On November 21, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. (ENSEM), a biotechnology company focusing on high-value and difficult-to-drug oncology targets, reported an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor (Press release, BeiGene, NOV 21, 2023, View Source [SID1234637896]).

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"We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership fits well with our strategic focus on breast cancer as an area with tremendous unmet need for innovative treatment options," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "This CDK2 inhibitor from ENSEM complements our internally discovered Phase 1 CDK4 inhibitor, which has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients, and strengthens our early development pipeline in breast cancer and other solid tumors. We are excited to work with ENSEM to bring this molecule into the clinic in the near future."

Under the terms of the agreement, ENSEM will receive an upfront payment, and will be eligible for additional payments upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.33 billion, in addition to tiered royalties.

"We are pleased to partner with BeiGene on the development of this differentiated CDK2 inhibitor," said Shengfang Jin, Ph.D., President and Chief Executive Officer at ENSEM. "We believe BeiGene is the right partner to advance our first IND-ready asset due to their wealth of expertise in bringing innovative cancer therapies to patients globally. This partnership validates the capabilities of ENSEM’s drug discovery and development team and the ability to rapidly advance potential best-in-class or first-in-class molecules utilizing our Kinetic Ensemble platform. We look forward to progressing our additional pipeline programs to help patients in need and supporting BeiGene’s important work to take this therapy into clinical trials."

On November 21, 2023 Alkermes plc (Nasdaq: ALKS) reported that management will participate in fireside chat presentations at two upcoming investor conferences (Press release, Alkermes, NOV 21, 2023, View Source [SID1234637895]).

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Piper Sandler 35th Annual Healthcare Conference
Date/Time: Tuesday, Nov. 28, 2023 at 11:00 a.m. ET (4:00 p.m. GMT)

6th Annual Evercore ISI HealthCONx Conference
Date/Time: Wednesday, Nov. 29, 2023 at 10:00 a.m. ET (3:00 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

On November 21, 2023 Orion reported that two new Phase 3 clinical trials to evaluate the safety and efficacy of ODM-208 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) have been posted to the ClinicalTrials.gov website (Press release, Orion, NOV 21, 2023, View Source [SID1234637869]). The studies are not yet recruiting patients.

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Further information is available on ClinicalTrials.gov

A study of MK-5684 Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (study identifier: NCT06136650)
A study of MK-5684 Versus Alternative NHA in mCRPC (study indentifier: NCT06136624)
About ODM-208/MK-5684

ODM-208 (or MK-5684) is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. ODM-208 is being developed through a collaboration with MSD (tradename of Merck & Co., Inc. Rahway NJ USA).

On November 20, 2023 Voltron Therapeutics, Inc., a Lucius Partners portfolio company, reported that it has finalized the protocol for a Dose-Ranging Efficacy Study of VTX-0P4, a protein-based cancer vaccine targeting Prostate Stem Cell Antigen (PSCA). PSCA is a key target in the treatment of Prostate Cancer (Press release, Voltron Therapeutics, NOV 20, 2023, https://voltrontx.com/lucius-partners-portfolio-company-voltron-therapeutics-inc-announces-completion-of-a-trial-protocol-to-study-its-self-assembling-vaccine-to-target-prostate-stem-cell-antigen/ [SID1234653953]). The ability of the SAV to target full proteins, as well as peptides, demonstrates that Voltron’s vaccine platform has the potential to target dozens of oncology and infectious disease targets – collectively multi- billions of dollars of market potential. The pre-clinical trial is expected to commence in December.

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Voltron recently demonstrated immunogenicity against PSCA in a double blind pre-clinical trial conducted at the Vaccine and Immunotherapy Center at the Massachusetts General Hospital. In that trial VTX-0P4 significantly augmented T-Cell responses when compared to controls against this important tumor target while, once again, exhibiting a very clean safety profile. The magnitude of these responses were comparable to those seen in the Company’s prior HPV E6/E7 studies, which subsequently translated into significant increases in survival and reductions in tumor progression in a mouse model of HPV induced cancer. This strongly suggests VTX-0P4 can address PSCA or other tumor antigen expressing cancers with a full protein approach.

Pat Gallagher, Voltron’s Chief Executive Officer commented, "In our HPV-related cancer proof of concept trial, Voltron validated that targeting hot spot epitopes, E6/E7, can lead to highly statistically significant increases in survival, reduced tumor growth, and increased tumor infiltration by beneficial immune T Cells. By using a full protein in our PSCA trial to attack solid tumors of interest, we are systematically moving into more complex targeting approaches that provide increased flexibility in developing treatments for additional cancer types and infectious diseases. As with our HPV design, this trial will also evaluate the specific vaccine as monotherapy and in combination with a Checkpoint Inhibitor (PD-1)."

The SAV Platform’s novel mechanism of action offers a promising solution for rapid development and production of vaccines at a reduced cost. It utilizes the same backbone for all vaccines, but with different ‘targeting warheads,’ allowing cost-effective production for specific cancer or infectious disease targets. With the SAV, ‘targeting warheads’ may potentially include different types of antigens including proteins, peptides, polysaccharides or nucleic acids. Importantly, utilizing the same core immune activating component across all the vaccines, MTBHSP70, reduces regulatory risks by largely eliminating off-target inflammation inherent in standard adjuvants. Additionally, this utilizes an expression system Voltron has already translated to good manufacturing processes production for clinical testing.

"We are excited to initiate Voltron’s PSCA pre-clinical efficacy trial," said James Ahern, Managing Partner of Laidlaw & Company and co-founder of Lucius Partners. "With success, we will have two immune-oncology vaccines that potentially address six unique cancers to move toward first-in-human trials. We will continue to build on our successful programs to address patient needs and create shareholder value."

On November 20, 2023 CBMG Holdings (the "Company") reported that following the spin-off of the Company’s stem cell business division, it has changed its name to AbelZeta Pharma, Inc. ("AbelZeta"), which will focus on immune cell business (Press release, AbelZeta, NOV 20, 2023, View Source [SID1234637956]). The spin-off, approved by the Company’s board of directors and shareholders, allows AbelZeta to focus greater resources on the development of immune cell therapy for cancer and Inflammation & Immunology (I&I) diseases.

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"We believe the name AbelZeta best reflects our Company’s culture and values and is the next step in our growth as a commercially focused immune cell therapeutics company," said Tony (Bizuo) Liu, Chairman and CEO of the Company. "Abel is an ancient name long associated with humility, integrity, and conviction, and the Greek letter ζ, or zeta, is a widely recognized component of the T-cell receptor in the immune cell research community. The name AbelZeta articulates our confidence in the T-cell based therapies to deliver transformative treatments to address aggressive cancers and serious immune disorders.

"The Company currently has 13 ongoing clinical studies in its immune cell pipeline in the United States and in China.