On September 26, 2023 Omega therapeutics presented its corporate presentation (Presentation, Omega Therapeutics, SEP 26, 2023, View Source [SID1234635413]).

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On September 26, 2023 Mythic Therapeutics, a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer (NSCLC) with cMET overexpression (Press release, Mythic Therapeutics, SEP 26, 2023, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-receives-fda-fast-track-designation-for-mytx-011-for-patients-with-non-small-cell-lung-cancer-nsclc-with-cmet-overexpression [SID1234635412]). This designation encompasses NSCLC patients with any level of cMET overexpression, including low and intermediate.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Receiving Fast Track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments," said Brian Fiske, PhD, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. "We are proud of this significant milestone as it highlights the potential of MYTX-011, which is enabled by our FateControl platform, to expand ADC therapy to more NSCLC patients."

Fast Track designation is intended to aid the development and expedite the review of drugs to treat serious and life-threatening conditions with unmet medical needs, with the goal of reaching patients earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s clinical trial designs and development plans.

"While a small fraction of NSCLC tumors highly express cMET, a much broader patient population have tumors which overexpress cMET, but at lower levels," said KisMET-01 study investigator Rebecca Heist, MD, MPH, Massachusetts General Hospital. "It’s important we continue investigating the potential of MYTX-011 for patients with NSCLC who need new approaches to treating their cancer as many either do not respond to, or develop resistance to, existing treatment options."

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

On September 26, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2023 (Press release, MEI Pharma, SEP 26, 2023, View Source [SID1234635411]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Over just the next few quarters we look forward to data readouts from two ongoing clinical studies of voruciclib and ME-344, advancing our strategy of assessing drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs," said David M. Urso, president and chief executive officer of MEI Pharma. "Focusing on the execution of these two clinical studies – voruciclib evaluated in combination with Venclexta in acute myeloid leukemia and ME-344 in combination with Avastin in colorectal cancer – we expect data readouts beginning with voruciclib early in calendar 2024 and in the first half of 2024 for ME-344. Positive data from the studies would provide important support for the further development of these therapies to address significant unmet medical needs among patients with acute myeloid leukemia and colorectal cancer."

Fiscal Year 2023 and Recent Highlights

•
In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.

•
In July 2023, at the Company’s Special Meeting of Stockholders, MEI did not obtain the necessary stockholder votes to approve a merger agreement for an all-stock transaction pursuant to which Infinity Pharmaceuticals would have become a wholly-owned subsidiary of the Company. The certified results showed that 59.70% of outstanding shares were voted, of which 47.86% voted in favor of the proposed transaction, and 51.44% against. Accordingly, MEI terminated the merger agreement.

•
In June 2023, in connection with the Company’s succession plan, David M. Urso was appointed president and chief executive officer and also joined the Company’s board of directors. Mr. Urso replaced Daniel P. Gold, Ph.D., president and chief Executive officer of MEI since 2010. Dr. Gold continues to serve on MEI’s board. In June 2023, also as part of the Company’s succession planning, it was announced that Jay File would be appointed chief financial officer, replacing Brian Drazba. Mr. File’s appointment became effective on August 1, 2023.
•
In May 2023, MEI announced an update to the ongoing Phase 1 study evaluating voruciclib, its oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a BCL2 inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies. The Company announced that early results demonstrated that voruciclib alone or in combination with venetoclax was generally well tolerated with no significant myelosuppression. The results further demonstrated encouraging clinical activity in heavily pretreated patients administered with voruciclib alone and at the initial dose level in combination with venetoclax. These early results are consistent with the hypothesis that voruciclib may address a common venetoclax resistance mechanism by inhibiting MCL-1 via CDK9 inhibition.
•
In May 2023, MEI regained compliance with the Nasdaq minimum bid requirement after the Company implemented a 1-for-20 reverse stock split in April 2023. The reverse stock split was approved by MEI’s stockholders on January 5, 2023.

•
In March 2023, the Safety Review Committee of the Phase 1 study evaluating voruciclib plus venetoclax completed a safety assessment of the initial dose escalation cohort evaluating the combination in patients with AML and recommended opening the next cohort. The combination stage of the study started after completing the single-agent dose exploration stage of the Phase 1 study in patients with either AML or B-cell malignancies.

•
In December 2022, MEI announced a realignment of its clinical development efforts following the discontinuation of zandelisib, its PI3K delta inhibitor drug candidate. As part of the realignment, the Company disclosed plans to streamline the organization towards the development of its two earlier clinical-stage assets, voruciclib and ME-344. We currently have 41 employees, which reflects a 61% reduction in full-time employees since our announcement in December 2022.

•
In December 2022, after receiving new guidance in an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), MEI and Kyowa Kirin announced the discontinuation of global development of zandelisib outside of Japan. The two companies concluded that a clinical trial consistent with the new FDA guidance, including modification of the then ongoing Phase 3 COASTAL trial, would likely not be feasible to complete within a time period that would support further investment. Kyowa Kirin, after meeting with the Pharmaceuticals and Medical Devices Agency (PMDA), subsequently discontinued zandelisib development in Japan after determining that conducting a randomized study consistent with that agency’s guidance to support a marketing application would also likely not be feasible to complete within a time period that would support further investment. In July 2023, the Company and Kyowa Kirin mutually entered a termination agreement between the parties pursuant to which MEI regained full global rights to zandelisib, subject to Kyowa Kirin receiving some limited rights to use zandelisib for compassionate use.

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
•
Report clinical data from the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.

ME-344 – Mitochondrial inhibitor in Phase 1b Study

•
Report clinical data from the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.

Fiscal Year 2023 Financial Results

•
As of June 30, 2023, MEI had $100.7 million in cash, cash equivalents, and short-term investments with no outstanding debt.

•
For the year ended June 30, 2023, cash used in operations was $52.5 million, compared to $48.7 million during the year ended June 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the close down of zandelisib activities with Kyowa Kirin.

•
Research and development expenses were $52.5 million for the year ended June 30, 2023, compared to $85.6 million for the year ended June 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the close down of development activities announced in December 2022.

•
General and administrative expenses increased by $2.6 million to $33.1 million for the year ended June 30, 2023, compared to $30.5 million for the year ended June 30, 2022. The net increase was primarily related to severance costs due to our staggered reductions in the workforce announced in December 2022 and higher external professional services offset by a decrease in noncash stock-based compensation.

•
MEI recognized revenue of $48.8 million for the year ended June 30, 2023, compared to $40.7 million for the year ended June 30, 2022. The increase in revenue primarily results from the discontinuation of the zandelisib program in December 2022 under our global License, Development and Commercialization Agreement with Kyowa Kirin that resulted in the recognition of $16.6 million of previously deferred revenue related to performance obligations that are being closed and $8.6 million of previously deferred revenue related to performance obligations associated with clinical trials that have not commenced and will no longer be initiated.

•
Net loss was $31.8 million, or $4.78 per share, for the year ended June 30, 2023, compared to net loss of $54.5 million, or $8.75 per share for the year ended June 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of June 30, 2023, compared with 6,657,602 shares as of June 30, 2022.

•
The adjusted net loss (a non-GAAP measure) for the year ended June 30, 2023 and 2022, excluding noncash gains recognized for changes in the fair value of warrants, was $33.4 million and $75.2 million, respectively

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.

Conference Call & Webcast Information

•
When: September 26, 2023, 5:00 p.m. ET

•
Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771 (International)

•
Please ask to join into the MEI Pharma earnings call

Please join the conference call at least 10 minutes early to register. You can access the live webcast here or under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived for at least 30 days after the call.

On September 26, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that several abstracts detailing new selinexor data have been selected to be presented at the 2023 International Myeloma Society (IMS) Annual Meeting, being held September 27-30 in Athens, Greece (Press release, Karyopharm, SEP 26, 2023, View Source [SID1234635410]). In addition, exploratory subgroup analyses from the SIENDO Study in patients with advanced or recurrent TP53 wild-type endometrial cancer will be presented in an oral session, "Abstract Session: Best Oral Session – Endometrial Cancer," at the 2023 European Society of Gynaecological Oncology (ESGO) Congress, being held September 28-October 1 in Istanbul, Turkey.

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"We are pleased to have a number of presentations at IMS and ESGO this year that continue to show the meaningful benefit achieved with selinexor across a number of tumor types," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "The breadth of data to be presented further demonstrates our commitment, as well as that of our collaborators, to develop first-in-class therapies that inhibit XPO1 with the goal to improve outcomes for patients across solid and hematological tumors."

Details for the Karyopharm presentations at ESGO are as follows:

Abstract Title

Presentation
Type

Abstract #

Session Date/Time

Endometrial Cancer

Long-term Follow up of Selinexor
Maintenance for Patients with TP53wt
Advanced or Recurrent Endometrial Cancer: A
Pre-Specified Subgroup Analysis from the
Phase 3 ENGO-EN5/GOG-3055/SIENDO Study

Oral

264

Sunday, October 1, 2023

12:05pm – 12:15 pm
GMT/ 5:05am -5:15am
EST

ENGOT-EN20/GOG-3083/XPORT-EC-042 a
Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter Trial of Selinexor in
Maintenance Therapy for Patients with
TP53wt, Advanced or Recurrent Endometrial
Carcinoma

Poster

265

Saturday, September 30, 2023

15:05-15:50pm
GMT/11:05am – 11:50am

Details for the Karyopharm IMS posters are as follows:

Abstract Title

Presentation
Type

Abstract #

Session Date/Time

Multiple Myeloma

A Phase 3 Randomized, Open-label Trial of
Selinexor, Pomalidomide, and Dexamethasone
Versus Elotuzumab, Pomalidomide, and
Dexamethasone in Patients with Relapsed
or Refractory Multiple Myeloma

Poster

P-323

Thursday, September 28, 2023

12:30pm – 1:30pm EEST/

5:30am -6:30am EST

Effectiveness of anti-B-cell maturation antigen
(BCMA)-targeting therapy after selinexor
treatment

Poster

P-232

Thursday, September 28, 2023

12:30pm – 1:30pm EEST/

5:30am -6:30am EST

In addition, Karyopharm will be featured as part of the following alliance partner and independent investigator posters at IMS:

Abstract Title

Presentation
Type

Abstract #

Session Date/Time

Multiple Myeloma

African American Relapsed/Refractory
Multiple Myeloma Patients Have a Progression
Free Survival Benefit with Selinexor Treatment
in the STORM Study

Poster

P-241

Thursday, September 28, 2023

12:30pm – 1:30pm EEST/

5:30am -6:30am EST

Efficacy, Survival and Safety of Selinexor,
Bortezomib and Dexamethasone (SVD) in
Patients with Lenalidomide-Refractory
Multiple Myeloma: Subgroup Data from the
BOSTON Trial

Poster

P-295

Thursday, September 28, 2023

12:30pm – 1:30pm EEST/

5:30am -6:30am EST

Selinexor, Bortexomib, and Dexamethasone in
Patients with Previously Treated Multiple
Myeloma: Updated Results of BOSTON Trial by
Prior Therapies

Poster

P-297

Thursday, September 28, 2023

12:30pm – 1:30pm EEST/

5:30am -6:30am EST

Investigation of T-cell Fitness and Mechanisms
of Drug Resistance in Selinexor Treated
Patients with Relapsed/Refractory Multiple
Myeloma

Poster

P-396

Friday, September 29, 2023

1:15pm – 2:15pm EEST/

6:15am -7:15am EST

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm’s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.

Please refer to the local Prescribing Information for full details.

Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326
Email: [email protected]

SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.

On September 26, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported its upcoming Research & Development Day on Thursday, October 12, 2023. The event will run from 9:00 a.m. to 12:00 p.m. ET and will be accessible both virtually and in-person in New York, NY. For in-person and virtual attendance, please register here (Press release, In8bio, SEP 26, 2023, View Source [SID1234635409]). The webcast will also be available under the "Events and Presentations" section of the Company’s website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The event will offer the opportunity to gain Key Opinion Leader (KOL) insights into IN8bio’s clinical and scientific programs along with upcoming catalysts. The agenda will feature an overview of gamma-delta T cells and their differentiation for cellular therapies, IN8bio’s cutting-edge manufacturing capabilities, clinical trial design and an overview of the upcoming data presentations at major medical meetings this fall, including Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), Society for Neuro-Oncology (SNO) and abstracts submitted for the American Society of Hematology (ASH) (Free ASH Whitepaper).

The feature presentations include IN8bio’s management team, as well as key oncology thought leaders, including:

Leo Luznik, M.D. is a Professor of Oncology at Johns Hopkins Medicine, renowned for his pioneering contributions to the advancement of allogeneic blood and marrow transplantation. Dr. Luznik is an expert in the mechanisms of anti-tumor immunity and graft versus host disease (GvHD). He is one of the architects of the Hopkins Protocol, which continues to be a mainstay of haplotransplantation for the treatment of leukemias, including in the INB-100 clinical program.

Michael Bishop, M.D. is the Director of the David and Etta Jonas Center for Cellular Therapy at the University of Chicago. Dr. Bishop is a prominent clinical investigator in acute leukemias, with a focus on improving transplant outcomes and preventing relapse. He is a faculty member and on the planning committee of the ASTCT/EBMT Conference on Relapse After Transplant and Cellular Therapy, and will be highlighting gamma-delta T cells as a clinical strategy to prevent relapse.

A live webcast of the presentation can be accessed through the Events and Presentations section of the Company’s website at View Source Following the live event, an archived replay of the webcast will be made available on our website.