On February 5, 2024 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on February 7, 2024 (View Source) (Press release, Regen BioPharma, FEB 5, 2024, View Source [SID1234639850]).

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to get through as many of them as possible.

"We plan to use this time to continue to update our shareholders on our fiscal and scientific goals for the upcoming year, introduce a new scientific consultant with public biotech experience who is joining our team, and discuss our continuing progress on our DuraCAR program," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting at 2:20-2:50 Eastern time on Wednesday February 7, 2024. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=d1cd45a6dc&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference
The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.

On February 5, 2024 ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, reported dosing has initiated in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789) (Press release, ProfoundBio, FEB 5, 2024, View Source [SID1234639849]).

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"By bringing the first ADC with our next generation MMAE linker-drug platform to the clinic, we are furthering our commitment to developing ADCs with the potential for improved outcomes for patients," said Naomi Hunder, MD, chief medical officer of ProfoundBio. "We believe our preclinical data support the potential of PRO1107 to provide much improved safety and activity compared to prior PTK7 ADCs, demonstrating the compelling attributes of our LD343 platform, which incorporates our novel highly hydrophilic linker combined with the clinically validated MMAE payload conjugated at a high drug-antibody ratio of 8. We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumors, and we are thankful to the investigators and patients who make this research possible."

PRO1107 is being evaluated in a global, open-label, multicenter Phase 1/2 trial. This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer. It is designed as a two part study: Part A, which is aimed at determining the recommended optimal dose regimen(s) through dose escalation and expansion, and Part B, which focuses on the expansion of treatment to specific tumor types.

"With three clinical-stage programs derived from two distinct proprietary ADC technology platforms, ProfoundBio is demonstrating our capability to efficiently bring innovative ADCs with best- and/or first-in-class potential to patients with unmet medical need. We first showcased this program and the LD343 linker-drug technology in our preclinical presentations at SITC (Free SITC Whitepaper) 2023, and we are thrilled to potentially provide benefit to patients across a wide range of PTK7-expressing tumors," said Baiteng Zhao, PhD, chief executive officer of ProfoundBio.

About PRO1107
PRO1107 is an ADC consisting of a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody conjugated to ProfoundBio’s novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous drug-antibody ratio (DAR) of 8. MMAE is a potent, membrane permeable microtubule inhibitor that has been clinically validated as an ADC payload by multiple vedotin-based ADCs incorporating MMAE at a DAR of ~4. LD343 incorporates a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of conjugated MMAE on the ADC, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC.

On February 5, 2024 Novartis reported that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys AG (FSE: MOR; NASDAQ: MOR), a Germany-based, global biopharmaceutical company developing innovative medicines in oncology (Press release, Novartis, FEB 5, 2024, View Source [SID1234639847]). The acquisition, which is subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals, further expands and complements Novartis pipeline in oncology, one of its priority therapeutic areas, while also enhancing Novartis global footprint in hematology.

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Upon completion of the acquisition, Novartis will own pelabresib (CPI-0610), a novel and potentially practice changing treatment option with a well-tolerated safety profile provided in combination with ruxolitinib for patients with myelofibrosis (MF). It will also include tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins currently being tested in patients with solid tumors or lymphomas.

Pelabresib in combination with ruxolitinib recently met its primary endpoint of spleen volume reduction in the Phase 3 MANIFEST-2 study in JAK inhibitor-naive MF patients1. The combination also demonstrated favorable trends in symptom improvement as evidenced by key secondary endpoints of absolute and 50% change in total symptom score (TSS) at week 24 compared to baseline. All four clinical hallmarks of disease in myelofibrosis – splenomegaly, disease-associated symptoms, anemia and bone marrow fibrosis – were improved with the pelabresib and ruxolitinib combination. In the earlier Phase 2 MANIFEST trial, the third arm of the study with a patient population comparable to MANIFEST-2, showed durable improvements in both spleen volume and total symptom score up to week 602. Regulatory filing with the U.S. FDA is planned for the second half of 2024.

"We are excited about the opportunity of bringing pelabresib, a potential next-generation treatment combined with ruxolitinib, to people living with myelofibrosis, a rare and debilitating form of blood cancer," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer of Novartis. "With the planned acquisition of MorphoSys, we aim to further strengthen our leading pipeline and portfolio in oncology, adding to our capabilities and expertise. Building on our long-standing development partnership with MorphoSys, we look forward to continuing our work together to realize the full impact and value of their investigational medicines for patients with unmet needs."

Pelabresib is an investigational small molecule designed to promote anti-tumor activity by selectively inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is also being studied in patients with essential thrombocythemia (ET), which is currently in Phase 2 in second line of treatment. Besides pelabresib, MorphoSys’ pipeline includes a broad portfolio of partnered assets of which some are in partnership with Novartis, including ianalumab (VAY736) which is studied across multiple immunological diseases and in hematology.

Transaction Details
Under the agreed transaction, which has been unanimously approved by the Board of Directors of both companies, Novartis will make a voluntary public takeover offer for all no-par value bearer shares of MorphoSys AG for EUR 68 per share (or an aggregate of EUR 2.7bn).

The transaction is subject to customary closing conditions, including acceptance of the takeover offer by at least 65% of MorphoSys AG’s outstanding shares and receipt of regulatory approvals and is expected to close in the first half of 2024. Until the transaction closes, MorphoSys AG will continue to operate as a separate, independent company.

About Pelabresib (CPI-0610)
Pelabresib (CPI-0610) is an investigational small molecule designed to promote anti-tumor activity selectively by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been approved by any regulatory authorities. The development of pelabresib was funded in part by The Leukemia and Lymphoma Society.

About Myelofibrosis
Myelofibrosis is a blood cancer – belonging to a group of diseases called myeloproliferative neoplasms – caused by genetic abnormalities in bone marrow stem cells and characterized by four hallmarks: enlarged spleen, anemia, impaired bone marrow microenvironment causing fibrosis, and debilitating disease-associated symptoms, including severe fatigue, night sweats, itching, increased bleeding and significant pain caused by their enlarged spleen. For many living with myelofibrosis, the combination of symptoms often severely impacts their quality of life. At diagnosis, several factors, such as age, genetics and bloodwork, help determine a patient’s long-term prognosis. About 90% of newly diagnosed patients have intermediate- to high-risk disease, which has a worse prognosis and a higher likelihood of disease-associated symptoms. While JAK inhibitors, the current standard of care, address some aspects of the disease, no agent provides broad disease control. There is an urgent need for novel, well-tolerated therapeutic options capable of changing the natural course of myelofibrosis to provide patients with deep and durable responses across its four hallmarks.

About Tulmimetostat (CPI-0209),
Tulmimetostat (CPI-0209) is an investigational compound designed to exert anti-tumor activity by inhibiting the function of enhancer of zeste homolog 1 and 2 (EZH2 and EZH1) proteins to reactivate silenced genes like tumor suppressor genes. Tulmimetostat is being tested as a once-daily oral treatment in a Phase 1/2 trial (NCT04104776) in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian clear cell carcinoma and endometrial carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer.

On February 5, 2024 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that the first patient has been dosed in its TACTIC-3 trial, a Phase I/II study, (NCT05862324) investigating the safety and efficacy of autologous TAC-T cell asset, TAC101-CLDN18.2, targeting Claudin 18.2+ solid tumors (Press release, Triumvira Immunologics, FEB 5, 2024, View Source [SID1234639846]). TAC101-CLDN18.2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that harnesses the inherent signaling pathways of the native T cell receptor complex and targets Claudin 18.2, an epithelial transmembrane protein overexpressed in gastric cancer and several other solid tumor types.

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"Claudin 18.2 is a promising target for cell therapy," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira Immunologics. "Among normal tissues, it is restricted to the stomach and hidden between neighboring cells. In gastric cancer and a few other solid tumors, however, it is accessible and abundantly expressed on tumor cell surfaces and, therefore, it represents a significant tumor selective opportunity to address these types of cancers."

"We are delighted to initiate this study at such a pivotal moment for Triumvira as we advance an exciting clinical program aimed at addressing a substantial therapeutic gap for solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "TAC101-CLDN18.2 represents a unique new therapy in our pipeline that has the potential to provide a new therapeutic solution for CLDN18.2 positive solid tumors including gastric, lung, ovarian and pancreatic cancers. There are currently no other approved treatment options against CLDN18.2, and novel therapeutics in development, such as TAC101-CLDN18.2, offer hope to a patient segment that constitutes ~40% of the gastric cancer population in the U.S. alone. Through our TAC technology, which harnesses the inherent signaling pathways of native TCRs, we aspire to bring forward innovative, chemotherapy-sparing therapeutic strategies for solid tumors."

TACTIC-3 is a first-in-human study investigating TAC101-CLDN18.2 to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetic profile, and efficacy in subjects with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase I and between 2-4 lines of prior therapy in Phase II. In each phase, subjects with pancreatic ductal adenocarcinoma may have been treated with 1 line of prior antineoplastic therapy. In addition, subjects who are being treated with the current lines of therapy with no demonstrated benefit may also be eligible on the condition that no measurable disease was reported at baseline as a starting reference point.

On February 5, 2024 Papyrus Therapeutics Inc., a biotechnology platform company for the development of potent, multi-cancer, tumor suppressor precision therapies for solid cancers, reported the upcoming poster presentation entitled "Oncolytic Vaccinia Virus Carrying OPCML Tumor Suppressor is active in Epithelial Ovarian Cancer" has been accepted for presentation at the forthcoming AACR (Free AACR Whitepaper) meeting in San Diego in the Immunology category from 9.00am – 12.30pm PT on April 10th (View Source) (Press release, Papyrus Therapeutics, FEB 5, 2024, View Source;utm_medium=rss&utm_campaign=papyrus-therapeutics-to-present-at-aacr-april-5-10-san-diego [SID1234639845]).

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The data demonstrate that vaccinia virus directed OPCML protein expression enhances OVV selectivity against ovarian cancer cells through direct oncolysis, inhibition of specific RTKs, suppression of angiogenesis, and activation of antitumor immune responses synergistically when combined with an anti-PD-1 inhibitor.

According to Papyrus’ co-founder / chief scientific officer, and renowned translational medical oncologist Hani Gabra, PhD FRCP, "A short treatment with novel OVV-OPCML / anti-PD-1 inhibitor combination showed a 50% increase in median survival in the mice studied, an encouraging outcome demonstrating promise as a targeted strategy for ovarian cancer treatment. This is important given the relatively poor treatment results with check-point inhibitors to date in ovarian cancer."