On March 30, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that COSMIC-313, the phase 3 pivotal trial evaluating the combination of cabozantinib (CABOMETYX), nivolumab (OPDIVO) and ipilimumab (YERVOY) versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC), has completed enrollment (Press release, Exelixis, MAR 30, 2021, https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-enrollment-completion-phase-3-cosmic-313 [SID1234577369]). The primary endpoint of the trial is progression-free survival, and additional endpoints include overall survival and objective response rate.

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"Following the promising final results of a phase 1b trial evaluating this triplet combination in advanced genitourinary tumors, this milestone in the phase 3 pivotal trial brings us a step closer to understanding whether cabozantinib in combination with nivolumab and ipilimumab may improve outcomes for patients with previously untreated advanced kidney cancer," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We look forward to sharing initial results from the event-driven analysis of COSMIC-313 when available and to learning more about the potential of cabozantinib in combination with immunotherapies."

COSMIC-313 is a multicenter, randomized, double-blind, controlled phase 3 pivotal trial that enrolled approximately 840 patients at 180 sites globally. Patients were randomized 1:1 to receive cabozantinib plus nivolumab and ipilimumab or matching placebo plus nivolumab and ipilimumab. The design of COSMIC-313 was informed by the results of the CheckMate -214 trial that supported regulatory approval of nivolumab in combination with ipilimumab for the first-line treatment of patients with intermediate- and poor-risk RCC, and by results from the phase 1b study of cabozantinib in combination with nivolumab with or without ipilimumab in patients with relapsed or refractory metastatic genitourinary cancers, including RCC. Final results from that phase 1b trial were presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium.

Bristol Myers Squibb is providing nivolumab and ipilimumab for use in this trial.

More information about this trial is available at ClinicalTrials.gov.

About RCC
The American Cancer Society’s 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common form of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.1 Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021.3

About 70% of RCC cases are known as "clear cell" carcinomas, based on histology.4 The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.6,7

About CABOMETYX (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with OPDIVO. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX is not indicated for use in combination with nivolumab and ipilimumab in previously untreated advanced renal cell carcinoma.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

On March 30, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the China National Medical Products Administration (NMPA) approved its Clinical Trial Application (CTA) for a Phase 2 basket trial of Trodelvy (sacituzumab govitecan-hziy) in a variety of cancers with high TROP-2 expression (Press release, Everest Medicines, MAR 30, 2021, View Source [SID1234577385]).

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The Phase 2 single arm, multiple-cohorts basket trial will evaluate sacituzumab govitecan-hziy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at selected sites in China. The incidence of these indications is higher in China/Asia than Western countries, and there are very limited treatment options in later line settings, represent a significant unmet medical need in China and Asia.

"As of 2019, the incidence of cancers with TROP-2 expression was more than 3.5 million, accounting for approximately 78% of all cancer occurrences in China," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Sacituzumab govetican-hziy’s unique TROP-2 directed antibody and topoisomerase inhibitor drug conjugate mechanism of action, along with its robust set of data in other TROP-2 expressing cancers suggest that it may be effective in a broad range of tumors. We look forward to advancing this important basket study as we work to expand potential indications of this novel therapy across a variety of cancers with high unmet medical need."

About Trodelvy (sacituzumab govitecan-hziy)

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. It is indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease and was granted accelerated approval by the U.S. Food and Drug Administration for this patient population in April 2020, based on overall response rate and duration of response results in a Phase 1/2 study.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

On March 30, 2021 InDex Pharmaceuticals Holding AB (publ) reported that the company has entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for the phase III study CONCLUDE(Press release, InDex Pharmaceuticals, MAR 30, 2021, View Source [SID1234584071]). The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.

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"We are excited to advance cobitolimod into phase III, which is the final stage of development before application for market approval. After the successful collaboration in our recent phase IIb study CONDUCT, we are very pleased to collaborate once again with Parexel Biotech as our clinical development partner", says Peter Zerhouni, CEO of InDex Pharmaceuticals. "Parexel Biotech is a leading global CRO with considerable experience managing phase III studies in inflammatory bowel disease, which will ensure an efficient execution of the study."

CONCLUDE is a randomised, double-blind, placebo-controlled, global phase III study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. The induction study will include approximately 400 patients, and the primary endpoint will be clinical remission at week 6. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo.

Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, the phase III study will also evaluate a higher dose, 500 mg x 2, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the phase IIb study.

"We are pleased to partner with InDex Pharmaceuticals on the phase III clinical trial CONCLUDE to evaluate a potential new therapy for patients with moderate to severe ulcerative colitis," said Jim Anthony, Senior Vice President and Global Head, Parexel Biotech. "Our collaboration with InDex Pharmaceuticals demonstrates our commitment to designing innovative solutions that draw from our global clinical experience and therapeutic expertise to fulfill unmet medical needs on behalf of patients worldwide."

For more information:
Peter Zerhouni, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]

Publication
The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on March 30, 2021.

Cobitolimod in brief
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results were recently published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.

On March 30, 2021 Cullinan Oncology, Inc. (Nasdaq: CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, reported its financial results for the full year ended December 31, 2020 and reported on recent business highlights (Press release, Cullinan Oncology, MAR 30, 2021, View Source [SID1234577328]).

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"We are proud of the significant progress across many facets of our business in 2020 and intend to maintain that momentum in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "We remain laser focused on delivering results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We look forward to sharing additional clinical and pre-clinical updates as the year unfolds."

2020 and Recent Portfolio Highlights:

Cullinan Pearl: Demonstrated encouraging clinical proof of concept for CLN-081 in NSCLC patients with EGFRex20ins mutations and initiated Phase 2a dose expansion in the 100 mg BID cohort.

CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants while sparing cells expressing wild type EGFR. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have progressed post chemotherapy. As of the November 10, 2020 data cut-off, among 25 evaluable patients across all dose cohorts, we observed a best overall response of partial response in 10 patients (confirmed and unconfirmed), stable disease in 14 patients and disease progression in one patient. Cullinan recently initiated Phase 2a dose expansion at the 100 mg BID dosing level, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
Cullinan MICA: Advanced CLN-619 through IND-enabling activities, including drug product manufacturing, to support an IND submission planned for the second quarter of 2021.

CLN-619 is a MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands expressed on tumor cells and recognized by the activating NKG2D receptor present on innate and adaptive immune cells. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including preventing the proteolytic cleavage of MICA/B from cancer cells.
Cullinan Florentine: Acquired an exclusive license from the German Cancer Research Center (DKFZ) and the University of Tübingen to develop CLN-049, a novel FLT3 x CD3 bispecific antibody for the treatment of patients with acute myeloid leukemia (AML).

CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. Cullinan submitted an IND to the U.S. Food and Drug Administration ("FDA") for its first-in-human clinical trial evaluating CLN-049 in relapsed or refractory AML patients in January 2021. After receiving FDA feedback, Cullinan is updating the clinical protocol and intends to resubmit its IND in mid-2021.
Cullinan Amber: Launched Cullinan Amber, a company focused on developing a next generation immuno-oncology platform to deliver immune-stimulatory cytokine combinations with an enhanced therapeutic window for the treatment of cancer.

Cullinan Amber’s lead program, CLN-617, is a fusion protein uniquely combining in a single agent two potent antitumor cytokines, IL-2 and IL-12, with a collagen-binding domain for the treatment of solid tumors. The collagen-binding domain engineered into CLN-617 is designed to retain cytokines in the tumor microenvironment following intratumoral administration, thereby minimizing systemic dissemination and associated toxicities while prolonging immunostimulatory antitumor activity. In preclinical studies, murine surrogates of CLN-617 demonstrated robust single agent antitumor activity in both injected and non-injected contralateral tumors without inducing systemic toxicity. Cullinan expects to submit an IND for CLN-617 in 2022.
Cullinan NexGem: Initiated IND-enabling studies for CLN-978, an internally derived asset that seeks to address the limitations of existing CD19 bispecific antibodies.

CLN-978 is a half-life extended, humanized, single-chain T cell engager designed to simultaneously engage CD19 on target cancer cells and CD3 on T cells, triggering redirected T cells to lyse the target cancer cells. In addition to CD19 and CD3 binding domains, CLN-978 has a human serum albumin binding domain, which is designed to prolong half-life. Several design components of CLN-978, including its high affinity binder to CD19, its serum half-life extension component and its overall stability, are intended to address limitations related to blinatumomab, the only CD19-targeting bispecific T cell engager approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia, or ALL. Cullinan expects to submit an IND for CLN-978 in 2022.
2020 and Recent Corporate Highlights:

Executed a strategic collaboration and licensing agreement in December 2020 with Zai Lab (Shanghai) Co., Ltd. ("Zai Lab") to develop and commercialize CLN-081 in Greater China.
Raised $131.2 million in gross proceeds from an oversubscribed Series C financing in December 2020, which broadened Cullinan’s shareholder base to include additional leading life sciences focused institutions.
Completed an oversubscribed initial public offering (IPO). In January 2021, Cullinan announced the closing of its IPO of 13,685,000 shares of common stock, including the exercise in full by the underwriters of their over-allotment option, at a public offering price of $21.00 per share for gross proceeds of $287.4 million before deducting underwriting discounts and commissions and other offering expenses.
Strengthened and expanded Cullinan’s management team and Board of Directors in 2020 by promoting Jennifer Michaelson, PhD, to Chief Development Officer, Biologics, and by adding Jon Wigginton, M.D. as Chief Medical Officer, Jeff Trigilio as Chief Financial Officer, and Raymond T. Keane, Esq. as Chief Legal Officer, along with Stephen Webster to its Board of Directors.
Financial Results for Full Year 2020

Cash Position: Cash, cash equivalents and short-term investments were $210.2 million as of December 31, 2020, compared to $98.6 million as of December 31, 2019. This does not include $264.7 million in net proceeds from the company’s IPO completed in January 2021 nor does it include upfront proceeds from the Zai Lab transaction, which were received in Q1 2021. Net cash used in operating activities was $29.8 million while net cash provided from financing activities was $140.1 million for the year ended December 31, 2020.
R&D Expenses: Research and development expenses were $43.2 million for the year ended December 31, 2020, including $5.9 million of non-cash equity-based compensation expense and $6.4 million of non-cash IPR&D expense related to the Cullinan MICA transaction, which was treated as an asset acquisition.
G&A Expenses: General and administrative expenses were $17.1 million, including $9.0 million of non-cash equity-based compensation expense.
Net loss: The Company’s net loss was $59.5 million for the year ended December 31, 2020, which included $22.8 million of non-cash charges.

On March 30, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments (Press release, IGM Biosciences, MAR 30, 2021, View Source [SID1234577354]).

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"IGM reached a number of important milestones in 2020, including the presentation of encouraging initial results from our Phase 1 trial of IGM-2323 at the 2020 ASH (Free ASH Whitepaper) Annual Meeting and the initiation of our Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and non-Hodgkin’s lymphoma," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "While 2020 was filled with significant accomplishments, we expect that 2021 will be even more productive. We expect to complete dose escalation in the Phase 1 study of IGM-2323 and establish a recommended Phase 2 dose, as well as complete initial dose escalation studies with IGM-8444 and initiate combination clinical studies of IGM-8444 with a standard chemotherapy regimen and with birinapant, our newly licensed Inhibitor of Apoptosis Proteins antagonist. We also expect to file an IND for our IL-15 x PD-L1 antibody, IGM-7354, in 2021."

Pipeline Updates

IGM-2323

Recommended Phase 2 dose expected in 2021. IGM has now cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs and is currently open to enrollment to what is planned to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling to the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the Phase 1 dose escalation study and establish a recommended Phase 2 dose in 2021.
IGM-8444

Additional dose cohorts cleared. IGM has now cleared the first two dose cohorts of the single-agent portion of its Phase 1 clinical study and is currently open to enrollment to the third (3 mg/kg) of four single-agent biweekly dose escalation cohorts. IGM is also currently open to enrollment to its first chemotherapy combination dose cohort and its first single-agent weekly dose cohort. IGM expects to report initial data in solid tumors from the dose escalation portion of this Phase 1 trial in the second half of 2021.
Entered into exclusive licensing agreement with Medivir for birinapant. In January 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. IGM plans to begin clinical testing of birinapant in combination with IGM-8444 this year.
IGM-7354

File Investigational New Drug (IND) application. IGM expects to file an IND application with the U.S. Food and Drug Administration (FDA) in 2021 for IGM-7354 in order to begin clinical testing. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is attached to the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.
Corporate Updates

Completed manufacturing facility. Construction of IGM’s new cGMP manufacturing facility in Mountain View, California has been completed. IGM expects that cGMP manufacturing at this facility will begin in 2021.
Completed upsized underwritten public offering of common stock.In December 2020, IGM closed a public offering of its common stock and prefunded warrants, with gross proceeds of $230.0 million, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Investments: Cash and investments as of December 31, 2020 were $366.3 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2020, R&D expenses were $19.6 million and $65.0 million, respectively, compared to $12.8 million and $35.3 million for the fourth quarter and year ended 2019, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2020, G&A expenses were $5.1 million and $18.3 million, respectively, compared to $3.2 million and $9.2 million for the fourth quarter and year ended 2019, respectively.
Net Loss: For the fourth quarter of 2020, net loss was $24.6 million, or a loss of $0.79 per share, compared to a net loss of $14.8 million, or a loss of $0.49 per share, for the fourth quarter of 2019. For the year ended 2020, net loss was $81.4 million, or a loss of $2.65 per share, compared to a net loss of $43.1 million, or a loss of $4.80 per share, for the year ended 2019.
2021 Financial Guidance
IGM expects full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments.

Conference Call and Webcast
IGM will host a conference call and webcast to discuss this announcement today, March 30, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2447309. A live audio webcast of the event may also be accessed through the "Investors" section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event.