On November 30, 2021 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported the publication of preclinical data regarding application of its proprietary Block–Removed Immunoglobulin Technology (BRITE) to enhance the efficacy of the CD20-targeting rituximab antibody in the presence of the immunosuppressive CA125 protein (Press release, Navrogen, NOV 30, 2021, View Source [SID1234596296]). The peer-reviewed study was published in Oncology Letters (www.spandidos-publications.com/10.3892/ol.2021.13120).

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The study results showed that CA125 can directly bind rituximab and suppress its immune-effector complement–dependent cytotoxicity (CDC) and antibody–dependent cellular cytotoxicity (ADCC) mechanisms of action. Recent clinical evidence suggests that high serum levels of CA125 reduce the effectiveness of rituximab’s clinical activity in patients with follicular lymphoma. In an attempt to overcome CA125-mediated suppression, BRITE was applied to generate antibody variants that were refractory to CA125 binding and retained efficient CDC and ADCC activity in the presence of CA125. BRITE is an engineering platform that generates and selects for proteins that are refractory to immunosuppressive factors. The application of BRITE resulted in the discovery of an antibody (NAV-006) with a single amino acid change that was refractory to CA125 immunosuppression while retaining similar antigen binding and immune-effector activities as the parental rituximab.

Dr. Luigi Grasso, Chief Scientific Officer of Navrogen said, "the findings here are another demonstration of the humoral immunosuppressive effects that proteins such as CA125 can have on antibody-mediated therapies and the opportunities that BRITE technology can bring to overcome their impact. Our BRITE-optimized rituximab NAV-006 will offer a new opportunity to treat CA125-positive follicular lymphoma patients in our efforts to combat this disease."

Navrogen is actively applying BRITE to improve other therapeutic antibodies affected by immunosuppressive factors for internal pipeline candidates and 3rd party collaborators.

On November 30, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that, based on discussions with the U.S. Food and Drug Administration (FDA), Secura Bio has submitted to FDA for the withdrawal of the approval of NDA 205353 for FARYDAK (panobinostat) oral capsules (Press release, Secura Bio, NOV 30, 2021, View Source;panobinostat-nda-301434428.html [SID1234596295]). FARYDAK received accelerated approval in February 2015 for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Secura Bio acquired FARYDAK in March 2019.

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The accelerated approval was based on progression-free survival and consistent with FDA regulations, required further adequate and well-controlled clinical studies to verify and describe the product’s clinical benefit. In its withdrawal submission, Secura Bio noted that, as previously discussed with FDA, it was not feasible for the company to complete the required post-approval clinical studies as designed as part of the accelerated approval process. Because those studies were required to verify and describe the clinical benefit of the drug product, the clinical benefit of FARYDAK has not been confirmed under the specific constraints of the accelerated approval process.

Because of the withdrawal submission, FARYDAK will no longer be discussed at the December 2, 2021 meeting of the Oncologic Drugs Advisory Committee. As provided for by FDA regulations, Secura Bio anticipates FDA publishing a Federal Register notice announcing withdrawal of the approval.

Secura Bio and its partners will continue to market FARYDAK in other markets where it has been approved.

About FARYDAK (panobinostat)

INDICATION

FARYDAK (panobinostat) capsules, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

IMPORTANT SAFETY INFORMATION

WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES

Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK.

Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.

Diarrhea

Severe diarrhea occurred in 25% of patients treated with FARYDAK (panobinostat) capsules. Diarrhea of any grade occurred in 68% of patients treated with FARYDAK compared with 42% of patients in the control arm. Diarrhea can occur at any time. Ensure patients have antidiarrheal medications on hand, and initiate antidiarrheal medication at the onset of diarrhea
Monitor hydration status and electrolyte blood levels at baseline, and weekly (or more often as clinically indicated) during therapy, and correct to prevent dehydration and electrolyte disturbances
Interrupt FARYDAK at the onset of moderate diarrhea (4-6 stools/day
For life-threatening diarrhea (grade 4), permanently discontinue FARYDAK and bortezomib
For severe diarrhea (≥7 stools/day), or IV fluids or hospitalization required (grade 3), interrupt FARYDAK and bortezomib until resolved and restart both at reduced doses
For moderate diarrhea (4-6 stools/day, grade 2), interrupt FARYDAK until resolved and restart at same dose. Consider interruption of bortezomib until resolved and restart at same dose
Cardiac Toxicities

Arrhythmias occurred in 12% of patients treated with FARYDAK compared with 5% of patients in the control arm. Cardiac ischemic events occurred in 4% of patients treated with FARYDAK compared with 1% of patients in the control arm
Do not initiate FARYDAK treatment in patients with history of recent myocardial infarction or unstable angina
ECG abnormalities such as ST-segment depression and T-wave abnormalities occurred more frequently in patients receiving FARYDAK compared with the control arm: 22% vs 4% and 40% vs 18%, respectively
FARYDAK may prolong QT interval. Do not initiate treatment with FARYDAK in patients with a QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities
Arrhythmias may be exacerbated by electrolyte abnormalities. If during treatment with FARYDAK, the QTcF increases to ≥480 msec, interrupt treatment. Correct any electrolyte abnormalities. If QT prolongation does not resolve, permanently discontinue treatment. Obtain ECG at baseline and periodically during treatment. Monitor electrolytes during treatment with FARYDAK, and correct abnormalities as clinically indicated
Hemorrhage

Fatal and serious cases of gastrointestinal and pulmonary hemorrhage occurred
In the phase 3 registration trial, 5 patients receiving FARYDAK, compared with 1 patient in the control arm, died due to a hemorrhagic event. All 5 patients had grade ≥3 thrombocytopenia at the time of the event
Grade 3/4 hemorrhage was reported in 4% of patients treated with FARYDAK and 2% of patients in the control arm
Monitor platelet counts and transfuse as needed
Myelosuppression

FARYDAK causes myelosuppression including severe thrombocytopenia, neutropenia, and anemia. Obtain a baseline CBC, and monitor the CBC weekly during treatment (or more often if clinically indicated or in patients >65 years of age)
Thrombocytopenia
In the phase 3 registration trial, 67% of patients treated with FARYDAK developed Grade 3/4 thrombocytopenia compared with 31% in the control arm
Thrombocytopenia led to treatment interruption and/or dose modification in 31% of patients receiving FARYDAK
For patients receiving FARYDAK, 33% required platelet transfusion
For patients with platelet count <50 x 109/L with bleeding (grade 3) or <25 x 109/L (grade 4)
Interrupt FARYDAK therapy and monitor platelets at least weekly until ≥50 x 109/L, and restart at reduced dose
Interrupt bortezomib until thrombocytopenia resolves ≥50 x 109/L
If only 1 dose of bortezomib was omitted prior to correction to these levels, restart bortezomib at same dose
If ≥2 doses were omitted consecutively, or within the same cycle, restart at a reduced dose
For patients with platelet count <50 x 109/L (grade 3), maintain FARYDAK and bortezomib doses and monitor platelet counts at least weekly
For patients with severe thrombocytopenia, consider platelet transfusions
Discontinue FARYDAK if thrombocytopenia does not improve despite the recommended treatment modifications or if repeated platelet transfusions are required
Neutropenia
Severe neutropenia occurred in 34% of patients treated with FARYDAK compared with 11% of patients in the control arm
Neutropenia led to treatment interruption and/or dose modification in 10% of patients receiving FARYDAK
Use of granulocyte-colony stimulating factor (G-CSF) was 13% in patients treated with FARYDAK (panobinostat) capsules
For patients with ANC <0.5 x 109/L (grade 4)
Interrupt FARYDAK and bortezomib therapy until ANC is ≥1.0 x 109/L. Restart FARYDAK at reduced dose
If only 1 dose of bortezomib was omitted prior to correction to these levels, restart at same dose. If ≥2 doses of bortezomib were omitted consecutively, or within the same cycle, restart at reduced dose
For patients with ANC <1.0 x 109/L (grade 3) and febrile neutropenia (any grade)
Interrupt FARYDAK and bortezomib therapy until febrile neutropenia is resolved and ANC >1.0 x 109/L
Restart FARYDAK at reduced dose
If only 1 dose of bortezomib was omitted prior to correction to these levels, restart at same dose. If ≥2 doses of bortezomib were omitted consecutively, or within the same cycle, restart at reduced dose
For patients with ≥2 occurrences of ANC between 0.5 – 0.75 x 109/L (grade 3)
Interrupt FARYDAK therapy until ANC ≥1.0 x 109/L, and restart at same dose
Maintain bortezomib dose
For patients with ANC between 0.75 – 1.0 x 109/L (grade 3)
Maintain FARYDAK and bortezomib doses
For grade 3 or 4 neutropenia, consider dose reduction and/or the use of growth factors
Discontinue FARYDAK if neutropenia does not improve despite dose modifications, CSF, or in case of severe infection
Anemia
For patients with hemoglobin <8 g/dL (grade 3), interrupt FARYDAK until hemoglobin ≥10 g/dL. Restart at reduced dose
Infections

Severe infections occurred in 31% of patients (including 10 deaths) treated with FARYDAK compared with 24% of patients (including 6 deaths) in the control arm
FARYDAK treatment should not be initiated in patients with active infections
Monitor patients for signs and symptoms of infections during treatment; if a diagnosis of infection is made, institute appropriate anti-infective treatment promptly and consider interruption or discontinuation of FARYDAK
Hepatotoxicity

Hepatic dysfunction, primarily elevations in aminotransferases and total bilirubin, occurred in patients treated with FARYDAK
Monitor liver function prior to and regularly during treatment. If abnormal liver function tests are observed, consider dose adjustments. Follow patient until values return to normal or pretreatment levels
Avoid use in patients with severe hepatic impairment
Reduce the starting dose of FARYDAK to 15 mg or 10 mg in patients with mild or moderate hepatic impairment, respectively
Embryo-Fetal Toxicity

FARYDAK can cause fetal harm when administered to a pregnant woman
If FARYDAK is used during pregnancy, or if the patient becomes pregnant while taking FARYDAK, the patient should be apprised of the potential hazard to the fetus
Advise females of reproductive potential to avoid becoming pregnant while taking FARYDAK
Advise sexually active females of reproductive potential to use effective contraception while taking FARYDAK, and for at least 3 months after the last dose of FARYDAK
Advise sexually active men to use condoms while on treatment, and for at least 6 months after their last dose of FARYDAK
DRUG INTERACTIONS

Reduce dose to 10 mg when coadministered with strong CYP3A inhibitors. Instruct patients to avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice
Avoid the concomitant use of strong CYP3A inducers
Avoid coadministration with sensitive CYP2D6 substrates or CYP2D6 substrates that have a narrow therapeutic index. If concomitant use of CYP2D6 substrates is unavoidable, monitor patients frequently for adverse reactions
Concomitant use of antiarrhythmic medicines, and other drugs that are known to prolong the QT interval, is not recommended. Antiemetic drugs with known QT-prolonging risk can be used with frequent ECG monitoring
ADVERSE REACTIONS

The most common adverse reactions (incidence of at least 20%) in clinical studies are diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, and vomiting
The most common nonhematologic laboratory abnormalities (incidence ≥40%) are hypocalcemia, hypophosphatemia, hypoalbuminemia, hypokalemia, hyponatremia, and increased creatinine. The most common hematologic laboratory abnormalities (incidence ≥60%) are thrombocytopenia, lymphopenia, leukopenia, neutropenia, and anemia
Serious adverse events (SAEs) occurred in 60% of patients in the FARYDAK arm. The most frequent (≥5%) treatment-emergent SAEs reported for patients treated with FARYDAK were pneumonia, diarrhea, thrombocytopenia, fatigue, and sepsis

On November 30, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported the closing of its previously announced private placement of equity (Press release, Regulus, NOV 30, 2021, View Source [SID1234596294]). The Company received gross proceeds of approximately $34.6 million from the sale of 58,923,352 shares of the Company’s common stock ("Common Stock") at a purchase price of $0.36 per share. In addition, the Company sold 3,725,720 shares of non-voting Class A-4 convertible preferred stock, in lieu of shares of Common Stock, at a price of $3.60 per share. Each share of non-voting Class A-4 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction for non-clinical and clinical development activities for its product candidates and general corporate purposes. SVB Leerink acted as the lead placement agent for the financing. H.C. Wainwright and Co. acted as co-placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Additional details regarding the private placement are included in the current reports on Form 8-K filed with the Securities and Exchange Commission on November 24, 2021 and November 30, 2021.

On November 30, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the novel drug olverembatinib has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test (Press release, Innovent Biologics, NOV 30, 2021, View Source [SID1234596293]). Olverembatinib is the sixth approved product and the second approved small-molecule drug of Innovent.

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Olverembatinib is a potentially best-in-class drug that developed by Ascentage Pharma and supported by the major new drug project of the Ministry of Science and Technology. Innovent and Ascentage will be mutually committed to the commercialization of olverembatinib in China market. As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval addresses an important unmet treatment need in T315I-mutant CML, bringing benefits for more patients and their families.

This approval for olverembatinib is based on the results from two pivotal Phase II studies – the HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and deepness of clinical response is expected to increase with prolonged treatment period.

CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for an effective treatment.

The leading principal investigator of olverembatinib in China, Prof. Xiaojun Huang, MD, Director of the Institute of Hematology, Peking University, Director of the Hematology Department at Peking University People’s Hospital, commented: "Efficacy and safety data from studies to date have consistently showed that olverembatinib has enormous potential in effectively addressing the unmet medical need in the treatment of chronic myeloid leukemia, and is a drug with best-in-class potential. The clinical progress with this novel therapeutic has also received widespread interest from the global hematology community over the years. I am excited that olverembatinib is now approved in China, as it finally brings about a breakthrough to the clinical conundrum caused by drug-resistance and a milestone in the treatment of CML. In a broad sense, this approval also signifies that China is rapidly emerging as an important player in hematology clinical development in the global landscape."

The principal investigator of olverembatinib in China, Prof. Qian Jiang, MD, Deputy Director of the Hematology Department at Peking University People’s Hospital, noted: "First- and second-generation TKIs are ineffective in patients with T315I-mutant CML-CP and CML-AP, and drug-resistant CML has been long presented as an urgent unmet clinical need. This approval for olverembatinib bears great significance for doctors and patients, offering a breakthrough to the CML treatment landscape. I am convinced that the approval of olverembatinib will bring new hope to adult patients with CML."

Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated: "We are pleased about the NDA approval of olverembatinib in China, which further strengthens Innovent’s franchise in oncology and hematology area by adding a new generation anti-cancer therapy to our commercial portfolio. In oncology area, Innovent has a robust pipeline of up to 20 assets, an industry-leading product development team, and a broad channel coverage with a commercial team of nearly 3000 people. We look forward to collaborating with Ascentage Pharma for the co-commercialization of olverembatinib, in order to bring forth this novel drug to solve the unmet medical needs from Chinese TKI-resistant T315I-mutated CML patients as early as possible."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said: "This approval for olverembatinib, Ascentage Pharma’s first product entering commercialization, marks a very encouraging milestone in our transition from a R&D-driven biotech into a full-fledged biopharmaceutical company with a commercialized product. At present, we are collaborating with Innovent to go full steam ahead to the buildout of the commercial infrastructure for olverembatinib, Meanwhile, we are partnering with key stakeholders such as genetic testing companies, commercial insurance companies, and online pharmacies, in order to bring this global-leading China-developed novel therapy to patients as soon as possible. We are honored about our commitment to global innovation and our mission of addressing unmet clinical needs in China and around the world. Moving forward, we will continue to explore additional indications of this drug, advance its clinical development overseas, and accelerate the global development of other drug candidates in our pipeline to further solidify our global presence. "

About Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a malignancy caused by the clonal proliferation of hematopoietic stem cell in the bone marrow. Also referred to as chronic myelocytic leukemia, CML is one of the most common subtypes of chronic leukemia, accounting for 15% of all leukemia cases in adults. According to epidemiology data, the onset of CML in Chinese patients happens at a younger age than that in the West; the median age of onset of CML in China is around 45 – 50 years old, while it is 67 years old in the West.

BCR-ABL tyrosine kinase inhibitors (TKIs) have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, therefore the mutation had long been a clinical obstacle undermining patients’ long-term survival.

About Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, the orally active, third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant chronic myeloid leukemia (CML). Olverembatinib can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.

In October 2020, olverembatinib was granted the Priority Review status by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients resistant to TKIs and with T315I-mutant chronic phase CML (CML-CP) and accelerated phase CML (CML-AP). In March 2021, it was granted the Breakthrough Therapy designation by the CDE. In overseas, olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. In May 2020, olverembatinib was sequentially granted an Orphan Drug designation and Fast Track designation by the US FDA. In November 2021, olverembatinib was granted an Orphan Designation by the European Union. Furthermore, since 2018, the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings for four consecutive years, and was nominated for "Best of ASH (Free ASH Whitepaper)" in 2019.

In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

*Olverembatinib has not been approved for any indication in the U.S.

Results from the two pivotal Phase II studies

1) The HQP1351CC201 study in patients with CML-CP

HQP1351CC201 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-CP who have received prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major cytogenetic response (MCyR).

As of data cut-off date of August 25, 2020, the median duration of follow-up in patients with CML-CP was 13.0 months (range: 7.2-16.3). Of the 31 patients evaluable for hematologic responses, all 31 (100%) patients achieved a complete hematologic response (CHR); In the 41 patients evaluable for cytogenetic responses, 31 (75.6%) patients achieved a MCyR, including 28 (68.3%) with complete cytogenetic response (CCyR), and 3 (7.3%) with partial cytogenetic response (PCyR); Among the 41 patients evaluable for molecular responses, 23 (56.1%) achieved a major molecular response (MMR). The 12-month progression-free survival (PFS) was 85.7% (95% CI: [63.6%-94.9%]) and the overall survival (OS) was 100% (95% CI: [100.0% -100.0%].

2) The HQP1351CC202 study in patients with CML-AP

HQP1351CC202 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-AP and resistance to TKIs developed on prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major hematologic response (MaHR).

As of data cut-off date of July 27, 2020, the median duration of follow-up in patients with CML-AP was 14.3 months (range: 6.6-15.2). Of the 17 patients evaluable for hematologic responses, 12 (70.6%) patients achieved a major hematologic response (MaHR), including 11 (64.7%) with CHR and 1 (5.9%) with no evidence of leukemia (NEL); Among the 17 evaluable patients, 8 (47.1%) achieved a MCyR, all of whom achieved (47.1%) a CCyR, and another 7 (41.2%) achieved MMR. The 12-month PFS was 73.3% (95% CI: [43.3%-89.1%]), and the 12-month OS was 88.2% (95% CI: [60.6%-96.9%].

On November 30 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to offer 17,500,000 shares of its common stock in an underwritten public offering (Press release, MEI Pharma, NOV 30, 2021, View Source [SID1234596292]). In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering. LifeSci Capital is acting as co-manager.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.