Lantern Pharma Enters into Strategic Collaboration with Deep Lens — Partnership Expected to Accelerate Enrollment in Upcoming Phase 2 Clinical Trial for Never-Smokers with Non-Small Cell Lung Cancer

On September 28, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development and Deep Lens, a digital healthcare company focused on enabling faster recruitment of the best-suited cancer patients for clinical trials at the time of diagnosis, reported that they have entered into a strategic collaboration that will leverage Deep Lens’ artificial intelligence clinical trial matching solution, VIPERÔ, creating an end-to-end A.I. enabled drug development pathway that is expected to accelerate trial enrollment for Lantern’s planned Phase 2 clinical trial for never-smokers with non-small cell lung cancer (NSCLC), utilizing LP-300 in combination with chemotherapy (Press release, Lantern Pharma, SEP 28, 2021, View Source [SID1234590408]).

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Lantern is developing oncology therapies by leveraging its proprietary RADR A.I. platform and machine learning to discover biomarker signatures that identify patients most likely to respond to its pipeline of therapeutics. Deep Lens’ proprietary A.I.-based platform, VIPER, identifies, triages and matches cancer patients to clinical trials in real time for which they may be eligible. Together, the companies are addressing two of the most complex and time-consuming parts of the drug development process: matching a novel molecule with a relevant indication and identifying the right patients to participate in clinical trials.

Panna Sharma, President & CEO of Lantern Pharma, stated, "The current drug development model is extremely expensive, with an estimated $2.6 billion in drug development costs for each Food and Drug Administration (FDA)-approved drug. Moreover, based on the estimated 5.3% success rate for oncology drugs, most therapies, will fail to reach commercialization, despite showing efficacy in certain subgroups. Not only do the majority of therapies in development fail to meet safety or efficacy endpoints, but an equally large number, 75% of clinical trials, fail to meet recruitment deadlines, due in large part to enrollment challenges. It is quite apparent that cancer treatment requires a lower cost of care and an increase in the choice and efficacy of precision therapies, which we believe we can deliver through a combination of A.I., machine learning, and large-scale biomarker analytics, with a goal of ultimately crushing the cost of cancer therapy development. For this reason, we are very excited to partner with Deep Lens and create an end-to-end A.I. enabled pathway from drug rescue to patient recruitment."

Mr. Sharma continued, "Our existing A.I. platform allows us to predict drug outcomes and response in very specific patient subsets, while Deep Lens’ VIPER serves as a tool to find and accelerate the enrollment of appropriate patients for clinical trials. We believe this accelerated and efficient process will help more cancer patients to have access to the right medicine at the right time. We hope to leverage this solution across additional trials and combine it with other advanced A.I. technologies that align with our mission of accelerating the timeline and reducing the costs of oncology drug discovery and development."

Lantern Pharma’s approach is to in-license and develop oncology therapies using genomic data, machine learning, and computational biology modeling to identify the patient groups most likely to respond to a therapy, and to clarify the potential underlying mechanisms of action. Lantern’s LP-300 is a small molecule entity that has been studied in multiple randomized, controlled multi-center NSCLC trials. In retrospective analyses of a multi-country Phase 3 trial, LP-300 with chemotherapy demonstrated substantial improvement in overall survival in the never-smoker subgroup. LP-300 is currently in preparation to enter a phase 2 clinical trial for use of LP-300 as a combination therapy for never-smoking NSCLC patients with histologically defined adenocarcinoma. Deep Lens will utilize the patient enrollment criteria identified by Lantern to find this subgroup of patients and match them to the LP-300 clinical trial across Deep Lens’ network of community oncology sites.

"Precision medicine has changed the way we think about treating and identifying certain types of cancer, but it has also significantly increased the complexity of clinical trials. Trials often have very narrow eligibility criteria, making enrollment objectives difficult to meet, and unfortunately, many companies will fail to move along the development path successfully," said Dave Billiter, Chief Executive Officer and Co-Founder of Deep Lens. "Deep Lens leverages their A.I. platform, VIPER, and supporting services to automate the patient identification and screening process, so that trials enroll faster and more efficiently. We believe that leveraging A.I. across multiple phases of drug development will decrease overall time-to-market timelines as well as associated costs. We look forward to partnering with Lantern to help them achieve their trial enrollment goals and to provide access to LP-300 to patients in need as quickly as possible."

Lantern is focused on developing LP-300 as a potential first-in-class combination therapy for never smoking NSCLC patients with histologically defined adenocarcinoma. NSCLC among never smokers has a distinct molecular profile and according to the American Cancer Society, as many as 20% of people who die from lung cancer in the United States every year have never smoked or used any other form of tobacco. Leading researchers have started to classify lung cancer in never and non-smokers as having unique and distinct clinical, biological and pathological characteristics that have the potential to be impacted by new therapeutic options. According to market research and data analytics firm, GlobalData, approximately $10 billion was spent on NSCLC therapies in 2020, across the leading eight markets (by annual drug sales), with approximately $4 billion of this drug spend in the U.S. alone.

Fortress Biotech to Participate in the Benzinga Healthcare Small Cap Conference

On September 28, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the Benzinga Healthcare Small Cap Conference, scheduled to take place from September 29-30, 2021 (Press release, Fortress Biotech, SEP 28, 2021, View Source [SID1234590407]).

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Details of the events are as follows:

Presentation: The company will present a corporate update on Thursday, September 30, 2021, at 11:30 a.m. ET and will participate in one-on-one meetings during the conference.
Panel: Dr. Rosenwald will also participate in a panel discussion entitled, Immuno-Oncology: Harnessing the Human Body’s Power to Battle Cancer, on Thursday, September 30, 2021, at 12:35 p.m. ET.
The live events will stream from this link at the appropriate times. A replay of each event will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com shortly after the meeting for approximately 30 days.

Mustang Bio Announces MB-101 (IL13Rα2‐targeted CAR T cells) Scientific Presentations at Upcoming Virtual Conferences

On September 28, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory and The Heritage Provider Network Professor in Immunotherapy, will present updated Phase 1 clinical data regarding MB-101 (IL13Rα2‐targeted CAR T cells) at two upcoming scientific conferences in October 2021 (Press release, Mustang Bio, SEP 28, 2021, View Source [SID1234590406]).

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Details of the virtual presentations are as follows:

First Annual Conference on CNS Clinical Trials, Co-sponsored by the Society for Neuro-Oncology and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

Title: CAR T Cells in Primary Brain Tumors
Session: Session 3: Immunotherapy – Hype and Hope
Date and Time: Friday, October 1, 2021 at 2:30 PM ET
For more information, please click here.

American Association for Cancer Research Virtual Special Conference: Brain Cancer

Title: Advancing CAR T Cell Therapy for Glioblastoma
Session: Plenary Session 2: Novel Therapeutics
Date and Time: Monday, October 25, 2021 at 1:15 PM ET
For more information, please click here.

Mustang is collaborating with City of Hope on several chimeric antigen receptor T cell clinical trials, including MB‐101 (IL13Rα2‐targeted CAR T cells) clinical trials for brain cancer. Additional information about the brain cancer clinical trials can be found on clinicaltrials.gov using identifiers NCT04661384, NCT02208362 and NCT04003649.

About MB‐101 (IL13Rα2‐targeted CAR T cells)
IL13Rα2 is an attractive target for CAR T therapy as it has limited expression in normal tissue but is overexpressed on the surface of the majority of malignant glioma cells, including glioblastoma multiforme, ependymoma and medulloblastoma. CAR T cells are designed to express a membrane‐tethered IL‐13 receptor ligand (IL‐13) incorporating a single‐point mutation that provides high affinity for IL13Rα2 and reduces binding to IL13Rα1 in order to reduce healthy tissue targeting. Mustang is developing MB‐101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence. MB‐101 includes a second‐generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off‐target Fc interactions, the 4-1BB (CD137) co‐stimulatory signaling domain for improved persistence of CAR T cells and the extracellular domain of CD19 as a selection/safety marker. To further improve persistence, central memory T cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion to reduce T cell exhaustion and maintain a memory T cell phenotype.

Moderna to Present at Chardan’s Virtual 5th Annual Genetic Medicines Conference

On September 28, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that Stephen Hoge, M.D., President, will participate in a fireside chat at Chardan’s Virtual 5th Annual Genetic Medicines Conference on Tuesday, October 5th at 1:00 p.m. ET (Press release, Moderna Therapeutics, SEP 28, 2021, View Source [SID1234590405]).

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A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

Aptevo Therapeutics Announces Publication of a Scientific Article in Peer-Reviewed Journal, Frontiers in Aging

On September 28, 2021 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the prestigious medical journal Frontiers in Aging, published a peer-reviewed article by Fatih Uckun, M.D., Ph.D., Chief Clinical Advisor at Aptevo who is coordinating the APVO436 clinical development program (Press release, Aptevo Therapeutics, SEP 28, 2021, View Source [SID1234590404]).

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The article discusses the clinical impact potential of bispecific antibodies (BiAB) capable of redirecting host T-cell cytotoxicity to malignant clones as well as immunosuppressive myeloid-derived suppressor cells (MDSC) as a new class of anti-MDS drug candidates.

The article, "CD123-Directed Bispecific Antibodies for Targeting MDS Clones and Immunosuppressive Myeloid-Derived Suppressor Cells (MDSC) in High-Risk MDS Patients," has been published in Frontiers in Aging, section "Neoplastic Pathologies of Aging,"

and it is available online. To view the online publication, click here:
http://journal.frontiersin.org/article/10.3389/fragi.2021.757276/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Aging&id=757276.

Citation Reference: Uckun FM and Watts J (2021) CD123-Directed Bispecific Antibodies for Targeting MDS Clones and Immunosuppressive Myeloid-Derived Suppressor Cells (MDSC) in High-Risk Adult MDS Patients. Front. Aging 2:757276. doi: 10.3389/fragi.2021.757276

Adult myelodysplastic syndrome (MDS), a heterogeneous group of clonal malignant hematologic disorders with an incidence rate of 4.5 per 100,000 persons per year, is characterized by an enhanced risk of transformation to acute myeloid leukemia (AML). There is no effective standard treatment that will prevent the leukemic transformation or result in sustained deep remissions in high-risk adult MDS patients.

The immunosuppressive bone marrow microenvironment (BMME) in adult MDS has been implicated in clonal evolution and disease progression. Expanded populations of myeloid-derived suppressor cells (MDSC) contribute to the immunosuppressive tumor microenvironment (TME) by inhibiting both memory and cytotoxic effector T-cell populations as well as natural killer (NK) cells, thereby promoting the immune evasion of MDS clones. The abundance of MDSC is associated with a higher risk of rapidly progressive disease and poor survival outcomes in adult MDS.

The expression of CD123 on MDSC as well as MDS clones provides a compelling rationale for targeting CD123 antigen on the malignant clones as well as the MDSC in the immunosuppressive BMME of adult MDS patients in an effort to delay disease progression and transformation to AML.

In a recently completed APTEVO study the results of which have been published in the respected oncology journal, Cancers, APVO436 induced bone marrow complete remissions in 3 of 6 evaluable high-risk MDS patients, providing the first proof of concept that APVO436 is a new candidate anti-MDS drug.

"There is an urgent need to identify effective strategies to prevent leukemic transformation and induce sustained deep remissions in adult high-risk myelodysplastic syndrome (MDS) patients," explained Fatih Uckun, M.D. Ph.D., the study’s lead author. "T-cell engaging bispecific antibodies targeting the CD123 antigen like our lead drug candidate APVO436 may help delay disease progression in high-risk adult MDS and potentially reduce the risk of transformation to secondary AML."

"Emerging data that show APVO436 can sufficiently empower dysfunctional and exhausted T-cells to induce remissions in relapsed AML and MDS patients is the driving motivation behind our current clinical development plan for our lead clinical candidate," said Marvin White, CEO of Aptevo.

About APVO436

Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo’s lead proprietary drug candidate, APVO436 is a bispecific ADAPTIR that targets CD123 x CD3 and is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger a rapid and complete destruction of leukemia cells. APVO436 has been engineered using Aptevo’s proprietary and enabling bioengineering methods and is designed to reduce the likelihood and severity of an unintended and potentially harmful activation of the immune system. APVO436 has been engineered to stay in the blood circulation long enough to locate, bind with and destroy target leukemia cells. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.