On December 12, 2022 Seagen Inc. (Nasdaq: SGEN) reported results from two parts of a phase 2 trial (SGN35-027) evaluating ADCETRIS (brentuximab vedotin) in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine (AN+AD) for the frontline treatment of patients with classical Hodgkin lymphoma (cHL) (Press release, Seagen, DEC 12, 2022, View Source;and-Early-Stage-Classical-Hodgkin-Lymphoma/default.aspx [SID1234625143]). Part B of the trial evaluated patients with advanced-stage disease and was presented as an oral presentation, and Part C evaluated patients with early-stage disease and was presented as a poster at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in New Orleans.

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Results demonstrated a complete response (CR) rate of 88% and an overall response rate (ORR) of 93% in patients with advanced-stage disease (Part B), and a CR rate of 92% and an ORR of 95% in patients with early-stage disease (Part C). The data showed that the combination was well-tolerated, with no new safety signals observed.

"We are encouraged that ADCETRIS in combination with the immunotherapy nivolumab and standard chemotherapy agents showed promising efficacy and safety as a first-line treatment in patients with early- and advanced-stage classical Hodgkin lymphoma," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development at Seagen. "These agents with complementary mechanisms of action warrant further investigation as a potential frontline treatment option for patients with Hodgkin lymphoma."

Part B Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Advanced Stage Classic Hodgkin Lymphoma (Abstract #314)
Part B of SGN35-027 is evaluating the novel ADCETRIS combination in 57 patients with advanced-stage cHL (Stage II with bulky disease, Stage III or IV). Results showed:

An 88% CR rate (95% Confidence Interval [CI]: 76.3, 94.9) and 93% ORR (95% CI: 83.0, 98.1) at the end of treatment.
The estimated 12-month progression-free survival (PFS) rate was 95% (median follow-up 17.2 months [95% CI: 15.5, 17.5]).
The most frequently reported treatment-related treatment-emergent adverse events (TEAEs) occurring in more than 40% of patients were nausea at 65% (37/57), fatigue at 47% (27/57) and peripheral sensory neuropathy at 44% (25/57).
Peripheral sensory neuropathy was primarily low grade (4% Grade ≥3), and no patients discontinued due to peripheral sensory neuropathy.
Part C Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Early-Stage Classic Hodgkin Lymphoma (Abstract #4230)
Part C of SGN35-027 is evaluating the novel ADCETRIS combination in 125 patients with early-stage (non-bulky Stage I or II) cHL. Of 125 patients in the study, 76 were included at the time of efficacy assessment. Results showed:

A 92% CR rate (95% CI: 83.6, 97.0) and a 95% ORR (95% CI: 87.1, 98.5) at end of treatment (N=76).
Follow up is ongoing and PFS results are not yet available.
The most frequently reported treatment-related TEAEs occurring in more than 30% of patients were nausea at 68% (85/125), peripheral sensory neuropathy at 42% (53/125), and fatigue at 38% (47/125).
Peripheral sensory neuropathy was primarily low grade (2% Grade ≥3), and no patients discontinued due to peripheral sensory neuropathy.
About the SGN35-027 Clinical Study

SGN35-027 is an ongoing open-label, multiple part, multicenter, phase 2 clinical trial evaluating two brentuximab vedotin treatment combinations in patients with advanced and early-stage cHL. The trial includes three parts (Parts A, B, and C). Part A includes a combination of brentuximab vedotin and doxorubicin, vinblastine and dacarbazine (A+AVD), while Parts B and C include brentuximab vedotin in combination with nivolumab, doxorubicin, and dacarbazine (AN+AD). The primary endpoint for Part A is the proportion of patients with treatment-emergent febrile neutropenia. The primary endpoint for Parts B and C is the proportion of participants with complete response at end of treatment according to the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). Incidence of adverse events is a secondary endpoint for Parts B and C.

About Hodgkin Lymphoma

According to the American Cancer Society, approximately 8,540 cases of Hodgkin lymphoma will be diagnosed in 2022 and more than 900 people will die from the disease.1

About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of cHL and expressed on the surface of several types of lymphomas. It is approved in seven indications in the U.S.:

Adult patients with previously untreated Stage III/IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine.
Pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide.
Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Seagen and Takeda jointly develop ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen recognizes royalty revenues from Takeda based on a percentage of Takeda’s net sales of ADCETRIS in its licensed territories based on annual net sales tiers. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

CONTRAINDICATION

Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

WARNINGS AND PRECAUTIONS

Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS.

Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections.

Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures.

Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment.

Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment.

Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.

Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.

Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.

Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to avoid pregnancy during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.

USE IN SPECIAL POPULATIONS

Lactation: Breastfeeding is not recommended during ADCETRIS treatment.

Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

Please see full Prescribing information, including BOXED WARNING, for ADCETRIS here.

On December 12, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported positive first data from a cohort of a pivotal Phase 2 trial evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) grades 1 to 3a (Press release, Regeneron, DEC 12, 2022, View Source [SID1234625141]). The data were presented in an oral session at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in New Orleans, LA, and follow the first Phase 2 results for odronextamab in R/R diffuse large B-cell lymphoma (DLBCL) from the same trial that were presented yesterday. The results will form the basis of planned submissions to regulatory authorities in 2023, including to the U.S. Food and Drug Administration (FDA). Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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"There is high unmet need for follicular lymphoma treatments that can improve tumor control and extend survival, given that there is no cure for this cancer and patients will experience multiple relapses," said Tae Min Kim, M.D., Ph.D., Department of Internal Medicine, Seoul National University Hospital in Seoul, South Korea, and a trial investigator. "These positive pivotal Phase 2 results investigating odronextamab in heavily pre-treated, relapsed/refractory follicular lymphoma patients showed deep and durable response – confirming earlier findings in this program – with the highest complete response rates seen in this patient population to date. We look forward to seeing the data continue to mature."

At ASH (Free ASH Whitepaper), efficacy in R/R FL was presented from 121 patients enrolled in a Phase 2 trial cohort (median follow-up: 22 months, range: 3-33 months). All patients had received at least two prior therapies, including a CD20 antibody and alkylating agent. Patients were treated with a step-up regimen of odronextamab in the first cycle to help mitigate the risk of cytokine release syndrome (CRS) before receiving the full dose of 80 mg. The step-up regimen was modified part way through the trial to further mitigate CRS. Results as assessed by independent central review were as follows:

82% objective response rate (ORR), with 75% achieving a complete response (CR). The median duration of complete response (mDOCR) was 20.5 months (95% confidence interval [CI]: 17 months to not evaluable [NE]).
Median progression-free survival was 20 months (PFS; 95% CI: 15 months to NE).
Median overall survival (OS) not reached (95% CI: NE to NE).
Among 131 patients assessed for safety, adverse events (AE) occurred in all patients, with 78% being ≥Grade 3. The most common AEs occurring in ≥20% of patients were CRS (56.5%), neutropenia (40%), pyrexia (31%), anemia (30%), infusion-related reaction (29%), arthralgia (21%), diarrhea (21%) and thrombocytopenia (20%). Discontinuations due to an AE occurred in 11.5% of patients, and there were 3 deaths due to pneumonia, progressive multifocal leukoencephalopathy and systemic mycosis where the relationship to odronextamab treatment could not be excluded.

CRS was the most common AE, of which 68% of cases were mild (Grade 1) and all resolved within a median of 2 days (range: 1-51 days). There were no Grade 4 or 5 CRS cases, and the incidence of both Grade 2 and Grade 3 was reduced with the modified step-up regimen when compared to the original regimen (original regimen n=68 vs. step-up regimen n=63; Grade 2: 18% vs. 11%, Grade 3: 6% vs. 2%).

Based on these data, the OLYMPIA Phase 3 development program investigating odronextamab is in the process of being initiated. In the U.S., odronextamab has been granted Fast Track Designation for FL by the FDA. In the European Union, Orphan Drug Designation was granted for FL by the European Medicines Agency. Odronextamab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s hematology portfolio on Wednesday, December 14 at 8:30 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

About the Trials
ELM-2 is an open-label, multicenter Phase 2 trial investigating odronextamab in more than 500 patients across five independent disease-specific cohorts, including FL, diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-cell non-Hodgkin lymphoma (B-NHL). The primary endpoint is ORR according to the Lugano Classification, and secondary endpoints include CR, PFS, OS, duration of response, disease control rate, safety and quality of life.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy. Subcutaneous administration is being evaluated in two disease specific cohorts.

About Follicular Lymphoma (FL)
One of the most common subtypes of B-NHL, FL is a slow-growing (indolent) form of B-NHL with most cases diagnosed in advanced stages. Although median survival ranges from 8 to 15 years in advanced FL, current therapeutic options are not curative, and most patients relapse within five years regardless of the regimen. In some cases, FL can transform into DLBCL, at which point it is often treated in the same way as DLBCL.

On December 12, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, reported new data supporting the clinical potential of LYT-200, a fully human monoclonal antibody (mAb) designed to inhibit the activity of galectin-9, as a therapeutic agent for the treatment of leukemia (Press release, PureTech Health, DEC 12, 2022, View Source [SID1234625137]). The data were shared in a scientific poster presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting. LYT-200 is a therapeutic candidate targeting galectin-9, which is expressed by tumors and immune cells and plays a key role in cancer treatment resistance. It is also in development as a treatment for a range of cancer indications with otherwise poor survival rates.

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"The data we are presenting at ASH (Free ASH Whitepaper) add further support to the hypothesis that galectin-9 is an important therapeutic target for not just AML but multiple blood cancers, suggesting LYT-200 may be beneficial across a range of hematologic malignancies and underscores the potential of LYT-200 in an area with significant clinical need for novel treatment regimens," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "The National Cancer Institute estimates that about 61,000 new cases of leukemia are diagnosed each year, including about 20,000 in AML. More than 50% of AML patients either don’t respond to initial treatment or experience relapse or death after responding to initial treatment, and have an approximately 12.6% five-year survival rate. The poor overall survival highlights the need for more effective therapies for patients with relapsed and refractory AML."

The ASH (Free ASH Whitepaper) poster evaluates galectin-9 expression and the effects of LYT-200 in multiple types of leukemia. Compared to healthy human peripheral blood mononuclear cells, where galectin-9 surface expression was low or absent, galectin-9 was highly expressed on the surface of all human blood cancer cells tested. Notably, surface expression of galectin-9 often exceeded that of the known inhibitory checkpoint proteins TIM-3 and PD-1.

In all models used, LYT-200 demonstrated significant anti-tumor activity and in addition to its established effects on the immune system in solid tumor models, it also notably induced direct apoptosis or cell death across all leukemia cell types. In a model assessing DNA damage in AML cells, LYT-200 significantly outperformed an anti-TIM3 antibody and had effects that were comparable to Venetoclax, an approved therapeutic for AML. The effects were greatest when both compounds were combined. The in vitro efficacy of LYT-200 against the leukemia subtypes also extended to in vivo survival benefit in both immunocompromised and immunocompetent patient-derived xenograft mouse models. In these models, LYT-200 outperformed chemotherapy and produced the greatest effect in combination.

Collectively, these new data support galectin-9 as a strong potential therapeutic target for a range of cancers. Based on this and other compelling preclinical data generated with LYT-200 in blood cancers, PureTech has initiated a clinical trial to evaluate LYT-200 as a single agent for the treatment of AML with results expected in 2023. PureTech has also completed the bi-monthly and weekly, monotherapy dose escalation portion of the Phase 1 program assessing the safety and tolerability of escalating doses of LYT-200 as a potential treatment of metastatic solid tumors. No dose-limiting toxicities were reported, and the full results will be presented in an upcoming scientific forum. The combination part of the Phase 1 trial in certain metastatic solid tumors with LYT-200 in combination with tislelizumab is expected to begin in the first quarter of 2023.

The scientific poster presented today is available at View Source

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, with otherwise poor survival rates. A wide variety of preclinical data supports the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. For example, PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found in several cancers that galectin-9 levels correlate with shorter time to disease relapse and poor survival. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial for the potential treatment of metastatic solid tumors and in a clinical trial for the potential treatment of AML.

On December 12, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported promising data with MNPR-202 from its ongoing collaboration with the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) (Press release, Monopar Therapeutics, DEC 12, 2022, View Source [SID1234625136]). The data are displayed in the poster that NUS and Monopar will be presenting this Sunday at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH 2022). Monopar has made the poster available on its website at the following link: View Source

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MNPR-202 is a promising DNA Damaging Response (DDR) drug candidate, and analog of doxorubicin. It has the same potentially non-cardiotoxic backbone as camsirubicin, Monopar’s clinical stage drug candidate that has shown a favorable heart toxicity profile to-date across three trials, but MNPR-202 is modified at additional sites with the intention of evading certain tumors’ resistance mechanisms to doxorubicin.

Prior exploratory preclinical studies in solid tumors have shown MNPR-202 to have a similar cytotoxic potency to doxorubicin while retaining that potency even in doxorubicin-resistant cancers. The present preclinical work by Dr. Anand Jeyasekharan, MD PhD, of CSI Singapore, which was highlighted by the Gates Cambridge in a recent article: View Source, corroborates MNPR-202’s similar cytotoxic potency to doxorubicin even in blood cancers, while expanding the research in several exciting new directions, including a comparison to doxorubicin on DNA damage response, immune activation, apoptosis, gene expression, and synergy with other cancer compounds for combination usage.

Preclinical Results To-Date

Data from blood cancer preclinical studies to date show that MNPR-202:

– has a similar cytotoxic potency to doxorubicin

– generates increased DNA damage compared to doxorubicin

– has a unique immune activation profile versus doxorubicin

– demonstrates increased apoptosis compared to doxorubicin

– causes a distinct set of genes to be upregulated and downregulated versus doxorubicin; and

-may be superior to doxorubicin in certain combination treatment regimens. A combination drug screen with 183 compounds was performed, revealing distinct differences in the synergy profile between doxorubicin and MNPR-202 with other compounds. As example, MNPR-202 demonstrated a more favorable synergy profile with volasertib compared to doxorubicin.

The results generated to date suggest doxorubicin and MNPR-202 have a similar cytotoxic potency, but likely work through distinct cellular pathways and cause a different ancillary innate immune activation. These intracellular differences also influence drug synergies observed with the two compounds, implying that in the context of certain combinatorial regimens, MNPR-202 may be superior to doxorubicin. MNPR-202 also shows the potential to work in cancers resistant to doxorubicin. Taken together, we believe MNPR-202 has potential to disrupt the current chemotherapy landscape and impact a broad range of cancers.

On December 12, 2022 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Imago BioSciences, Inc. (Nasdaq: IMGO) (Press release, Merck & Co, DEC 12, 2022, View Source [SID1234625134]). On Nov. 21, 2022, Merck announced that it had entered into a definitive agreement to acquire Imago.

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Upon the successful closing of the tender offer, stockholders of Imago will receive $36 in cash for each share of Imago common stock validly tendered and not validly withdrawn in the offer, without interest and subject to deduction for any required tax withholding. Following the purchase of shares in the tender offer, Imago will merge with and into a subsidiary of Merck, with Imago surviving the merger. As a result, Imago will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Imago will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Imago board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at one minute after 11:59 p.m., Eastern Time, on January 10, 2023, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Imago’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the first quarter of 2023.