On February 23, 2023 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update (Press release, Insmed, FEB 23, 2023, View Source [SID1234627615]).

"Insmed had a strong finish to 2022 as we rounded out a year of commercial and clinical execution that set the stage for what I believe will be the most meaningful period in our company’s history," commented Will Lewis, Chair and Chief Executive Officer of Insmed. "As we begin 2023, we are excited to share outputs from across our research and development programs that we hope will demonstrate clear benefit for patients with serious unmet medical needs. We expect that achieving this outcome will bolster the value of our pipeline and potentially enable us to grow from addressing tens of thousands of patients to more than a million. For example, with today’s announcement that screening is complete in adult patients in the Phase 3 ASPEN study of brensocatib in bronchiectasis, we are well on our way toward reporting topline results in the second quarter of 2024 and potentially bringing this first-in-disease therapy to patients. Importantly, we are fully capitalized to achieve these milestones and more."

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Recent Pillar Highlights

Pillar 1: ARIKAYCE

ARIKAYCE global revenue grew 30% in 2022 compared with 2021, reflecting strong U.S. performance, the ongoing launch in Japan, and contributions from European markets.

Insmed continues to advance the development of ARIKAYCE in a frontline setting of patients with Mycobacterium avium complex (MAC) lung disease, consisting of the post-marketing confirmatory ARISE and ENCORE trials. Insmed anticipates sharing topline efficacy and safety data from the ARISE study in the third quarter of 2023 and completing enrollment in the ENCORE study by the end of 2023.

Pillar 2: Brensocatib

Patient screening has been completed in adult patients in the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled trial to assess the efficacy, safety, and tolerability of brensocatib in bronchiectasis. Insmed continues to anticipate completing enrollment in this study in the first quarter of 2023 and sharing topline data in the second quarter of 2024.

As previously shared, Insmed plans to initiate a Phase 2 study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) in mid-2023. Subject to U.S. Food and Drug Administration input, the Company anticipates that the trial will enroll approximately 270 patients randomized to either 10 mg brensocatib, 40 mg brensocatib, or placebo over a 24-week treatment period, with a primary endpoint of change in daily sinus total symptom score.

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Pillar 3: TPIP

Insmed is currently enrolling two Phase 2 studies of treprostinil palmitil inhalation powder (TPIP), one in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and the other in patients with pulmonary arterial hypertension (PAH).

The Company anticipates sharing interim, blinded dose titration and safety and tolerability data from both the PH-ILD and PAH studies in the second half of 2023, pending the rate of enrollment. Topline results from the PH-ILD study are on track to be shared in the first half of 2024.

Pillar 4: Early-Stage Research

Insmed plans to provide an update on its early-stage research portfolio, which encompasses gene therapy, artificial intelligence-driven protein engineering, and protein manufacturing, during an event on May 8, 2023. The event will take place in person in New York and will be webcast live. The Company will offer a deep dive into the various platforms comprising its research engine and an introduction to the experts leading these teams.

As previously shared, Insmed anticipates having at least six investigational new drug (IND) applications filed or Phase 1 studies underway from this portfolio by the end of 2025. The first IND is expected to be filed prior to the May 8 event.

Insmed anticipates sharing clinical data from a few of the earliest patients in a Phase 1/2 gene therapy study in a musculoskeletal disease in the first half of 2024.

Fourth Quarter and Full-Year 2022 Financial Results

Total revenue for the fourth quarter ended December 31, 2022, was $59.3 million, compared to total revenue of $56.1 million for the fourth quarter of 2021. Total revenue for the full year 2022 was $245.4 million, compared to total revenue of $188.5 million for the full year 2021.

Total revenue for the full year 2022 comprised ARIKAYCE net sales of $186.0 million in the U.S., $56.5 million in Japan, and $2.9 million in Europe and rest of world. In the fourth quarter of 2022, Insmed reached an agreement with the French authorities on a final reimbursement price for the temporary authorization for use (Autorisation Temporaire d’Utilisation) program, which resulted in a change in estimate that reduced revenue by approximately $7.5 million in the fourth quarter of 2022, of which $5.8 million related to periods prior to 2022.

Cost of product revenues (excluding amortization of intangibles) was $13.1 million for the fourth quarter of 2022, compared to $13.3 million for the fourth quarter of 2021. For the full year 2022, cost of product revenues (excluding amortization of intangibles) was $55.1 million compared to $44.2 million in 2021.

Research and development (R&D) expenses were $124.8 million for the fourth quarter of 2022, compared to $76.4 million for the fourth quarter of 2021. For the full year 2022, R&D expenses were $397.5 million compared to $272.7 million in 2021.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2022 were $73.5 million, compared to $65.3 million for the fourth quarter of 2021. For the full year 2022, SG&A expenses were $265.8 million, compared to $234.3 million in 2021.

For the fourth quarter of 2022, Insmed reported a net loss of $160.1 million, or $1.21 per share, compared to a net loss of $113.0 million, or $0.95 per share, for the fourth quarter of 2021. For the full year 2022, Insmed reported a net loss of $481.5 million, or $3.91 per share, compared to a net loss of $434.7 million, or $3.88 per share, in 2021.

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Balance Sheet, Financial Guidance, and Planned Investments

As of December 31, 2022, Insmed had cash, cash equivalents, and marketable securities of $1.15 billion.

The Company’s total operating expenses for the fourth quarter of 2022 were $210.8 million and for the full year 2022 were $702.7 million.

Insmed continues to expect full-year 2023 global revenues for ARIKAYCE to be between $285 million and $300 million.

In 2023, Insmed anticipates that over 80% of total expenditures will be on its mid-to-late stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company’s historical approach to spending.

The Company plans to invest in the following key activities in 2023:

(i)
commercialization and expansion of ARIKAYCE globally;

(ii)
advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis and commercial launch readiness activities, as well as development across additional neutrophil-mediated diseases;

(iii)
advancement of the confirmatory, frontline clinical trial program for ARIKAYCE (ARISE and ENCORE); and

(iv)
advancement of its earlier-stage pipeline, including the Phase 2 clinical development programs for TPIP and development of its early-stage research platforms.

Conference Call

Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S.) or (929) 526-1599 (international) and referencing access code 397951. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 30 minutes after its completion through March 25, 2023, by dialing (866) 813-9403 (U.S.) or (+44) 204-525-0658 (international) and referencing access code 828224. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

On February 23, 2023 Immedica’s partner Actinium Pharmaceuticals Inc. has reported results for the primary and secondary endpoints from its pivotal phase 3 SIERRA trial of Iomab-B in patients aged 55 and above with relapsed or refractory acute myeloid leukemia (r/r AML) with active disease (Press release, Immedica Pharma, FEB 23, 2023, View Source [SID1234627614]).

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The SIERRA trial met its primary endpoint of superior durable Complete Remission (dCR = CR or CRp (CR with incomplete platelet recovery) lasting ≥6 months after initial CR/CRp following hematopoietic stem cell transplantation HSCT) with a high degree of statistical significance (p<0.0001). The median overall survival (OS) was 6.4 months for Iomab-B and 3.2 months for the physician´s choice of conventional care arm. More importantly, of the 13 patients (22 %) who achieved dCR on the Iomab-B arm 92% were still alive at 1 year and 60% at 2 years, and hence long-term survivors. Iomab-B enabled access to HSCT with 100% engraftment in all patients receiving a therapeutic dose of Iomab-B. Only 14 of the 77 patients randomized to the conventional care arm achieved a CR on physician’s choice of standard therapy and could proceed to HSCT. None of them had a CR duration of ≥6 months (dCR). Iomab-B was well tolerated compared to conventional care.

Results from the SIERRA trial were presented at the Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). The full abstract is found here: View Source

In April 2022, Immedica and Actinium Pharmaceuticals, Inc. entered a license and supply agreement for Iomab-B, where Immedica has the commercial rights in Europe, the Middle East, and North Africa.

Anders Edvell, CEO of Immedica commented: "We are very encouraged by these results. Iomab-B has the potential to significantly improve the outcomes in a patient population that is underserved by current therapies. We look forward to continuing our collaboration with Actinium to make Iomab-B available for patients in our territories".

SIERRA trial results

The SIERRA trial is a prospective, randomized, controlled phase 3 study comparing Iomab-B to physician’s choice of conventional therapy to patients ≥55 years of age with relapsed or refractory acute myeloid leukemia with active disease, a group of patients with dismal prognosis and few effective therapeutic options. Primary endpoint was the rate of dCR (≥ 6 months). Patients not achieving CR with conventional care could crossover (CO) to Iomab-B-based conditioning followed by HSCT. Forty patients from the conventional care arm actually crossed over. The outcome for CO patients receiving Iomab-B was similar to what was seen in the group randomized to Iomab-B.

SIERRA was conducted at 24 of the leading HSCT centers in the United States and Canada. SIERRA enrolled older, heavily pre-treated patients with active disease and high-risk characteristics who would not be offered HSCT in standard practice outside of a clinical trial and therefore have dismal survival outcomes of two to three months.

HSCT access and engraftment:

All patients (N=66) receiving the therapeutic dose of Iomab-B were able to access HSCT with 100% engraftment. Only 14 patients in the conventional care arm did eventually achieve a CR and could proceed to HSCT. The time from randomization to HSCT was more than doubled for these patients compared to patients transplanted after Iomab-B (median 29 vs. 66.5 days)

Primary endpoint – dCR:

Iomab-B met the primary endpoint of dCR, i.e., a CR (or CRp) with a duration of at least 6 months following initial CR after HSCT, with a high degree of statistical significance (p<0.0001)
22% of patients (13/59) in the per protocol analysis achieved dCR in the Iomab-B arm compared to 0% of patients on the control arm.
Secondary endpoints – event free survival and overall survival:

Iomab-B demonstrated significant improvement in EFS with a Hazard Ratio = 0.22, p<0.0001, which means Iomab-B reduced the probability of an event by 78%. Iomab-B numerically doubled the median overall OS compared to patients who were treated with conventional care without crossover (6.4 months vs 3.2 months).
A high percentage of patients achieving dCR after Iomab-B are long term survivors: 92% and 60% were still alive 1 and 2 years after initial CR respectively.
The median OS in the CO arm was 7.1 months.
Safety information:

Iomab-B was well tolerated compared to conventional care.
The incidence of sepsis was four times lower in the Iomab-B arm compared to patients undergoing HSCT in the control arm (6.1% vs 28.6%).

About Iomab-B
Iomab-B is an anti-CD-45 monoclonal antibody conjugated to the radioisotope 131I. CD45 is widely expressed on leukemia and immune cells including bone marrow progenitor stems cells. The radiation emitted from Iomab-B kills both the cells that the antibody binds to, and also the neighboring cells thereby delivering targeted radiation directly to leukemic cells and white blood cells in the myeloid tissue ablating the bone marrow while sparing healthy organs.

Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative HSCT. Multiple studies have demonstrated increased survival in patients receiving HSCT, however, an overwhelming majority of patients with r/r AML do not receive HSCT as current approaches do not produce a remission, which is needed to advance to HSCT, or are too toxic.

Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B in 2023 to address patients age 55+ with r/r AML with active disease. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037. Iomab-B has also been granted Orphan Drug Designation by the European Medicines Agency (EMA) and Immedica will now start to prepare marketing approval applications relevant for the European territory.

On February 23, 2023 MEI Pharma, Inc. (Nasdaq: MEIP) ("MEI"), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, and Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate, reported that the companies entered into a definitive merger agreement for an all-stock transaction forming a company combining the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates (Press release, Infinity Pharmaceuticals, FEB 23, 2023, View Source [SID1234627613]). All three clinical-stage development programs have the potential, in combination with current therapies, to overcome known resistance mechanisms and meaningfully improve patient outcomes.

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The combined company’s clinical-stage oncology development pipeline consists of three differentiated programs:

Eganelisib, an oral immuno-oncology macrophage reprogramming product candidate, which is planned to be evaluated in combination with the PD-1 targeted checkpoint inhibitor pembrolizumab (KEYTRUDA) in patients with head and neck squamous cell carcinoma (HNSCC);
Voruciclib, an oral CDK9 inhibitor, currently being studied in combination with venetoclax (VENCLEXTA) in patients with hematologic malignancies; and
ME-344, a novel tumor selective mitochondrial inhibitor targeting the OXPHOS pathway, to be evaluated in combination with bevacizumab (AVASTIN) in patients with relapsed colorectal cancer.
"We are very excited to enter into this agreement with Infinity given the strength of a combined organization that builds on each company’s potential. The combined organization will have three differentiated clinical-stage oncology assets, expected funding into mid-2025 to reach clinical data in all three programs, and a team with extensive oncology clinical development expertise. I believe these ingredients place the merged organization in a strong position to create value for all our stakeholders," said Daniel Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "The new company’s lead program, eganelisib, has already been tested in over 350 patients with demonstrated clinical activity in multiple settings, including in combination therapy with immune checkpoint inhibitors. Along with voruciclib and ME 344, this gives us three promising clinical-stage programs that we believe have significant potential to deliver improved therapeutic options for patients."

"With this planned merger, we are creating a company that is well capitalized to advance a differentiated clinical-stage therapeutic development pipeline leveraging an experienced drug development and leadership team," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "With data supporting multiple potential development paths for eganelisib, we have prioritized head and neck cancer based on our ability to leverage encouraging progression free survival data from this patient population in MARIO-1. Unfortunately, head and neck cancer remains an area of high unmet medical need with a relatively short PFS and overall survival in patients treated with checkpoint inhibitor monotherapy. Because of this, we prioritized the initiation of a randomized, controlled Phase 2 clinical study combining eganelisib with pembrolizumab in head and neck cancer patients which is intended to demonstrate improved clinical benefit."

"I am looking forward to leading the combined company which, beyond the promising clinical-stage pipeline, leverages the capabilities and resources of two organizations sharing a commitment to developing new oncology therapeutics. The combined company is built around extensive small molecule development experience based on solid science and backed by promising data," said David Urso, J.D., Chief Operating Officer and General Counsel of MEI Pharma, and the Chief Executive Officer of the combined company upon closing of the merger. "At closing, the combined company is projected to have a strong balance sheet of approximately $100 million which is expected to fund planned studies for our clinical candidates through mid-2025 with the potential to deliver near and long-term value for patients and shareholders."

About the Combined Clinical Pipeline Drug Candidates

The combined company’s pipeline includes three differentiated, clinical-stage, small molecule oncology therapeutic candidates:

Eganelisib: A potential first-in-class, oral, once-daily, immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma. Eganelisib has demonstrated encouraging clinical results and tolerability across a broad range of solid tumors in over 350 patients, including head and neck squamous cell carcinoma (HNSCC), metastatic triple-negative breast cancer (mTNBC), as well as urothelial, ovarian and melanoma cancers. The combined company plans to initiate in Q3 2023, subject to U.S. Food and Drug Administration review, a global, randomized, controlled Phase 2 clinical trial of eganelisib plus pembrolizumab vs pembrolizumab for the potential treatment of first line relapsed/metastatic head and neck squamous cell carcinoma. The primary endpoint of the Phase 2 study will be overall survival. In the second half of 2024 we plan to have initial data on safety and progression free survival.
Voruciclib: An orally administered Cyclin-Dependent Kinase 9 (CDK9) inhibitor being clinically investigated for hematological malignancies. CDK9 has important functions in cell cycle regulation, including the modulation of two therapeutic targets in cancer: myeloid leukemia cell differentiation protein (MCL1) and the MYC proto-oncogene protein, which regulate cell proliferation and growth. Voruciclib is currently being evaluated in a Phase 1b trial exploring dose and schedule in patients with acute myeloid leukemia (AML) and B-cell malignancies as a single-agent and in combination with venetoclax. The ongoing Phase 1b trial is expected to report initial results from the combination regimen around the end of 2023.
ME-344: A novel, parenteral, tumor selective mitochondrial inhibitor drug candidate targeting the OXPHOS pathway involved in the production of adenosine. Clinical investigation of ME-344 is focused on use in combination with the VEGF inhibitor bevacizumab (Avastin). Data reported from an investigator-initiated, multi-center, randomized study of ME-344 in combination with the VEGF inhibitor bevacizumab (Avastin) demonstrated biologic activity supporting further clinical investigation. Initiation of a Phase 1b trial is planned to evaluate ME-344 plus bevacizumab in patients with relapsed colorectal cancer in the first half of 2023. Data from the Phase 1b trial to support opening enrollment in an expansion cohort are expected to be reported around the end of 2023.
About the Proposed Merger

Under the terms of the merger agreement, Infinity will become a wholly owned subsidiary of MEI Pharma. Pursuant to an exchange ratio set forth in the merger agreement, the pre-merger MEI Pharma shareholders are expected to own approximately 58.0% and pre-merger Infinity shareholders are expected to own approximately 42.0% of the outstanding equity of the combined company immediately following the merger.

Subject to shareholder approval and the subsequent closing of the merger, the combined company is expected to be renamed and trade on the Nasdaq Stock Market. The combined company would be headquartered in San Diego, California and led by a team with extensive industry and oncology drug development expertise, including David Urso, Chief Executive Officer, Robert Ilaria, Jr., M.D., Chief Medical Officer, and Stéphane Peluso, Ph.D., Chief Scientific Officer. Daniel Gold, Ph.D., and Adelene Perkins, the current chief executive officers of MEI and Infinity, respectively, would serve on the Board of Directors of the combined company. The Board of Directors is expected to be composed of eight members, consisting of Mr. Norman C. Selby, currently Infinity’s Lead Independent Director, who will Chair the Board, Mr. Urso, Dr. Gold, Ms. Perkins, two additional members designated by MEI Pharma, one additional member designated by Infinity and one member mutually agreed upon by MEI Pharma and Infinity.

The merger agreement has been approved by the Boards of Directors of both companies. The merger is expected to close in mid-2023, subject to approvals by MEI Pharma and Infinity shareholders, respectively, and other customary closing conditions.

Torreya Capital, LLC is serving as financial advisor to MEI Pharma, and Morgan, Lewis & Bockius LLP is serving as legal counsel to MEI Pharma. Aquilo Partners, L.P. is serving as financial advisor to Infinity, and WilmerHale is serving as legal counsel to Infinity.

Conference Call and Webcast Information

MEI Pharma and Infinity Pharmaceuticals will host a conference call and webcast today at 8:00 a.m. ET to discuss the merger. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI and Infinity merger conference call.

The conference call will also be webcast live here, as well as from the Events Calendar page in the Investors section of MEI Pharma’s website at www.meipharma.com and the Events & Presentations page in the Investors/Media section of Infinity’s website at www.infi.com. All participants are encouraged to join 10 minutes prior to the start time. An archived version of the webcast will be available on each company’s website for 30 days following the event.

On February 23, 2023 IN8bio, a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, reported the ability of its novel non-signaling gamma-delta CAR-T platform (nsCAR) to selectively target leukemic cells while preserving healthy B cells (Press release, In8bio, FEB 23, 2023, View Source [SID1234627612]). The findings were presented by Dr. Lawrence Lamb, IN8bio’s Chief Scientific Officer, during a Plenary session titled "Leveraging the Nexus of the Immune System with Gamma-Delta CAR-T Cells" at the 6th CAR-TCR Summit Europe on February 23rd.

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The current generation of CAR-T technology eliminates the target antigen regardless of whether it is expressed on tumor or healthy tissues. However, IN8bio’s nsCAR platform uses the innate immune recognition of gamma-delta T cells to distinguish between tumor and healthy tissue, offering a targeted but potentially less toxic approach. In a 48-hour in vitro cytotoxicity experiment, the nsCAR platform demonstrated a greater than 15x difference in killing between leukemic cells and healthy B cells (E:T=2:1, 79.7% versus 5.2%) when both express the CD19 target antigen.

The nsCAR platform is also engineered to express the cytokine interleukin-15 (IL-15) to enhance cellular persistence and the ability to target and kill tumor cells over time. The platform has the potential to broaden the utilization of CAR technology for previously "undruggable" solid and liquid tumor targets.

"This powerful approach could be used in indications such as acute myeloid leukemia (AML) and solid tumor cancers where on-target, off-tumor expression would result in toxicities with significant risks to patients," said Lawrence Lamb, Ph.D., co-founder and Chief Scientific Officer of IN8bio. "While CD19 was a preclinical proof-of-concept, we look forward to advancing the nsCAR platform into solid tumor indications as well as promising targets for AML, such as CD33."

The data presented supports the potential of IN8bio’s nsCAR platform to revolutionize the development of future CAR-T therapies, with the findings demonstrating the ability of the novel approach to distinguish between tumor cells and healthy tissue. The presentation is available on the company’s website at View Source

About INB-300

INB-300, our non-signaling CAR gamma-delta T cell platform, includes several preclinical product candidates combining our expertise in gamma-delta T cells and genetic engineering. These nsCAR constructs lack signaling domains in order to take advantage of the unique properties of gamma-delta T cells to differentiate between healthy and tumor tissues. IN8bio is advancing new nsCAR constructs against multiple targets to treat both solid and liquid tumors.

On February 23, 2023 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported that it will report full year 2022 results, before the US markets open on Wednesday, March 1, 2023 (Press release, Immunocore, FEB 23, 2023, View Source [SID1234627611]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. ET (1:00 p.m. GMT) to discuss their financial results and provide a business and portfolio update.

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Audio Webcast
The call will be made available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 90 days.

Conference Call Details:
Domestic (toll-free): 877-405-1239
International (toll): +1 201-389-0851