On September 22, 2021 Synlogic (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that it has commenced an underwritten public offering of its common stock (Press release, Synlogic, SEP 22, 2021, View Source [SID1234590153]). All shares of common stock to be sold in the offering will be offered by Synlogic. Synlogic intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies and SVB Leerink are acting as joint book-running managers for the offering.

The securities described above are being offered by Synlogic pursuant to its shelf registration statement on Form S-3 (File No. 333-258151) filed with the Securities Exchange Commission (the "SEC") on July 23, 2021 and declared effective by the SEC on July 30, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by phone at 877-821-7388; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On September 22, 2021 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the appointment of Louis J. Denis, M.D., as Chief Medical Officer (Press release, Verastem, SEP 22, 2021, View Source [SID1234590138]). Dr. Denis brings more than 25 years of clinical development and oncology expertise to Verastem.

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"Louis’ proven track record in drug development, including targeting the RAS pathway for treatment of cancer, and his background as a medical oncologist will be invaluable as we advance our registration-directed trials of VS-6766 and defactinib through the clinic," said Brian Stuglik, CEO of Verastem Oncology.

"I am delighted to join Verastem at such an exciting time. The encouraging results from the Phase 1/2 FRAME study presented at ESMO (Free ESMO Whitepaper), along with the recent FDA breakthrough therapy designation in recurrent low-grade serous ovarian cancer and the clinical partnership with Amgen in KRAS G12C-mutant non-small cell lung cancer sets the Company up for its next stages of growth," said Dr. Denis. "I look forward to working alongside Verastem’s experienced leadership team and scientific advisory board to advance its development programs and deliver new treatment options to cancer patients."

Prior to joining Verastem, Dr. Denis was the Chief Medical Officer of Asana BioSciences, where he provided strategic direction as well as medical and safety oversight to Asana’s portfolio of oncology and immunology assets. Previously, Dr. Denis held various leadership roles in Oncology clinical development and medical affairs at Boehringer Ingelheim and Pfizer. Dr. Denis received his M.D. from Vrije Universiteit Brussel Medical School, Belgium, and did his post-doctoral fellowships in Internal Medicine/Medical Oncology at Middelheim Hospital, Antwerp; the Rotterdam Cancer Institute, The Netherlands; and the Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas.

About the VS-6766/Defactinib Combination

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with low-grade serous ovarian cancer (LGSOC), KRAS mutant NSCLC and colorectal cancer (CRC). The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC. Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma. Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program).

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its focal adhesion kinase (FAK) inhibitor, for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

On September 22, 221 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Panna Sharma, President & CEO of Lantern Pharma will present at the Benzinga Healthcare Small Cap Conference, which is being held virtually from September 29 – 30, 2021 (Press release, Lantern Pharma, SEP 22, 2021, View Source [SID1234590154]).

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Mr. Sharma will deliver his corporate presentation on Wednesday, September 29th at 11:55 AM ET and will also be available for one-on-one meetings throughout the conference.

Investors can register for the conference here: View Source

On September 22, 2021 The Charcot–Marie–Tooth Association (CMTA), the largest philanthropic funder of CMT research worldwide, and Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported a collaboration to investigate a potential therapy for CMT type 1A (CMT1A), the most common subtype of the disease, which affects approximately 1.5 million people (Press release, Addex Therapeutics, SEP 22, 2021, View Source [SID1234590196]).

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The primary goal of the collaboration is to evaluate the benefit of Addex’s proprietary positive allosteric modulator’s (PAM’s) targeting the gamma-aminobutyric acid subtype B (GABAB) receptor in rodent models of CMT1A. The GABAB receptor has previously been shown to be instrumental in controlling the overexpression of Peripheral Myelin Protein-22 (PMP22) in a rat model of CMT1A. Elevated PMP22 is closely associated with the disabling peripheral neuropathy that accompanies CMT1A.

The CMTA’s Strategy to Accelerate Research (STAR) connects leading CMT clinicians and researchers with pharmaceutical partners committed to developing treatments and a cure for CMT. Strategic alliances with pharmaceutical partners like Addex Therapeutics support drug development efforts to deliver therapies to CMT patients.

"We are excited to establish this partnership with Addex Therapeutics as they work to advance their PAM’s to treat CMT1A," said CMTA’s CEO Amy Gray. "Strategic research partnerships with companies like Addex is a central part of our strategy to accelerate the development of treatments for the CMT community. Since launching STAR 12 years ago, the CMTA has been able to establish research partnerships with almost 40 pharmaceutical and biotech companies, and leading research labs around the world. We share Addex’s enthusiasm and passion for developing life-changing treatments for patients."

The research alliance with Addex will include joint study planning aimed at the chronic dosing of select GABAB PAM’s in rodent models of CMT1A, followed by detailed assessments aimed at measuring the improvement of key outcomes. These outcome measures include biomarkers, motor function, electrophysiology and peripheral nerve histology. This is made possible through the CMTA’s preclinical testing alliance: www.cmtausa.org/our-research/for-researchers/cmta-preclinical-testing-network/

"By combining the expertise of both the Charcot-Marie Tooth Association with our proven track record in the discovery and development of allosteric modulators, we aim to further understand how targeting GABAB with a positive allosteric modulator could benefit patients with CMT1A," said Tim Dyer, CEO of Addex Therapeutics. "As we move towards IND enabling studies, we look forward to working with the CMTA to build scientific evidence supporting our approach to tackle this tremendous unmet need."

On September 22, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the publication of VMT01 preclinical data in an article titled, Targeted Alpha-Particle Radiotherapy and Immune Checkpoint Inhibitors Induces Cooperative Inhibition on Tumor Growth of Malignant Melanoma1 in the peer-reviewed journal Cancers (Press release, Viewpoint Molecular Targeting, SEP 22, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-announces-publication-of-preclinical-data-of-vmt01-in-peer-reviewed-journal-cancers/ [SID1234590123]).

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VMT01 is Viewpoint’s specialized peptide designed to target the melanocortin 1 receptor (MC1R) on tumor cells. The results from preclinical studies indicate that MC1R-targeted therapies, such as peptide receptor radionuclide therapies (PRRT), are a promising alternative to current therapies for metastatic melanoma. In the published preclinical data, the 212 Pb radiolabeled peptide [212 Pb]VMT01 targeting MC1R was used to deliver α-particle radiation to melanoma cells. Robust anti-tumor specific cooperation between [212 Pb]VMT01 and systemic immune checkpoint inhibitor (ICI) immunotherapy was observed in preclinical melanoma models. This cooperation relies on the combination of the intact adaptive immunity and the immunogenicity caused by [212 Pb]VMT01.

"We are very pleased with the results of this preclinical study and are honored with the acceptance of this manuscript for publication in Cancers. We continue to be encouraged by the potential of VMT01 to significantly enhance responses to currently available immunotherapies for the treatment of metastatic melanoma," commented Michael K. Schultz, PhD, Chief Science Officer of Viewpoint. "Our data suggest that our targeted alpha-particle therapies have the potential to significantly enhance responses to currently available immunotherapies for the treatment of metastatic melanoma. We look forward to providing updates on our imaging study of VMT01 and the rest of our pipeline leveraging our proprietary 212 Pb alpha-particle radiotherapies and complementary 203 Pb diagnostic imaging agents."

Key findings of the publication are summarized below:

The combination of [212 Pb]VMT01 and immune checkpoint inhibitor therapy resulted in 43% complete and durable response rate in the syngeneic mouse model.
Further in vivo assays and rechallenge studies (in which naïve tumor cells were reintroduced to treated mice after a complete response) suggested a tumor specific T-cell mediated immune response.
Mice who demonstrated complete response to the combination of VMT01 and immune checkpoint inhibitors demonstrated resistance to the reintroduction of tumor cells, with either no growth or much slower tumor growth observed in these animals compared with control cohorts.
The results of this study suggest that targeted radionuclide therapy (TRT) such as [212 Pb]VMT01 is emerging as an effective approach to systemically deliver α-particle radiation that can induce anti-tumor immunity and enhance the efficacy of immunotherapies in a cooperative, potentially synergistic manner.
Data demonstrated that [212 Pb]VMT01 induced immunogenic cell death, tumor infiltrating lymphocytes, and sensitized immunotolerant melanoma tumors to ICI treatments (i.e., tumors were unresponsive to ICI therapy alone).
Viewpoint’s VMT01 program is intended to address an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma. This image-guided approach is often referred to as "theranostics." Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 ligand is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues. VMT01 represents a unique way to treat metastatic melanoma that has been vetted as scientifically sound by rigorous peer review and has the potential to be transformative for melanoma patients.

VMT01 is currently being evaluated in a Phase 1 imaging study being conducted at the Mayo Clinic. Provisional results for the VMT01 imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.