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Philogen Announces R&D Program Update

On July 2, 2021 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor targeting antibodies and small molecule ligands, reported to provide an update on three R&D programs: Fibromun, OncoFAP and ABBV-022 (Press release, Philogen, JUL 2, 2021, View Source [SID1234584934]). A full pipeline update will be made to the market on 28 September, 2021, in the Company’s Half Year results announcement.

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Prof. Dr. Dario Neri, Co-Founder, Chief Executive Officer and Chief Scientific Officer of Philogen S.p.A., said: "We are extremely pleased to see that our technology has been delivering exciting product candidates of diverse nature, both by our partners such as AbbVie and under our ownership, across a variety of clinical trials. The early signs of activity support our ambition to bring innovative treatment options to patients with serious unmet medical need."

Fibromun

Fibromun (L19TNF), wholly-owned by Philogen, is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain loco-regional clinical applications.

Promising interim survival benefits have been demonstrated in the European Phase I/II trial, investigating Fibromun as a monotherapy for the treatment of IDH wildtype WHO Grade III-IV High-Grade Glioma at first recurrence/relapse. Data on progression free survival at six months are being finalized, while the overall survival data will be consolidated by the end of 2021, with expected publication in a peer-reviewed scientific journal in 2022.
In the European Phase I/II trial, in which Fibromun is combined with lomustine for the treatment of Glioblastoma at first recurrence/relapse, a partial response has been observed already in the first patient treated in the study. The historical overall response rate for this patient population is 4.3% (Wick et al., J Clin Oncol 2010, 28,1168)
A Parallel Scientific Advice (PSA) with the European Medicines Agency and the US Food and Drug Administration has been completed in June 2021. The development plan for the treatment of glioblastoma and the proposed strategy for marketing authorization have been discussed and agreed with competent authorities. Philogen will follow the recommendations that were provided during the PSA.
In the European Phase II trial, in which Fibromun is combined with dacarbazine for the treatment of pretreated advanced/metastatic Soft Tissue Sarcoma (3rd line), the second patient treated in the study enjoyed a partial response. The historical overall response rate for this patient population is 4.0% (Garcia-del-Muro et al., J Clin Oncol 2011, 29,2528). After the run-in part of the trial, the trial progresses to a randomized part.
Fibromun is investigated in six clinical trials, of which five have a pivotal potential. In Soft Tissue Sarcoma, the European Phase III trial in 1st line and the Phase II trial in 3rd line are expected to read out by the end of 2023.

OncoFAP

OncoFAP is a small molecule radiotracer, wholly-owned by Philogen, with ultra-high affinity for Fibroblast Activation Protein (FAP). The product is suitable for the non-invasive detection of a variety of metastatic solid tumors, as FAP is overexpressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as in some soft tissue and bone sarcomas)

Clinicians from the Department of Nuclear Medicine at the University Hospital of Münster have employed a OncoFAP-based radionuclide conjugate (OncoFAP-68Ga) in clinical scanning of patients with various FAP-positive cancer types and have shown excellent tumor uptake in both primary and metastatic lesions with low uptake in healthy organs (including kidneys) after intravenous injection.
These clinical results also support the investigation of OncoFAP-177Lu for Radionuclide Ligand Therapy (RLT).
Philogen is currently planning international, exploratory, clinical trials to investigate OncoFAP in a variety of cancer indications. The results from these studies will provide the basis for a pivotal clinical program in selected cancer types.

ABBV-022

ABBV-022, a product out-licensed by Philogen to AbbVie, consists of an IL-22 payload fused to a targeting antibody. The cytokine, selectively delivered to the epithelial surface of damaged gut mucosa, promotes survival of intestinal stem cells, improves goblet cell function and epithelial barrier, thereby reducing inflammation.

ABBV-022 has started a Phase I clinical trial for the treatment of Ulcerative Colitis. The original collaboration between Philogen and AbbVie began in 2014.

Detecting oesophageal cancer with AI

On July 2, 2021 Experts at UCL and spinout company Odin Vision working with clinicians at UCLH reported that have used artificial intelligence (AI) to help detect early signs of oesophageal cancer (Press release, UCLB, JUL 2, 2021, View Source [SID1234584584]).

The first procedure in the world using the AI technology was performed at University College Hospital by UCLH consultant gastroenterologist Dr Rehan Haidry. The system, called CADU, uses AI to support doctors in identifying cancerous tissue.

CADU achieved regulatory approval at the start of 2021 making it the first medical device using AI for oesophageal cancer to be CE and UKCA approved for use on patients.

It has been developed in collaboration with UCL scientists, including Dr Haidry, who is also Associate Professor at UCL, and Odin Vision, a spinout formed out of the research and innovation work at the UCL Wellcome / EPSRC Centre for Interventional and Surgical Sciences.

Peter Mountney, Odin Vision CEO and Honorary Associate Professor, UCL Computer Science, said: "AI has great potential to transform healthcare. We are very excited to achieve this landmark procedure and use our AI technology to support doctors in the fight against one of the most aggressive forms of cancer."

Odin Vision has previously received support from the UCL Technology Fund and was also one of the first spinouts to arise from Portico Ventures, a UCLB commercialisation model designed to help UCL researchers set up technology-based businesses that can thrive in a fast-moving ecosystem.

Dr Anne Lane, CEO of UCL Business, said: "This milestone for Odin Vision’s oesophageal cancer detection system demonstrates the huge potential of UCL research to change lives through its successful commercialisation. We are proud to have supported Odin Vision from its early stages through the UCL Technology Fund and are excited to see what the future holds."

Panbela Announces Closing of $10.0 Million Bought Deal Offering of Common Stock

On July 2, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA) (the "Company" or "Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the closing of its previously announced public offering of 3,333,334 shares of common stock of the Company at a price to the public of $3.00 per share, less underwriting discounts and commissions (Press release, Panbela Therapeutics, JUL 2, 2021, View Source [SID1234584583]).

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds of the offering were approximately $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Panbela. The Company intends to use the net proceeds of the offering for the continued clinical development of its initial product candidate SBP-101 and for working capital and other general corporate purposes.

The shares of common stock described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255751) filed with the Securities and Exchange Commission ("SEC") and declared effective on May 11, 2021. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

Sonic Healthcare USA to Offer Assay to Aid in the Selection of JEMPERLI (dostarlimab-gxly) Therapy in Endometrial Cancer

On July 2, 2021 LMC Pathology Services (LMC), a Sonic Healthcare USA Anatomic Pathology Practice,reported that it is the first reference laboratory in the United States to offer the VENTANA MMR RxDx Panel from Roche Diagnostics for evaluation of endometrial cancer, approved by the FDA on April 22, 2021 (Press release, Sonic Healthcare, JUL 2, 2021, View Source [SID1234584580]). LMC is located in Las Vegas, Nevada, and specializes in anatomic pathology services for the Southwest region.

Aurora Research Institute (ARI), also a part of Sonic Healthcare USA’s Anatomic Pathology Division, served as a research test site to collect data to support Roche’s submission for U.S. Food and Drug Administration (FDA) approval of the test.

The VENTANA MMR RxDX Panel is the first FDA-approved immunohistochemical (IHC) companion diagnostic (CDx) to identify endometrial cancer patients eligible for immunotherapy. It is intended for the qualitative assessment of DNA mismatch repair proteins in endometrial tumor tissue. Determination of MMR status is based on a panel of four IHC stains scored by LMC pathologists following the FDA-approved protocol. Endometrial cancers determined to be dMMR (mismatch repair deficient) by Roche’s assay may be eligible for treatment with JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody approved by the FDA for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA approved test, that has progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"This is a revolutionary breakthrough in managing the personalized treatment of women with endometrial cancer," said Jonathan Hughes, MD, PhD, Managing Director of LMC Pathology Services. "Our practice is honored to be the first practice in the country performing and interpreting this assay, and our pathologists look forward to assisting our client physicians by providing the results as they plan therapeutic treatments for their patients," added Dr. Hughes.

Transcenta Provides Program Update for Anti-Claudin18.2 Monoclonal Antibody TST001 and Reports Promising Early Anti-Tumor Responses in Patients with Gastric Cancer

On July 2, 2021 Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that promising anti-tumor responses have been observed in the ongoing TST001 (anti-Claudin18.2 monoclonal antibody) trials (Press release, Transcenta, JUL 2, 2021, View Source [SID1234584579]).

TST001 is currently in dose-escalation study as monotherapy in both US and China. In addition, Transcenta initiated combination study with chemotherapies in second line (paclitaxel) and first line (CAPOX) setting for gastric cancer in April and May 2021, respectively. Over forty patients have been evaluated and data from patients treated with the current doses of either TST001 alone or in combination with chemotherapies supports that TST001 is safe.

Promising early anti-tumor activities have also been observed from these studies. One heavily pretreated late-line gastric cancer patient out of the three patients at 6 mg/kg dose cohort in the monotherapy dose-escalation study achieved partial response according to RECIST1.1 criteria after 6 weeks of treatment. In addition, the patient also had rapid and significant tumor biomarker reduction post-TST001 treatment. The patient previously failed multiple lines of chemotherapies, PD-1 immunotherapy and anti-VEGF inhibitor. In addition, in the TST001 plus CAPOX combination study in first-line gastric cancer, a patient in the first dosing cohort achieved partial response after 6 weeks of treatment according to the RECIST1.1 criteria.

With these data, Transcenta plans to complete the ongoing dose-escalation study and initiate Phase 2a monotherapy studies in Q4 2021 in Claudin18.2-expressing solid tumors including gastric cancer, pancreatic cancer and other tumor types. Detailed data from the TST001 Phase 1a study will be submitted for presentation in a future medical conference.

"Recently, Claudin18.2 has emerged to be an exciting target for the treatment of gastric cancer. The ability of TST001 to induce significant anti-tumor activities in patient failed multiple previous treatments at 6mg/kg during dose-escalation indicated that TST001 is a very promising anti-Claudin18.2 targeting agent. I look forward to seeing even better anti-tumor responses in gastric cancer patients expressing high levels of Claudin18.2 at higher dose and in combination therapies." said Professor Lin Shen from Beijing Cancer Hospital.

"From the clinical studies, we are very excited to observe positive efficacy signals in heavily pre-treated late-line gastric cancer patients with high expression of Claudin18.2 who failed all available classes of front-line, second-line and third-line standard therapies in gastric cancer. In addition, we are quickly advancing TST001 in earlier lines of gastric cancer development in combination with chemotherapies and immunotherapies. The preliminary safety and efficacy of TST001 monotherapy and its combination with chemotherapies showed that TST001 has great potential for patients whose tumor expressed Claudin18.2. I look forward to additional clinical data in the future that will further reinforce TST001’s efficacy and safety profiles, and accelerate our clinical development programs in multiple tumor types targeting Claudin18.2." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta.

About TST001

TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally after Zolbetuximab (IMAB362). TST001 is a high-affinity recombinant humanized monoclonal antibody targeted Claudin18.2 generated by Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 can kill Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced the ADCC-mediated tumor killing activity of TST001. TST001 displayed more potent anti-tumor activities than IMAB362 analog in mouse xenograft experiments. Clinical trials for TST001 are ongoing in China and US since July 2020 (NCT04396821, NCT04495296/CTR20201281).