On August 30, 2023 Eucure (Beijing) Biopharma Co., Ltd. ("Eucure"), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen"), reported that the company has entered into a technology transfer agreement with Syncromune, Inc. ("Syncromune"), a US-based clinical-stage biopharmaceutical company focused on the development of SYNC-T, a platform technology designed to synchronize in situ neoantigen T cell education and immunostimulation, for the development and clinical supply of certain compounds (Press release, Syncromune, AUG 30, 2023, View Source [SID1234637482]).

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 agreement is an expansion to the license agreement executed in 2022 where Biocytogen/Eucure licensed worldwide rights for YH002 (anti-OX40 antibody) and other active ingredients to Syncromune for the exclusive development and commercialization of intratumoral immunotherapy based on SYNC-T technology. Under the newly signed agreement, Syncromune will be granted an option right and upon option-exercise, Eucure will transfer technology to Syncromune for the manufacture of YH002 and other clinical-stage antibodies currently being evaluated for intratumoral immunotherapy based on SYNC-T technology. Under the newly signed agreement, Syncromune will pay Eucure an upfront fee and, upon option-exercise, Eucure is entitled to receive milestone fees.

Currently, Syncromune’s SYNC-T investigational therapy is being used in Phase 1 investigator initiated trials and has produced preliminary clinical data supporting further development of the candidates.

"We are pleased to expand what has been a fruitful collaboration, to date, with Syncromune," said Yuelei Shen, Ph.D., President and CEO of Biocytogen. "As we continue identifying novel therapeutic antibodies suitable for development into tumor vaccine and other modalities, we look forward to establishing more strategic partnerships to advance the field of immunotherapy."

"We are excited that SYNC-T has shown initial anti-tumor activity based on the preliminary Phase 1 clinical data," said Eamonn Hobbs, President and Chief Executive Officer of Syncromune. "We believe this technology transfer agreement may help accelerate our FDA IND filling process, and we are optimistic that our proprietary SYNC-T investigational therapy may have the potential to provide a treatment benefit to cancer patients."

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 agonistic antibody. The specificity, safety, and anti-cancer efficacy of YH002 have been evaluated in a comprehensive panel of pre-clinical studies. A first-in-human (FIH), multicenter, open-label, Phase 1 dose-escalation study is currently underway in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of YH002 in adult subjects with advanced solid malignancies.

About SYNC-T

Syncromune is developing SYNC-T, a disruptive personalized in situ platform drug immunotherapy designed to educate T cells and stimulate the immune system to treat metastatic solid tumors where other therapies have failed. SYNC-T utilizes a combination approach of tumor activation and targeted delivery, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. To achieve tumor activation, a portion of a target tumor is lysed to generate immunogenic cell death and the release of Damage Associated Molecular Patterns (DAMPs) and tumor antigens, changing the tumor microenvironment by creating an in situ vaccine. The second component of the platform, targeted delivery, involves the intratumoral infusion of a proprietary fixed-dose combination drug with 4 active ingredients into the lysed portion of the tumor. This is designed to activate the immune system and combat immune suppression, which may result in patient-specific T cell education. The expansion of anti-cancer specific T cells can enable the immune system to recognize and destroy cancer in the treated tumor as well as in metastases throughout the body.

On August 30, 2023 BioLineRx, a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, reported its unaudited financial results for the second quarter ended June 30, 2023, and provided corporate and portfolio updates (Press release, BioLineRx, AUG 30, 2023, View Source [SID1234634868]).

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!

"We had a very productive second quarter across all areas of the company, including our focused pre-launch preparation activities tied to the potential U.S. approval of motixafortide in the next few weeks, as well as the formation of a new strategic partnership, announced today, to develop and commercialize motixafortide in Asia," said Philip Serlin, Chief Executive Officer of BioLineRx. "The partnership, which is subject to certain closing conditions, provides a pathway forward to pursue potential indications for motixafortide in stem cell mobilization and pancreatic cancer in Asia, as well as a source of substantial funding to the company.

Additionally, we advanced our second major development program for motixafortide in pancreatic cancer through the initiation of a randomized Phase 2 clinical trial with Columbia University in first line metastatic pancreatic cancer based on promising data from a single-arm pilot phase.

"Finally, our clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress, and we anticipate clinical trial initiation this year. I am extremely pleased with our progress to date and look forward to a fruitful second half of the year, including our potential transition to a commercial stage company," Mr. Serlin concluded.

Corporate Updates

On track for September 9, 2023 PDUFA target action date on NDA for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma
Signed exclusive license agreement to develop and commercialize motixafortide in Asia with concurrent equity investment; license agreement includes $15 million upfront payment, plus potential development, regulatory and sales milestones, and tiered double-digit royalties, as well as various development obligations for the licensee, including the planned initiation in China of a registrational study in stem-cell mobilization and a randomized Phase 2/3 study in first-line pancreatic cancer; straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants; effectiveness and closing of transactions is contingent upon approval by Israeli Innovation Authority of license agreement within four months of execution, and other closing conditions
Clinical Portfolio Updates

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced publication in Nature Medicine of GENESIS Phase 3 clinical trial data evaluating motixafortide and G-CSF in stem cell mobilization for autologous transplantation in multiple myeloma
Pancreatic Ductal Adenocarcinoma

Announced initiation of randomized, investigator-initiated Phase 2 clinical trial in collaboration with Columbia University, with joint funding of the study by Regeneron and BioLineRx, assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with mPDAC. Anticipate initial patient data in 2023. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June
Sickle Cell Disease & Gene Therapy

Continued to advance plans for a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate trial initiation later this year
AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022. Study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
Second Quarter 2023 Financial Results

Research and development expenses for the three months ended June 30, 2023 were $3.0 million, a decrease of $2.4 million, or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
Sales and marketing expenses for the three months ended June 30, 2023 were $5.6 million, an increase of $4.4 million, or 383.9% compared to $1.2 million for the three months ended June 30, 2022. The increase resulted primarily from the ramp-up of pre-launch activities related to motixafortide
General and administrative expenses for the three months ended June 30, 2023 were $1.3 million, an increase of $0.3 million, or 24.4% compared to $1.0 million for the three months ended June 30, 2022. The increase resulted primarily from an increase in payroll and related expenses due to a small increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses
Net loss for the three months ended June 30, 2023 was $18.5 million, compared to $7.4 million for the three months ended June 30, 2022. The Company’s net loss for the six months ended June 30, 2023 amounted to $30.7 million, compared to $12.4 million for the six months ended June 30, 2022. The increases in net loss for both the three and six months ended June 30, 2023 were due primarily to a non-operating expense of approximately $7.8 million and $10.8 million respectively, related to the revaluation of outstanding warrants resulting from an increase in the Company’s share price over the preceding three and six months
As of June 30, 2023, the Company held cash, cash equivalents, and short-term bank deposits of $32.8 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024. This amount does not include $29.6 million in total funding from the exclusive license agreement and equity investment announced today, which the Company anticipates closing in Q3 subject to formal transaction approval by the Israeli Innovation Authority and other closing conditions

On August 30, 2023 BioInvent reported its interim report for January-June 2023 (Presentation, BioInvent, AUG 30, 2023, https://www.bioinvent.com/sites/bioinvent/files/pr/20230830-cb906e7c-ce8a-4f6e-8240-2cd14a254fc7-1.pdf?ts=1693375214 [SID1234634867]).

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!

On August 30, 2023 Serina Therapeutics, Inc. ("Serina"), a privately-held, clinical-stage biotechnology company developing a pipeline of therapies for the treatment of Parkinson’s Disease and other neurological diseases, entered into a merger agreement with AgeX Therapeutics, Inc. (NYSE American: AGE) ("AgeX") on August 29, 2023, under which Serina will merge with a wholly-owned subsidiary of AgeX in an all-stock transaction (Press release, Serina Therapeutics, AUG 30, 2023, View Source [SID1234634788]). The combined company will continue under the Serina Therapeutics name and will focus on advancing Serina’s pipeline of small molecule drug candidates targeting central nervous system ("CNS") indications, enabled by the company’s proprietary POZ Platform delivery technology. In addition to advancing the company’s wholly-owned pipeline assets, Serina is working with companies in the pharmaceutical industry currently advancing pre-clinical studies exploring POZ polymer lipid-nanoparticles ("LNPs") in next generation RNA vaccines.

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!

"The merger with AgeX positions Serina to advance our CNS pipeline assets and expand our platform partnering opportunities," said Milton Harris, PhD, Co-Founder and Chair of the Board of Serina. "We believe it represents the best path forward for Serina in accessing transformative capital to advance our platform technology. As a board director of the combined company, I look forward to collaborating with our new partners AgeX and Juvenescence, as we continue the work of translating our science into innovative therapeutics."

"We are delighted to announce the proposed merger with Serina," said Joanne M. Hackett, PhD, Chairperson and Interim Chief Executive Officer of AgeX. "The AgeX team thoroughly reviewed and evaluated numerous strategic alternatives for creating stockholder value, and we believe this transaction with Serina presented the most compelling option for our stockholders. We see exciting potential to generate novel drug candidates with the POZ Platform delivery technology."

"Serina merging with AgeX is an important step towards recognizing the potential to develop the POZ Platform to deliver novel medicines and treatment modalities," said Richard Marshall, Chief Executive Officer of Juvenescence Limited ("Juvenescence"). "We plan to leverage our deep pharmaceutical expertise and network to assist the combined company to reach its goal in maximizing value for stockholders."

The combined company will focus on advancing Serina’s lead drug candidate (SER-252, POZ-apomorphine) for the treatment of advanced Parkinson’s Disease through pre-clinical studies, with the goal of submitting an investigational new drug submission ("IND") to the Food and Drug Administration for the initiation of a Phase I clinical trial during the fourth quarter of 2024. Serina has two other pipeline assets that are positioned to enter IND enabling studies, SER-227 (POZ-buprenorphine) for certain post-operative pain indications and SER-228 (POZ-cannabidiol) for refractory epilepsy indications. Additionally, the combined company will focus on expanding Serina’s LNP and antibody drug conjugate ("ADC") partnering collaborations.

About the Transaction, Management and Organization

Under the terms of the merger agreement, pending stockholder approval of the transaction, Serina will merge with a wholly-owned subsidiary of AgeX, and stockholders of Serina will receive shares of AgeX common stock ("merger"). AgeX following the merger is referred to herein as the "combined company." The merger has been approved by the boards of directors of both companies and is expected to close in the first quarter of 2024, subject to customary closing conditions.

Upon completion of the merger, pre-merger AgeX stockholders are expected to own approximately 25% of the newly combined company while pre-merger Serina stockholders are expected to own approximately 75% of the newly combined company. The final percentage of the combined company owned by pre-merger Serina stockholders and pre-merger AgeX stockholders upon completion of the merger may be subject to certain adjustments and assumptions. As part of the merger, pre-merger AgeX stockholders will be issued Post-Merger Warrants. The Post-Merger Warrants issued to AgeX stockholder, Juvenescence, have a cash exercise requirement that will provide an additional $15 million in capital to the combined company in three equal tranches over the term of the warrant, which expires July 31, 2025. AgeX stockholders that exercise the Post-Merger Warrants will additionally receive Incentive Warrants that expire four (4) years after the merger closing date. The terms and conditions for each type of warrant will be further detailed in the forms of warrant agreements that will be negotiated between the parties prior to the merger closing date.

Prior to the execution of the merger agreement, AgeX invested $10 million in Serina through the purchase of a Senior Convertible Loan Note ("CLN") described on the Current Report on Form 8-K that AgeX filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2023. Immediately prior to completion of the merger, the CLN will be converted into Serina capital stock as a capital contribution. It is expected that the funds provided by the CLN, together with the additional $15 million of proceeds from the Juvenescence required warrant cash exercises, will provide working capital for the combined company to help fund operations into calendar year 2026.

Following the merger, it is anticipated that the combined company will be led by a new Chief Executive Officer ("CEO"). Current members of the executive team of Serina are expected to continue in key leadership roles, including Dr. Randall Moreadith as the Chief Science Officer, and Dr. Tacey Viegas as Chief Operating Officer and Secretary. Serina’s current Chief Financial Officer ("CFO") Steve Ledger is expected to serve as the interim CEO of the combined company until such time as the new CEO is hired. AgeX’s current CFO, Andrea Park, is expected to serve as the interim CFO and Chief Accounting Officer of the combined company until such time as the new CFO is hired, and is then expected to continue in the role of Chief Accounting Officer. The board of directors will be comprised of seven directors and are expected to include AgeX director Dr. Gregory Bailey, Juvenescence CEO Dr. Richard Marshall, Serina’s directors Dr. J. Milton Harris and Steve Ledger, and the Buck Institute for Aging’s Vice President of Business and Technology Advancement Remy Gross III. Two additional directors will be appointed in accordance with the merger agreement to fill the remaining seats on the board of directors.

Upon completion of the transaction, the combined company will operate under the Serina Therapeutics name, and the combined company’s common stock is expected to trade on the NYSE American under the ticker symbol "SER." The corporate headquarters will be in Huntsville, Alabama.

Gibson, Dunn & Crutcher LLP is providing legal counsel to AgeX. Bradley Arant Boult Cummings LLP is legal counsel to Serina.

On August 30, 2023 Diverse Biotech reported that it has been granted USPTO patent approval of its novel CUSP synthesis platform creating an entirely new class of drugs that are part-antibody and part-cannabinoid in one new molecule (Press release, Diverse Biotech, AUG 30, 2023, View Source [SID1234634787]). Starting with DBT-50201, its novel PEMBROLIZUMAB compound, Diverse expects to develop multiple treatments for many diseases with highly unmet needs. According to John Patrick, M.D., Executive Vice President and Chief Medical Officer for Diverse Biotech, "We are very excited about being granted our first patent for our monoclonal antibody class of drugs with our flagship drug DBT-50201 which represents a significant advancement for PEMBROLIZUMAB. We expect that our monoclonal drug DBT-50201 will mirror the results we have seen thus far in trials with our Temozolomide drug used to treat Glioblastomas (brain cancer), DBT-30180. We have observed significant increases in potency and efficacy with our CUSP technology averaging about 2,000% when compared to standard chemotherapy alone. Coupled with other potential decreases in toxicity, these results represent a major step forward in the treatment and cure of multiple cancers."

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!