On July 5, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported that Jeffrey Eisenberg, Chief Executive Officer and Curtis A. Lockshin, PhD, Chief Scientific Officer of Xenetic Biosciences will participate in the Virtual Investor Summer Spotlight Series on Wednesday, July 12, 2023 at 10:00 AM ET (Press release, Xenetic Biosciences, JUL 5, 2023, View Source [SID1234633072]).

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!

A live video webcast of the presentation will be available on the Events page in the Investors section of the Company’s website (www.XeneticBio.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On July 5, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy to treat cancers, reported the appointment of Anders Månsson as Chief Executive Officer (CEO), effective September 1st, 2023 (Press release, Oncoinvent, JUL 5, 2023, View Source [SID1234633071]).

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!

"Following a comprehensive search process, it was determined that Anders was the preferred candidate to lead Oncoinvent forward. Anders’s extensive leadership experience in various positions within the pharmaceutical industry, including large multinationals, start-ups, and companies listed on the stock exchange, will add immeasurable value to Oncoinvent, as we advance towards providing best in class therapies to patients in serious need," said Roy Larsen, Ph.D., Chairman of Oncoinvent’s Board of Directors. "On behalf of the Board and everyone at Oncoinvent, I would like to thank Jan Alfheim for his leadership and contributions to our company. We appreciate his commitment to ensuring a seamless transition and we wish him all the best."

"I am honored to join Oncoinvent at this pivotal time in the company’s development, specifically with the continued very promising advancement of Radspherin. I look forward to collaborating with the Oncoinvent board and management team to develop novel and unique radiopharmaceutical treatments for peritoneal carcinomatosis originating from colorectal and ovarian cancers," said Anders Månsson, newly appointed Chief Executive Officer of Oncoinvent.

Anders has nearly three decades of extensive experience in strategic leadership, business development, and commercialization in the pharmaceutical industry. He has most recently served as CEO of LIDDS, a technology platform company specialising in depot formulations for intra-tumoral injections with its NanoZolid technology. Prior to LIDDS, Anders served as CEO of RhoVac (now CHOSA Oncology AB), a biopharmaceutical company developing immuno-therapeutic treatments for metastatic cancers. Before this, he was CEO and served on the board of directors at Amniotics AB, a clinical stage biotechnology company developing therapies based on stem cells.

Anders has also held several senior management roles in business development in multinational companies such as LEO Pharma and Ferring Pharmaceuticals, spanning close to two decades. Anders currently serves on the board of directors for EQL Pharma AB and Immetric AB, and he has previously held several other board director and advisor positions. Anders holds an M.B.A. from Business School Lausanne and a bachelor’s degree in Business and Economics from Lund University.

On July 5, 2023 Verastem Oncology (Nasdaq: VSTM) (the "Company"), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has finalized with the U.S. Food and Drug Administration (FDA) the design of its confirmatory Phase 3 trial to evaluate the combination of avutometinib and defactinib for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) (Press release, Verastem, JUL 5, 2023, View Source [SID1234633069]). RAMP 301, a randomized global confirmatory trial, will evaluate the efficacy and safety of avutometinib and defactinib versus standard of care (SOC) chemotherapy and hormonal therapy in patients with recurrent LGSOC. RAMP 301 is expected to begin enrollment in the second half of this year.

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!

RAMP 301 is the follow-up confirmatory study for full approval in recurrent LGSOC. The Company intends to file for Accelerated FDA Approval for the combination of avutometinib and defactinib based on mature data from the Company’s Phase 2 registration-directed RAMP 201, together with the results of the investigator-initiated FRAME trial. The Company recently reported results of Part A of RAMP 201 including confirmed objective response rates (ORR) by blinded independent central review of 45% (13/29; 95% CI: 26%,64%) with a tolerable safety profile.​

"We are pleased to partner with GOG and ENGOT and announce the final study design for RAMP 301, another important milestone in advancing our avutometinib and defactinib program and bringing us closer to addressing the unmet needs of patients living with LGSOC," said Brian Stuglik, Chief Executive Officer, Verastem Oncology. "This trial builds on the encouraging results of Part A of the RAMP 201 trial and our breakthrough therapy designation, after one or more prior lines of therapy, and we are committed to bringing the first FDA-approved therapy for LGSOC to patients as quickly as possible."

RAMP 301 is an international collaboration between The GOG Foundation, Inc. (GOG) and the European Network of Gynaecological Oncological Trial groups (ENGOT) sponsored by Verastem Oncology. The trial will enroll approximately 270 patients who will be randomized to either the combination of avutometinib and defactinib or SOC chemotherapy (pegylated liposomal doxorubicin, paclitaxel, topotecan) or hormone therapy (letrozole, anastrozole). Selection of the SOC regimen will be based on the preference of the investigator. The primary endpoint is progression free survival (PFS) by Blinded Independent Central Review. Secondary endpoints include overall response rates, duration of response​, disease control rate, safety and tolerability, patient reported outcomes and overall survival. The RAMP 301 trial will be led globally and in the U.S. by Rachel Grisham, MD, Section Head, Ovarian Cancer and Director, Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center in Westchester, NY. Susana Banerjee, MBBS, MA PhD, FRCP, global and lead investigator of the RAMP 201 study, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London, will be leading the RAMP 301 trial in Europe.

Financial Update

As of March 31, 2023, Verastem Oncology had cash and short-term investments of $111.2 million. With the net proceeds from the underwritten public offering completed in June 2023 of approximately $91.5 million after deducting estimated underwriting discounts and commissions and estimated offering expenses, the Company has pro-forma cash and short-term investments as of March 31, 2023 of approximately $202.7 million.

Recent historical operating expenses have ranged between $16.0M — $20.0M per quarter, which the Company does not anticipate will change significantly in the near term as the RAMP 301 trial commences.

Dr. Banerjee and Dr. Grisham have consulting relationships with Verastem Oncology.

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

On July 5, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported that the trial’s Independent Drug Safety Monitoring Board (DSMB) provided a positive recommendation on the continuation until its completion of the Phase 2 clinical trial of IL-7 Receptor (IL-7R) antagonist Lusvertikimab (OSE-127) in ulcerative colitis (Press release, OSE Immunotherapeutics, JUL 5, 2023, View Source [SID1234633068]).

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!

In parallel, the European Medicines Agency (EMA) provided a positive opinion on Orphan Drug Designation for Lusvertikimab for the treatment of Acute Lymphoblastic Leukemia (ALL).

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "After the planned DSMB review recommendation to continue the study until its completion, the Company’s primary and strategic focus remains clinical evaluation of Lusvertikimab in this ongoing ulcerative colitis Phase 2 study with end of accrual expected in the following months. In parallel, based on strong preclinical activity demonstrated by Lusvertikimab using patient’s leukemic samples, we are happy to have received a positive opinion on Orphan Drug Designation from the European Medicines Agency. Lusvertikimab orphan status for the treatment of Acute Lymphoblastic Leukemia from B or T cell precursors is opening future potential new indications in ALL, rare diseases with limited treatment options. We warmly thank our academic and clinician partners in Kiel, involved with us in this innovative research program."

ABOUT LUSVERTIKIMAB CLINICAL EVALUATION IN ULCERATIVE COLITIS (UC)

The ongoing Phase 2 clinical trial sponsored by OSE Immunotherapeutics is evaluating the efficacy and safety of Lusvertikimab (OSE-127) versus placebo in patients with moderate to severe active UC who failed or lost response or were intolerant to previous treatment(s) (CoTikiS trial: NCT04882007). A positive interim futility analysis was observed in the prespecified first 50 patients (i.e., 33% of the total patient enrollment in the study) having completed the induction phase. The upcoming major milestone for this Phase 2 clinical trial is expected in the following months with the top-line results after the induction phase (primary endpoint at week 10) and in H1 2024 for the first early assessment in maintenance after 6 months of therapy. UC is a debilitating and chronic inflammatory bowel disease which affects 3.3 million patients in US, Europe and Japan (1), representing 12.2 per 100,000 people by year (2). Despite broad available options, remission rates remain only 25-30% (3), leaving most patients without satisfactory treatments.

(1) EvaluatePharma
(2) Updated Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota (1970-2011). Loftus EV et al. October 2014).
(3) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572

ABOUT THE LUSVERTIKIMAB RESEARCH PROGRAM IN ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

This collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany) evaluated the therapeutic potential of Lusvertikimab in targeting and blocking the high and dysregulated IL-7R expression observed in 84% of B- or T-Cell ALL (B- and T-ALL) patients. In particular, significant preclinical activity of Lusvertikimab has been demonstrated in models using leukemic samples from refractory and relapsed patients. The latest preclinical data on the use of Lusvertikimab for the treatment of B- and T-ALL and its dual anti-leukemic efficacy were presented and awarded at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2022.

In Europe, 7,000 cases of ALL are diagnosed each year (1). The condition is estimated to be affecting approximately 1.7 in 10,000 persons in the European Union (2). More globally, the number of diagnosed incident cases of ALL in Europe, US, Japan and China is estimated to achieve 26,482 cases in 2029(3).

(1) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are not so rare: The rare cancer burden in Europe. Eur. J. Cancer. 2011; 47: 2493-2511.
(2) Using epidemiological information from the European Cancer Information System (ECIS)(
(3) Global Data

ABOUT ORPHAN MEDICINAL PRODUCT DESIGNATION

Orphan designation in the European Union (EU) is granted by the European Commission after the opinion is issued by the EMA’s Committee for Orphan Medicinal Products (COMP). The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU and for which no satisfactory method of diagnosis, prevention or treatment are authorized, or, if such exists, the medicine being developed must provide significant benefit. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include protocol assistance from the EMA at reduced fees during the product development phase and access to centralized authorization procedure and a 10-year period of marketing exclusivity in the EU after product approval.

On July 5, 2023 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported the closing of its upsized initial public offering of 3,900,000 shares of common stock at a public offering price of $5.00 per share (Press release, Intensity Therapeutics, JUL 5, 2023, View Source [SID1234633067]). In addition, Intensity has granted the underwriters a 45-day option to purchase an additional 585,000 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

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!

In connection with the offering, the Company’s common stock began trading on The Nasdaq Capital Market on June 30, 2023, under the ticker symbol "INTS."

The net proceeds to Intensity from the offering (prior to any exercise of the underwriter’s over-allotment option), after deducting the underwriting discounts, commissions and transaction expenses were approximately $16.2 million.

The Benchmark Company and Freedom Capital Markets acted as the joint book-running managers for the offering.

The securities described above were being offered by the Company pursuant to a registration statement on Form S-1 (Registration No. 333-260565) that was previously filed with the U.S. Securities and Exchange (the "SEC") and declared effective on June 29, 2023. This offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus can be obtained through the SEC’s website at www.sec.gov or from: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155 at 212-312-6700 or by email at [email protected] and Freedom Capital Markets, 40 Wall Street, 58th Floor, New York, NY 10005, via email at [email protected] and via telephone at (800) 786-1469.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.