On August 6, 2024 Thermo Fisher Scientific Inc., the world leader in serving science, reported that its SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices (Press release, Thermo Fisher Scientific, AUG 6, 2024, View Source [SID1234645447]). Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults.

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

                  Schedule Your 30 min Free Demo!

Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.

While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and may play a role in many immune-mediated conditions. Thermo Fisher’s Transplant Diagnostics business is committed to leveraging its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.

"We are thrilled to expand the labeling of our companion diagnostic SeCore CDx HLA A Sequencing System to include TECELRA and to support clinicians in identifying which patients may benefit from this first-of-its-kind treatment," says Tina Liedtky, president, Transplant Diagnostics, Thermo Fisher Scientific. "Our knowledge of the human immune system and how it might impact treatment options across the healthcare continuum continues to evolve. We look forward to ongoing opportunities to collaborate with innovative companies like Adaptimmune to expand patient access to breakthrough treatments that improve quality of life."

For more information about the SeCore CDx HLA Sequencing System, visit www.thermofisher.com/us/en/home/clinical/transplant-solutions/pre-transplant-testing/hla-typing.html

For full TECELRA Prescribing Information, including Important Safety Information, visit www.tecelra.com.

On August 6, 2024 AbCellera (Nasdaq: ABCL) reported financial results for the second quarter of 2024 (Press release, AbCellera, AUG 6, 2024, View Source [SID1234645446]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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

                  Schedule Your 30 min Free Demo!

"This quarter, we made important progress on our internal pipeline and aim to submit applications for clinical trials for ABCL635 and ABCL575 in the second quarter of 2025. In parallel, we have focused preclinical work on our T-cell engager platform to four molecules for indications in oncology and autoimmunity," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Since our last earnings release, two of our partners have achieved notable milestones, including Abdera’s IND clearance and Fast Track designation for ABD-147 and Invetx’s upcoming acquisition by a global leader in animal health. AbCellera is a founding partner of both Abdera and Invetx. In addition, we have recently announced an expansion of our partnership with Lilly."

Q2 2024 Business Summary

ABCL635 and ABCL575 remain on track for anticipated Clinical Trial Applications (CTAs) in the second quarter of 2025.
Disclosed three T-cell engager programs under evaluation targeting PSMA, B7-H4, and CD-19.
The U.S. FDA cleared Abdera’s Investigational New Drug (IND) application for ABD-147, and also granted it a Fast Track designation. AbCellera is a founding partner in Abdera, has a low-single-digit royalty stake in Abdera’s programs, and has a mid-single-digit equity ownership position.
Reported the start of three additional partner-initiated programs with downstreams to reach a cumulative total of 93 partner-initiated program starts with downstreams.
Reported the addition of one molecule in the clinic, bringing the cumulative total to 14 molecules advanced to the clinic.
Recent Developments

On July 31, 2024, announced an expanded collaboration with Lilly to discover therapeutic antibodies for programs in immunology, cardiovascular disease, and neuroscience.
On July 18, 2024, Invetx announced its upcoming acquisition by Dechra Pharmaceuticals for up to $520 million in total consideration. AbCellera is a founding partner in Invetx, has a low-single-digit royalty stake in Invetx’s programs, and has a mid-single-digit equity ownership position.
Key Business Metrics

Cumulative Metrics

June 30, 2023

June 30, 2024

Change %

Partner-initiated program starts with downstreams

80

93

16 %

Molecules in the clinic

9

14

56 %

AbCellera started discovery on an additional three partner-initiated programs with downstreams to reach a cumulative total of 93 partner-initiated program starts with downstreams in Q2 2024 (up from 80 on June 30, 2023). AbCellera’s partners have advanced a cumulative total of 14 molecules into the clinic (up from nine on June 30, 2023).

Discussion of Q2 2024 Financial Results

Revenue – Total revenue was $7.3 million, compared to $10.1 million in Q2 2023. Partnerships generated research fees of $5.5 million, compared to $9.8 million in Q2 2023. Milestone payments contributed $1.5 million in the quarter.
Research & Development (R&D) Expenses – R&D expenses were $40.9 million, compared to $36.5 million in Q2 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $3.8 million in Q2 2023.
General & Administrative (G&A) Expenses – G&A expenses were $20.2 million, compared to $15.5 million in Q2 2023.
Net Loss – Net loss of $36.9 million, or $(0.13) per share on a basic and diluted basis, compared to net loss of $30.5 million, or $(0.11) per share on a basic and diluted basis in Q2 2023.
Liquidity – $697.6 million of total cash, cash equivalents, and marketable securities and with approximately $220 million in available non-dilutive government funding to execute on AbCellera’s strategy, bringing total available liquidity to over $900 million.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On August 6, 2024 Nammi Therapeutics, Inc. (Nammi) reported a $1M investment commitment by the Myeloma Investment Fund (MIF) in a $30M Series B financing round prior to the planned start of a first-in-human Phase 1 study of our lead program, QXL138AM, in patients with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma (Press release, Nammi Therapeutics, AUG 6, 2024, View Source [SID1234645445]).

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

                  Schedule Your 30 min Free Demo!

QXL138AM is a Masked Immunocytokine (MIC) comprised of a masked interferon alpha (IFNa) fused to an antibody that targets the CD138 protein on the surface of the tumor cells. Once QXL138AM binds to the tumor cell, proteases on the cell surface cleave the mask off of the IFNa allowing it to bind its receptor. Activation of the IFNa receptor complex induces direct killing of tumor cells in addition to activating innate and adaptive anti-tumor immunity. Preclinical data has demonstrated significant anti-tumor efficacy across more than 10 tumor types including multiple myeloma where complete regression at doses as low as 0.1 mg/kg have been observed. Nammi has secured Orphan Drug Designation in multiple myeloma from the FDA on the strength of this data.

"While the multiple myeloma field has greatly benefitted from development of bispecific and cell therapies, there unfortunately remains a significant need for novel therapeutics such as QXL138AM.", said David Stover, Ph.D., President and CEO of Nammi. "We are very excited to partner with MIF and the Multiple Myeloma Research Foundation (MMRF) and leverage their expertise to accelerate the development of QXL138AM. Together, we will work to realize the potential of this therapy to improve the lives of patients with multiple myeloma."

With this investment by MIF, Nammi anticipates the $30M Series B financing round will be fully subscribed upon its closing when the first patient has been treated with QXL138AM.

"Nammi’s innovative technology and its application in multiple myeloma is an important step for the myeloma patient community," said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. "Advancing new therapeutic options for patients is the most critical task-at-hand, so we are thrilled to support Nammi’s Phase-1 trial to learn the potential of this exciting new immunotherapy approach."

On August 6, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Compugen, AUG 6, 2024, View Source [SID1234645444]).

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

                  Schedule Your 30 min Free Demo!

"Continuing our track record in delivering on our plans, we have executed well in the second quarter of 2024," said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We achieved FDA IND clearance for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics, triggering a right to receive a $30 million milestone payment from our partner Gilead. We are on track to initiate a Phase 1 clinical trial for COM503, as monotherapy and in combination with the anti-PD1 zimberelimab in advanced solid tumors, in the fourth quarter of 2024."

Dr. Cohen-Dayag continued, "We are also on track to present data from our COM701 + COM902 + pembrolizumab study in platinum resistant ovarian cancer in the fourth quarter of 2024. There is a significant unmet medical need for women with ovarian cancer who could benefit from potentially safe, efficacious and durable alternative treatment options. We previously demonstrated encouraging data in this patient population, including monotherapy activity, overall response rate of 20% and durable responses with some patients benefiting from treatment for over 16 months comparing favorably to standard of care. We believe showing data consistent with what we have previously reported in this indication, will once again confirm that COM701 combinations are active. We plan to share next steps for COM701 combinations at the time of data presentation in the fourth quarter of 2024."

Dr. Cohen-Dayag added, "Our partner, AstraZeneca, is advancing development of rilvegostomig, their PD-1/TIGIT bispecific, and provided a non-risk-adjusted peak year revenue target of more than $5 billion for this asset, reflecting the potential of rilvegostomig. Compugen is eligible for future milestones and mid-single-digit tiered royalty payments, presenting a significant potential revenue source for the Company."

Upcoming Expected Milestones

COM701 +COM902 + pembrolizumab proof-of-concept study

Platinum resistant ovarian cancer – data presentation in the fourth quarter of 2024
COM503 (licensed to Gilead; Compugen leads through Phase 1 development)

Initiation of COM503 Phase 1 trial in the fourth quarter of 2024
Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)

AstraZeneca anticipates data from Phase 1/2 ARTEMIDE-01 trial in the second half of 2024; poster presentation from Phase 2 GEMINI-Gastric trial accepted at ESMO (Free ESMO Whitepaper) 2024
Second Quarter 2024 Financial Highlights

Cash: As of June 30, 2024, Compugen had approximately $92.3 million cash, cash equivalents, short-term bank deposits, restricted cash and short-term bank deposit, and cash investments, compared with approximately $51.1 million as of December 31, 2023. Compugen expects that its cash and cash-related balances together with the additional expected $30 million milestone payment on COM503 IND clearance achieved in July, which is subject to a 15% withholding tax, will be sufficient to fund its operating plans into 2027. The Company has no debt.

Revenues: Compugen reported approximately $6.7 million in revenues for the second quarter ended June 30, 2024, compared to no revenues for the comparable period in 2023. The revenues reported reflect recognition of a portion of the upfront payment from the license agreement with Gilead and the clinical milestone from the license agreement with AstraZeneca in the amount of $5 million.

R&D expenses for the second quarter of 2024 were approximately $6.2 million compared with approximately $7.8 million for the comparable period in 2023.

G&A expenses for the second quarter of 2024 were approximately $2.2 million, compared with approximately $2.4 million for the comparable period in 2023.

Net loss for the second quarter of 2024 was approximately $2.1 million, or $0.02 per basic and diluted share, compared with a net loss of approximately $9.3 million, or $0.11 per basic and diluted share, in the second quarter of 2023.

Full financial tables are included below.

Conference Call and Webcast Information

Compugen will hold a conference call today, August 6, 2024, at 8:30 AM ET to review its second quarter 2024 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on Compugen’s website.

On August 6, 2024 Servier reported that the U.S. Food and Drug Administration (FDA) has approved VORANIGO, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection (Press release, Servier, AUG 6, 2024, View Source [SID1234645443]). VORANIGO is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill.

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

                  Schedule Your 30 min Free Demo!

Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age. They are not curable with current therapies and without treatment they continue to grow and infiltrate normal brain tissue.

"Today’s approval of VORANIGO is an enormous leap forward in cancer care, and a defining moment for people living with Grade 2 IDH-mutant glioma," said Arjun H. Prasad, Chief Commercial Officer, Servier Pharmaceuticals. "VORANIGO, which is the first breakthrough in this specific disease area in nearly 25 years, offers patients unprecedented improvement in progression free survival. We are proud to deliver this first-of-its-kind therapy to patients in need, and we remain committed to bringing innovative targeted therapies to people with cancer."

In healthy human cells, a family of genes called isocitrate dehydrogenases (IDH) help break down nutrients and generate energy for cells. Mutations in IDH1 and IDH2 are associated with a variety of cancers, where they prevent cells from differentiating, or specializing, into the kind of cells they are ultimately supposed to become. When cells cannot differentiate properly, they may begin to grow out of control.4 In IDH-mutant gliomas, VORANIGO works by reducing the activity of the mutant IDH1 and IDH2 enzymes, to help control the disease.

"Patients living with Grade 2 IDH-mutant gliomas have long faced the harsh reality of an incurable disease with very limited post-surgery treatment options," said Ralph DeVitto, President & CEO, of the American Brain Tumor Association. "The FDA approval of VORANIGO marks a monumental breakthrough in glioma treatment, offering renewed hope for patients and their families living with this relentless disease."

The approval of VORANIGO is supported by results from the pivotal Phase 3 INDIGO clinical trial published in The New England Journal of Medicine and presented during the Plenary Session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which showed that VORANIGO significantly extended progression free survival and time to next intervention, when compared to placebo. The INDIGO study showed that VORANIGO was well tolerated, and its safety profile was consistent with results from the Phase 1 studies. The most common (≥15%) adverse reactions were fatigue, COVID-19, musculoskeletal pain, diarrhea and seizure.5

"Glioma is a unique cancer. Many of the patients I’ve met are in their 30’s and 40’s and in the prime of their lives. They have small children and are at the height of their careers. A glioma diagnosis is devastating. VORANIGO can offer patients and their families hope for the future," said David K. Lee, CEO, Servier Pharmaceuticals. "As we advance more targeted therapies, identifying mutations and understanding how these mutations impact cancer and its progression are key to helping the right patients find the right treatment, at the right time. We are humbled to lead the field of IDH-mutant inhibition, and we are committed to researching its applicability in glioma and other cancers."

About the INDIGO Phase 3 Trial (NCT04164901)5
INDIGO, the pivotal Phase 3 clinical trial, met its major efficacy outcome of progression free survival (PFS) per a blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The major efficacy outcome, PFS was statistically significant and clinically meaningful in favor of the vorasidenib arm. Median PFS was 27.7 months in the vorasidenib group, compared with 11.1 months in the placebo group (Hazard Ratio [HR], 0.39; 95% Confidence Interval [CI], 0.27 to 0.56; 1-sided P<0.001). TTNI was also statistically significant (HR, 0.26; 95% CI, 0.15 to 0.43; 1-sided P<0.001). Median TTNI was not reached for vorasidenib and was 17.8 months for placebo. Vorasidenib was also shown to reduce the tumor volume by a mean of 2.5% (TGR of –2.5%; 95% CI: -4.7% to -0.2%) every 6 months, while tumor volume increased by a mean of 13.9% (TGR of 13.9%; 95% CI: 11.1% to 16.8%) every 6 months for patients randomized to the placebo arm, as measured by a BIRC.

The INDIGO study showed that vorasidenib was well tolerated, and its safety profile was consistent with results from the Phase 1 studies.

INDIGO was a registration-enabling Phase 3 global, randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent Grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment.

About Glioma6
Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:

Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
Oligodendroglioma, IDH-mutant and1p19q-codeleted (CNS WHO grades 2-3)
Glioblastoma, IDH-wildtype (CNS WHO grade 4)