On September 28, 2023 Vaccinex, Inc. (Nasdaq: VCNX) ("Vaccinex" or the "Company"), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported that it has entered into securities purchase agreements with healthcare focused institutional investors along-side significant participation from an entity affiliated with the Chairman of the Company’s Board of Directors, and existing investors of the Company for the purchase and sale of 9,600,000 shares of the Company’s common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 9,600,000 shares of common stock at a purchase price per share (and accompanying warrant) of $1.00 in its "reasonable best efforts" public offering (Press release, Vaccinex, SEP 28, 2023, View Source [SID1234635504]). The warrants will have an exercise price of $1.00 per share, will be immediately exercisable and will expire five years from the initial exercise date.

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The closing of the offering is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $9.6 million. The Company intends to use the net proceeds from the offering to fund the ongoing development and clinical trials of its lead drug candidate, pepinemab, in Alzheimer’s disease and cancer and for working capital and other general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-274520) previously filed with the Securities and Exchange Commission (SEC) which became effective on September 28, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the preliminary prospectus and, when available, copies of the final prospectus, relating to the offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 28, 2023 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), (the "Company"), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported the pricing of its underwritten public offering of an aggregate of 15,700,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, TransCode Therapeutics, SEP 28, 2023, View Source [SID1234635503]). Each share of common stock (or Pre-Funded Warrant) is being sold at a public offering price of $0.51 per share (inclusive of the Pre-Funded Warrant exercise price of $0.01). All of the shares and Pre-Funded Warrants in the offering are being sold by the Company. Total gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $8 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to 2,339,200 additional shares of its common stock and/or Pre-Funded Warrants at the public offering price less the underwriting discount.

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ThinkEquity is acting as sole book-running manager for the offering.

The closing of the offering is expected to occur on or about September 28, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering, together with its existing funds, for one or more clinical trials with TTX-MC138, its lead therapeutic candidate, including related investigational new drug enabling studies, and for working capital and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-274251), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 25, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting ThinkEquity at 17 State St., 41st Floor, New York, NY 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 28, 2023 TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, reported that it is bringing BNCT to this year’s annual meeting of the American Society for Radiation Oncology (ASTRO) in San Diego (Press release, TAE Life Sciences, SEP 28, 2023, View Source [SID1234635502]). The company is set to revolutionize the way attendees perceive BNCT with an immersive Augmented Reality (AR) experience that offers an in-depth look at the future of cancer treatments, informative talks about the state of BNCT, and a variety of captivating exhibits.

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TAE Life Sciences Brings BNCT to ASTRO

The AR experience at the TAE Life Sciences booth will offer visitors a captivating journey into the world of BNCT, featuring:

● A virtual tour of the Alphabeam system, showcasing the clinical workflow of BNCT and illustrating the inner workings of this revolutionary technology.

● Insights into the setup of a BNCT system, including details on building requirements, layout, and the treatment process.

"We’re on the verge of redefining how the world treats cancer and ASTRO is the perfect venue to showcase the capabilities of our Alphabeam BNCT system. We’re not just showing a glimpse of our technology at the show; we’re sharing a vision for a future where cancer is treated with unprecedented precision. We hope that the immersive experience we’re bringing to the show ignites a spark of hope in the hearts of attendees, and together, we can work towards a brighter future for cancer patients," said Rob Hill, CEO at TAE Life Sciences.

TAE Life Sciences will host a presentation, titled "Reimagining BNCT for Biologically Targeted Radiation Therapy," at its booth stage on October 1 at 11:00 AM. Featuring talks from Rob Hill, CEO of TAE Life Sciences, Minesh Mehta, MD, from Miami Cancer Institute, and Sandro Rossi, General Manager and Technical Director at CNAO, this presentation will include updates on the global progress of BNCT, preclinical and clinical results, and insight into the treatment’s profound significance in shaping the future of cancer treatment.

Presentation Details:
Who: Robert Hill, CEO at TAE Life Sciences; Minesh Mehta, Chief of Radiation Oncology at Miami Cancer Institute; Sandro Rossi, General Manager at CNAO

What: Presentation: Reimagining BNCT for Biologically Targeted Radiation Therapy When: October 1, 2023 at 11:00 AM

Where: San Diego Convention Center, Booth 3732

Sandro Rossi from CNAO shared his enthusiasm, stating, "Our collaboration with TAE Life Sciences marks a significant step forward in BNCT and brings an exciting addition to Europe’s first Hadrontherapy center. By incorporating BNCT into our comprehensive treatment offerings, we are expanding the horizons of radiation therapy to treat metastatic cancers. This groundbreaking approach has the potential to redefine how we combat cancer, making treatments more effective and tailored to each patient’s unique needs. Together with TAE Life Sciences, we are not just advancing technology; we are advancing the future of cancer care in Europe and beyond."

At ASTRO, TAE Life Sciences will have several exciting exhibits on display in its booth, including:

● BNCT treatment planning demonstration featuring TAE Life Sciences’ proprietary dose engine running on the Raysearch treatment planning engine.
● Details about TAE Life Sciences’ innovative BNCT drug development program, showcasing the latest advancements in its antibody boron conjugate (ABC) drugs as well as pre-clinical data.
● A compelling poster comparing treatment planning outcomes with TAE Life Sciences’ Boronotyrosine (BTS) drug versus Boronophenylalanine (BPA), shedding light on the significant advantages of BTS in boron delivery for BNCT interventions.

Minesh Mehta, representing Miami Cancer Institute, passionately emphasized the importance of accelerating BNCT research in the United States, stating, "Collaborations like the one between TAE Life Sciences and CNAO are essential to advancing cancer care. The opportunity for BNCT is burgeoning, especially with the increasing availability of antibody-drug conjugates (ADCs). Currently, there are a dozen or more ADCs that can be harnessed for boron conjugation. Fast-tracking BNCT research in the USA is not just a priority; it’s an urgent necessity. We must seize this moment to bring BNCT to the forefront of modern cancer treatment and offer new hope to patients across the nation and beyond."

For more information about TAE Life Sciences, Alphabeam, and the company’s proprietary boronated BNCT drugs, please visit www.taelifesciences.com.

On September 28, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported preclinical data supporting the development of its next-generation farnesyl transferase inhibitor (FTI) KO-2806 in combination with KRASG12C inhibitors to drive tumor regressions and durable responses in KRASG12C-mutant non-small cell lung cancer (NSCLC) (Press release, Kura Oncology, SEP 28, 2023, View Source [SID1234635501]).

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The new findings are being presented in an oral session today at the 5th RAS-Targeted Drug Development Summit in Boston. A copy of the presentation, entitled "Farnesyl Transferase Inhibitors – Evolution from Targeting HRAS to Overcoming Adaptive Resistance to Targeted Therapies," is available in the Posters and Presentations section on Kura’s website.

KRASG12C inhibitors have previously been shown to activate RTK signaling, leading to ERK-RSK and/or mTOR-S6 pathway reactivation. The Company’s new preclinical data show that co-treatment of preclinical models of KRASG12C-mutant NSCLC with KO-2806 and adagrasib deepens signaling inhibition at multiple nodes, including the MAPK and mTOR pathways, while decreasing cell proliferation. In both cell-derived (CDX) and patient-derived (PDX) xenograft models originating from NSCLC tumors, the combination of KO-2806 with adagrasib induced tumor regressions. In addition, the CDX and PDX models demonstrated enhanced duration and depth of antitumor response compared to adagrasib as a single-agent therapy.

"Despite advances with KRAS-targeted therapies, a significant unmet need remains for patients with KRASG12C-mutant NSCLC as acquired resistance occurs early and often," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are highly encouraged by these first preclinical data for KO-2806, which demonstrate the potential for FTIs as a mechanism-based combination agent to enhance antitumor activity of targeted therapies, such as KRASG12C inhibitors."

Kura is on track to dose the first patient in its Phase 1 dose-escalation trial of KO-2806 (FIT-001) in the second half of 2023. Concurrent with the monotherapy dose escalation, the Company plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies in advanced solid tumors, including clear cell renal cell carcinoma (ccRCC) and KRASG12C NSCLC.

On September 28, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company focused on developing DNA-mediated immunotherapies and next-generation vaccines, reported interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2 Study (Press release, IMUNON, SEP 28, 2023, View Source [SID1234635500]). IMNN-001 is the Company’s IL-12 gene-mediated immunotherapy based on its TheraPlas technology. Full enrollment of 110 patients was reached in September 2022.

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OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

As expected for a Phase 1/2 study, the study is directional and was designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate (ORR), pathological response, surgical response and serologic response. The study was not powered for p values of 0.05. The final readout of this study is expected by mid-2024. A positive readout would inform next development steps.

Interim data from the intent-to-treat (ITT) population being reported today show efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm.

Subgroup analyses show patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001 compared with patients treated with NACT only. This was not a pre-specified subgroup as PARP inhibitors were approved after the OVATION 2 Study was initiated.

The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively.
The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.
While the data is still preliminary, the Company has concluded at this point that patients treated with a combination of NACT + PARPi + IMNN-001 appear to have the greatest benefit and should be the focus of on-going follow up.

IMUNON also continues to see benefits in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. Safety analyses continue to show good tolerability of IMNN-001 in this setting.

Commenting on the interim data, Dr. Corinne Le Goff, IMUNON’s president and chief executive officer, said, "We are encouraged by these interim results and are particularly intrigued by the overall survival trends in the subgroup of patients who received PARP inhibitors, neoadjuvant chemotherapy and IMNN-001. While the number of patients in this subgroup is relatively small, this regimen may hold potential in treatment strategies as we continue to monitor patients enrolled in OVATION 2, with expectations to report topline results in mid-2024."

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The Company previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75% in Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.