On November 14, 2022 Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad pipeline targeting cancer and infectious disease, reported expanded data from the Company’s Phase 1 study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with treatment-resistant tumors, including MSS-CRC, ovarian, sarcoma and NSCLC (Press release, Agenus, NOV 14, 2022, View Source [SID1234624040]). The data presented represents four of the most mature data sets from the nine cancer types where responses have been observed to date. The data was presented at a plenary session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and a company-hosted R&D event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This expanded dataset demonstrates the tremendous potential of botensilimab and balstilimab to treat a wide range of immunotherapy-resistant tumors," said Steven O’Day, M.D., Chief Medical Officer of Agenus. "Importantly, the superior efficacy we observed in our MSS-CRC presentation at GI ESMO (Free ESMO Whitepaper) earlier this year has remained consistent across a larger dataset. Further, we are seeing a strong signal with higher response rates than has been reported with other immunotherapies in multiple tumor types, including anti-PD-(L)1 relapsed/refractory NSCLC. These data provide compelling support for our ongoing Phase 2 botensilimab development program and highlight the broad therapeutic potential of botensilimab across solid tumors."

Study Design and Highlights

Out of over 250 enrolled patients, data on 125 patients has matured to efficacy and safety evaluation. These include four primary expansion cohorts in MSS CRC, recurrent platinum refractory/resistant ovarian, sarcoma and PD-(L)1 relapsed/refractory NSCLC. Patients in these cohorts received either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg balstilimab every 2 weeks, with imaging assessments every six weeks. Fixed dosing was also permitted whereby patients received botensilimab 150 mg every 6 weeks, and balstilimab 450 mg every 3 weeks. Trial enrollees were heavily pre-treated with the majority receiving at least 3 prior lines of therapy.

MSS-CRC:

59 evaluable patients
76% failed on ≥3 prior lines of therapy
34% did not respond to prior experimental I-O
22% overall response rate: 1 complete response (CR), 12 partial responses (PR)
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 1-5% response rates1,2
73% disease control rate
Median duration of response not reached
69% of responses are ongoing
31% of responses have already exceeded 1 year
Median Progression Free Survival (mPFS) of 4.1 months; 12 month Overall Survival (OS) of 60.4%; median Overall Survival (mOS) has not been reached
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved a 1.8 mPFS and 6.6 mOS
Ovarian:

19 evaluable patients
71% received ≥3 prior lines of therapy
26% overall response rate: 1 CR, 4 PRs
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 3-10% response rates3,4
63% disease control rate
Median duration of response not reached
Sarcoma:

12 evaluable patients
73% received ≥3 prior lines of therapy
42% overall response rate: 1 CR, 4 PRs
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 12-16% response rates5,6
50% response rate in angiosarcoma, including 3 of 4 patients with visceral angiosarcoma
Other PD-(L)1 + CTLA-4 combinations achieved only 20-25% response rates with no reported responses in 7 treated patients with visceral angiosarcoma6,7
67% disease control rate
Median duration of response not reached
60% of responses have already exceeded 1 year and are ongoing
Anti-PD-(L)1 Relapsed/Refractory NSCLC:

5 evaluable patients (including 1 evaluable patient dosed after the data cut-off)
60% overall response rate
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 6-13% response rates8,9
80% disease control rate
Median duration of response not reached
67% of responses are ongoing
Tolerability:

Botensilimab was well tolerated, with no new immune-mediated safety signals outside of those observed in the class. Rates of gastrointestinal and skin toxicities were comparable to those reported with first-generation CTLA-4 inhibitors, while other immune mediated toxicities were less frequent than expected, consistent with botensilimab’s design to reduce complement binding.

"There is an urgent need to develop new therapies for patients suffering with cold and refractory tumors as current standards of care typically offer only single-digit response rates, "said Breelyn Wilky, M.D., Principal Investigator and Director of Sarcoma Medical Oncology at the University of Colorado School of Medicine. "The robust and durable clinical responses demonstrated by botensilimab and balstilimab in this study across a wide spectrum of refractory tumor types, coupled with its well-tolerated safety profile, provide strong support for the further development of this combination in a broad range of patients."

Presentation Details:

Abstract Number: 778

Abstract Title: Botensilimab, a novel innate/adaptive immune activator, plus or minus balstilimab (anti-PD-1) in ‘cold’ and I-O refractory metastatic solid tumors

Presenting Author: Breelyn A. Wilky, M.D., Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research University of Colorado School of Medicine

The data were presented on Saturday, November 12 at both the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and "The Road Taken" R&D event hosted offsite by Agenus. An archived version of each presentation will be available on the Agenus website.

On November 14, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported that it has entered into securities purchase agreements with certain accredited investors for a $30 million private investment in public equity (PIPE) financing (Press release, Cue Biopharma, NOV 14, 2022, View Source [SID1234624039]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The PIPE financing included a life sciences-focused investment fund that is a new investor in the company as well as participation from other new and existing investors.

Piper Sandler & Co. acted as lead placement agent and Public Ventures LLC acted as co-placement agent to Cue Biopharma for the PIPE financing.

In the PIPE financing, Cue Biopharma agreed to sell 7,656,966 shares of its common stock and, in lieu of shares of common stock to certain investors, pre-funded warrants ("Pre-Funded Warrants") to purchase an aggregate of 1,531,440 shares of common stock, and, in each case, accompanying warrants ("Warrants") to purchase an aggregate of up to 9,188,406 additional shares of common stock (or Pre-Funded Warrants in lieu thereof) at a price of $3.265 per share and accompanying Warrant (or $3.2649 per Pre-Funded Warrant and accompanying Warrant). The exercise price of the Warrants is $3.93 per share, or if exercised for a Pre-Funded Warrant in lieu thereof, $3.9299 per Pre-Funded Warrant. The Warrants are exercisable at any time after they are issued and ending on the fifth anniversary of the closing. The Pre-Funded Warrants are exercisable at any time after they are issued and will not expire.

The transaction is expected to close on or about November 16, 2022, subject to the satisfaction of customary closing conditions.

Net proceeds from the PIPE financing are expected to be used to advance the clinical development of CUE-101, Cue Biopharma’s lead interleukin 2 (IL-2)-based Immuno-STAT biologic, business development activities, working capital and other general corporate purposes.

The securities to be sold in the PIPE financing have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Cue Biopharma has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issued in the PIPE financing and the shares of common stock issuable upon the exercise of the Pre-Funded Warrants and Warrants issued in the PIPE financing.

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 offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On November 14, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the three-month and nine-month periods ended September 30, 2022 (Press release, Navidea Biopharmaceuticals, NOV 14, 2022, View Source [SID1234624038]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter 2022 Highlights and Subsequent Events

Continued enrollment into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."
Announced the opening of nine additional sites for recruitment into the Company’s pivotal NAV3-33 Phase 3 clinical trial, for a total of 12 sites now open and recruiting.
Presented positive results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the positive preliminary results of its ongoing NAV3-32 Phase 2B study at the Annual Meeting of the American College of Rheumatology held November 10-14, 2022 in Philadelphia, PA.
Presented results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 8-12, 2022 in Boston, MA. Results demonstrate efficacy of new constructs at macrophage phenotype change and in a mouse tumor model.
Received gross cash proceeds of $6.2 million in connection with the Rights Offering.
Received $800,000 from a strategic partner as reimbursement for certain manufacturing and research and development expenses.
Received an additional $1.0 million under a bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Appointed Joshua M. Wilson, a seasoned banking and finance executive with more than 23 years of financial services and family office experience, to the Company’s Board of Directors.
Received notification of issuance of patent from the USPTO and the state of Israel for the application titled, "Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same" (Patent No. US 11,369,680 B2; State of Israel Patent Office No. 265830).
Filed a provisional patent application describing a new degradable linker for dexamethasone and paclitaxel containing Manocept therapeutic constructs. These constructs are being evaluated preclinically for effects on macrophages and in animal models of oncology and inflammatory indications.
Announced publication of a manuscript titled "Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach," based on work performed at the Massachusetts General Hospital ("MGH") and Harvard Medical School, Boston MA, and sponsored by the Company. The research, appearing in The Journal of Infectious Diseases (PMID: 35856671), was led by Principal Investigator Steven Grinspoon, MD, Chief of the Metabolism Unit at MGH and Professor of Medicine at Harvard Medical School.
Announced publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia. The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The company continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 and NAV3-32 Phase 2B trials continue to enroll. We are pleased with the preliminary positive results from the NAV3-32 study that thus far support our hypothesis that we can distinguish between fibroid and non-fibroid pathotypes of RA with a single scan." Dr. Rosol continued, "Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards IND filing and clinical trials. The promising results to date of our RA trials and the preclinical studies of our therapeutics demonstrate the significant potential of our macrophage-targeting Manocept platform."

Financial Results

Total revenues for the three-month period ended September 30, 2022 were approximately $8,000, compared to $96,000 for the same period in 2021. Total revenues for the nine-month period ended September 30, 2022 were $65,000, compared to $481,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015, the 2021 receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs, decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, and decreased license revenue from transitional sales of Tc99m tilmanocept in Europe.
Research and development expenses for the three-month period ended September 30, 2022 were $1.2 million, compared to $1.0 million for the same period in 2021. R&D expenses for the nine-month period ended September 30, 2022 were $4.1 million, compared to $3.8 million for the same period in 2021. The increase was primarily due to increased employee compensation including incentive-based awards offset by decreases in drug project expenses and regulatory consulting expenses.
Selling, general and administrative ("SG&A") expenses for the three-month period ended September 30, 2022 were $3.6 million, compared to $1.5 million for the same period in 2021. SG&A expenses for the nine-month period ended September 30, 2022 were $6.7 million, compared to $5.1 million for the same period in 2021. Following the ruling by the Texas Court in August 2022, the Company recorded $2.6 million in legal fees in SG&A pursuant to the CRG judgment. Increases in legal and professional services, insurance, director fees, losses on the abandonment of certain intellectual property, and depreciation and amortization were partially offset by decreases in employee compensation including fringe benefits and incentive-based awards, expenses related to European operations, investor relations and shareholder services, travel, facilities costs, general office expenses and franchise taxes.
Navidea’s net loss attributable to common stockholders for the three-month period ended September 30, 2022 was $7.7 million, or $0.25 per share, compared to $2.4 million, or $0.08 per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2022 was $13.7 million, or $0.45 per share, compared to $8.1 million, or $0.28 per share, for the same period in 2021.
Navidea ended the third quarter of 2022 with $4.6 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

On November 14, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the third quarter ended September 30, 2022, and provided an update on business highlights, including the announcement of a strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) for the commercialization of PNT2002 & PNT2003 (Press release, Point Biopharma, NOV 14, 2022, View Source [SID1234624036]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Upon consummation of the agreements, in exchange for the exclusive worldwide rights1, Lantheus will pay a total of $260 million in upfront payments between the two agreements to POINT, with the potential for additional milestone payments of approximately $1.8 billion between the two products based on U.S. Food and Drug Administration (FDA) approval and net sales and commercial milestones. Additionally, Lantheus will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20% for PNT2002 and 15% for PNT2003. Additional terms of the agreements are summarized below and a website with more information about the collaboration is accessible at View Source and the Company’s website.

"We are very pleased to have reported the Lantheus strategic collaboration earlier this morning. The terms of the deal affirm for us the value of POINT’s platform and maximizes value for both shareholders and patients," said Joe McCann, Ph.D., CEO of POINT Biopharma. "We founded POINT to accelerate the discovery, development, and global access to life-changing radiopharmaceuticals, and with this collaboration POINT is now better positioned than ever to execute on our mission. With our financial position further strengthened, we can continue to focus on our core competencies and dedicate resources to our pipeline. Specifically, we believe that PNT2004 is an incredibly exciting, high value opportunity. PNT2004 is our pan-cancer FAP-α program, which is currently in Phase 1. We will also continue to invest in PNT2001, our actinium-225 next-generation PSMA program, which is expected to begin Phase 1 in 2023, and other next-generation radioligand opportunities."

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In September 2022, the Company published a poster at ESMO (Free ESMO Whitepaper) Congress 2022 containing efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The poster was titled "Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P). Key findings include a median rPFS time of 11.5 months, along with a well-tolerated safety profile with no treatment-related deaths and few treatment-related adverse events of grade 3 or higher.

The SPLASH trial is currently enrolling patients across 55 sites in North America, Europe, and United Kingdom, and recruitment is expected to be completed by the end of the calendar year. The Company continues to expect to report top line data from SPLASH in mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The phase 1 FRONTIER trial (NCT05432193) for the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004, commenced in July 2022. FRONTIER is evaluating PNT6555 (the lead candidate of PNT2004) in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcomas. A gallium-68 (68Ga)-based PNT6555 molecular imaging agent is being used to select patients for the study, those selected then receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent.

The primary objective of the study is to determine the recommended phase 2 dose (RP2D), as guided by a modified toxicity probability interval-2 design. Phase 1 data from FRONTIER is expected in H1 2024.

PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical

In October 2022, POINT published promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001. The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand," at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM) in Barcelona, Spain. The Company is targeting an IND/CTA submission for PNT2001 in H1 2023, with the first patient expected for a phase 1 clinical trial by EOY 2023.

Corporate Updates:

In September 2022, the Company closed a previously announced underwritten public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share. Subsequent to closing, the underwriter exercised its option to purchase an additional 1,589,779 shares. The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $140 million.

Three Months and Nine Months Ended 2022 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2022, POINT had approximately $291.5 million in cash, cash equivalents and investments, which is anticipated to fund operations into the fourth quarter of 2024.

Net Loss: Net loss was $24.0 million, or $0.26 net loss per share, for the three months ended September 30, 2022, as compared to a net loss of $17.1 million, or $0.19 net loss per share, for the same period in 2021. Net loss was $65.0 million, or $0.71 net loss per share, for the nine months ended September 30, 2022, as compared to a net loss of $31.7 million, or $0.46 net loss per share, for the same period in 2021.

Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended September 30, 2022, as compared to $13.0 million for the same period in 2021. Research and development expenses were $54.1 million for the nine months ended September 30, 2022, as compared to $24.0 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2022, as compared to $4.0 million for the same period in 2021. General and administrative expenses were $11.7 million for the nine months ended September 30, 2022, as compared to $7.4 million for the same period in 2021.

1. Excluding the following territories: China (inclusive of Taiwan, Hong Kong and Macau), Japan, South Korea, Indonesia and Singapore, which are retained by POINT.

About the SPLASH Trial

The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

About the FRONTIER Trial

The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The phase 1 clinical trial commenced in summer 2022 in Canada and uses a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.‍

On November 14, 2022 ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), reported its third quarter 2022 financial results and recent highlights (Press release, ProMIS Neurosciences, NOV 14, 2022, View Source [SID1234624035]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to progress our therapeutic antibodies selective for toxic oligomers that are associated with the development and progression of neurodegenerative and other misfolded protein diseases. We are excited that our lead compound, PMN310, is advancing toward clinical stage development. Most notably, we recently closed a $7.4 million private placement, which will be used to advance PMN310 into a first-in-human study. We anticipate enrolling the first subject in the first half of 2023," said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. "We believe our novel discovery platform gives us the potential to advance differentiated next-generation products to address urgent unmet medical needs as in ALS and MSA, and we are excited to continue our transition toward a clinical phase biotechnology company."

Recent Highlights and Anticipated Milestones

Alzheimer’s Disease Program (PMN310)
PMN310, ProMIS’s lead compound, is a novel monoclonal antibody that is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD.

ProMIS completed pilot toxicology, pharmacokinetics (PK) and tissue cross reactivity (TCR) studies and conducted the formal GLP studies to support an IND application to the U.S. Food and Drug Administration (FDA) and anticipate enrollment of the first subject in our Phase 1a trial in the first half of 2023 subject to FDA’s acceptance of the IND.
ProMIS completed the first stage of development towards a high concentration formulation that could potentially support subcutaneous dosing as a future step to improve overall convenience and patient compliance.
Other programs

Using ProMIS’s discovery platform, the Company generated high-affinity monoclonal antibodies that are selective for the misfolded toxic form of TDP-43. In April 2022, the Company announced that it selected monoclonal antibody PMN267 as the drug candidate for an ALS indication based on its binding profile and activity in cell systems and a mouse model of disease. PMN267 is undergoing humanization in a human IgG1 framework for future clinical testing.
ProMIS has selected monoclonal antibody PMN442 as its alpha-synuclein antibody drug candidate. In vivo testing in mouse disease models is ongoing with results expected in the second half of 2022. PMN442 is currently being humanized in a human IgG1 framework for future clinical testing.
ProMIS continues to advance its amyloid-beta vaccine program with the aim of developing an AD vaccine containing its oligomer target epitopes conjugated to a carrier protein in formulation with an adjuvant. A vaccination study in a mouse model of AD is ongoing.

Corporate

In October 2022, ProMIS executed a securities purchase agreement to sell, through a private investment in public equity (PIPE) financing, 1,383,755 Units of the Company at a price of $5.40 per Unit for aggregate gross proceeds of $7.4 million, before deducting placement agent fees and other offering expenses.
In September 2022, the Board of Directors approved the appointment of Gail Farfel, Ph.D., as the Company’s Chief Executive Officer, effective September 19, 2022.
The Company’s co-founder and former Chief Executive Officer, Eugene Williams, remains as Chairman of the Board.

Third Quarter Financial Highlights

Cash and cash equivalents were $4.0 million as of September 30, 2022, compared to $17.0 million as of December 31, 2021. Net proceeds from the October 2022 financing were $6.4 million.
Research and development expenses were $4.6 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same period in 2021. The increase is primarily attributable to increased spending on the PMN310 program.
General and Administrative expenses were $1.4 million for the third quarter ended September 30, 2022, compared to $1.3 million for the same period in 2021.
Net loss was $6.0 million for the third quarter ended September 30, 2022, compared to $1.2 million for the same period in 2021.