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Alpha Tau Announces Multiple Corporate Updates Ahead of 2022 Annual Meeting of the American Society for Radiation Oncology

On October 21, 2022 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported its participation in the upcoming 2022 Annual Meeting of the American Society for Radiation Oncology ("ASTRO"), being held October 23 – 25, 2022 in San Antonio, TX, where the Company will be at Booth #3719 (Press release, Alpha Tau Medical, OCT 21, 2022, View Source [SID1234622260]). Participants interested in meeting with the Alpha Tau team at the conference can do so by booking a slot via the following link: https://calendly.com/michaelt-alpha-dart/. Ahead of the conference, the Company is pleased to announce a number of recent developments:

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The Medicines and Healthcare products Regulatory Agency ("MHRA") of the United Kingdom has approved the Company’s request to initiate a clinical trial for the treatment of primary and recurrent Squamous Cell Carcinoma of the vulva using the Alpha DaRT. The trial is expected to be conducted with 10 patients, and will be led by Dr. Li Tee Tan of Addenbrooke’s Hospital of the Cambridge University Hospitals NHS Trust. The trial seeks to measure the feasibility, safety, efficacy and immunological response associated with treatment with the Alpha DaRT.
Health Canada has approved the Company’s request to revise its Investigational Testing Authorization for the Company’s clinical trial testing the feasibility and safety of the Alpha DaRT treatment in patients with advanced pancreatic cancer. The revision allows the Company to add Jewish General Hospital in Montreal, Canada as a second site to the trial, alongside Centre Hospitalier de l’Université de Montréal (CHUM).
Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center in New York will deliver a presentation at the ASTRO 2022 Annual Meeting, on Wednesday, October 26, 2022 at 8:20am in the Henry B. Gonzalez Convention Center, Room 303, entitled "A Multicenter Prospective Trial of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Cutaneous Cancers: Early Results from a Pilot Feasibility Study in the United States," providing further detail on the results of the Company’s U.S. pilot feasibility study that was conducted in 2021, the initial results of which were reported earlier in 2022, including a 100% complete response rate observed at 12 and 24 weeks after treatment with the Alpha DaRT.
Following the Company’s announcement in January 2022 that it had signed a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center, the investigators presented a poster at the Radiation Research Society’s 2022 Annual Meeting, held October 16 – 19, 2022 in Waikoloa Village, Hawaii. The poster detailed results of the investigators’ pre-clinical study using the Alpha DaRT to treat mice with 4T1 triple-negative breast cancer tumors, demonstrating significantly smaller tumor volume as well as a significant two-fold increase in CD8+ cell populations in the spleens of mice when treated with the Alpha DaRT vs. those treated with inert sources. The investigators concluded that, "[Alpha] DaRT seeds were effective in delaying tumor growth with activation of the immune system…The magnitude of increase in CD8+ populations in the irradiated spleens of mice suggests systemic activation of the immune system."
Alpha Tau CEO Uzi Sofer commented, "Following the completion of our U.S. pilot study earlier this year, we are laser-focused on initiating our U.S. multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT, which we expect to occur before the end of the year, as we are currently progressing on the associated preparatory logistics such as IRB approvals and site initiations. At the same time, we continue to forge ahead in our strategy to broaden the application of the Alpha DaRT to other indications, and are very excited to see continued meaningful progress across three different indications: cancer of the vulva, pancreas and breast. We look forward to further advances in these and other indications, as we continue to explore ways that the Alpha DaRT can help patients around the world."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Entry into a Material Definitive Agreement

On October 21, 2022, HTG Molecular Diagnostics, Inc. (the "Company") reported that it entered into a Purchase Agreement (the "Purchase Agreement") with Ann Hanham, Ph.D., the Chair of the Company’s Board of Directors ("Purchaser"), pursuant to which the Company agreed to issue and sell one share of the Company’s newly designated Series A Preferred Stock, par value $0.001 per share (the "Series A Preferred"), to the Purchaser for a purchase price of $100.00 (Filing, 8-K, HTG Molecular Diagnostics, OCT 21, 2022, View Source [SID1234622259]). The closing of the sale and purchase of the share of Series A Preferred was completed on October 21, 2022.

Additional information regarding the rights, preferences, privileges and restrictions applicable to the Series A Preferred is set forth under Item 5.03 of this report.

Pursuant to the Purchase Agreement, the Purchaser has agreed to cast the votes represented by the share of Series A Preferred on any Reverse Stock Split Proposal (defined below) in the same proportion as shares of common stock of the Company ("Common Stock") are voted (excluding any shares of Common Stock that are not voted, whether due to abstentions, broker non-votes are otherwise) on such proposal; provided, however, that unless and until at least one-third of the outstanding shares of Common Stock on the record date established for the meeting of stockholders at which the Reverse Stock Split Proposal is presented are present in person or represented by proxy at such meeting, the Purchaser will not vote the share of Series A Preferred on such Reverse Stock Split Proposal. A "Reverse Stock Split Proposal" means any proposal approved by the Company’s Board of Directors and submitted to the stockholders of the Company to adopt an amendment, or a series of alternate amendments, to the Company’s Amended and Restated Certificate of Incorporation to combine the outstanding shares of Common Stock into a smaller number of shares of Common Stock at a ratio specified in or determined in accordance with the terms of such amendment or series of alternate amendments.

Spectrum Pharmaceuticals Announces Commercial Availability of ROLVEDON™ (eflapegrastim-xnst) Injection

On October 21, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the commercial availability of ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia (Press release, Spectrum Pharmaceuticals, OCT 21, 2022, View Source [SID1234622256]). ROLVEDON received U.S. Food and Drug Administration approval in September 2022.

"We are thrilled to launch ROLVEDON into an estimated $2 billion market. Our distribution partners have stocked the product and we are ready to take advantage of this compelling market opportunity," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "This is an important milestone in Spectrum’s transition to a commercial stage company, and we are excited to deliver ROLVEDON to the patients who need it."

About ROLVEDON

ROLVEDON (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.

Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.

Indications and Usage

ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use

ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Contraindications

ROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.

Warnings and Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)

ARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.
Sickle Cell Crisis in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis

Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs.
Thrombocytopenia

Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome

Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON acts has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis

Aortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Adverse Reactions

The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.

Invitation to presentation of Q3 and first 9 months 2022 result

On October 21, 2022 Biotec Pharmacon reported that it will host a presentation for investors, analysts and media at 08:30 CET on Thursday, 27 October 2022 at Hotel Continental, Stortingsgata 24/26, Oslo (Press release, Biotec Pharmacon, OCT 21, 2022, View Source [SID1234622255])

The presentation will be given by CEO, Jethro Holter and CFO, Børge Sørvoll

The presentation can also be followed as a live webcast from Hegnar TV on www.arcticzymes.com or https://channel.royalcast.com/landingpage/hegnarmedia/20221027_3/ . It will be possible to post questions through the webcast console.

The report for the third quarter and first 9 months 2022 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 CET on Thursday, 27. October 2022.

OSE Immunotherapeutics Updates on Tedopi®, a Cancer Vaccine as Potential New Standard of Care in Non-Small Cell Lung Cancer After Failure to Immunotherapies

On October 20, 2022 OSE Immunotherapeutics reported an update on Tedopi, an immunotherapy activating tumor specific T-cells, developed in advanced or metastatic non-small cell lung cancer (NSCLC), ovarian cancer and pancreatic cancer (Press release, OSE Immunotherapeutics, OCT 20, 2022, View Source [SID1234646958]). Authorizations for compassionate use* of Tedopi in NSCLC have recently been granted by Health Agencies in Europe. Regulatory meetings are planned to validate the confirmatory Phase 3 clinical trial in NSCLC.

Compelling Phase 3 Clinical Data
Tedopi is the first cancer vaccine to show clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) post-immune checkpoint inhibitors (ICI) failure in advanced or metastatic NSCLC:

– Significant overall survival (primary endpoint) (p=0.017, HR=0.59) with 44.4% overall survival (OS) rate at 1 year with Tedopi versus 27.5% for chemotherapy and a meaningful gain of median OS of 3.6 months (ESMO 2021);
– Improved post-progression survival benefit in the Tedopi arm (7.7 months versus 4.6 months, p=0.004, HR=0.46) (ESMO 2021);
– Significant delayed median time to worsening ECOG** performance status with a difference of 5.3 months (p<0.01, HR=0.43) (ASCO 2022);
– Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy, p<0.05) (ESMO 2021);
– Significant better Quality of Life (Global health status: p=0.045; Role Functioning: p=0.025) (ASCO 2022) and positive Net Treatment Benefit (p=0.032) with Tedopi compared to chemotherapy (ESMO 2022).

These positive clinical results in a clearly-defined target population for this first Phase 3 trial are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi differs from ICI releasing the break of immune response.

Compassionate Use Authorizations in Europe – Regulatory Meeting with FDA Planned
The significant medical need for new therapeutic options in NSCLC patients post-ICI failure associated with promising efficacy, safety and quality of life data resulted in authorizations for compassionate use** of Tedopi from Health Agencies in Europe – in France, Italy and Spain – in third line post-chemotherapy and immunotherapy. The medical need in this targeted population with high mortality previously led to an orphan drug designation by the FDA, while Tedopi was recognized as a precision medicine in Europe for the treatment of HLA-A2 positive NSCLC patients.

OSE Immunotherapeutics is preparing a confirmatory Phase 3 pivotal trial to support the regulatory registration of Tedopi as a new standard of care in advanced or metastatic NSCLC in secondary resistance post-ICI failure***. The Company has filed a formal request for a "Type C meeting" with the US Food and Drug Administration (FDA) to validate the new study protocol in NSCLC metastatic patients in second line after ICI-failure. OSE Immunotherapeutics has already received a "Scientific advice" from the European Medicines Agency (EMA) on this targeted population.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "Despite progress made with immune checkpoint inhibitor-based therapies, today only a minority of NSCLC patients achieve longterm survival post-chemotherapy and immunotherapy. No treatment has yet shown efficacy and safety results in randomized controlled studies post-ICI failure. Tedopi is the first treatment option to address this high unmet medical need in advanced or metastatic NSCLC. Considering HLA-A2-positive patients represent about 45% of all NSCLC patients, given the large use of anti-PD(L)1 and based on ICI failure data, the targeted population for Tedopi in second line could be estimated up to 100,000 patients per year in 7 major markets across the US, Europe, China and Japan.

The strong medical need in the identified targeted population underlined by recent compassionate use authorization along with the clinically meaningful study results confirm that Tedopi can be positioned as a potential new standard of care in advanced or metastatic NSCLC in secondary resistance post-ICI failure.

OSE Immunotherapeutics is committed to make this innovative therapeutic option available to improve lives of patients who clearly need access to much improved treatment options.

Given the potential of Tedopi, OSE Immunotherapeutics has further strengthened the global intellectual property for Tedopi until 2038. This has been achieved through the grant of patents in 2022 for Europe, the US, China and Japan. These patents protect the innovative emulsion manufacturing process validated for the ready-to-use peptides combination.

On-going Combination Studies – A Further Source of Clinical Value
Tedopi is currently being evaluated in phase 2 combination trials in three indications:
– NSCLC: Tedopi plus docetaxel or Tedopi plus nivolumab or docetaxel alone, in second-line treatment in metastatic NSCLC, progressing after first-line chemo-immunotherapy (CombiTED study: NCT04884282, 105 patients planned, sponsor: FoRT);
– Pancreatic cancer: Tedopi plus FOLFIRI vs FOLFIRI as maintenance treatment in patients with advanced or metastatic pancreatic adenocarcinoma with no progression after 8 cycles of FOLFIRINOX (TEDOPaM study: NCT03806309, 106 patients planned, sponsor: GERCOR);
– Ovarian cancer: Tedopi alone or in combination with pembrolizumab vs best supportive care as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients (TEDOVA study: NCT04713514, 180 patients planned, sponsor: ARCAGY-GINECO).