Upstate Cancer Center receives grant from American Cancer Society to support patient transportation needs

On July 19, 2021 SUNY Upstate reported that Cancer patients undergoing treatment frequently require assistance getting to and from facilities, often creating a financial and logistical burden (Press release, SUNY Upstate, JUL 19, 2021, View Source [SID1234584963]). That’s why the American Cancer Society has awarded a $10,000 transportation grant to the Upstate Cancer Center. These funds will be used to address the transportation needs of cancer patients in Central New York.

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To help patients get the critical care they need, American Cancer Society community transportation grants are awarded at a local level to health systems, treatment centers and community organizations. These grants are available in select communities through an application process and focus on addressing unmet transportation needs of cancer patients, particularly vulnerable populations experiencing an unequal burden of cancer.

"Disparities predominantly arise from inequities in work, wealth, income, education, housing and overall standard of living, as well as social barriers to high-quality cancer prevention, early detection and treatment services," said Joanie Richter of the American Cancer Society. "The Society collaborates with community health partners to reach individuals in areas with higher burdens of cancer and limited or no access to transportation because even the best treatment can’t work if a patient can’t get there."

The Upstate Cancer Center received a $10,000 transportation grant.

"The goal of this project is to remove transportation as a barrier to receiving cancer treatment," said Richard Kilburg, associate administrator of the Upstate Cancer Center. "We hope to ensure that no Upstate Cancer Center patient misses an appointment due to lack of transportation or lack of transportation resources."

"On behalf of our patients, we thank the American Cancer Society for their generous support," Kilburg said.

Caption: From left: Amy Williams, social worker; Joni Richter, American Cancer Society manager, Strategic Partnerships, Cancer Control Northeast Region; Dick Kilburg, associate administrator of the Upstate Cancer Center; and Linda Naples, financial counselor.

Iovance Biotherapeutics to Host Second Quarter Financial Results Conference Call and Webcast on Thursday, August 5, 2021

On July 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its second quarter financial results on Thursday, August 5, 2021 (Press release, Iovance Biotherapeutics, JUL 19, 2021, View Source [SID1234584962]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1489438. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

PEP-Therapy extends Series-A financing, raising a total of €5.4 million to progress the clinical development of its lead candidate PEP-010

On July 19, 2021 PEP-Therapy, a biotechnology company developing cell penetrating peptides as targeted therapies for the treatment of cancers, reported that it raised an additional €2.6 million ($3 million) in an extension of its Series A financing round, bringing the total raised in this round to €5.4 million ($6.4 million) (Press release, PEP-Therapy, JUL 19, 2021, View Source;301335760.html [SID1234584956]). This new funding comprises €1.6 million in equity from Anaxago, i&i Prague and BADGE as well as a €1 million loan from Bpifrance. This increased financial support highlights the potential of PEP-010, as well as PEP-Therapy’s Cell Penetrating & Interfering Peptide (CP&IP) technology platform, which was first developed at Sorbonne University and Institut Curie.

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PEP-010 is the first of a new class of therapeutic peptides based on PEP-Therapy’s innovative Cell Penetrating & Interfering Peptide (CP&IP) technology. These innovative molecules penetrate cells and specifically block relevant intracellular protein-protein interactions, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms.

PEP-Therapy will use the funds to finance the Phase I a/b clinical trial of PEP-010, PEP-Therapy’s lead candidate, for the treatment of advanced solid tumors. The first part of the Series A, which closed in April 2021, will finance the Phase Ia dose escalation part of the study, with the additional funds being used for the development of PEP-010 until the end of the expansion cohorts, Phase Ib.

PEP-Therapy expects to generate promising clinical data from this study, particularly in two indications: metastatic triple negative breast cancer and platinum resistant ovarian cancer. Patients with these two types of solid tumors have a poor prognosis and limited therapeutic alternatives.

Antoine Prestat, CEO and co-founder of PEP-Therapy, said: "We are delighted to have completed this financing round via an attractive balance of dilutive and non-dilutive funds from new high quality and diversified investors who will bring expertise and new insights to support our development."

Jaromír Zahrádka, PhD, CEO of i&i, commented: "PEP-Therapy has developed an extensive knowledge of targeted peptides and the promising preclinical data the company has generated show great potential. We are looking forward to seeing the confirmation of the positive results seen in preclinical data in the upcoming Phase I study."

Gaston Vasseur, Investment Manager at Anaxago, added "This extended financing highlights PEP-Therapy’s capacity to attract highly specialized as well as diversified investors. The Company has managed to rapidly secure the funding for the Phase I trial with PEP-010, a very important milestone for the company. We are happy to contribute to this financing round in conjunction with a number of experienced life science investors."

In addition, PEP-Therapy and its clinical partners, Institut Curie and Gustave Roussy, previously received a €2.9 million grant from the French state innovation fund – Fonds Unique Interministériel (FUI) – to finance nonclinical and early clinical development of PEP-010.

Compugen Doses First Patient in Phase 1/2 Triple Combination Cohort Expansion of COM701 with Opdivo® and Bristol Myers Squibb’s Anti-TIGIT Antibody, BMS-986207

On July 19, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the cohort expansion arm of the Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Opdivo (nivolumab) and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, JUL 19, 2021, View Source [SID1234584955]).

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"We continue to push forward as leaders in the DNAM axis space and as the only company evaluating a potential synergistic triple blockade of PVRIG, TIGIT and PD-1 in the clinic," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that the future of immuno-oncology will be driven by combination therapy and this study examining our three-pathway hypothesis is an important component of our overall strategy and a key differentiator for Compugen in the TIGIT space. The study is designed to evaluate simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1 and test the hypothesis that blockade of both PVRIG and TIGIT, parallel DNAM pathways, may be required in certain tumor types to generate or enhance an anti-tumor immune response. The initiation of the cohort expansion phase of the study, allowing us to focus with the selected dose for expansion on specific patient populations where we believe the DNAM axis is dominant, is an important step to examine the potential benefit of this unique immunotherapy combination in a broader range of patients. We are on track to report preliminary data from the triple combination dose escalation arm of the study in the fourth quarter of this year."

Dr. Cohen-Dayag added, "We are delighted to have Bristol Myers Squibb as our partner in this study and are pleased to have their continued support and commitment to the collaboration."

The open-label Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207. Additional information is available at www.clinicaltrials.gov (NCT04570839).

Opdivo is a trademark of Bristol-Myers Squibb Company.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to more fully exploit the potential of blocking these parallel and complementary members of the DNAM axis to drive robust immune responses.

Oblato Announces that it has received a Positive Response from the FDA for the use of OKN-007 for patients with high-grade gliomas in an Expanded Access Program

On July 19, 2021 Oblato, Inc. (the Company) reported that it has received an agreement from the FDA for its plan to submit an intermediate size expanded access protocol for use of OKN-007 in patients with high-grade gliomas (Press release, Oblato, JUL 19, 2021, View Source [SID1234584954]). The company is already developing OKN-007 as a treatment of glioblastoma multiforme.

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In a December 2020 meeting with the FDA, the agency agreed to Oblato’s plan to initiate a clinical trial for diffuse intrinsic pontine glioma (DIPG) pediatric patients, a rare and difficult to treat brain cancer. Currently, the Company is in discussion for this trial with a consortium consisting of pediatric cancer hospitals. The eligible patients who can participate in this clinical trial for pediatric DIPG must meet specific inclusion and exclusion criteria.

Unfortunately, there are many additional patients with similar aggressive gliomas with a poor prognosis and some of these patients will not have access this treatment as they are not eligible for the clinical trial or are unable to get to the clinical trial sites. Based on this difficult situation faced by many patients who have various life-threatening malignant gliomas including DIPG, Oblato recently received an agreement from the FDA that OKN-007 can be administered outside of the clinical trial to both pediatric and adult patients diagnosed with several types of high-grade gliomas under an intermediate size expanded access program (iEAP). The FDA recommended that the Oblato submit a complete protocol for FDA review and feedback. The Company will submit the protocol as soon as possible to initiate the iEAP.

Expanded access refers to a pathway in which patients with serious or life-threatening diseases with no available treatment options may gain access to investigational medical products, which are either under development or have not yet received marketing approved. In particular, iEAPs are used for a wide range of patients in a number of medical institutions. Pediatric and adult patients who will be eligible for the iEAP using OKN-007 include those with gliomas similar to DIPG involving the thalamus, hypothalamus, brain stem, pons, bone marrow, or spinal cord, or midline tumors including malignant gliomas, gangliocytoma, and anaplastic astrocytoma morphologies.

Regarding the iEAP, an official from the Company stated that "After we released the news regarding the development of our new DIPG treatment, several DIPG patient families reached out to the Company asking to participate in the clinical trial. Since DIPG and other gliomas progress rapidly, Oblato wanted to make the treatment available as quickly as possible and to as many of these patients as possible. The Company decided to use the iEAP first to give an opportunity for patients with either DIPG or high-grade gliomas for which there is either no effective treatment or they are ineligible to participate in a clinical trial. Using the iEAP, Oblato can administer our investigational medicinal product even before we initiate the clinical trial. Currently, we are in discussion with a firm experienced with the iEAP and plan to submit the protocol for the iEAP to the FDA as soon as possible."

"iEAP not only meets the target to provide treatment opportunities to patients, but accords with our company’s GBM and DIPG development strategy. There are a number of new orphan drugs that were approved using the clinical data obtained through an iEAP. An iEAP can also be one way to determine the potential benefit and risk through treatment outcomes with various types of patients," stated an official from the Company regarding the strategic background.