On November 14, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the US Food and Drug Administration (FDA) has granted accelerated approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens (Press release, ImmunoGen, NOV 14, 2022, View Source [SID1234623992]). ELAHERE was approved under FDA’s accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. ELAHERE is a first-in-class ADC directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA approved ADC for platinum-resistant disease.

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This press release features multimedia. View the full release here: View Source

"The approval of ELAHERE is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "ELAHERE’s impressive anti-tumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option, and I look forward to treating patients with ELAHERE."

"With an indication for use regardless of prior treatment with Avastin, we believe ELAHERE is positioned to become the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "ELAHERE’s accelerated approval is a testament to the decades of work dedicated to developing the next generation of ADCs and marks ImmunoGen’s transition to a fully-integrated oncology company and the start of an exciting new chapter for us as a leader in the development and commercialization of innovative oncology products. With a highly experienced commercial and medical team in place, we are well prepared to support a successful launch and deliver ELAHERE rapidly to patients across the US."

ELAHERE was evaluated in the pivotal SORAYA trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRα and who had been treated with one to three prior systemic treatment regimens – at least one of which included Avastin (bevacizumab). The primary endpoint was confirmed ORR as assessed by investigator and the key secondary endpoint was DOR. Per the label, ELAHERE demonstrated an ORR by investigator of 31.7% (95% confidence interval [CI]: 22.9, 41.6), including five complete responses (CRs). The median DOR was 6.9 months (95% CI: 5.6, 9.7) as assessed by investigator. The safety of ELAHERE has been evaluated in a pooled analysis from three studies among a total of 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least one dose of ELAHERE (6 mg/kg adjusted ideal body weight (AIBW) administered intravenously once every 3 weeks).

The prescribing information for ELAHERE includes a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. The most common adverse reactions (greater than or equal to 20% of patients), including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

"Platinum-resistant ovarian cancer is a notoriously challenging disease to treat. Given there have been no new therapies approved by FDA for this indication since 2014, ELAHERE’s accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We are thrilled with today’s approval and extend our sincere thanks to the patients, families, caregivers, and investigators who helped make this achievement a reality and have supported the broader mirvetuximab development program. As we work to deliver more good days to patients, we look forward to the continued evaluation of mirvetuximab in earlier lines of treatment, in combination, and across a wider range of levels of FRα expression."

MIRASOL, the confirmatory randomized trial designed to convert the accelerated approval of ELAHERE to full approval, is fully enrolled and top-line data are expected in early 2023. During the Biologics License Application review, FDA requested ImmunoGen submit preliminary ORR and DOR data from both arms of MIRASOL. To maintain data integrity for the ongoing MIRASOL trial, an independent third-party statistician performed the analyses and submitted the outputs directly to FDA.

FDA has also granted approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the only companion diagnostic to aid in identifying patients eligible for treatment with ELAHERE, developed by Roche. Approximately 35-40% of ovarian cancer patients express high levels of FRα, which is defined as greater than or equal to 75% tumor cells staining with 2+ intensity. Testing can be done on fresh or archived tissue; newly diagnosed patients can test at diagnosis to determine if ELAHERE will be an option for them at the time of progression to platinum resistance. Testing is now available in the US through four centralized laboratories and is expected to expand to additional laboratories over time. For the current list of US laboratories that offer testing, please visit View Source

ImmunoGen is committed to helping eligible platinum-resistant ovarian cancer patients gain access to treatment with ELAHERE and is providing support through our ELAHERE Support Services program. For more information, call 1-833-ELAHERE or visit www.elahere.com.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call tomorrow, November 15 at 8:00 a.m. ET to discuss the FDA approval of ELAHERE. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT OVARIAN CANCER

Ovarian cancer is the leading cause of death from gynecological cancers in the US. Each year, roughly 20,000 patients are diagnosed, and 13,000 patients will die. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities.

ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX)

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Indication and Usage

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

BOXED WARNING: OCULAR TOXICITY

ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
Administer prophylactic artificial tears and ophthalmic topical steroids.
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
Discontinue ELAHERE for Grade 4 ocular toxicities.
WARNINGS and PRECAUTIONS

Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%).

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 0.6% of patients.

Premedication and use of lubricating and ophthalmic topical steroids eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases.

Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).

Monitor patients for signs and symptoms of neuropathy. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA < 20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for at least 1 month after the last dose.

Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

On November 14, 2022 Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on developing lenzilumab (LENZ), a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported financial results for the third quarter and nine months ended September 30, 2022 (Press release, Humanigen, NOV 14, 2022, View Source [SID1234623991]).

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In July 2022, the company announced a strategic realignment of its pipeline, resources and regulatory strategy. The company is accelerating the development of lenzilumab in chronic myelomonocytic leukemia (CMML), a rare blood cancer, for which the PREACH-M study is already underway. The company is also continuing its plans for the RATinG study in acute graft versus host disease (aGvHD) that occurs in patients undergoing bone marrow transplant. These studies are majority funded by the company’s partners. In addition, the company is currently assessing requests for investigator-initiated trials (IITs) of lenzilumab in combination with CAR-T therapies. The company also plans to continue the development of ifabotuzumab, an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (ADC), for certain solid tumors. Under the realignment plan, the company will deemphasize the deployment of resources for the development of lenzilumab for COVID-19 and currently does not plan to pursue regulatory pathways, pending further data from ACTIV-5/BET-B or a future large-scale study in which lenzilumab may be a part. In a continuation of the strategic realignment, the company has engaged SC&H Capital, an affiliate of SC&H Group, to advise Humanigen on exploration of strategic options to maximize value around its pipeline. SC&H is an investment banking and advisory firm providing merger and acquisition (M&A), financial restructuring and related business advisory solutions to emerging and growing companies. Humanigen’s board of directors has not set a timetable for the conclusion of its review of strategic alternatives, and there can be no assurance that this process will result in any transaction.

Third Quarter and Nine Months Ended September 30, 2022 Financial Results

Net loss for the quarter ended September 30, 2022 was $23.7 million, or $0.23 per share, as compared to $66.7 million, or $1.12 per share, for the quarter ended September 30, 2021. The net loss for the nine months ended September 30, 2022 was $75.1 million or $0.95 per share, as compared to $203.1 million or $3.56 per share for the nine months ended September 30, 2021. The decrease in net loss for both periods was largely due to a decrease in expenses, mainly Research and Development (R&D) expense. R&D expense decreased by $41.9 million from $60.8 million for the three months ended September 30, 2021 to $18.9 million for the three months ended September 30, 2022 and decreased by $121.2 million from $183.8 million for the nine months ended September 30, 2021 to $62.6 million for the nine months ended September 30, 2022. The decrease in R&D expense is primarily due to decreased lenzilumab manufacturing costs for the quarter ended September 30, 2022 of $38.4 million, and for the nine months ended September 30, 2022 of $108.7 million.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $62.1 million for the nine months ended September 30, 2022. During the first nine months of 2022, the company sold shares of its common stock under its At-the-Market (ATM) facility, raising net proceeds of approximately $41.8 million. As of September 30, 2022, the company had cash and cash equivalents of approximately $24.7 million.

On November 14, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported business highlights and financial results for the third quarter of 2022 (Press release, Hookipa Biotech, NOV 14, 2022, View Source [SID1234623990]).

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"We’re proud of our steady momentum and the external validation of our arenaviral technology over the past few months. Securing our Roche collaboration to develop HB-700 for KRAS-mutated cancers was a key recent achievement, and we’re pleased to move our prostate cancer product candidate, HB-300, toward the clinic following FDA clearance," said Joern Aldag, Chief Executive Officer at HOOKIPA. "With our cash position and upfront cash proceeds from the Roche collaboration, we are positioned to fund multiple clinical readouts in 2023 and 2024, including from our Phase 2 HB-200 program in combination with pembrolizumab."

Business Highlights and Recent Developments

In the Phase 2 study of HB-200 in combination with pembrolizumab for patients with HPV16+ metastatic/recurrent head and neck cancer in the first- and second-line settings, enrollment is ongoing.

More than 20 patients have been dosed, including those in the safety run-in who received lower doses than the recommended Phase 2 dose. As of today, only a small number of patients have received the recommended Phase 2 dose of HB-200 with pembrolizumab. More time and additional imaging assessments are required to mature the dataset and inform the next phase of development. HOOKIPA will provide a comprehensive data update in the first half of 2023.
In October, HOOKIPA announced a strategic collaboration and licensing agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy candidate. The Roche collaboration represents the first oncology licensing agreement for HOOKIPA. Under the terms of the agreement, HOOKIPA received $25 million in upfront cash, with an additional $15 million payment if Roche exercises the option to add an additional product candidate, and potential future milestone payments up to approximately $930 million for both programs, plus tiered royalties.

In July, HOOKIPA announced that the U.S. Food and Drug Administration accepted HOOKIPA’s investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer. A Drug Master File also was accepted, reducing cycle time between completion of preclinical studies and clinical entry of HOOKIPA’s pipeline projects.

Following the submission of the clinical trial application (IND equivalent) for HB-400, a Hepatitis B therapeutic, in 2022, HOOKIPA expects the first patient to be dosed in a Phase 1 clinical trial during 2023.
Upcoming Milestones

First patient enrolled in HB-300 Phase 1 study (prostate cancer) expected in the first quarter of 2023
Phase 2 HB-200 data in combination with pembrolizumab in the first- and second-line setting for HPV16+ head and neck cancer expected in the first half of 2023
Randomized Phase 2 HB-200 study in combination with pembrolizumab in the first-line setting for HPV16+ head and neck cancer expected to launch in 2023 (Fast Track designation)
Phase 2 HB-101 data for the prevention of Cytomegalovirus (CMV) in kidney transplant recipients expected in the first half of 2023
HB-400 Hepatitis B therapeutic (Gilead-led): first patient dosed 2023
Third Quarter 2022 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2022 was $100.7 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement and the follow-on financing in March 2022, partly offset by cash used in operating activities.

HOOKIPA’s cash position as of September 30; 2022 does not include a $25.0 million upfront payment that the Company is entitled to receive under the strategic collaboration and licensing agreement signed with Roche in October 2022 and up to $30.0 million from the issuance of common stock that Gilead is required to purchase at the discretion of the Company pursuant to the terms of a stock purchase agreement signed in February 2022.

Revenue: Revenue was $2.2 million for the three months ended September 30, 2022, compared to $3.9 million for the three months ended September 30, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead as Hookipa neared completion of HBV program assets in preparation for Gilead to progress with a Phase 1 clinical trial. The main parts of the $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022, remained recorded as deferred revenue to be recognized in future accounting periods.

Research and Development Expenses: HOOKIPA’s research and development expenses were $18.3 million for the three months ended September 30, 2022, compared to $20.7 million for the three months ended September 30, 2021. The decrease for the three months ended September 30, 2022, compared to the three months ended September 30, 2021, was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs, a decrease in laboratory consumables, and a decrease in personnel-related expenses including stock-based compensation that was partially offset by an increase in training and recruitment expenses.

General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2022, were $4.9 million, compared to $4.3 million for the three months ended September 30, 2021. The increase was primarily due to an increase in professional and consulting fees and an increase in training and recruitment expenses that was partially offset by a decrease in personnel-related expenses and a decrease in other expenses. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, that was partially offset by a growth in headcount along with increased salaries in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $18.3 million for the three months ended September 30, 2022, compared to a net loss of $20.0 million for the three months ended September 30, 2021. This decrease was primarily due to a decrease in research and development expenses.

On November 14, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the third quarter ended September 30, 2022 (Press release, Harpoon Therapeutics, NOV 14, 2022, View Source [SID1234623989]).

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"Harpoon continues to advance its next-generation T cell engagers to address a broad patient population with unmet needs in both solid tumor and blood cancer indications," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "We have made the decision to fully focus our resources on our collaborations and the clinical development of HPN217 targeting BCMA, HPN328 targeting DLL3 and HPN601 targeting EpCAM, all of which are in or nearing the clinic. As a result, we will be reducing our workforce by approximately 45%, primarily research and supportive functions."

Ms. Eastland continued, "We have implemented a corporate restructuring designed to reduce operating expenses and align core activities with the organization’s focused clinical programs that are expected to drive long-term growth. We are grateful for the dedication and contributions of our valued colleagues whose efforts have innovated and advanced this novel T cell engager technology into the clinic. These restructuring and cost reduction efforts are expected to fund and support our operations, further extending our cash position through the end of 2023."

Business Update / Recent and Upcoming Highlights

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1/2 trial for relapsed, refractory multiple myeloma

"We are really encouraged by what we are seeing with HPN217 in heavily pretreated relapsed/refractory multiple myeloma," said Luke Walker, M.D., Chief Medical Officer of Harpoon Therapeutics. "We look forward to presenting updated clinical results, including additional safety, efficacy and pharmacodynamic data from patients enrolled at higher dose levels at ASH (Free ASH Whitepaper) 2022."

Abstract accepted for poster presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held in New Orleans. The presentation, scheduled for December 11, 2022 at 6 p.m. CT, will provide updated interim data from the Phase 1 dose escalation clinical trial evaluating HPN217 in heavily pretreated patients with relapsed/refractory multiple myeloma.

HPN217 has received Fast Track designation for the treatment of patients with relapsed and refractory multiple myeloma.

Dose exploration is continuing with ongoing patient enrollment in the Phase 1 trial expected to reach completion in the first half of 2023.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

The HPN328 Phase 1 study continues to explore dose regimens to optimize tolerability and benefit in patients with neuroendocrine tumors. Recently, Harpoon lowered the priming dose from 2mg to 1mg for future cohorts and amended the protocol to exclude patients from being treated with HPN328 who require oxygen prior to dosing, to help reduce the risk of respiratory complications. These changes follow two events of Grade 3 cytokine release syndrome (CRS) following an initial 2mg priming dose of HPN328 during the dose escalation portion of the study. CRS in one patient resolved with treatment. CRS in a second patient was complicated by a requirement for oxygen prior to dosing and other complications that led to an additional event of Respiratory Failure, which led to the patient’s death. The events have been reported to regulatory authorities as required.

Harpoon has voluntarily paused new patient enrollment temporarily while it works closely with the FDA and site investigators to implement planned mitigation measures.

Resumption of new patient enrollment in the study is expected by year end.

Patients already enrolled in the study continue to receive treatment at their current dose and participate in the trial per the protocol.

Upcoming milestones for this program are planned as follows:

Identify an initial dose for expansion and dose optimization in the first half of 2023.

Provide interim data for the highest target doses studied in mid-2023.

Begin enrolling additional cohorts in the Phase 1 dose escalation study evaluating HPN328 in combination with atezolizumab (Tecentriq) for the treatment of patients with SCLC in the first half of 2023.

HPN536 (MSLN) Phase 1/2a trial in ovarian cancer and other solid tumors

HPN536 has successfully dose escalated in both fixed and step-dosing regimens and has been well tolerated at doses up to 7.2mg/kg once weekly. Based on corporate priorities, Harpoon is seeking a partner to further develop HPN536 in monotherapy or combination studies.

ProTriTAC

ProTriTAC is a conditionally active T cell engager platform designed to be preferentially active in the tumor. This enables Harpoon’s T cell engagers to address more broadly expressed solid tumor targets across multiple tumor types.

HPN601 (EpCAM)

HPN601 is the first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

Harpoon expects to be ready to file an IND in the first half of 2023 to enable a Phase 1 dose exploration study. Trial initiation will be dependent on available resources.

TriTAC-XR

The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and reduce the efficacy of these potent anti-tumor drugs.

Nomination of a second clinical candidate from one of Harpoon’s new discovery platforms is expected in the first half of 2023.

Corporate Update

In November 2022, the Company announced a corporate restructuring designed to reduce operating expenses and align its core activities with the organization’s focused clinical programs that are expected to drive long-term growth.

In October 2022, Harpoon appointed Luke Walker, M.D., as Chief Medical Officer. Dr. Walker leads the clinical development strategy and execution for Harpoon’s multiple clinical programs.

In September 2022, Harpoon named Lauren Silvernail to its Board of Directors and as the Chairperson of its Audit Committee. She has led and played key roles in a broad range of transactions, including mergers, acquisitions, and financings.

Third Quarter 2022 Financial Results

Harpoon ended the third quarter of 2022 with $66.1 million in cash, cash equivalents and marketable securities, compared to $136.6 million as of December 31, 2021. Current cash is expected to fund operations through the end of 2023.

Revenue for the third quarter ended September 30, 2022 was $13.6 million, compared to $4.5 million for the quarter ended September 30, 2021. For the nine months ended September 30, 2022, revenue was $27.8 million, compared to $19.3 million for the nine months ended September 30, 2022. The increase for both periods primarily arose from revenue recognized in the third quarter of 2022 for research and development services performed on the third and fourth targets under Harpoon’s Restated Collaboration Agreement with AbbVie, and an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed.

Research and development (R&D) expense for the third quarter ended September 30, 2022 was $21.0 million, compared to $17.0 million for the quarter ended September 30, 2021. For the nine months ended September 30, 2022, R&D expense was $62.4 million, compared to $51.5 million for the nine months ended September 30, 2021. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN601, HPN217 and HPN328.

General and administrative (G&A) expense for the third quarter ended September 30, 2022 was $4.5 million, compared to $4.2 million for the quarter ended September 30, 2021. For the nine months ended September 30, 2022, G&A expense was $15.0 million, compared to $13.1 million for the nine months ended September 30, 2021. The increase for both periods was primarily attributable to an increase in legal fees and other professional services to support Harpoon’s operations.

Net loss for the third quarter ended September 30, 2022 was $11.6 million, compared to $16.7 million for the quarter ended September 30, 2021. The net loss for the nine months ended September 30, 2022 was $49.3 million compared to $95.2 million in the first nine months of the prior year.

On November 14, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported its financial results for the quarter ended September 30, 2022 (Press release, Galena Biopharma, NOV 14, 2022, View Source [SID1234623988]).

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"As announced this morning, we look forward to executing on our revised protocol and statistical analysis plan (SAP) for the Phase 3 registrational REGAL study of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) as well as evaluating the next steps for our ovarian cancer program for GPS in combination with PD1 inhibitors following our release last week of the promising final top-line data from our Phase 1/2 study of GPS in combination with pembrolizumab (Keytruda). We are pleased with the preclinical in vitro study results received in the third quarter for GFH009 in neuroendocrine prostate cancer (NEPC), other solid tumors and AML which will help guide our planning for a Phase 2 clinical program for GFH009 in 2023. In addition, we presented data at the 2022 SOHO Meeting, which highlighted bioequivalence data for GFH009 formulations, allowing us to explore a range of dosing strategies and prepare for dosage and administration, and are looking forward to two poster presentations at the upcoming 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December," stated Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"These activities in the third quarter and early fourth quarter are laying the groundwork for the continued advancement in 2023 for both of our clinical programs," added Dr. Stergiou.

Pipeline Updates:

GPS: Wilms Tumor-1 (WT1) targeting peptide immunotherapeutic

•Phase 3 REGAL Study: SELLAS is holding a virtual investor event today at 8.30 am ET to discuss refinements to the protocol and SAP for the REGAL study and the participation of 3D Medicines Inc., SELLAS’ licensee for the development and commercialization of GPS in China, Hong Kong, Macau and Taiwan, in the REGAL study. Webcast information for the update call can be found below.
•Phase 1/2 Study with Keytruda: On November 10, 2022, SELLAS announced confirmatory top-line data showing survival and clinical benefits based on the final analysis of the Phase 1/2 clinical trial of GPS in combination with pembrolizumab (Keytruda) in patients with WT1+ relapsed or refractory platinum-resistant advanced ovarian cancer.
•First Patient Dosed in 3DMed Phase 1 Clinical Trial in China: In October 2022, SELLAS announced that 3D Medicines dosed the first patient in its Phase 1 clinical trial in China of GPS.

GFH009: small molecule, highly selective CDK9 inhibitor

•Preclinical Results: In August 2022, SELLAS announced results from preclinical in vitro studies in solid tumor cell lines, including NEPC, and AML cell lines demonstrating significant anti-tumor effects and cancer cell growth inhibition in selected cell lines.

•Phase 1 Clinical Trial Protocol Amendment: In July 2022, SELLAS announced that a second, once-a-week dose cohort has been added in its ongoing Phase 1 clinical trial in both the United States and China, beginning at the higher dose level of 30 mg.

Corporate Updates:

•New Board Member: In August 2022, SELLAS appointed Katherine Bach Kalin to its Board of Directors. Ms. Kalin’s healthcare industry experience spans pharmaceuticals, diagnostics, medical devices and digital health.

Financial Results for the Third Quarter 2022:

Licensing revenue: There was no licensing revenue for the third quarter of 2022 or 2021. There was $1.0 million in licensing revenue for the nine months ended September 30, 2022, which related to approval by Chinese regulatory authorities of an investigational new drug application by 3D Medicines. This compares to $7.6 million for the nine months ended September 30, 2021.

R&D Expenses: Research and development expenses for the third quarter of 2022 were $4.3 million, compared to $4.5 million for the same period in 2021. The decrease was primarily due to the timing of start-up fees and drug supply purchases in the prior year related to the Company’s ongoing Phase 3 REGAL clinical trial of GPS in AML patients. Research and development expenses were $14.4 million for the first nine months of 2022, compared to $12.3 million for the same period in 2021. The increase was primarily due to an increase in clinical trial expenses related to the REGAL study and personnel related expenses due to increased headcount.

Acquired In-Process Research and Development: There was no acquired in-process research and development for the third quarter of 2022. Acquired in-process research and development was $10.0 million for the first nine months of 2022, resulting from the in-licensing of GFH009. There was no acquired in-process research and development during the same periods in 2021.

G&A Expenses: General and administrative expenses for the third quarter of 2022 were $2.9 million, as compared to $2.4 million for the same period in 2021. The increase was primarily due to personnel related expenses due to increased headcount. General and administrative expenses were $9.0 million for the first nine months of 2022, compared to $8.8 million for the same period in 2021. The increase was primarily due to personnel related expenses due to increased headcount, which were partially offset by a decrease in amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement.

Net Loss: Net loss was $7.0 million for the third quarter of 2022, or a basic and diluted loss per share of $0.34, compared to a net loss of $7.1 million for the same period in 2021, or a basic and diluted loss per share of $0.45. Net loss was $32.2 million for the first nine months of 2022, or a basic and diluted loss per share of $1.70, compared to a net loss of $14.1 million for the same period in 2021, or a basic and diluted loss per share of $0.92.

Cash Position: As of September 30, 2022, cash and cash equivalents totaled approximately $21.3 million.

Webcast Information for Phase 3 REGAL Study Update

The Company will host a virtual investor event on its Phase 3 REGAL clinical trial of GPS in patients with AML today at 8:30 a.m. ET. The event will be facilitated by SELLAS management, including SELLAS’ President and CEO, Angelos Stergiou, MD, ScD h.c., and Dragan Cicic, MD, Senior Vice President, Clinical Development, who will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center, and member of the REGAL Steering Committee.

To attend the live video webcast, please register or email KCSA Strategic Communications at [email protected].

For interested individuals unable to join the live event, an archived version of the webcast will also be available on SELLAS’ Investor Relations site: View Source