On November 14, 2022 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, reported financial results for the three-month and nine-month periods ended September 30, 2022 (Press release, IMUNON, NOV 14, 2022, View Source [SID1234623994]). Highlights of the quarter and recent weeks include:

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Compelling results from ongoing NHP study confirms PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines
Agreement with Acuitas Therapeutics to evaluate IMUNON’s plasmid DNA with Acuitas lipid nanoparticle delivery system
Enrollment of Phase I/II OVATION 2 study with GEN-1 in advanced ovarian cancer fully completed
Cash runway expected into 2025
The Company also provided an update on its preclinical studies of PLACCINE, a proprietary DNA-based plasmid technology powered by synthetic, non-viral delivery systems, being evaluated in proof-of-concept studies in COVID-19; its clinical development of GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer; and, recent partnership agreements aiming at strengthening the development of our DNA plasmid platform.

"I am pleased to report that IMUNON is making excellent progress with our innovative development modalities in infectious diseases and immuno-oncology, while maintaining a strong financial position," said Dr. Corinne Le Goff, IMUNON’s President and Chief Executive Officer. "Our PLACCINE modality continues to advance with very promising data from a non-human primate proof-of-concept study comparing our vaccine with commercial mRNA vaccines. Furthermore, I am looking forward to productive collaborations to continue developing our next generation DNA plasmid platform. Enrollment in our 110-patient OVATION 2 Study of GEN-1 in advanced ovarian cancer was completed during the third quarter." She added: "With the continuing volatility of the public markets, our decision to raise additional capital earlier this year to strengthen our balance sheet and extend our operating roadway into 2025 was well timed. We expect to report several value-creating developments during this period."

Recent Developments

PLACCINE: Development of the prophylactic vaccines of the future

Partial Results from Ongoing Non-Human Primate Study Support PLACCINE as Viable Prophylactic Vaccine Development Modality. In October 2022, the Company reported partial results from an ongoing non-human primate study designed to examine the immunogenicity of its proprietary DNA-based vaccine in support of PLACCINE as a viable alternative to commercial mRNA vaccines. The study examined a single plasmid DNA vector containing the SARS-CoV-2 Alpha variant spike antigen formulated with a synthetic DNA delivery system and administered by intramuscular injection.

In the study, Cynomolgus monkeys were vaccinated with the PLACCINE vaccine or a commercial mRNA vaccine on Day 1, 28 and 84. Analysis of blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity both in PLACCINE and mRNA vaccinated subjects. Analysis of bronchoalveolar lavage for viral load by quantitative PCR showed viral clearance by more than 90% of the non-vaccinated controls. Viral clearance from nasal swab followed a similar pattern in a majority of vaccinated animals and a similar clearance profile was observed when viral load was analyzed by the tissue culture infectious dose method.

In a head-to-head comparison, the protection efficiency as measured by viral clearance following challenge with the SARS-CoV-2 virus was similar between PLACCINE and a commercial mRNA vaccine. In an ongoing stability study, the physio-chemical properties and immunogenicity of the Company’s PLACCINE vaccine did not change during storage at 4° C for up to three months.

PLACCINE DNA-based Vaccine Demonstrated Robust Response in Murine Model. In September 2022, the Company provided an update on the development of a DNA-based vaccine using its PLACCINE platform technology.

Final data from its completed proof-of-concept mouse challenge study confirmed that a PLACCINE DNA-based vaccine can produce robust levels of IgG, neutralizing antibodies and T-cell responses. The data demonstrated the ability of the PLACCINE vaccine to protect a SARS-CoV-2 mouse model in a live viral challenge. In the study, mice were vaccinated with a PLACCINE vaccine expressing the SARS-CoV-2 spike antigen from the D614G variant, the Delta variant or a combination vaccine expressing both the D614G and Delta spike variants. The vaccinations were administered by intramuscular injection on Day 0 and Day 14, followed by challenge with live SARS-CoV-2 virus on Day 42. All three vaccines, including the single and dual antigen vaccines, were found to be safe and elicited IgG responses and inhibited the viral load by 90-95%. The dual-antigen vaccine was equally effective against both variants of the SARS CoV-2 virus. The murine model data suggest that the Company’s approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect expected to exceed six months.

GEN-1 Immunotherapy

Full Enrollment Reached in Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer. In September 2022, the Company announced its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the first half of 2024.

The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

In October 2022, following a pre-planned interim safety review, the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit. No dose-limiting toxicities were reported. The Company also announced that interim clinical data from 87 patients who underwent interval debulking surgery showed that those in the GEN-1 treatment arm had improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores versus the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on examination of the omentum. However, with only 50% of the PFS events so far, the data are still very immature.

In 2021 the Company announced GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. The Company plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

Partnerships and Collaborations

IMUNON entered into an agreement with Acuitas Therapeutics to evaluate PLACCINE Plasmid DNA with Acuitas’ lipid nanoparticle delivery system. Under this agreement, Acuitas will evaluate the administration of IMUNON’s vector constructs formulated in various LNP formulations for gene expression and immunogenicity in murine models.

Corporate Developments

During the third quarter of 2022, Company management presented at two healthcare conferences. They are:

Chardan’s 6th Annual Genetic Medicines Conference held October 3-4, 2022.
H.C. Wainwright 24th Annual Global Investment Conference held September 12-14, 2022.
Dr. Le Goff presented a corporate overview and members of senior management participated in the conferences.

James E. Dentzer, CEO of Curis, appointed to IMUNON’s Board of Directors. In October 2022, the Company announced the appointment of James E. Dentzer to its Board of Directors. Mr. Dentzer is the chief executive officer of Curis, Inc., a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer and brings to IMUNON more than 20 years of leadership in the global pharmaceutical industry.

Mr. Dentzer has been President and Chief Executive Officer and a member of the Board of Directors of Curis, Inc. since September 2018. From March 2018 to September 2018, Mr. Dentzer served as Curis’ Chief Operating Officer and Chief Financial Officer. From March 2016 to March 2018, Mr. Dentzer served as Curis’ Chief Administrative Officer and Chief Financial Officer. Prior to joining Curis, Mr. Dentzer served as Chief Financial Officer of Dicerna Pharmaceuticals, Inc. from December 2013 to December 2015, and of Valeritas and Amicus Therapeutics, Inc. from October 2006 to October 2009. In prior positions, he spent six years as Corporate Controller of Biogen Inc. and six years in various senior financial roles at E.I. du Pont de Nemours and Company in the U.S. and Asia.

Dr. Corinne Le Goff Appointed as President and Chief Executive Officer; Michael H. Tardugno Appointed Executive Chairman of the Board. In July 2022, the Company announced its Board of Directors appointed biopharmaceutical executive Corinne Le Goff, Pharm. D., MBA as President, Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno continues to serve as Executive Chairman of IMUNON’s Board of Directors. Dr. Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology, vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from her tenure at large pharmaceutical companies and small, innovative biotech companies.

Prior to IMUNON, Dr. Le Goff most recently served as Chief Commercial Officer of Moderna, responsible for developing the global presence and capabilities necessary to ensure the global distribution of Moderna’s COVID-19 vaccine. She also led the development of Moderna’s mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President of the U.S. business, driving the growth strategy with increased contributions from Repatha and Aimovig.

Dr. Le Goff was recently recognized by Forbes magazine as one of the women over the age of 50 who are changing the world.

Third Quarter Financial Results

IMUNON reported a net loss for the third quarter of 2022 of $6.1 million ($0.87 per share), compared with a net loss of $5.4 million ($0.94 per share) for the third quarter of 2021. Operating expenses were $6.3 million for the third quarter in 2022, an increase of $1.1 million (21%) from $5.2 million for the comparable prior-year period.

Research and development expenses were $2.4 million for the third quarter of 2022, a decrease of $0.1 million (2%) from $2.5 million for the comparable period in 2021. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA vaccine technology platform increased to $1.5 million for the third quarter of 2022, compared with $1.3 million for the same period of 2021. Costs associated with the OPTIMA Phase III study were $0.1 million for the third quarter of 2022, which represented expenses associated with closing out this previously discontinued study. Other clinical, CMC and regulatory costs were $0.8 million for the third quarter of 2022, compared with $1.0 million for the comparable period of 2021.

General and administrative expenses were $3.9 million for the third quarter of 2022, compared with $2.7 million for the same period of 2021. This $1.2 million increase was primarily attributable to higher professional fees (largely legal fees to defend various suits filed after the announcement in July 2020 of the OPTIMA Phase III study results), higher premiums for directors’ and officers’ insurance and higher compensation expenses related to the CEO succession plan announced in July 2022, offset by lower non-cash stock compensation expense.

Other non-operating income was $26,276 for the third quarter of 2022, compared with other non-operating expenses of $0.3 million for the comparable prior-year period. This increase was attributable to higher investment income in the current quarter.

Nine Month Financial Results

For the nine months ended September 30, 2022, the Company reported a net loss of $22.7 million ($3.42 per share), compared with a net loss of $16.5 million ($3.12 per share) for the same period of 2021. Operating expenses were $18.4 million for the first nine months of 2022, a $2.5 million (16%) increase from $15.9 million for the comparable prior-year period.

Research and development expenses increased $1.1 million for the first nine months of 2022 to $8.7 million, compared with $7.6 million for the comparable prior-year period. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA technology platform increased to $5.3 million for the first nine months of 2022, compared with $4.1 million for the comparable 2021 period. Costs for the OPTIMA Phase III study increased $0.4 million to $1.0 million for the first nine months of 2022, compared with $0.6 million for the first nine months of 2021, due to closing out this discontinued study in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs decreased $0.5 million for the first nine months of 2022, compared with the same prior-year period.

General and administrative expenses were $9.6 million for the first nine months of 2022, compared with $8.3 million for the same period of 2021. The $1.4 million increase was primarily attributable to higher legal and professional fees coupled with higher compensation expenses related to the CEO succession plan announced in July 2022, offset by lower non-cash stock compensation expense.

Other non-operating expenses were $4.7 million for the first nine months of 2022, compared with $1.0 million for the comparable prior-year period. The increase was primarily attributable to the one-time payment of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022 offset by higher investment income.

Net cash used for operating activities was $18.1 million for the first nine months of 2022, compared with $11.4 million for the same period in 2021. This increase was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022, as well as higher operating costs attributable to the development of GEN-1 and the PLACCINE DNA technology platform and higher legal and professional fees. Cash provided by financing activities of $6.3 million during the first nine months of 2022 resulted from an at-the-market equity offering (with no warrants) in April 2022. The Company also received net proceeds of $1.4 million from the sale of its unused 2020 New Jersey NOLs in February 2022. The Company’s projected cash utilization for the balance of 2022 is approximately $5 million.

The Company ended the third quarter of 2022 with $43.4 million in cash, investments, restricted cash and accrued interest receivable. Along with future planned sales of the Company’s State of New Jersey NOLs, the Company believes it has sufficient capital resources to fund its operations into 2025.

Conference Call and Webcast

The Company is hosting a conference call to provide a business update, discuss third quarter 2022 financial results and answer questions at 11:00 a.m. ET today. To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll). The call will also be broadcast live at www.imunon.com.

The call will be archived for replay until November 28, 2022 at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll), using replay access code 8042590. An audio replay will also be available at www.imunon.com for 90 days.

On November 14, 2022 Immunome, Inc. (Nasdaq: IMNM), a clinical stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Immunome, NOV 14, 2022, View Source [SID1234623993]).

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"We look forward to completing our clinical trial for IMM-BCP-01, our COVID-19 antibody program, while continuing to expand our oncology portfolio including our planned submission of the IND for IMM-ONC-01 by mid-2023. Our Discovery Engine provides unique insights into how the human immune system sees disease and continues to highlight interesting areas of cancer biology and identify novel targets and corresponding antibodies."

Dr. Sarma continued, "In parallel with our oncology pre-clinical initiatives, we continue to monitor the evolution of multiple new variants of SARS-CoV-2, including BA.4.6, BQ.1, BQ.1.1 and BF.7, and expect to complete enrolment of our Phase 1b trial of IMM-BCP-01 by the end of the year. We also anticipate obtaining topline safety and PK data by the end of the year and look forward to announcing those results in the beginning of 2023."

Highlights

Preclinical Data on Novel Anti-EPN1 Antibody IMM20059 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting. In November 2022, Immunome announced that it presented a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Immunome’s preclinical research of IMM20059 demonstrated that IMM20059, in the combination with the anti-PD-L1 atezolizumab, significant tumor regression was induced compared to IMM20059 or atezolizumab treatment alone, suggesting a potential combinatorial effect between the two anti-tumoral pathways.
Publication in Clinical & Translational Immunology Highlighting B Cell Repertoires in Patients with Breast Cancer. In August 2022, Immunome announced the publication of a peer-reviewed article in Clinical & Translational Immunology characterizing B cell repertories in tissue samples from patients with breast cancer. The results published by Immunome and its collaborators, provide a framework for understanding how features of tumours relate to the potential for B cells to target cancer cells and these cancer specific B cells are disseminated across tumours, sentinel lymph nodes and blood in the same patient.
IMM-BCP-01 Retains Neutralizing Activity Against Prevalent Omicron Subvariants, BA.4/.5 and BA.2.12.1. In July 2022, Immunome announced that its antibody cocktail retained activity against the BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing. Data recently published in the peer-reviewed journal Science Immunology provides a mechanistic basis for how IMM20253 binding, which is conserved across all variants to date including Omicron and its sub-lineages, neutralized SARS-CoV-2.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2022, were $5.2 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2022, were $3.3 million.
Net loss: Net loss for the three months ended 2022 was $8.5 million.
Cash and cash equivalents: As of September 30, 2022, cash and cash equivalents totaled $27.1 million.
The investigational work for IMM-BCP-01 was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

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.