professor emeritus at the School of Medicine, is co-investigator.
This new round of funding builds on a $3.7 million grant Jin and his research team received from NCI in July 2020 to study HIV and lung cancer—specifically why lung cancer rates are higher for people living with HIV, and the mechanism and markers to predict and treat the disease.

HIV infects immune cells; cancers in the lung and oral cavity affect epithelial cells. If researchers can figure out the link between HIV and higher cancer rates—and how to break that connection—then the next step would be to focus on therapies to treat the diseases.

"The first thing is," Jin said, "identifying how and why they can talk with each other."

On January 27, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that audited financial results for the year ended 30 September 2021, as well as an operational update (Press release, Redx Pharma, JAN 27, 2022, View Source [SID1234607428]).

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Lisa Anson, Chief Executive Officer of Redx, commented:
"During the period, we have made strong progress in advancing our pipeline. Our lead oncology asset, RXC004, entered a Phase 2 clinical trial and our lead fibrosis asset, RXC007, entered a Phase 1 clinical trial. Our discovery pipeline of differentiated programmes continues to progress driven by the strength of our science and validated by milestone revenue increasing during the year. We are in a position to deliver meaningful results in the clinic which could drive benefits for patients and value for shareholders."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor product candidate:
o Completed monotherapy module of Phase 1 trial showing differentiated level of activity in Wnt-ligand dependent tumours; o Presented Phase 1 data at theEuropean Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress; o Selected 2 mg as recommended dose for monotherapy Phase 2 studies;
o Post period, initiated Phase 2 trial in monotherapy treatment in genetically selected MSS metastatic colorectal cancer, with US IND now open (PORCUPINE trial); and o Post period, initiated second Phase 2 trial in monotherapy treatment in genetically selected pancreatic cancer and unselected biliary cancer (PORCUPINE2 trial). · Initiated Phase 1 clinical trial in healthy volunteers for RXC007, an orally bioavailable selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions:
o Post period, reported interim Phase 1 safety, tolerability and pharmacokinetic (PK) data on11 October 2021 showing no adverse events and an attractive PK profile. · Progressed discovery portfolio, including our Discoidin Domain Receptor (DDR) inhibitor fibrosis programme:
o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in lead optimisation. · Increased milestone revenue from progress of partnered programmes: o Milestones totalling $7 million received from AstraZeneca ($4 million related to RXC006) and Jazz Pharmaceuticals ($3 million related to Pan-RAF) during the period; o Revenue from the Jazz Pharmaceuticals collaborations received during the year for the progress on research programmes;
o Post period, on9 December 2021 Redx announced a $10 million milestone was earned from Jazz Pharmaceuticals for the progress in ongoing research collaboration and on 23 December 2021 Redx announced a $9 million milestone was earned from AstraZeneca as RXC006 entered clinical trials.

· Further strengthened the Redx management team and Board of Directors reflecting the transformation of the company into a clinical stage organisation: o Appointment of experienced key senior management-DrJane Robertson as Chief Medical Officer andPeter Collum as US-based Chief Financial Officer; o Creation of new role of Chief Operating Officer to be held byJames Mead and General Counsel role held byClaire Solk, who joined Redx on 17 January 2022 from her previous role as Senior Legal Counsel at AstraZeneca; o Board appointments of Natalie Berner in May 2021 as Non-Executive Director and DrJane Griffiths in December 2021 as new Chair, following the departure of Iain Ross in June 2021.

Financial Highlights
· Placing and Open Offer inDecember 2020 of £25.7 million (gross), which received strong support from existing investors and added healthcare specialist investors including Polar Capital; · Cash balance at30 September 2021 of £29.6 million (30 September 2020: £27.5 million);
· Total revenue for the year of£10.0 million (2020: £5.7 million); o Including milestone payments of $4 million from AstraZeneca, and $3 million from Jazz Pharmaceuticals;
· Loss for the year of£21.5 million (2020: £9.2 million);
· Total R&D expenditure of £24.4 million (2020: £10.5 million); · Cash balance funds operations through calendar year 2022.

For the purposes of MAR, the person responsible for arranging for the release of this announcement on behalf of Redx iAsndrew Booth, Company Secretary