On November 30, 2022 Memgen, Inc., a biopharmaceutical company developing potentially life-saving cancer immunotherapies, reported the first clinical data for MEM-288, its oncolytic viral therapy, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA (Press release, Memgen, NOV 30, 2022, View Source [SID1234624630]).

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The interim results from this ongoing first-in-human Phase 1 trial indicate that MEM-288 is well tolerated and expands tumor-fighting T cells. Seven patients with solid tumors received at least one intratumoral injection of MEM-288 with no dose-limiting toxicity or discontinuation due to toxicity. The only reported adverse event in more than one patient was grade 1 injection site tenderness. The 7 patients included 6 with non-small cell lung cancer (NSCLC) and 1 with pancreatic cancer. All 6 NSCLC patients had already received 2 to 4 lines of therapy including one or more lines with checkpoint inhibitors before enrollment.

Two of five NSCLC patients evaluable for RECIST response in non-injected, distant tumors exhibited best response of stable disease. This "abscopal effect" suggests that local administration of MEM-288 could stimulate immune system reactivity to tumors elsewhere in the body without corresponding systemic toxicity. The remaining three NSCLC patients evaluable for RECIST response had progressive disease.

One of the NSCLC patients with progressive disease had already had three lines of prior treatment, including osimertinib, carboplatin/paclitaxel/bevacizumab/atezolizumab, and radiation therapy for brain metastasis. This patient achieved a complete response after treatment with MEM-288 and then docetaxel and ramucirumab.

"We’re encouraged by the initial safety, tumor shrinkage, and immune responses seen so far in metastatic NSCLC with MEM-288 as a monotherapy," said Mark Cantwell, Ph.D., Chief Scientific Officer of Memgen. "We look forward to completing this part of the trial and starting on our study of MEM-288 in combination with an anti-PD-1 antibody for relapsed/refractory metastatic NSCLC."

About MEM-288

MEM-288 is an oncolytic adenovirus uniquely engineered to express two immune modulators: MEM40, Memgen’s proprietary recombinant membrane-stable form of CD40 ligand, and the cytokine interferon beta (IFNβ). MEM-288 selectively targets cancer cells and boosts the anti-tumor immune response. MEM-288 leverages validated targets that are potent activators of the immune system. Based on the early results presented at SITC (Free SITC Whitepaper), MEM-288 may successfully deploy the CD40 pathway to stimulate immune responses directed against tumors.

For more information about the ongoing Phase 1 study of MEM-288, visit: View Source

On November 30, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the virtual JMP Securities Hematology and Oncology Summit being held from December 6-7, 2022 (Press release, Adicet Bio, NOV 30, 2022, View Source [SID1234624629]).

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Details of the event are as follows:

Date: Tuesday, December 6, 2022
Time: 9:40 a.m. ET

The live audio webcast of the presentation can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On November 30, 2022 Aura Biosciences, Inc. ("Aura") (Nasdaq: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the pricing of an underwritten public offering of 6,700,000 shares of its common stock at a price to the public of $12.00 per share (Press release, Aura Biosciences, NOV 30, 2022, View Source [SID1234624627]). The gross proceeds from the offering to Aura are expected to be $80.4 million, before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about December 5, 2022, subject to customary closing conditions. In addition, Aura has granted the underwriters a 30-day option to purchase up to 1,005,000 additional shares of common stock at the public offering price, less the underwriting discount.

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SVB Securities, Cowen and Evercore ISI are acting as joint bookrunning managers for the offering and JMP Securities, a Citizens Company, and BTIG are acting as co-managers for the offering.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on November 1, 2022 and declared effective by the SEC on November 7, 2022. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055; by telephone at (888) 474-0200, or by email at [email protected].

On November 30,2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that three posters showcasing IPH5201 and IPH5301 will be presented on December 8 at the 2022 European Society for Medical Oncology I-O (ESMO Immuno-Oncology) Annual Congress in Geneva, Switzerland (Press release, Innate Pharma, NOV 30, 2022, View Source [SID1234624626]).

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The following posters will be presented:

IPH5201 as monotherapy or in combination with durvalumab in advanced solid tumors (AstraZeneca)

Abstract Number: 472
Session Name: Poster Display 188P
Session Time: 8 December, 12:30-13:15
Location: Palexpo exhibition centre – Foyer ABC
Presenter: Dr. Martina Imbimbo, Head of Clinic for the Immuno-oncology Department within the Department of Oncology at UNIL CHUV (Lausanne, Switzerland)
Combination of IPH5201, a block antibody targeting the CD39 immunosuppressive pathway, with durvalumab and chemotherapies: Preclinical rationale

Abstract Number: 384
Session Name: Poster Display 190P
Session Time: 8 December, 12:30-13:15
Location: Palexpo exhibition centre – Foyer ABC
Presenter: Carine Paturel, Senior Director, Research and Drug Development, Products Portfolio Strategy, Innate Pharma (Marseille, France)
A first-in-human phase I study of IPH5301, an anti-CD73 monoclonal antibody, alone or in combination with chemotherapy and trastuzumab, in patients with advanced solid tumors (CHANCES) (Institut Paoli-Calmettes)

Abstract Number: 290
Session Name: Poster Display 199TiP
Session Time: 8 December, 12:30-13:15
Location: Palexpo exhibition centre – Foyer ABC
Presenter: Dr. Anthony Gonçalves, Professor of Medical Oncology, Institut Paoli-Calmettes (Marseille, France)
The posters will be available on the Publications section of Innate’s website following the meeting.

About IPH5201

IPH5201 is a CD39-blocking monoclonal antibody that may promote antitumor immunity by increasing immunostimulatory ATP and reducing immunosuppressive adenosine levels in the tumor microenvironment. It is being developed in partnership with AstraZeneca.

A first-in-human, multi-centre, non-randomised, open-label, phase 1 study (NCT04261075) sponsored by AstraZeneca assessed the safety, efficacy, pharmacokinetics and pharmacodynamics of IPH5201 as monotherapy and in combination with durvalumab in patients with advanced solid tumors.

A Phase 2 clinical trial conducted by Innate in lung cancer is in planning.

About IPH5301

IPH5301 is a CD73-blocking monoclonal antibody currently in an investigator-sponsored Phase 1 trial in collaboration with the Institut Paoli-Calmettes (IPC) and Oncodistinct Network.

By targeting the adenosine immunosuppressive pathway, IPH5301 has the potential to promote anti-tumor immune responses across a wide range of tumors.

On November 30, 2022 Nectin Therapeutics Ltd., (Nectin) a biotechnology company developing novel targeted immunotherapies to address resistance to approved immuno-oncology (IO) treatments, reported dosing of the first patient in its Phase 1 clinical trial of NTX1088, Nectin’s first-in-class PVR (CD155) blocker, in cancer patients with locally advanced and metastatic solid tumors (Press release, Nectin Therapeutics, NOV 30, 2022, View Source [SID1234624625]). The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) with an investment from the Cancer Focus Fund, LP. The trial will include up to 90 patients treated with NTX1088 as a monotherapy and in combination with a PD-1 blocker.

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Additionally, Nectin announced that it has extended its Series A financing to over $25 million. IBF and Peregrine Ventures led the round, with participation from aMoon Fund and other existing investors. The funding will be used to support the ongoing clinical evaluation of NTX1088, and to further advance the company’s pipeline of targeted immunotherapies and Antibody Drug Conjugates (ADCs).

NTX1088 is a first-in-class high-affinity monoclonal antibody directed against PVR, a transmembrane protein expressed on cancer cells and associated with resistance to PD-1 and PD-L1 immune checkpoint inhibitors. PVR blockade by NTX1088 is the first and only therapeutic approach that aims to restore DNAM-1 (CD226) to the surface of immune cells. DNAM-1 is a cell surface glycoprotein, central to the activation of anti-cancer T and NK cells. Following interaction with PVR-expressing tumor cells, DNAM-1 is removed from the surface of immune cells. Restoring the expression and activation of DNAM-1 by blocking PVR results in increased anti-tumor activity from T and NK cells. PVR blockade additionally stimulates an anti-tumor immune response by preventing the immune-suppressing signaling of the two checkpoint receptors TIGIT and CD96.

PVR is overexpressed in many solid tumors across different cancer indications, including lung, colorectal, liver, ovarian, breast, adrenal, pancreatic, uterine, head and neck, gastric and esophageal. High PVR expression is associated with poor prognosis and with resistance to PD-1 and PD-L1 blockade, making PVR an attractive therapeutic target for novel immuno-oncology therapies, both as a monotherapy and in combination with PD-1 blockers.

"PVR blockade by NTX1088, with its first-in-class differentiated mechanism of action, has demonstrated compelling preclinical anti-tumor activity both as a monotherapy and in combination with other cancer immunotherapies," said Dr. Pini Tsukerman, Co-Founder and Chief Scientific Officer of Nectin. "Importantly, NTX1088 has potent activity in ICI refractive models where TIGIT or PD-1 blockade has failed to show a benefit."

"Nectin has developed a highly innovative pipeline that has the potential to fundamentally overcome the limitations of existing IO therapies, delivering new treatment options for patients suffering from difficult-to-treat cancers, and we look forward to the results of the Phase 1 clinical trial of NTX1088," said Fabian Tenenbaum, CEO at Nectin Therapeutics. "As we continue to build on this foundation, we are delighted to welcome IBF as our new partner, joining our longstanding investors at aMoon Fund, Peregrine Ventures and Integra Holdings."

"NTX1088’s triple mechanism of action represents a unique approach to treating challenging cancers and we are excited by its potential to address a range of treatment-resistant tumors," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "Cancer Focus Fund was established to help finance cancer clinical trials with exceptional potential and we are delighted that this Phase 1 study of NTX1088 is underway."

The Phase 1 trial is an open-label study consisting of a dose escalation stage in up to 50 patients and an expansion stage in 40 patients. NTX1088 will be investigated as a single agent and in combination with a PD-1 blocker. The primary objectives of the dose escalation stage are to assess safety and tolerability and to select a recommended safe and effective Phase 2 dose. In the expansion stage, NTX1088’s safety and tolerability will be further evaluated, along with efficacy measures and exploratory assessments of pharmacodynamic and predictive biomarkers. Dr. Sarina Piha-Paul, Associate Professor of Investigational Cancer Therapeutics at MD Anderson is the trial Principal Investigator.

About NTX1088

NTX1088 is a first-in-class monoclonal antibody directed against a key immune checkpoint, PVR, also known as CD155. NTX1088 has a triple mechanism of action. NTX1088 blocks the interaction between PVR and DNAM-1, also known as CD226, a molecule involved in the activation of anti-cancer T and NK cells. By preventing internalization and degradation of DNAM-1, NTX1088 leads to restoration of DNAM-1 expression on the surface of immune cells and results in robust antitumor activity. NTX1088 also blocks PVR interactions with TIGIT and CD96, preventing their immune inhibitory signaling. NTX1088 demonstrated superior antitumor activity compared to approved and investigational immune checkpoint inhibitors in preclinical models and had a favorable safety profile in non-human primates.