On July 13, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells ("NPTs") (Press release, Genocea Biosciences, JUL 13, 2021, View Source [SID1234584804]).

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"Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy," said Thomas Davis, M.D., the company’s Chief Medical Officer. "We believe our GEN-011 therapy employs better targeting – using our ATLASTM platform to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive InhibigensTM – and better T cells, derived from easily accessible peripheral blood as opposed to the tumor itself. We are grateful to the patients eager to participate in our trial, to our investigators, and to our colleagues here at Genocea for their great dedication to improve patients’ outcomes. We look forward to reporting top-line results from this study on a subset of patients late in the fourth quarter of 2021 or the first quarter of 2022."

About GEN-011
GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial
TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated lower dose regimen of GEN-011 without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected in late Q4 2021 or Q1 2022.

On July 13, 2021 AVM Biotechnology, a clinical-stage company, reported that FDA permission to modify its ongoing clinical study, AVM0703-001, entitled "The WWRD Study: AVM0703 for Treatment of Leukemia or Lymphoma" (Press release, AVM Biotechnology, JUL 13, 2021, View Source [SID1234584822]). The initial protocol, a 3 x 3-based design, called for dose escalation of 3 mg/kg for each of the six cohorts, ranging from 6 mg/kg to 21 mg/kg, with a minimum of three patients per cohort as part of an adaptive-design/expansion cohort trial.

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The approved protocol modification involves the elimination of three of the cohorts and reduction of the interval between cohorts. Eliminating the 9, 12 and 15 mg/kg dose requirements and moving directly to the anticipated effective clinical dose of 18 mg/kg is important for this study. Preclinical research and compassionate use data indicate 18-21 mg/kg will be the target effective dose for the expansion phase of the study. Bypassing the intermediate dose levels should accelerate completion of the dose-escalation part of the study, enabling the efficacy portion to commence immediately thereafter, much sooner than planned.

"We are pleased that the FDA agreed with our proposal, which leveraged the safety data amassed from the ongoing study and Expanded Access (Compassionate Use) patient data obtained to date," remarked Janet R Rea, MSPH, Chief Regulatory Officer. "This accelerates our clinical development program and propels it toward an earlier NDA submission."

Clinical experience has shown the drug to be well tolerated with mild and self-limiting side effects. Patients have reported feeling "great." The emerging safety profile is promising, to treat these seriously ill patients.

A single dose of AVM0703 triggers the rapid activation and mobilization of novel gamma delta positive Natural Killer T (NKT) cells. NKT cells exhibit properties of both innate and adaptive immunity. AVM-NKT cells home to abnormal cells including cancer and autoreactive lymphocytes sparing platelets, red blood cells and stem cells. These unique AVM-NKT cells could play a significant role in addressing several serious conditions, including various types of cancer and autoimmune diseases such as type 1 diabetes. Preclinical data also indicate AVM0703 can be synergistic with chemotherapy, allowing total cycles of chemotherapy to be reduced while maintaining patient response, thus significantly impacting patient quality of life, treatment compliance, and secondary complications from cancer treatment.

"AVM has developed an entirely new drug that demonstrates a novel mechanism of action related to tissue-bound gamma delta NKT cells. We believe this drug will have great benefit to patients in a wide variety of disease settings," stated AVM Chief Business Officer, Joe Luminiello.

AVM Biotechnology is a clinical-stage company advancing AVM0703 in Non-Hodgkin’s Lymphoma/Leukemia as an initial indication as well as autoimmune diseases and other indications. While planning for a direct commercial launch of AVM0703, the company is also developing the AVM-NKT as an ‘off-the-shelf’ cell therapy product with broad applications. Strategic partnerships are being explored.

AVM Biotechnology’s mission is to develop and deliver treatments that save lives and improve outcomes by unlocking the untapped potential of the body’s own immune system.

On July 13, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that it has expanded its ongoing collaboration with IntoCell Inc., a biotechnology company based in South Korea (Press release, Cellectar Biosciences, JUL 13, 2021, View Source [SID1234612852]).

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The parties have been collaborating on combining IntoCell’s validated novel Ortho-Hydroxy Protected Aryl Sulfate (OHPAS) linker chemistry with Cellectar’s validated novel targeting platform, phospholipid ethers (PLEs) to develop new PDCs. IntoCell’s platform significantly enhances the utility of traditional antibody drug conjugate linkers by customizing the entire linker to a specific project. The collaboration has exceeded the necessary preclinical results to warrant further development and the initiation of Investigational New Drug (IND) enabling studies with multiple payloads. Cellectar will have the right to globally develop and commercialize any OHPAS containing PDC.

"Since initiating our multi-target collaboration, Cellectar has been able to advance various PDC candidates which leverage the differentiated advantages of IntoCell’s technology," said James Caruso, president and CEO of Cellectar. "Through this arrangement we are excited to broaden our research into next-generation targeted therapies and anticipate the development of additional candidates for Cellectar’s growing small molecule PDC pipeline."

"We have built a strong partnership with Cellectar through the multi-target PDC platform collaboration. Our partnership has validated the use of PLEs with our novel OHPAS linker platform technology and the competitive potential of these innovative PDCs. This validation has led to the expansion of our collaboration," said Tae Kyo Park, Founder and CEO of IntoCell. "We will continue to cooperate closely with Cellectar to accelerate the advancement of IntoCell-related PDC candidates into clinical trials."

About IntoCell and the OHPAS linker
IntoCell is a Korea-based biotechnology company dedicated to the development and commercialisation of novel antibody drug conjugate (ADC) platform technologies comprising scaffold moiety, ligands, toxins, linkers and conjugation methods. IntoCell has developed a novel self-immolative Ortho-Hydroxy Protected Aryl Sulfate (OHPAS) linker that works with a wide variety of functional groups, triggering groups, and both phenolic and non-phenolic payloads. The resulting ADCs have proven to be highly stable in chemical and biological environments and have demonstrated excellent potencies in-vitro and in-vivo. IntoCell has also developed proprietary benzodiazepine dimers and modified duocarmycinoids that show high potency with improved safety in preclinical models. IntoCell has created an OHPAS Linker-toxin Library containing a variety of toxins that can be optimized for the fast delivery of a pre-clinical candidate in novel ADC programs.

Using its novel chemistries, IntoCell is developing a pipeline of proprietary ADCs that includes a B7-H3 programme which is demonstrating excellent preclinical data.

For more information, please visit View Source

On July 13, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that its CEO, Anker Lundemose, will be presenting at the 5th annual EU Investor Tour hosted by Solebury Trout, Venrock, and Oppenheimer on 13-14 July (Press release, Mission Therapeutics, JUL 13, 2021, View Source [SID1234584805]).

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Anker will discuss the Company’s business strategy, technology, discovery platform and development programmes in a presentation to investors on Wednesday, 14 July at 10.15am ET / 3.15pm BST. The 30-minute presentation will be followed by a Q&A.

For individuals interested in attending the meeting, please contact the organisers for more information.

On July 13, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported the closing of its initial public offering of 7,187,500 shares of its common stock at a public offering price of $4.00 per share (Press release, TransCode Therapeutics, JUL 13, 2021, View Source [SID1234584823]). Gross proceeds from the offering totaled $28,750,000, before deducting underwriting discounts and offering expenses. The shares sold in the offering include the exercise in full by the underwriters of their over-allotment option to purchase up to 937,500 shares of common stock, in addition to the 6,250,000 shares of the Company’s common stock which the underwriters initially agreed to purchase. The shares sold in the offering began trading on July 9, 2021 on the Nasdaq Capital Market under the symbol "RNAZ".

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The Company intends to use the proceeds for testing required to file an Investigational New Drug application ("IND") for the Phase 0 trial of its lead candidate, TTX-MC138, and for further development of TTX-MC138. Proceeds will also be used for strategic expansion of TransCode’s drug candidate portfolio and for working capital and general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-253599) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on July 8, 2021. This offering is being made only by means of a prospectus. This registration statement can be obtained by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected].

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.